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5/16/2011
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Orthovita, Inc. Agrees To Be Acquired by
Stryker Corporation for $3.85 Per Share in Cash
05162011-Orthovita Agrees to be Acquired by Stryker Corp.pdf
Stryker will commence all-cash tender offer shortly
Tender Offer expected to be completed in the second quarter of 2011
Malvern, PA – May 16, 2011 – Orthovita, Inc. (Nasdaq: VITA) today announced that it has entered into a merger agreement under which Stryker Corporation (NYSE: SYK) has agreed to acquire all of the common stock of Orthovita for $3.85 per share in cash which represents a total value of approximately $316 million.
William E. Tidmore, Chairman of the Board, said, “The Board of Directors unanimously concluded that this transaction is in the best interests of Orthovita and its shareholders. We believe this is a very positive outcome for our shareholders and maximizes the value of Orthovita’s orthobiologic and biosurgery platforms.”
“This transaction is a great event for our shareholders, customers and employees,” said Antony Koblish, President and Chief Executive Officer. Mr. Koblish added, “This transaction delivers significant value to our shareholders and allows us to combine our portfolio of orthobiologic and biosurgery products as well as our novel and unique proprietary biomaterials pipeline with Stryker’s industry-leading sales and marketing teams. We look forward confidently to an exciting future with a great partner.”
Under the terms of the merger agreement, Stryker will commence an all-cash tender offer to acquire all of the outstanding common stock of Orthovita for $3.85 per share within 10 business days. The tender offer is expected to be completed in the second quarter of 2011. The tender offer is subject to customary closing conditions, including the tender of a majority of the outstanding shares of Orthovita common stock on a fully diluted basis, and the expiration or termination of the Hart-Scott-Rodino Antitrust Improvements Act waiting period. Following the tender offer, Stryker will acquire the remaining outstanding shares of Orthovita common stock through a second step merger.
Orthovita’s board of directors has approved the tender offer and resolved to recommend that Orthovita shareholders tender their shares to Stryker in the tender offer. In addition, shareholder Essex Woodlands Health Ventures Fund VII, L.P., whose representative R. Scott Barry is a member of Orthovita’s Board of Directors, as well as Messrs. Tidmore and Koblish and all of Orthovita’s other directors and executive officers, who collectively own approximately 14.5% of the fully diluted common stock of Orthovita, have committed to tender their shares in the tender offer.
J.P. Morgan Securities, LLC acted as exclusive financial advisor to Orthovita in connection with the transaction.
Important Additional Information Will Be Filed with the SEC
This press release is neither an offer to purchase nor a solicitation of an offer to sell shares of Orthovita, Inc. (the “Company”).
The tender offer described in this document has not yet commenced. At the time the tender offer is commenced, Stryker Corporation (“Parent”) will file with the U.S. Securities and Exchange Commission (the “SEC”) and mail to the Company’s shareholders a Tender Offer Statement on Schedule TO, and the Company will file with the SEC and mail to its shareholders a Tender Offer Solicitation/Recommendation Statement on Schedule 14D-9 in connection with the transaction. These will contain important information about Parent, the Company, the transaction and other related matters. Investors and security holders are urged to read each of these documents carefully when they are available.
Investors and security holders will be able to obtain free copies of the Tender Offer Statement, the Tender Offer Solicitation/Recommendation Statement and other documents filed with the SEC by Parent and the Company through the website maintained by the SEC at www.sec.gov once such documents are filed with the SEC. A copy of the Tender Offer Solicitation/Recommendation Statement on Schedule 14D-9 (once it becomes available) may be obtained free of charge from Orthovita’s website at www.orthovita.com, or by directing a request to Orthovita at 77 Great Valley Parkway, Malvern, PA 19355, Attn: Nancy C. Broadbent. In addition, a copy of the Tender Offer Statement, letter of transmittal and certain other related tender offer documents (once they become available) may be obtained free of charge from Stryker’s website at www.stryker.com or by directing a request to Stryker at 2825 Airview Boulevard, Kalamazoo, MI 49002, Attn: Investor Relations.
Cautionary Note Regarding Forward-Looking Statements
Statements in this press release regarding the proposed transaction between Parent and the Company, the expected timetable for completing the transaction, the potential benefits of the transaction, and any other statements about management’s future expectations, beliefs, goals, plans or prospects constitute forward-looking statements. Any statements that are not statements of historical fact (including statements containing the words “believes,” “plans,” “anticipates,” “expects,” “estimates” and similar expressions) should also be considered to be forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward-looking statements, including: uncertainties as to the timing of the tender offer and merger; uncertainties as to how many shareholders will tender their stock in the offer; the possibility that various closing conditions for the transaction may not be satisfied or waived; and the effects of disruption from the transaction making it more difficult to maintain relationships with employees, customers, and other business partners; and other risks and the other factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2010 filed with the SEC. Except as otherwise required by law, the Company disclaims any intention or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.
About Orthovita, Inc.
Orthovita, Inc. is a specialty spine and orthopedic company with a portfolio of orthobiologic and biosurgery products. Our products are based on novel and unique proprietary biomaterials that have innovative mechanisms of action in the body. Our orthobiologic platform offers products for the fusion, regeneration and fixation of human bone. Our biosurgery platform offers products for controlling intra-operative bleeding, also known as hemostasis. Our current fusion and regeneration products are based on our proprietary Vitoss™ Bone Graft Substitute technology and address the non-structural bone graft market with synthetic, bioactive alternatives to patient- and cadaver-derived bone tissue. Cortoss™ Bone Augmentation Material, an injectable, polymer composite that mimics the mechanical properties of weight-bearing human cortical bone, provides the basis for our fixation portfolio. Our hemostasis portfolio includes Vitagel™ Surgical Hemostat, a proprietary, collagen-based matrix that controls bleeding and facilitates healing, and Vitasure™ Absorbable Hemostat, a plant-based product that can be deployed quickly throughout surgery. For more information about Orthovita, please visit www.orthovita.com.
About Stryker Corporation
Stryker Corporation is one of the world’s leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care. Stryker offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives. For more information about Stryker, please visit www.stryker.com. |
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5/11/2011
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Orthovita Notes Noridian, a Medicare Contractor, Issues Future Local Coverage Decision Covering Vertebroplasty and Vertebral Augmentation
05112011-Noridian LCD.pdf
Physician reimbursement for vertebroplasty and vertebral augmentation will continue; appropriate documentation and examinations required before and after procedures
MALVERN, Pennsylvania, USA, Wednesday, May 11, 2011 – Orthovita, Inc. (NASDAQ: VITA), an orthobiologics and biosurgery company, notes that on May 5, 2011, Noridian® Administrative Services, LLC (Noridian) published a Part B Future Local Coverage Determination (LCD) covering percutaneous vertebroplasty and percutaneous vertebral augmentation when medical record documentation supports that the procedure is conducted in accordance with the clinical and procedural criteria established in the literature produced in recent years. The revision is effective June 20, 2011 and provides for continued reimbursement of physician fees for vertebroplasty and vertebral augmentation procedures related to vertebral compression fractures. Cortoss™ Bone Augmentation Material, Orthovita’s novel biomaterial approved and launched in the U.S. in 2009, is indicated for use in vertebroplasty and vertebral augmentation.
Noridian is the Centers for Medicare & Medicaid Services’ Part B Medicare Administrative Contractor in jurisdiction 3, covering Arizona, Montana, North Dakota, South Dakota, Utah and Wyoming, and is the Part B carrier in Alaska, Oregon and Washington. After The New England Journal of Medicine published two articles in August 2009 that questioned the effectiveness of vertebroplasty for painful osteoporotic compression fractures, Noridian announced Part A and Part B Future Draft LCDs in May 2010 that considered not covering vertebral augmentation procedures, including kyphoplasty, and invited comments from affected and interested parties. The Part A LCD covers reimbursement for the hospital or facility, and the Part B LCD covers reimbursement of physician fees. After reviewing the literature and over 100 comments, the Part B Future LCD was published last week and outlined the indications and limitations of coverage and medical necessity, including medical record documentation support necessary for coverage. The review period for the Part A Draft LCD, which is identical to the Part B Final LCD, expires June 20, 2011.
Key points in the Part B Future LCD include:
• No clear evidence demonstrates that one procedure (vertebroplasty or vertebral augmentation, including kyphoplasty) is different from another in terms of short- or long-term efficacy, complications, mortality, or any other parameter useful in differentiating coverage.
• Coverage is limited to no more than three vertebral levels on any date of service.
• The pain must be significant, interfere with activities of daily living, and be unresponsive to appropriate doses of an appropriate analgesic for a reasonable amount of time.
• The healthcare provider’s detailed medical assessment of the patient must be appropriately documented.
• The presence of one or more vertebral compression fractures, confirmed by such means as x-rays or MRIs, and that the patient’s pain is predominantly, if not solely, related to the demonstrated fractures, must be appropriately documented.
• The medical record must document that reasonable follow-up for the patient is arranged for by the operating provider for at least one year. The medical record must contain evidence of follow-up assessment of the patient at one month postoperatively and on an at least every-three-month basis for the first year following treatment and must contain patient comfort/activity/pain scores for each of those visits.
• Coverage under the Future LCD will be maintained for a maximum three-year period. If relevant clinical outcomes data collected during this period warrants expansion or narrowing of coverage, Noridian may modify the LCD at the end of the three-year period.
The full Part B Future LCD is available at: http://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=24383&ContrNum=03102. The Part A Draft LCD is available at: http://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=32021&ver=3.
“Vertebroplasty and vertebral augmentation procedures will continue to be covered by Noridian for patients with significant, proven fracture-related pain who have failed appropriate analgesia for at least a few days. There is no prescribed period of time for conservative therapy prior to a procedure, which ensures that affected patients who do not respond will not have to suffer unnecessarily. The decisions leading up to the procedure, the procedure itself, as well as the patient follow-up results, need to be well documented. In my opinion, this guidance is balanced and fair and reflects good medical care,” said Dr. Maarten Persenaire, Chief Medical Officer of Orthovita. “It also is our understanding,” Dr. Persenaire added, “that many specialists have already adopted these practices.”
“This decision removes some of the uncertainty surrounding this market since the publication of the NEJM articles in August 2009, which coincided with the U.S. launch of our Cortoss™ product,” Antony Koblish, President and CEO of Orthovita commented. “We anticipate that the Final Part A LCD will be published shortly after the end of the comment period and be identical to the Final Part B LCD just published. We also believe that the new rules announced by Noridian will stimulate future research in both new and improved materials and techniques, and in identifying those patients who are most likely to benefit from the procedures. In this regard, Cortoss™ is the first FDA-cleared alternative to polymethylmethacrylate (PMMA) and has been shown to improve clinical outcomes in a direct comparison. Other local Medicare contractors and private payers may offer their own assessments over time. Assuming that their reimbursement decisions will follow the positive precedent set by Noridian, we anticipate that the vertebral compression fracture market will become more receptive to our Cortoss™ product over time as market dynamics and conditions improve.”
About the Company
Orthovita, Inc. is a specialty spine and orthopedic company with a portfolio of orthobiologic and biosurgery products. Our products are based on novel and unique proprietary biomaterials that have innovative mechanisms of action in the body. Our orthobiologic platform offers products for the fusion, regeneration and fixation of human bone. Our biosurgery platform offers products for controlling intra-operative bleeding, also known as hemostasis. Our current fusion and regeneration products are based on our proprietary VitossTM Bone Graft Substitute technology and address the non-structural bone graft market with synthetic, bioactive alternatives to patient- and cadaver-derived bone tissue. CortossTM Bone Augmentation Material, an injectable, polymer composite that mimics the mechanical properties of weight-bearing human cortical bone, provides the basis for our fixation portfolio. Our hemostasis portfolio includes VitagelTM Surgical Hemostat, a proprietary, collagen-based matrix that controls bleeding and facilitates healing, and Vitasure™ Absorbable Hemostat, a plant-based product that can be deployed quickly throughout surgery.
Disclosure Notice
This press release contains forward-looking statements regarding Orthovita’s current expectations of future events that involve risks and uncertainties, including, without limitation, demand and market acceptance of Cortoss and our other products, future reimbursement coverage decisions relating to procedures in which our Cortoss product is indicated for use, the ability of our sales force to market Cortoss, and other aspects of our business. Such statements are based on management’s current expectations and are subject to a number of substantial risks and uncertainties that could cause actual results or timeliness to differ materially from those addressed in the forward-looking statements. Factors that may cause such a difference are listed from time to time in reports filed by the Company with the U.S. Securities and Exchange Commission (SEC), including but not limited to risks described in our most recently filed Form 10-K under the caption "Risk Factors,” as well as other matters such as our ability to manufacture sufficient quantities of Cortoss to meet demand for the product. Further information about these and other relevant risks and uncertainties may be found in Orthovita’s filings with the SEC, all of which are available from the SEC as well as other sources. Orthovita undertakes no obligation to publicly update any forward-looking statements.
Source: Orthovita, Inc. |
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5/10/2011
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Orthovita to Present at the
Bank of America Merrill Lynch Health Care Conference
05102011-BofAMerrill Lynch 2011 Health Care Conf-May 12.pdf
MALVERN, Pennsylvania, Tuesday, May 10, 2011 – Orthovita, Inc. (NASDAQ: VITA), an orthobiologics and biosurgery company, announced today that it will present at the Bank of America Merrill Lynch Health Care Conference in Las Vegas. Antony Koblish, President and Chief Executive Officer of Orthovita, is scheduled to present on Thursday, May 12, 2011, at 9:50 a.m. Pacific Time, at the Encore at Wynn Las Vegas, 3121 Las Vegas Boulevard South, Las Vegas, NV 89109. A live audio webcast of the presentation will be available, and can be accessed through Friday, May 27, 2011, by visiting http://www.veracast.com/webcasts/baml/healthcare2011/id45234200.cfm.
About the Company
Orthovita, Inc. is a specialty spine and orthopedic company with a portfolio of orthobiologic and biosurgery products. Our products are based on novel and unique proprietary biomaterials that have innovative mechanisms of action in the body. Our orthobiologic platform offers products for the fusion, regeneration and fixation of human bone. Our biosurgery platform offers products for controlling intra-operative bleeding, also known as hemostasis. Our current fusion and regeneration products are based on our proprietary Vitoss(TM)Bone Graft Substitute technology and address the non-structural bone graft market with synthetic, bioactive alternatives to patient- and cadaver-derived bone tissue. Cortoss(TM)Bone Augmentation Material, an injectable, polymer composite that mimics the mechanical properties of weight-bearing human cortical bone, provides the basis for our fixation portfolio. Our hemostasis portfolio includes Vitagel(TM)Surgical Hemostat, a proprietary, collagen-based matrix that controls bleeding and facilitates healing, and Vitasure(TM) Absorbable Hemostat, a plant-based product that can be deployed quickly throughout surgery.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s current expectations of future events that involve risks and uncertainties, including, without limitation, the demand and market acceptance of our products and other aspects of our business. Such statements are based on management’s current expectations and are subject to a number of substantial risks and uncertainties that could cause actual results or timeliness to differ materially from those addressed in the forward-looking statements. Factors that may cause such a difference are listed from time to time in reports filed by the Company with the U.S. Securities and Exchange Commission (SEC), including but not limited to risks described in our most recently filed Form 10-K under the caption “Risk Factors.” Further information about these and other relevant risks and uncertainties may be found in Orthovita’s filings with the SEC, all of which are available from the SEC as well as other sources. Orthovita undertakes no obligation to publicly update any forward-looking statements.
Source: Orthovita, Inc. |
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5/4/2011
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4/19/2011
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Orthovita Schedules First Quarter 2011
Financial Results Conference Call
04192011-1Q2011 Earnings Call Announcement.pdf
MALVERN, Pennsylvania, Tuesday, April 19, 2011 – Orthovita, Inc. (NASDAQ: VITA), an orthobiologics and biosurgery company, will hold a conference call on Thursday, May 5, 2011, at 8:30 a.m. Eastern Time, to review and discuss its financial results for the first quarter 2011. Antony Koblish, President and Chief Executive Officer, and Nancy C. Broadbent, Senior Vice President and Chief Financial Officer of Orthovita, will host the call.
The telephone number to join the conference call from within the U.S. is (888) 815-2919, and from outside the U.S. is (706) 643-3675. The conference identification number is 60306495. Participants should dial in ten minutes prior to the scheduled start time for the conference call.
A replay of the conference call will be available for two weeks beginning May 5, 2011, at 11:30 a.m. Eastern Time, and ending May 19, 2011, at 11:59 p.m. Eastern Time. You may listen to the replay by dialing within the U.S. (800) 642-1687 or by dialing from outside the U.S. (706) 645-9291. The replay identification number is 60306495.
About the Company
Orthovita, Inc. is a specialty spine and orthopedic company with a portfolio of orthobiologic and biosurgery products. Our products are based on novel and unique proprietary biomaterials that have innovative mechanisms of action in the body. Our orthobiologic platform offers products for the fusion, regeneration and fixation of human bone. Our biosurgery platform offers products for controlling intra-operative bleeding, also known as hemostasis. Our current fusion and regeneration products are based on our proprietary Vitoss(TM) Bone Graft Substitute technology and address the non-structural bone graft market with synthetic, bioactive alternatives to patient-and cadaver-derived bone tissue. Cortoss(TM) Bone Augmentation Material, an injectable, polymer composite that mimics the mechanical properties of weight-bearing human cortical bone, provides the basis for our fixation portfolio. Our hemostasis portfolio includes Vitagel(TM) Surgical Hemostat, a proprietary, collagen-based matrix that controls bleeding and facilitates healing, and Vitasure(TM) Absorbable Hemostat, a plant-based product that can be deployed quickly throughout surgery.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s current expectations of future events that involve risks and uncertainties, including, without limitation, the demand and market acceptance of our products and other aspects of our business. Such statements are based on management’s current expectations and are subject to a number of substantial risks and uncertainties that could cause actual results or timeliness to differ materially from those addressed in the forward-looking statements. Factors that may cause such a difference are listed from time to time in reports filed by the Company with the U.S. Securities and Exchange Commission (SEC), including but not limited to risks described in our most recently filed Form 10-K under the caption “Risk Factors.” Further information about these and other relevant risks and uncertainties may be found in Orthovita’s filings with the SEC, all of which are available from the SEC as well as other sources. Orthovita undertakes no obligation to publicly update any forward-looking statements.
Source: Orthovita, Inc. |
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4/13/2011
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Orthovita Launches the
Aliquot™ Directional Bone Tamp
04132011-Launch Aliquot Directional Bone Tamp.pdf
MALVERN, Pennsylvania, Wednesday, April 13, 2011 – Orthovita, Inc. (NASDAQ: VITA), an orthobiologics and biosurgery company, announced today the launch of the Aliquot™ Directional Bone Tamp. The Directional Bone Tamp, a channel creation device that allows safe and targeted placement of Cortoss™ Bone Augmentation Material into the vertebral body, expands the procedural options for Cortoss in the vertebral compression fracture (VCF) market.
Over 130,000 VCFs are treated annually in the United States. Thirty to forty percent of fractures are treated with vertebroplasty, while the remaining sixty to seventy percent are treated by creating a channel or cavity within the vertebral body prior to cement injection. The commercial launch of the Aliquot Directional Bone Tamp provides Orthovita with the opportunity to compete in the cavity creation space using a cost-effective and safe technology that is designed to work with Cortoss.
The Directional Bone Tamp integrates with the existing vertebral body access tools offered with the Aliquot Delivery System to core and displace bone. Gently actuating the stainless steel cutting element of the Directional Bone Tamp creates curvilinear channels that produce pathways to reduce material flow resistance and optimize therapeutic material placement.
According to Antony Koblish, CEO of Orthovita, “the Aliquot Directional Bone Tamp enhances the material flow benefits of Orthovita’s proprietary bone augmentation material, Cortoss, an injectable, bioactive composite that mimics the mechanical properties of human cortical bone. Cortoss is the only alternative to polymethylmethacrylate (PMMA) cement that has been evaluated in a large-scale, multi-center, randomized, controlled clinical study and is cleared in the United States for the treatment of vertebral compression fractures. The introduction of this device allows Orthovita to more effectively compete in the kyphoplasty segment of the VCF market.”
About the Company
Orthovita, Inc. is a specialty spine and orthopedic company with a portfolio of orthobiologic and biosurgery products. Our products are based on novel and unique proprietary biomaterials that have innovative mechanisms of action in the body. Our orthobiologic platform offers products for the fusion, regeneration and fixation of human bone. Our biosurgery platform offers products for controlling intra-operative bleeding, also known as hemostasis. Our current fusion and regeneration products are based on our proprietary Vitoss™ Bone Graft Substitute technology and address the non-structural bone graft market with synthetic, bioactive alternatives to patient- and cadaver-derived bone tissue. Cortoss™ Bone Augmentation Material, an injectable, polymer composite that mimics the mechanical characteristics of human bone, provides the basis for our fixation portfolio. Our hemostasis portfolio includes Vitagel™ Surgical Hemostat, a proprietary, collagen-based matrix that controls bleeding and facilitates healing, and Vitasure™ Absorbable Hemostat, a plant-based product that can be deployed quickly throughout surgery.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s current expectations of future events that involve risks and uncertainties, including, without limitation, the demand and market acceptance of our products, our ability to successfully launch the Aliquot Directional Bone Tamp and effectively compete in the kyphoplasty market, and other aspects of our business. Such statements are based on management’s current expectations and are subject to a number of substantial risks and uncertainties that could cause actual results or timeliness to differ materially from those addressed in the forward-looking statements. Factors that may cause such a difference are listed from time to time in reports filed by the Company with the U.S. Securities and Exchange Commission (SEC), including but not limited to risks described in our most recently filed Form 10-K under the caption “Risk Factors.” Further information about these and other relevant risks and uncertainties may be found in Orthovita’s filings with the SEC, all of which are available from the SEC as well as other sources. Orthovita undertakes no obligation to publicly update any forward-looking statements.
Source: Orthovita, Inc. |
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4/11/2011
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Orthovita Announces Presentation of Clinical Results Evaluating Vitagel™ Surgical Hemostat in Reducing Blood Loss During Primary Unilateral Total Knee Arthroplasty
04112011-Pres of Clinical Results Eval Vitagel.pdf
MALVERN, Pennsylvania, Monday, April 11, 2011 – Orthovita, Inc. (NASDAQ: VITA), an orthobiologics and biosurgery company, is pleased to announce that Michael Bloomfield, M.D., of Cleveland Clinic, presented results of a study entitled “Prospective Randomized Evaluation of a Collagen/Thrombin and Autologous Platelet Hemostatic Agent During Total Knee Arthroplasty” on Friday, April 8, at the 29th Annual Meeting of the Mid-America Orthopaedic Association in Tucson, Arizona. Wael Barsoum, M.D. and Alison Klika, M.S. of the Cleveland Clinic, Cleveland OH, served as the principal investigators of the study.
The prospective, double-blind, randomized 100-patient study evaluated the ability of Vitagel™ Surgical Hemostat (Vitagel), a microfibrillar collagen, thrombin and autologous plasma composite hemostatic agent, to reduce blood loss during primary unilateral total knee arthroplasty. In this study, standard hemostasis with Vitagel was found to reduce blood transfusions following primary total knee arthroplasty as compared to standard hemostasis alone (electrocautery). Key findings were:
• Transfusion requirements were significantly lower in the Vitagel group (0 blood transfusions in the 50-patient Vitagel arm compared to 5 transfusions in the 50 patient control arm; p=0.007).
• There was a trend toward higher hemoglobin levels in the Vitagel group starting on the second postoperative day; this trend achieved significance by the fourth day (10.0±1.0 vs. 8.8±1.1; p=0.01).
• No adverse events were attributed to the use of Vitagel.
Antony Koblish, President and CEO of Orthovita, stated, “This study represents an important resource for surgeons seeking options to minimize bleeding and the need for transfusions associated with joint replacement surgery. As a novel biomaterials company, Orthovita is committed to substantiating the use of products like Vitagel based upon clinical evidence.”
Dr. Bloomfield received the Mid-America Orthopaedic Association E. W. Johnson, Jr., M.D. Physician-In-Training Award for his contribution to the study.
About the Company
Orthovita, Inc. is a specialty spine and orthopedic company with a portfolio of orthobiologic and biosurgery products. Our products are based on novel and unique proprietary biomaterials that have innovative mechanisms of action in the body. Our orthobiologic platform offers products for the fusion, regeneration and fixation of human bone. Our biosurgery platform offers products for controlling intra-operative bleeding, also known as hemostasis. Our current fusion and regeneration products are based on our proprietary VitossTM Bone Graft Substitute technology and address the non-structural bone graft market with synthetic, bioactive alternatives to patient- and cadaver-derived bone tissue. CortossTM Bone Augmentation Material, an injectable, polymer composite that mimics the mechanical properties of weight-bearing human cortical bone, provides the basis for our fixation portfolio. Our hemostasis portfolio includes VitagelTM Surgical Hemostat, a proprietary, collagen-based matrix that controls bleeding and facilitates healing, and Vitasure™ Absorbable Hemostat, a plant-based product that can be deployed quickly throughout surgery.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s current expectations of future events that involve risks and uncertainties, including, without limitation, the demand and market acceptance of our products and other aspects of our business. Such statements are based on management’s current expectations and are subject to a number of substantial risks and uncertainties that could cause actual results or timeliness to differ materially from those addressed in the forward-looking statements. Factors that may cause such a difference are listed from time to time in reports filed by the Company with the U.S. Securities and Exchange Commission (SEC), including but not limited to risks described in our most recently filed Form 10-K under the caption “Risk Factors.” Further information about these and other relevant risks and uncertainties may be found in Orthovita’s filings with the SEC, all of which are available from the SEC as well as other sources. Orthovita undertakes no obligation to publicly update any forward-looking statements. |
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3/8/2011
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2/16/2011
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Orthovita Launches Vitoss™ Bioactive Foam-2X Bone Graft Substitute at AAOS (American Academy of Orthopedic Surgeons) Meeting
02162011-Orthovita Launches Vitoss BA2X Bone Graft Substitute at AAOS Mtg.pdf
MALVERN, Pennsylvania, Wednesday, February 16, 2011 – Orthovita, Inc. (NASDAQ: VITA), an orthobiologics and biosurgery company, confirmed today at the American Academy of Orthopedic Surgeons (AAOS) annual meeting in San Diego, California, that it is launching Vitoss Bioactive Foam-2X Bone Graft Substitute (“Vitoss BA2X”), a non-structural bone void filler for use in the pelvis, extremities and posterolateral spine.
Vitoss BA2X is the first in a series of new product introductions planned by Orthovita that is designed to meet the various bone grafting needs of patients, surgeons and hospitals. “Vitoss BA2X has the same structure and porosity of Vitoss BA but contains increased levels of bioactive glass,” said Antony Koblish, President and CEO of Orthovita. “Our in-vitro data indicate that the increased levels of bioactive glass double the overall bioactivity of the product. Other studies have shown that increasing the bioactivity leads to faster and more abundant bone formation. We believe the combination of increased bioactivity and our unique scaffold design will support more effective bone formation than before.”
“Orthovita has chosen the AAOS meeting to launch this new product as over 14,000 surgeons and allied health professionals are expected to attend the 2011 annual meeting,” said Christopher Smith, Senior Vice President of U.S. Sales. “Orthovita will begin its educational and promotional efforts starting Wednesday, February 16th, when convention doors open. Product will be commercially available the same day,” added Mr. Smith.
Vitoss BA2X contains Orthovita’s proprietary Vitoss beta-tricalcium phosphate scaffold and Kensey Nash Corporation’s proprietary collagen material. Pursuant to its contract with Kensey Nash Corporation, Orthovita will pay Kensey Nash to manufacture the Vitoss BA2X product as well as make certain royalty payments to Kensey Nash based on the net sales of such product.
About the Company
Orthovita, Inc. is a specialty spine and orthopedic company with a portfolio of orthobiologic and biosurgery products. Our products are based on novel and unique proprietary biomaterials that have innovative mechanisms of action in the body. Our orthobiologic platform offers products for the fusion, regeneration and fixation of human bone. Our biosurgery platform offers products for controlling intra-operative bleeding, also known as hemostasis. Our current fusion and regeneration products are based on our proprietary Vitoss™ Bone Graft Substitute technology and address the non-structural bone graft market with synthetic, bioactive alternatives to patient- and cadaver-derived bone tissue. Cortoss™ Bone Augmentation Material, an injectable, polymer composite that mimics the mechanical characteristics of human bone, provides the basis for our fixation portfolio. Our hemostasis portfolio includes Vitagel™ Surgical Hemostat, a proprietary, collagen-based matrix that controls bleeding and facilitates healing, and Vitasure™ Absorbable Hemostat, a plant-based product that can be deployed quickly throughout surgery.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s current expectations of future events that involve risks and uncertainties, including, without limitation, our ability to successfully market and sell Vitoss Bioactive Foam-2X, our ability to obtain regulatory clearance for and successfully launch other Vitoss product iterations, the demand and market acceptance of our products, and other aspects of our business. Such statements are based on management’s current expectations and are subject to a number of substantial risks and uncertainties that could cause actual results or timeliness to differ materially from those addressed in the forward-looking statements. Factors that may cause such a difference are listed from time to time in reports filed by the Company with the U.S. Securities and Exchange Commission (SEC), including but not limited to risks described in our most recently filed Form 10-K under the caption “Risk Factors.” Further information about these and other relevant risks and uncertainties may be found in Orthovita’s filings with the SEC, all of which are available from the SEC as well as other sources. Orthovita undertakes no obligation to publicly update any forward-looking statements.
Source: Orthovita, Inc. |
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2/14/2011
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Orthovita Schedules Conference Call for Fourth Quarter and Year-End 2010 Financial Results and 2011 Guidance
02142011-4Q2010 Earnings Call Announcement.pdf
MALVERN, Pennsylvania, Monday, February 14, 2011 – Orthovita, Inc. (NASDAQ: VITA), an orthobiologics and biosurgery company, will hold a conference call on Wednesday, March 9, 2011, at 8:30 a.m. Eastern Time, to review and discuss its financial results for the fourth quarter and year-end 2010 and provide new financial guidance for 2011. Antony Koblish, President and Chief Executive Officer, and Nancy C. Broadbent, Senior Vice President and Chief Financial Officer of Orthovita, will host the call.
The telephone number to join the conference call from within the U.S. is (888) 815-2919, and from outside the U.S. is (706) 643-3675. The conference identification number is 43723232. Participants should dial in ten minutes prior to the scheduled start time for the conference call.
A replay of the conference call will be available for two weeks beginning March 9, 2011, at 11:30 a.m. Eastern Time, and ending March 23, 2011, at 11:59 p.m. Eastern Time. You may listen to the replay by dialing within the U.S. (800) 642-1687 or by dialing from outside the U.S. (706) 645-9291. The replay identification number is 43723232.
About the Company
Orthovita, Inc. is a specialty spine and orthopedic company with a portfolio of orthobiologic and biosurgery products. Our products are based on novel and unique proprietary biomaterials that have innovative mechanisms of action in the body. Our orthobiologic platform offers products for the fusion, regeneration and fixation of human bone. Our biosurgery platform offers products for controlling intra-operative bleeding, also known as hemostasis. Our current fusion and regeneration products are based on our proprietary VitossTM Bone Graft Substitute technology and address the non-structural bone graft market with synthetic, bioactive alternatives to patient- and cadaver-derived bone tissue. CortossTM Bone Augmentation Material, an injectable, polymer composite that mimics the mechanical properties of weight-bearing human cortical bone, provides the basis for our fixation portfolio. Our hemostasis portfolio includes VitagelTM Surgical Hemostat, a proprietary, collagen-based matrix that controls bleeding and facilitates healing, and Vitasure™ Absorbable Hemostat, a plant-based product that can be deployed quickly throughout surgery.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s current expectations of future events that involve risks and uncertainties, including, without limitation, the demand and market acceptance of our products and other aspects of our business. Such statements are based on management’s current expectations and are subject to a number of substantial risks and uncertainties that could cause actual results or timeliness to differ materially from those addressed in the forward-looking statements. Factors that may cause such a difference are listed from time to time in reports filed by the Company with the U.S. Securities and Exchange Commission (SEC), including but not limited to risks described in our most recently filed Form 10-K under the caption “Risk Factors.” Further information about these and other relevant risks and uncertainties may be found in Orthovita’s filings with the SEC, all of which are available from the SEC as well as other sources. Orthovita undertakes no obligation to publicly update any forward-looking statements.
Source: Orthovita, Inc. |
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2/10/2011
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Orthovita Receives FDA Clearance for
Vitoss™ Bimodal Bone Graft Substitute
02102011-FDA Clearance for Vitoss Bimodal Bone Graft Substitute.pdf
MALVERN, Pennsylvania, Thursday, February 10, 2011 – Orthovita, Inc. (NASDAQ: VITA), an orthobiologics and biosurgery company, announced today that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market Vitoss™ BA Bimodal Bone Graft Substitute as a non-structural bone void filler for use in the extremities, pelvis and posterolateral spine. Vitoss™ Bimodal is anticipated to launch in the United States in 9-12 months after the introduction of Vitoss™ BA2X which will be commercially introduced by Orthovita next week at the 2011 Meeting of the American Academy of Orthopedic Surgeons.
Vitoss BA Bimodal differs from previous versions of Vitoss BA by modifying the size distribution of the bioactive glass particles to accelerate resorption of the bioactive glass. Orthopedic and spine surgeons believe accelerated resorption is an important characteristic in grafting material.
“Surgeons need an array of spine and orthopedic bone grafting products with properties designed to fit the unique patient challenges that present each day,” said Antony Koblish, President and Chief Executive Officer of Orthovita. “Our goal is to develop best in class orthobiologic products that meet these needs. By introducing a broader array of product offerings, we better serve the needs of patients, surgeons and hospitals.”
In addition, said Koblish, “We are pleased by our success in effectively working with FDA to continue to gain product clearances and execute against our strategy of progressing sequential versions of Vitoss including new bioactive technologies.”
Vitoss™ BA Bimodal contains Orthovita’s proprietary Vitoss beta-tricalcium phosphate bone graft substitute scaffold and Kensey Nash Corporation’s proprietary collagen material. In the event Orthovita launches Vitoss BA Bimodal, Orthovita would be obligated to pay Kensey Nash to manufacture the product as well as make certain royalty payments to Kensey Nash based on the net sales of such product in accordance with Orthovita’s development, manufacturing and supply agreement with Kensey Nash Corporation.
About the Company
Orthovita, Inc. is a specialty spine and orthopedic company with a portfolio of orthobiologic and biosurgery products. Our products are based on novel and unique proprietary biomaterials that have innovative mechanisms of action in the body. Our orthobiologic platform offers products for the fusion, regeneration and fixation of human bone. Our current fusion and regeneration products are based on our proprietary Vitoss™ Bone Graft Substitute technology and address the non-structural bone graft market with synthetic, bioactive alternatives to patient- and cadaver-derived bone tissue. Cortoss™ Bone Augmentation Material, an injectable, polymer composite that mimics the mechanical properties of human bone, provides the basis for our fixation portfolio. Our hemostasis portfolio includes Vitagel™ Surgical Hemostat, a proprietary, collagen-based matrix that controls bleeding and facilitates healing, and Vitasure™ Absorbable Hemostat, a plant-based product that can be deployed quickly throughout surgery.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s current expectations of future events that involve risks and uncertainties, including, without limitation, whether Orthovita will decide to launch Vitoss BA Bimodal, the success or timing of any launch of Vitoss BA Bimodal, our ability to obtain regulatory clearance for other Vitoss product iterations, the demand and market acceptance of our products and other aspects of our business. Such statements are based on management’s current expectations and are subject to a number of substantial risks and uncertainties that could cause actual results or timeliness to differ materially from those addressed in the forward-looking statements. Factors that may cause such a difference are listed from time to time in reports filed by the Company with the U.S. Securities and Exchange Commission (SEC), including but not limited to risks described in our most recently filed Form 10-K under the caption “Risk Factors.” Further information about these and other relevant risks and uncertainties may be found in Orthovita’s filings with the SEC, all of which are available from the SEC as well as other sources. Orthovita undertakes no obligation to publicly update any forward-looking statements.
Source: Orthovita, Inc. |
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2/8/2011
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Orthovita to Present at the
Canaccord Genuity Musculoskeletal Conference
02082011-Canaccord Genuity Conf-Feb 15.pdf
MALVERN, Pennsylvania, Tuesday, February 8, 2011 – Orthovita, Inc. (NASDAQ: VITA), an orthobiologics and biosurgery company, announced today that it will present at the Canaccord Genuity Musculoskeletal Conference in San Diego. Antony Koblish, President and Chief Executive Officer of Orthovita, is scheduled to present on Tuesday, February 15, 2011, at 10:20 a.m. Pacific Time, at the Westin San Diego Hotel, 400 W. Broadway, San Diego, CA 92101. A live audio webcast of the presentation will be available, and can be accessed for 90 days following the conference, by visiting http://www.newswire.ca/en/webcast/viewEvent.cgi?eventID=3389980.
About the Company
Orthovita, Inc. is a specialty spine and orthopedic company with a portfolio of orthobiologic and biosurgery products. Our products are based on novel and unique proprietary biomaterials that have innovative mechanisms of action in the body. Our orthobiologic platform offers products for the fusion, regeneration and fixation of human bone. Our biosurgery platform offers products for controlling intra-operative bleeding, also known as hemostasis. Our current fusion and regeneration products are based on our proprietary VitossTM Bone Graft Substitute technology and address the non-structural bone graft market with synthetic, bioactive alternatives to patient- and cadaver-derived bone tissue. CortossTM Bone Augmentation Material, an injectable, polymer composite that mimics the mechanical properties of weight-bearing human cortical bone, provides the basis for our fixation portfolio. Our hemostasis portfolio includes VitagelTM Surgical Hemostat, a proprietary, collagen-based matrix that controls bleeding and facilitates healing, and Vitasure™ Absorbable Hemostat, a plant-based product that can be deployed quickly throughout surgery.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s current expectations of future events that involve risks and uncertainties, including, without limitation, the demand and market acceptance of our products and other aspects of our business. Such statements are based on management’s current expectations and are subject to a number of substantial risks and uncertainties that could cause actual results or timeliness to differ materially from those addressed in the forward-looking statements. Factors that may cause such a difference are listed from time to time in reports filed by the Company with the U.S. Securities and Exchange Commission (SEC), including but not limited to risks described in our most recently filed Form 10-K under the caption “Risk Factors.” Further information about these and other relevant risks and uncertainties may be found in Orthovita’s filings with the SEC, all of which are available from the SEC as well as other sources. Orthovita undertakes no obligation to publicly update any forward-looking statements.
Source: Orthovita, Inc. |
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12/15/2010
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Orthovita to Present at the
J.P. Morgan 29th Annual Healthcare Conference
12152010-JP Morgan Conf Jan 13.pdf
MALVERN, Pennsylvania, Wednesday, December 15, 2010 – Orthovita, Inc. (NASDAQ: VITA), an orthobiologics and biosurgery company, announced today that it will present at the J.P. Morgan 29th Annual Healthcare Conference in San Francisco. Antony Koblish, President and Chief Executive Officer of Orthovita, is scheduled to present on Thursday, January 13, 2011, at 7:30 a.m. Pacific Time, at the Westin St. Francis Hotel, 335 Powell Street, San Francisco, CA 94102. A live audio webcast of the presentation will be available, and can be accessed for 90 days following the conference, by visiting http://jpmorgan.metameetings.com/webcasts/healthcare11/directlink?ticker=vita.
About the Company
Orthovita, Inc. is a specialty spine and orthopedic company with a portfolio of orthobiologic and biosurgery products. Our products are based on novel and unique proprietary biomaterials that have innovative mechanisms of action in the body. Our orthobiologic platform offers products for the fusion, regeneration and fixation of human bone. Our biosurgery platform offers products for controlling intra-operative bleeding, also known as hemostasis. Our current fusion and regeneration products are based on our proprietary VitossTM Bone Graft Substitute technology and address the non-structural bone graft market with synthetic, bioactive alternatives to patient- and cadaver-derived bone tissue. CortossTM Bone Augmentation Material, an injectable, polymer composite that mimics the mechanical properties of weight-bearing human cortical bone, provides the basis for our fixation portfolio. Our hemostasis portfolio includes VitagelTM Surgical Hemostat, a proprietary, collagen-based matrix that controls bleeding and facilitates healing, and Vitasure™ Absorbable Hemostat, a plant-based product that can be deployed quickly throughout surgery.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s current expectations of future events that involve risks and uncertainties, including, without limitation, the demand and market acceptance of our products and other aspects of our business. Such statements are based on management’s current expectations and are subject to a number of substantial risks and uncertainties that could cause actual results or timeliness to differ materially from those addressed in the forward-looking statements. Factors that may cause such a difference are listed from time to time in reports filed by the Company with the U.S. Securities and Exchange Commission (SEC), including but not limited to risks described in our most recently filed Form 10-K under the caption “Risk Factors.” Further information about these and other relevant risks and uncertainties may be found in Orthovita’s filings with the SEC, all of which are available from the SEC as well as other sources. Orthovita undertakes no obligation to publicly update any forward-looking statements.
Source: Orthovita, Inc. |
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12/7/2010
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Orthovita Receives FDA Clearance for
Vitoss™ Bioactive Foam-2X Bone Graft Substitute
20101207 Vitoss BA-2X.pdf
MALVERN, Pennsylvania, Tuesday, December 7, 2010 – Orthovita, Inc. (NASDAQ: VITA), an orthobiologics and biosurgery company, announced today that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market Vitoss Bioactive Foam-2X Bone Graft Substitute for use as a non-structural bone void filler for use in the spine, pelvis and extremities. Orthovita expects to launch the newest addition to its bone graft substitute product line by late February or early March of 2011.
As compared to Orthovita’s current Vitoss Bioactive Foam Bone Graft Substitute products, the Vitoss Bioactive Foam-2X product has the same structure and porosity but contains increased levels of bioactive glass, which in-vitro testing has shown induces two times the deposition of calcium phosphate growth onto the surface of the implant, while retaining the same handling properties.
Antony Koblish, President and Chief Executive Officer of Orthovita, said, “Our in-vitro data indicate the increased levels of bioactive glass double the overall bioactivity of the product. Other studies have shown that increasing the concentration of bioactive glass leads to faster and more abundant bone formation. We believe that the combination of increased bioactivity and our unique scaffold design will support more effective bone formation than before. We are pleased to offer physicians and their patients a new, enhanced product that combines increased bioactivity with our market-leading synthetic bone scaffold technology. This is the first in a series of anticipated product innovations Orthovita expects to introduce into the market over the next 18 months.”
Vitoss Bioactive Foam-2X shares additional key characteristics with the other products in the Vitoss Foam product portfolio. For example, Vitoss Bioactive Foam-2X has the ability to soak and hold its own volume in bone marrow aspirate while retaining these biological fluids in pliable and compression-resistant forms, thereby providing all three key components for bone regeneration: scaffold, cells, and signals. In addition, Vitoss Bioactive Foam-2X contains Orthovita’s proprietary Vitoss beta-tricalcium phosphate bone graft substitute scaffold and Kensey Nash Corporation’s proprietary collagen material.
Pursuant to its contract with Kensey Nash Corporation, Orthovita will pay Kensey Nash to manufacture the Vitoss Bioactive Foam-2X product as well as make certain royalty payments to Kensey Nash based on the net sales of such product.
About the Company
Orthovita, Inc. is a specialty spine and orthopedic company with a portfolio of orthobiologic and biosurgery products. Our products are based on novel and unique proprietary biomaterials that have innovative mechanisms of action in the body. Our orthobiologic platform offers products for the fusion, regeneration and fixation of human bone. Our biosurgery platform offers products for controlling intra-operative bleeding, also known as hemostasis. Our current fusion and regeneration products are based on our proprietary VitossTM Bone Graft Substitute technology and address the non-structural bone graft market with synthetic, bioactive alternatives to patient- and cadaver-derived bone tissue. CortossTM Bone Augmentation Material, an injectable, polymer composite that mimics the structural characteristics of human bone, provides the basis for our fixation portfolio. Our hemostasis portfolio includes VitagelTM Surgical Hemostat, a proprietary, collagen-based matrix that controls bleeding and facilitates healing, and Vitasure™ Absorbable Hemostat, a plant-based product that can be deployed quickly throughout surgery.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s current expectations of future events that involve risks and uncertainties, including, without limitation, our ability to timely and successfully launch Vitoss Bioactive Foam-2X, our ability to obtain regulatory clearance for and successfully launch other Vitoss product iterations, the demand and market acceptance of our products, and other aspects of our business. Such statements are based on management’s current expectations and are subject to a number of substantial risks and uncertainties that could cause actual results or timeliness to differ materially from those addressed in the forward-looking statements. Factors that may cause such a difference are listed from time to time in reports filed by the Company with the U.S. Securities and Exchange Commission (SEC), including but not limited to risks described in our most recently filed Form 10-K under the caption “Risk Factors.” Further information about these and other relevant risks and uncertainties may be found in Orthovita’s filings with the SEC, all of which are available from the SEC as well as other sources. Orthovita undertakes no obligation to publicly update any forward-looking statements.
Source: Orthovita, Inc. |
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11/17/2010
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Orthovita to Present at the
Piper Jaffray 22nd Annual Health Care Conference
11172010-Piper Jaffray Conf-Nov 30.pdf
MALVERN, Pennsylvania, Wednesday, November 17, 2010 – Orthovita, Inc. (NASDAQ: VITA), an orthobiologics and biosurgery company, announced today that it will present at the Piper Jaffray 22nd Annual Health Care Conference in New York. Antony Koblish, President and Chief Executive Officer of Orthovita, is scheduled to present on Tuesday, November 30, 2010, at 8:00 a.m. Eastern Time, at The New York Palace Hotel, 455 Madison Avenue, New York, NY 10022. A live audio webcast of the presentation will be available, and can be accessed for 90 days following the conference, by visiting http://www.corporate-ir.net/ireye/confLobby.zhtml?ticker=VITA&item_id=3528029.
About the Company
Orthovita, Inc. is a specialty spine and orthopedic company with a portfolio of orthobiologic and biosurgery products. Our products are based on novel and unique proprietary biomaterials that have innovative mechanisms of action in the body. Our orthobiologic platform offers products for the fusion, regeneration and fixation of human bone. Our biosurgery platform offers products for controlling intra-operative bleeding, also known as hemostasis. Our current fusion and regeneration products are based on our proprietary VitossTM Bone Graft Substitute technology and address the non-structural bone graft market with synthetic, bioactive alternatives to patient- and cadaver-derived bone tissue. CortossTM Bone Augmentation Material, an injectable, polymer composite that mimics the mechanical properties of weight-bearing human cortical bone, provides the basis for our fixation portfolio. Our hemostasis portfolio includes VitagelTM Surgical Hemostat, a proprietary, collagen-based matrix that controls bleeding and facilitates healing, and Vitasure™ Absorbable Hemostat, a plant-based product that can be deployed quickly throughout surgery.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s current expectations of future events that involve risks and uncertainties, including, without limitation, the demand and market acceptance of our products and other aspects of our business. Such statements are based on management’s current expectations and are subject to a number of substantial risks and uncertainties that could cause actual results or timeliness to differ materially from those addressed in the forward-looking statements. Factors that may cause such a difference are listed from time to time in reports filed by the Company with the U.S. Securities and Exchange Commission (SEC), including but not limited to risks described in our most recently filed Form 10-K under the caption “Risk Factors.” Further information about these and other relevant risks and uncertainties may be found in Orthovita’s filings with the SEC, all of which are available from the SEC as well as other sources. Orthovita undertakes no obligation to publicly update any forward-looking statements.
Source: Orthovita, Inc. |
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11/4/2010
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Orthovita to Present at the
Maxim Group 4th Annual Growth Conference
11042010-Maxim Group Conf-Nov 18.pdf
MALVERN, Pennsylvania, Thursday, November 4, 2010 – Orthovita, Inc. (NASDAQ: VITA), an orthobiologics and biosurgery company, announced today that it will present at the Maxim Group 4th Annual Growth Conference in New York. Nancy C. Broadbent, Senior Vice President and Chief Financial Officer of Orthovita, is scheduled to present on Thursday, November 18, 2010, at 9:00 a.m. Eastern Time, at the Grand Hyatt Hotel, 109 East 42nd Street, New York, NY 10017. A live webcast of the presentation will be available, and can be accessed for 90 days following the conference, by visiting http://www.wsw.com/webcast/maxim3/vita/.
About the Company
Orthovita, Inc. is a specialty spine and orthopedic company with a portfolio of orthobiologic and biosurgery products. Our products are based on novel and unique proprietary biomaterials that have innovative mechanisms of action in the body. Our orthobiologic platform offers products for the fusion, regeneration and fixation of human bone. Our biosurgery platform offers products for controlling intra-operative bleeding, also known as hemostasis. Our current fusion and regeneration products are based on our proprietary VitossTM Bone Graft Substitute technology and address the non-structural bone graft market with synthetic, bioactive alternatives to patient- and cadaver-derived bone tissue. CortossTM Bone Augmentation Material, an injectable, polymer composite that mimics the mechanical properties of weight-bearing human cortical bone, provides the basis for our fixation portfolio. Our hemostasis portfolio includes VitagelTM Surgical Hemostat, a proprietary, collagen-based matrix that controls bleeding and facilitates healing, and Vitasure™ Absorbable Hemostat, a plant-based product that can be deployed quickly throughout surgery.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s current expectations of future events that involve risks and uncertainties, including, without limitation, the demand and market acceptance of our products and other aspects of our business. Such statements are based on management’s current expectations and are subject to a number of substantial risks and uncertainties that could cause actual results or timeliness to differ materially from those addressed in the forward-looking statements. Factors that may cause such a difference are listed from time to time in reports filed by the Company with the U.S. Securities and Exchange Commission (SEC), including but not limited to risks described in our most recently filed Form 10-K under the caption “Risk Factors.” Further information about these and other relevant risks and uncertainties may be found in Orthovita’s filings with the SEC, all of which are available from the SEC as well as other sources. Orthovita undertakes no obligation to publicly update any forward-looking statements.
Source: Orthovita, Inc. |
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11/2/2010
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Orthovita Reports 2010 Third Quarter Financial Results
And Updates Full Year Financial Guidance
Orthovita Inc Third Quarter 2010 Press Release_2NOV2010.pdf
• As previously reported, third quarter 2010 product sales increased 5% to $23.3 million compared to $22.3 million in the third quarter of 2009
• Third quarter 2010 operating income improved to $0.7 million compared to a $1.0 million operating loss in the third quarter of 2009
• Third quarter 2010 net loss also improved to $0.3 million, or $0.00 per common share, compared to a net loss of $1.7 million, or $0.02 per common share, in the third quarter of 2009
• Cash and short-term investments increased from $18.6 million at June 30, 2010 to $20.9 million at September 30, 2010
• 2010 financial guidance updated to reflect current expectations for product sales in the range of $94 million to $96.0 million and net loss between $1.0 million and $2.0 million
MALVERN, Pennsylvania, USA, November 2, 2010 – Orthovita, Inc. (NASDAQ: VITA), an orthobiologics and biosurgery company, reported financial results for the quarter ended September 30, 2010. As previously reported, product sales for the third quarter of 2010 were $23.3 million, a 5% increase over product sales of $22.3 million in the third quarter of 2009.
Sales of Vitoss™ Synthetic Bone Graft Substitute products increased 1% in the third quarter of 2010 compared to the year-earlier quarter. Within the Vitoss product family, sales of Vitoss Bioactive Foam products increased 12%, but this increase was largely offset by decreases in Vitoss Morsels and Foam products. U.S. sales of Cortoss™ Bone Augmentation Material and the Aliquot™ Delivery System used with Cortoss were $1.0 million in the third quarter of 2010 compared to $0.4 million in the third quarter of 2009. The Company initiated a limited launch of Cortoss and Aliquot in the U.S. in the third quarter of 2009. Sales of the Company’s biosurgery products increased 4% during the third quarter of 2010 compared to the year-earlier quarter.
Antony Koblish, President and Chief Executive Officer, said, “As we described in our second quarter financial release, in August 2010 we implemented a restructuring of our sales organization in an effort to better align our core direct and third-party distribution channels with changes in the spine and orthopedic markets, particularly the shift of vertebral augmentation procedures from the inpatient to the outpatient setting. Our direct sales representatives are marketing our three product platforms to the inpatient hospital market, where they are leveraging their relationships to cross-market our products within a select group of high-potential hospital accounts. We are shifting to greater reliance on distributors to market Cortoss to the outpatient market. While we are in the early stages of making this transition, we are encouraged that we achieved modest year-over-year increases in third quarter 2010 product sales. However, based on our financial results for the first nine months of 2010 and the continuing weakness in the spine market, we currently expect 2010 product sales to be between $94.0 and $96.0 million, and we have narrowed our guidance for our 2010 net loss to be between $1.0 million and $2.0 million. Prior to this revision, our guidance had been for 2010 product sales to be between $96.0 and $100.0 million and our net income/loss to range from net income of $1.0 million to a net loss of $2.0 million.”
Gross profit for the quarter ended September 30, 2010 was $15.1 million, or 65% of product sales, compared to $15.1 million, or 68% of product sales, for the third quarter of 2009. The reduction in gross profit as a percentage of product sales was due to higher charges in 2010 for unused manufacturing capacity and increased reserves for expiring inventory.
During the third quarter of 2010, Orthovita recorded operating income of $0.7 million compared to an operating loss of $1.0 million in the third quarter of 2009. The net loss for the third quarter of 2010 was $0.3 million, or $0.00 per common share, compared to a net loss of $1.7 million, or $0.02 per common share, in the third quarter of 2009. The considerable improvement in operating income and net loss reflects cost reduction efforts implemented in late June 2010 that included a 10% reduction in headcount and decreases in certain other discretionary expenses.
Orthovita’s earnings before interest, taxes, depreciation and amortization and stock-based compensation expense, or Adjusted EBITDA, was $2.4 million in the third quarter of 2010, or $0.03 per basic and diluted share, compared to $0.5 million, or $0.01 per basic and diluted share, in the third quarter of 2009. A reconciliation of our reported GAAP net loss to Adjusted EBITDA is included with the Summary Financial Information included with this release.
Nancy C. Broadbent, Chief Financial Officer, commented, “The restructuring of our sales organization and streamlining of headcount and other expenses at the end of the second quarter of 2010 enabled us to improve our operating performance and balance sheet during difficult market conditions. As a result, we achieved an operating profit and significantly reduced our net loss during the third quarter of 2010. Moreover, we added $2.3 million to our cash and short-term investments at September 30, 2010 compared to June 30, 2010.”
For the first nine months of 2010, product sales increased 4% to $71.3 million compared to $68.5 million for the first nine months of 2009. Sales of Vitoss products declined by 3% during the nine months ended September 30, 2010 compared to the corresponding period in 2009, which included an 11% increase in Vitoss Bioactive Foam products offset by declines in Vitoss Morsels and Foam products. For the first nine months of 2010, U.S. sales of Cortoss and Aliquot were $3.2 million compared to $0.4 million during the first nine months of 2009. As noted above, the Company initiated a limited launch of Cortoss and Aliquot in the U.S. in the third quarter of 2009. Product sales for the first nine months of 2010 and 2009 included $1.1 million and $0.6 million, respectively, from sales to one customer of the Company’s Vitomatrix™ bone graft material for use as a raw material in dental products. The supply agreement with this customer was terminated in March 2010, and no further sales relating to this agreement are expected. For the first nine months of 2010, biosurgery product sales increased 8% compared to the corresponding year-earlier period.
For the nine months ended September 30, 2010, gross profit was $47.5 million, or 67% of product sales, compared to $46.7 million, or 68% of product sales, for the first nine months of 2009. Gross profit was higher in the 2010 period compared to the 2009 period as a result of higher sales; however, gross profit as a percent of product sales was lower for the first nine months of 2010 compared to the corresponding year-earlier period due to higher charges for unused manufacturing capacity and increased reserves for expiring inventory.
During the first nine months of 2010, Orthovita recorded operating income of $0.7 million compared to a $1.5 million operating loss for the first nine months of 2009. The net loss for the first nine months of 2010 was $2.0 million, or $0.03 per common share, compared to a net loss of $3.6 million, or $0.05 per common share, for the first nine months of 2009.
Adjusted EBITDA for the first nine months of 2010 was $5.1 million, or $0.07 per basic and diluted share, compared to $2.4 million, or $0.03 per basic and diluted share, for the first nine months of 2009. A reconciliation of our reported GAAP net loss to Adjusted EBITDA is included with the Summary Financial Information included with this release.
Cash, cash equivalents and short-term investments were $20.9 million at September 30, 2010, compared to $23.1 million at December 31, 2009. For the nine months ended September 30, 2010 and 2009, the net cash and cash equivalents used in operating activities was $1.7 million and $6.0 million, respectively.
Conference Call
Antony Koblish, President and Chief Executive Officer, and Nancy C. Broadbent, Senior Vice President and Chief Financial Officer of Orthovita, will host a conference call at 8:30 a.m. Eastern Time on Wednesday, November 3, 2010 to review and discuss the third quarter 2010 financial results and updated full-year guidance. The phone number to join the conference call from within the U.S. is (888) 815-2919, and from outside the U.S. is (706) 643-3675; the conference identification number is 16286234. Listeners are advised to dial in ten minutes prior to the scheduled start time for the conference call. A replay of the conference call will be available for two weeks beginning November 3, 2010 at 11:30 a.m. Eastern Time, and ending November 17, 2010, at 11:59 p.m. Eastern Time. You may listen to the replay by dialing within the U.S. (800) 642-1687 or by dialing from outside the U.S. (706) 645-9291. The replay identification number is 16286234.
About the Company
Orthovita, Inc. is a specialty spine and orthopedic company with a portfolio of orthobiologic and biosurgery products. Our products are based on novel and unique proprietary biomaterials that have innovative mechanisms of action in the body. Our orthobiologic platform offers products for the fusion, regeneration and fixation of human bone. Our biosurgery platform offers products for controlling intra-operative bleeding, also known as hemostasis. Our current fusion and regeneration products are based on our proprietary VitossTM Bone Graft Substitute technology and address the non-structural bone graft market with synthetic, bioactive alternatives to patient- and cadaver-derived bone tissue. CortossTM Bone Augmentation Material, an injectable, polymer composite that mimics the mechanical properties of weight-bearing human cortical bone, provides the basis for our fixation portfolio. Our hemostasis portfolio includes VitagelTM Surgical Hemostat, a proprietary, collagen-based matrix that controls bleeding and facilitates healing, and Vitasure™ Absorbable Hemostat, a plant-based product that can be deployed quickly throughout surgery.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s current expectations of future events that involve risks and uncertainties, including, without limitation, achieving product sales and net loss projections for 2010, the demand and market acceptance of our products, sales growth of our products, our ability to manage and optimize our hybrid sales model, and other aspects of our business. Such statements are based on management’s current expectations and are subject to a number of substantial risks and uncertainties that could cause actual results or timeliness to differ materially from those addressed in the forward-looking statements. Factors that may cause such a difference are listed from time to time in reports filed by the Company with the U.S. Securities and Exchange Commission (SEC), including but not limited to risks described in our most recently filed Form 10-K under the caption "Risk Factors.” Further information about these and other relevant risks and uncertainties may be found in Orthovita’s filings with the SEC, all of which are available from the SEC as well as other sources. Orthovita undertakes no obligation to publicly update any forward-looking statements.
Source: Orthovita, Inc.
Summary Financial Information can be found on attached PDF document. |
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11/1/2010
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Orthovita to Present at the
Lazard Capital Markets 7th Annual Healthcare Conference
11012010-Lazard Capital Conf-Nov 16.pdf
MALVERN, Pennsylvania, Monday, November 1, 2010 – Orthovita, Inc. (NASDAQ: VITA), an orthobiologics and biosurgery company, announced today that it will present at the Lazard Capital Markets 7th Annual Healthcare Conference in New York. Antony Koblish, President and Chief Executive Officer of Orthovita, is scheduled to present on Tuesday, November 16, 2010, at 2:10 p.m. Eastern Time, at the St. Regis Hotel, 2 East 55th Street, New York, NY 10022. A live webcast of the presentation will be available, and can be accessed for 90 days following the conference, by visiting http://www.wsw.com/webcast/lz8/vita/.
About the Company
Orthovita, Inc. is a specialty spine and orthopedic company with a portfolio of orthobiologic and biosurgery products. Our products are based on novel and unique proprietary biomaterials that have innovative mechanisms of action in the body. Our orthobiologic platform offers products for the fusion, regeneration and fixation of human bone. Our biosurgery platform offers products for controlling intra-operative bleeding, also known as hemostasis. Our current fusion and regeneration products are based on our proprietary VitossTM Bone Graft Substitute technology and address the non-structural bone graft market with synthetic, bioactive alternatives to patient- and cadaver-derived bone tissue. CortossTM Bone Augmentation Material, an injectable, polymer composite that mimics the mechanical properties of weight-bearing human cortical bone, provides the basis for our fixation portfolio. Our hemostasis portfolio includes VitagelTM Surgical Hemostat, a proprietary, collagen-based matrix that controls bleeding and facilitates healing, and Vitasure™ Absorbable Hemostat, a plant-based product that can be deployed quickly throughout surgery.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s current expectations of future events that involve risks and uncertainties, including, without limitation, the demand and market acceptance of our products and other aspects of our business. Such statements are based on management’s current expectations and are subject to a number of substantial risks and uncertainties that could cause actual results or timeliness to differ materially from those addressed in the forward-looking statements. Factors that may cause such a difference are listed from time to time in reports filed by the Company with the U.S. Securities and Exchange Commission (SEC), including but not limited to risks described in our most recently filed Form 10-K under the caption “Risk Factors.” Further information about these and other relevant risks and uncertainties may be found in Orthovita’s filings with the SEC, all of which are available from the SEC as well as other sources. Orthovita undertakes no obligation to publicly update any forward-looking statements.
Source: Orthovita, Inc. |
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10/25/2010
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Orthovita Schedules Third Quarter 2010
Financial Results Conference Call
10252010-3Q2010 Earnings Call Announcement.pdf
MALVERN, Pennsylvania, Monday, October 25, 2010 – Orthovita, Inc. (NASDAQ: VITA), an orthobiologics and biosurgery company, will hold a conference call on Wednesday, November 3, 2010, at 8:30 a.m. Eastern Time, to review and discuss its financial results for the third quarter 2010. Antony Koblish, President and Chief Executive Officer, and Nancy C. Broadbent, Senior Vice President and Chief Financial Officer of Orthovita, will host the call.
The telephone number to join the conference call from within the U.S. is (888) 815-2919, and from outside the U.S. is (706) 643-3675. The conference identification number is 16286234. Participants should dial in ten minutes prior to the scheduled start time for the conference call.
A replay of the conference call will be available for two weeks beginning November 3, 2010, at 11:30 a.m. Eastern Time, and ending November 17, 2010, at 11:59 p.m. Eastern Time. You may listen to the replay by dialing within the U.S. (800) 642-1687 or by dialing from outside the U.S. (706) 645-9291. The replay identification number is 16286234.
About the Company
Orthovita, Inc. is a specialty spine and orthopedic company with a portfolio of orthobiologic and biosurgery products. Our products are based on novel and unique proprietary biomaterials that have innovative mechanisms of action in the body. Our orthobiologic platform offers products for the fusion, regeneration and fixation of human bone. Our biosurgery platform offers products for controlling intra-operative bleeding, also known as hemostasis. Our current fusion and regeneration products are based on our proprietary VitossTM Bone Graft Substitute technology and address the non-structural bone graft market with synthetic, bioactive alternatives to patient- and cadaver-derived bone tissue. CortossTM Bone Augmentation Material, an injectable, polymer composite that mimics the structural characteristics of human bone, provides the basis for our fixation portfolio. Our hemostasis portfolio includes VitagelTM Surgical Hemostat, a proprietary, collagen-based matrix that controls bleeding and facilitates healing, and Vitasure™ Absorbable Hemostat, a plant-based product that can be deployed quickly throughout surgery.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s current expectations of future events that involve risks and uncertainties, including, without limitation, the demand and market acceptance of our products and other aspects of our business. Such statements are based on management’s current expectations and are subject to a number of substantial risks and uncertainties that could cause actual results or timeliness to differ materially from those addressed in the forward-looking statements. Factors that may cause such a difference are listed from time to time in reports filed by the Company with the U.S. Securities and Exchange Commission (SEC), including but not limited to risks described in our most recently filed Form 10-K under the caption “Risk Factors.” Further information about these and other relevant risks and uncertainties may be found in Orthovita’s filings with the SEC, all of which are available from the SEC as well as other sources. Orthovita undertakes no obligation to publicly update any forward-looking statements.
Source: Orthovita, Inc. |
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10/21/2010
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Orthovita Announces 2010 Third Quarter Product Sales
10212010-OV Announces 2010 Third Quarter Product Sales.pdf
MALVERN, PA, USA, October 21, 2010 – Orthovita, Inc. (NASDAQ: VITA), an orthobiologics and biosurgery company, today announced that product sales for the third quarter of 2010 were $23.3 million, a 5% increase over product sales of $22.3 million in the third quarter of 2009. For the first nine months of 2010, product sales increased 4% to $71.3 million compared to $68.5 million for the first nine months of 2009. Product sales for the first nine months of 2010 and 2009 included $1.1 million and $0.6 million, respectively, from sales to one customer of the Company’s Vitomatrix™ bone graft material for use as a raw material in dental products. The supply agreement with this customer was terminated in March 2010, and no further sales relating to this agreement are expected.
Sales of Vitoss™ synthetic bone graft products increased 1% in the third quarter of 2010 compared to the year-earlier quarter. Within the Vitoss product family, sales of Vitoss Bioactive Foam products increased 12%, but this increase was largely offset by decreases in Vitoss Morsels and Foam products. For the nine months ended September 30, 2010, total Vitoss sales declined by 3% compared to the year-earlier period, with an 11% increase in Vitoss Bioactive Foam products offset by declines in Vitoss Morsels and Foam products.
U.S. sales of Cortoss™ Bone Augmentation Material and the Aliquot™ Delivery System used with Cortoss, were $1.0 million in the third quarter of 2010 compared to $0.4 million in the third quarter of 2009. For the first nine months of 2010, U.S. sales of Cortoss and Aliquot were $3.2 million compared to $0.4 million during the first nine months of 2009. The Company initiated a limited launch of Cortoss in the U.S. in the third quarter of 2009.
Sales of the Company’s biosurgery products increased 4% during the third quarter of 2010 compared to the year-earlier quarter. For the first nine months of 2010, biosurgery product sales increased 8% compared to the corresponding year-earlier period.
Antony Koblish, President and Chief Executive Officer, said, “As we described in our second quarter financial release, in August 2010 we implemented a restructuring of our sales organization in an effort to better align our core direct and third-party distribution channels with changes in the spine and orthopedic markets, particularly the shift of vertebral augmentation procedures from the inpatient to the outpatient setting. Our direct sales representatives are marketing our three product platforms to the inpatient hospital market, where they are leveraging their relationships to cross-market our products within a select group of high-potential hospital accounts. We are shifting to greater reliance on distributors to market Cortoss to the outpatient market. While we are in the early stages of making this transition, we are encouraged that we achieved modest year-over-year increases in third quarter 2010 product sales, despite general weakness in the spine market.”
The Company plans to release complete financial results for the third quarter of 2010 on November 2, 2010.
Conference Call
Antony Koblish, President and Chief Executive Officer, and Nancy C. Broadbent, Senior Vice President and Chief Financial Officer of Orthovita, will host a conference call at 8:30 a.m. Eastern Time on Wednesday, November 3, 2010 to review and discuss the third quarter 2010 financial results. The phone number to join the conference call from within the U.S. is (888) 815-2919, and from outside the U.S. is (706) 643-3675; the conference identification number is 16286234. Listeners are advised to dial in ten minutes prior to the scheduled start time for the conference call. A replay of the conference call will be available for two weeks beginning November 3, 2010 at 11:30 a.m. Eastern Time, and ending November 17, 2010, at 11:59 p.m. Eastern Time. You may listen to the replay by dialing within the U.S. (800) 642-1687 or by dialing from outside the U.S. (706) 645-9291. The replay identification number is 16286234.
About the Company
Orthovita, Inc. is a specialty spine and orthopedic company with a portfolio of orthobiologic and biosurgery products. Our products are based on novel and unique proprietary biomaterials that have innovative mechanisms of action in the body. Our orthobiologic platform offers products for the fusion, regeneration and fixation of human bone. Our biosurgery platform offers products for controlling intra-operative bleeding, also known as hemostasis. Our current fusion and regeneration products are based on our proprietary VitossTM Bone Graft Substitute technology and address the non-structural bone graft market with synthetic, bioactive alternatives to patient- and cadaver-derived bone tissue. CortossTM Bone Augmentation Material, an injectable, polymer composite that mimics the structural characteristics of human bone, provides the basis for our fixation portfolio. Our hemostasis portfolio includes VitagelTM Surgical Hemostat, a proprietary, collagen-based matrix that controls bleeding and facilitates healing, and Vitasure™ Absorbable Hemostat, a plant-based product that can be deployed quickly throughout surgery.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s current expectations of future events that involve risks and uncertainties, including, without limitation, the demand and market acceptance of our products, our ability to align our sales force model to increase product revenues, and other aspects of our business. Such statements are based on management’s current expectations and are subject to a number of substantial risks and uncertainties that could cause actual results or timeliness to differ materially from those addressed in the forward-looking statements. Factors that may cause such a difference are listed from time to time in reports filed by the Company with the U.S. Securities and Exchange Commission (SEC), including but not limited to risks described in our most recently filed Form 10-K under the caption "Risk Factors.” Further information about these and other relevant risks and uncertainties may be found in Orthovita’s filings with the SEC, all of which are available from the SEC as well as other sources. Orthovita undertakes no obligation to publicly update any forward-looking statements.
Source: Orthovita, Inc. |
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10/6/2010
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Orthovita Announces Presentation of
Cortoss 24-Month Pivotal Study Results
at the 25th Annual Meeting of the North American Spine Society
10062010-Cortoss NASS paper.pdf
MALVERN, Pennsylvania, Wednesday, October 6, 2010 – Orthovita, Inc. (NASDAQ: VITA), an orthobiologics and biosurgery company, is pleased to announce that Hyun W. Bae, M.D., of The Spine Institute at Saint John’s Health Center in Santa Monica, California, will present an abstract entitled, “Correlation of Early Pain and Long-Term Functional Results from a Multi-Center, Prospective, Randomized, Controlled FDA-IDE Vertebroplasty Trial,” at the 25th Annual Meeting of the North American Spine Society (NASS) being held October 5-9, 2010 at the Orange County Convention Center in Orlando, Florida. The presentation will take place on Friday, October 8, 2010 at 7:37 a.m. The abstract has been selected for presentation during the prestigious Friday Best Papers session of the meeting.
Dr. Bae’s abstract is based on clinical data from Orthovita’s multi-center, prospective, randomized, investigational device exemption (IDE) study. In this study, the safety and efficacy of Orthovita’s Cortoss™ Bone Augmentation Material was compared to a polymethylmethacrylate (PMMA) control in the treatment of vertebral compression fractures. Dr. Bae participated in the study as a clinical investigator.
In this study, the safety and effectiveness of Cortoss was found to be non-inferior to the control. In addition, key findings from the 256-patient clinical study include the following statistically significant benefits for the Cortoss patient group:
• Early patient outcomes assessed at 3 months: With 86.6% of Cortoss patients and 75.0% of PMMA patients achieving successful pain relief as measured by the Visual Analogue Pain Scale (VAS), the Cortoss patient group experienced a statistically significant benefit in pain success over the PMMA group.
• Long-term patient outcomes assessed at 24 months: With 96.7% of Cortoss patients and 88.4% of PMMA patients maintaining or improving their function as measured by the Oswestry Disability Index (ODI), the Cortoss patient group experienced a statistically significant benefit in function success over the PMMA group.
In addition to the statistically significant benefit in pain success at three months and function success at 24 months, the Cortoss population experienced measurable benefits over the PMMA cohort in the following outcomes:
• A 43.4% reduction in subsequent, adjacent level fractures in Cortoss patients treated for a primary fracture at one level, as measured at the end of the 24-month follow-up period.
• An average of 30% less material was required to achieve adequate fracture fill in Cortoss patients.
Dr. Bae stated, “On behalf of my co-investigators, I’d like to express our appreciation to NASS for having selected our work in vertebroplasty as one of the Best Papers for this year’s meeting. With all of the discussions surrounding vertebral augmentation that are taking place today, this Level I study provides important evidence that should be included in the debate. The results show that the majority of properly selected vertebroplasty patients experience early, substantial and sustained reduction in pain and improvement in function. Furthermore, the results show that the improved material characteristics of Cortoss as compared to PMMA do lead to measurable improvements in outcomes.”
This most recent presentation at NASS represents the culmination of over a decade of pre-clinical and human clinical research on Cortoss Bone Augmentation Material. Since 1999, this research has been highlighted in 49 podium and 33 poster presentations at a variety of national and international specialty society meetings, as well as published in 18 peer-reviewed, scientific journals. “Orthovita would like to join the investigators in expressing its appreciation for NASS’s recognition, which confirms the quality of the IDE study. The sheer number and nature of scientific presentations over the years reflect our commitment to develop and clinically evaluate this unique material, for which we plan to seek regulatory clearance in additional indications,” said Maarten Persenaire, M.D., Chief Medical Officer.
About the Company
Orthovita is an orthobiologics and biosurgery company that develops and markets novel medical devices. Our orthobiologics platform offers products for the fusion, regeneration and fixation of human bone. Our biosurgery platform offers products for controlling intra-operative bleeding, also known as hemostasis. Our current fusion and regeneration products are based on our proprietary VITOSS™ Bone Graft Substitute technology and address the non-structural bone graft market with synthetic, bioactive alternatives to patient- and cadaver-derived bone tissue. CORTOSS™ Bone Augmentation Material, an injectable, polymer composite that mimics the structural characteristics of human bone, provides the basis for our fixation portfolio. Our hemostasis portfolio includes VITAGEL™ Surgical Hemostat, a unique, collagen-based matrix that controls bleeding and facilitates healing, and VITASURE™ Absorbable Hemostat, a plant-based product that can be deployed quickly throughout surgery.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s current expectations of future events that involve risks and uncertainties, including, without limitation, the demand and market acceptance of our products and other aspects of our business and our ability to obtain regulatory clearance for additional indications for Cortoss. Such statements are based on management’s current expectations and are subject to a number of substantial risks and uncertainties that could cause actual results or timeliness to differ materially from those addressed in the forward-looking statements. Factors that may cause such a difference are listed from time to time in reports filed by the Company with the U.S. Securities and Exchange Commission (SEC), including but not limited to risks described in our most recently filed Form 10-K under the caption “Risk Factors.” Further information about these and other relevant risks and uncertainties may be found in Orthovita’s filings with the SEC, all of which are available from the SEC as well as other sources. Orthovita undertakes no obligation to publicly update any forward-looking statements. |
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10/4/2010
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Orthovita Receives FDA Clearance for VITOMATRIX™ Bone Graft Substitute in Dental Applications
20101004 Vitomatrix clearance.pdf
MALVERN, Pennsylvania, Monday, October 4, 2010 – Orthovita, Inc. (NASDAQ: VITA), an orthobiologics and biosurgery company, announced that it received 510(k) clearance from the U.S. Food and Drug Administration to market VITOMATRIX Bone Graft Substitute as a bone grafting material in certain dental procedures.
VITOMATRIX is a resorbable, highly porous synthetic scaffold that utilizes the core proprietary technology from our VITOSS™ Bone Graft Substitute product line. VITOMATRIX is indicated for use in procedures to fill, augment or reconstruct periodontal or bony defects of the oral and maxillofacial region. An estimated 375,000 procedures are performed domestically each year where VITOMATRIX can be used.
Orthovita is evaluating potential commercial partners to distribute the product or license its underlying technology.
About the Company
Orthovita is an orthobiologics and biosurgery company that develops and markets novel medical devices. Our orthobiologics platform offers products for the fusion, regeneration and fixation of human bone. Our biosurgery platform offers products for controlling intra-operative bleeding, also known as hemostasis. Our current fusion and regeneration products are based on our proprietary VITOSS™ Bone Graft Substitute technology and address the non-structural bone graft market with synthetic, bioactive alternatives to patient- and cadaver-derived bone tissue. CORTOSS™ Bone Augmentation Material, an injectable, polymer composite that mimics the structural characteristics of human bone, provides the basis for our fixation portfolio. Our hemostasis portfolio includes VITAGEL™ Surgical Hemostat, a unique, collagen-based matrix that controls bleeding and facilitates healing, and VITASURE™ Absorbable Hemostat, a plant-based product that can be deployed quickly throughout surgery.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s current expectations of future events that involve risks and uncertainties, including, without limitation, our ability to successfully distribute or license the VITOMATRIX product or underlying technology through a partnership arrangement; the demand and market acceptance of our products and other aspects of our business. Such statements are based on management’s current expectations and are subject to a number of substantial risks and uncertainties that could cause actual results or timeliness to differ materially from those addressed in the forward-looking statements. Factors that may cause such a difference are listed from time to time in reports filed by the Company with the U.S. Securities and Exchange Commission (SEC), including but not limited to risks described in our most recently filed Form 10-K under the caption “Risk Factors.” Further information about these and other relevant risks and uncertainties may be found in Orthovita’s filings with the SEC, all of which are available from the SEC as well as other sources. Orthovita undertakes no obligation to publicly update any forward-looking statements. |
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9/20/2010
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Orthovita Announces Publication of 24-Month Data from Cortoss Clinical Pilot Studies in Vertebroplasty and Kyphoplasty
09202010-CortossSpine publication.pdf
MALVERN, Pennsylvania, Monday, September 20, 2010 – Orthovita, Inc. (NASDAQ: VITA), an orthobiologics and biosurgery company, is pleased to announce the publication of “Clinical Experience Using Cortoss for Treating Vertebral Compression Fractures with Vertebroplasty and Kyphoplasty” in the September 15, 2010 edition of Spine. The article presents the clinical data from two FDA-approved investigational device exemption (IDE) pilot studies sponsored by Orthovita. These multi-center, prospective trials assessed the feasibility and clinical outcomes of Cortoss™ Bone Augmentation Material using the two different vertebral augmentation techniques of vertebroplasty and kyphoplasty.
Cortoss, an injectable, bioactive composite, was used to treat 40 patients with osteoporotic vertebral compression fractures (VCFs) in two multi-center studies. Key findings from the clinical studies include:
• Vertebral augmentation with Cortoss provides sustained postoperative relief of pain and improvement in disability and quality of life through 24 months of patient follow-up.
• Comparable pain relief and quality-of-life improvements were achieved with both vertebroplasty and kyphoplasty techniques, with approximately 50% less material volume required for vertebroplasty.
• Cortoss trabecular interdigitation and bone bonding were observed in histology obtained 6 months following vertebral augmentation with kyphoplasty.
The paper concludes that, based on the results of these pilot studies:
• Cortoss is safe and effective in treating osteoporotic VCFs using either vertebroplasty or kyphoplasty; and
• VCF pain relief and functional restoration achieved with Cortoss is comparable to the results reported in the literature for VCFs treated with polymethylmethacrylate (PMMA).
Dr. Bae of The Spine Institute at Saint John’s Health Center in Santa Monica, California, lead author of the article, stated, “These positive results formed the motivation and justification for us to continue to evaluate Cortoss in these patients, which we did with the prospective randomized IDE study we completed in 2009. The results of this study were the basis of Cortoss’ clearance by FDA.”
About the Company
Orthovita is an orthobiologics and biosurgery company that develops and markets novel medical devices. Our orthobiologics platform offers products for the fusion, regeneration and fixation of human bone. Our biosurgery platform offers products for controlling intra-operative bleeding, also known as hemostasis. Our current fusion and regeneration products are based on our proprietary VITOSS™ Bone Graft Substitute technology and address the non-structural bone graft market with synthetic, bioactive alternatives to patient- and cadaver-derived bone tissue. CORTOSS™ Bone Augmentation Material, an injectable, polymer composite that mimics the structural characteristics of human bone, provides the basis for our fixation portfolio. Our hemostasis portfolio includes VITAGEL™ Surgical Hemostat, a unique, collagen-based matrix that controls bleeding and facilitates healing, and VITASURE™ Absorbable Hemostat, a plant-based product that can be deployed quickly throughout surgery.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s current expectations of future events that involve risks and uncertainties, including, without limitation, the demand and market acceptance of our products and other aspects of our business. Such statements are based on management’s current expectations and are subject to a number of substantial risks and uncertainties that could cause actual results or timeliness to differ materially from those addressed in the forward-looking statements. Factors that may cause such a difference are listed from time to time in reports filed by the Company with the U.S. Securities and Exchange Commission (SEC), including but not limited to risks described in our most recently filed Form 10-K under the caption “Risk Factors.” Further information about these and other relevant risks and uncertainties may be found in Orthovita’s filings with the SEC, all of which are available from the SEC as well as other sources. Orthovita undertakes no obligation to publicly update any forward-looking statements.
Source: Orthovita, Inc. |
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9/10/2010
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Orthovita to Present at the
UBS Global Life Sciences Conference
09102010-UBS Conf Sep 20.pdf
MALVERN, Pennsylvania, Friday, September 10, 2010 – Orthovita, Inc. (NASDAQ: VITA), an orthobiologics and biosurgery company, announced today that it will present at the UBS Global Life Sciences Conference in New York. Nancy Broadbent, Senior Vice President and Chief Financial Officer of Orthovita, is scheduled to present on Monday, September 20, 2010, at 3:30 p.m. Eastern Time, at the Grand Hyatt New York Hotel, 109 East 42nd Street at Grand Central Terminal, New York, NY 10017. A live webcast of the presentation will be available, and can be accessed for 90 days following the conference, by visiting http://cc.talkpoint.com/ubsx001/092110a_lv/?entity=30_S31I7I5.
About the Company
Orthovita is an orthobiologics and biosurgery company that develops and markets novel medical devices. Our orthobiologics platform offers products for the fusion, regeneration and fixation of human bone. Our biosurgery platform offers products for controlling intra-operative bleeding, also known as hemostasis. Our current fusion and regeneration products are based on our proprietary VITOSS™ Bone Graft Substitute technology and address the non-structural bone graft market with synthetic, bioactive alternatives to patient- and cadaver-derived bone tissue. CORTOSS™ Bone Augmentation Material, an injectable, polymer composite that mimics the structural characteristics of human bone, provides the basis for our fixation portfolio. Our hemostasis portfolio includes VITAGEL™ Surgical Hemostat, a unique, collagen-based matrix that controls bleeding and facilitates healing, and VITASURE™ Absorbable Hemostat, a plant-based product that can be deployed quickly throughout surgery.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s current expectations of future events that involve risks and uncertainties, including, without limitation, the demand and market acceptance of our products and other aspects of our business. Such statements are based on management’s current expectations and are subject to a number of substantial risks and uncertainties that could cause actual results or timeliness to differ materially from those addressed in the forward-looking statements. Factors that may cause such a difference are listed from time to time in reports filed by the Company with the U.S. Securities and Exchange Commission (SEC), including but not limited to risks described in our most recently filed Form 10-K under the caption “Risk Factors.” Further information about these and other relevant risks and uncertainties may be found in Orthovita’s filings with the SEC, all of which are available from the SEC as well as other sources. Orthovita undertakes no obligation to publicly update any forward-looking statements.
Source: Orthovita, Inc. |
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9/1/2010
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Orthovita to Present at the
Stifel Nicolaus 2010 Healthcare Conference
09012010-Stifel Nicolaus Conf Sep 15.pdf
MALVERN, Pennsylvania, Wednesday, September 1, 2010 – Orthovita, Inc. (NASDAQ: VITA), an orthobiologics and biosurgery company, announced today that it will present at the Stifel Nicolaus 2010 Healthcare Conference in Boston. Antony Koblish, President and Chief Executive Officer of Orthovita, is scheduled to present on Wednesday, September 15, 2010, at 3:15 p.m. Eastern Time, at the Four Seasons Hotel, 200 Boylston Street, Boston, MA 02116. A live webcast of the presentation will be available, and can be accessed for 30 days following the conference, by visiting http://www.veracast.com/webcasts/stifel/healthcare2010/05113557.cfm.
About the Company
Orthovita is an orthobiologics and biosurgery company that develops and markets novel medical devices. Our orthobiologics platform offers products for the fusion, regeneration and fixation of human bone. Our biosurgery platform offers products for controlling intra-operative bleeding, also known as hemostasis. Our current fusion and regeneration products are based on our proprietary VITOSS™ Bone Graft Substitute technology and address the non-structural bone graft market with synthetic, bioactive alternatives to patient- and cadaver-derived bone tissue. CORTOSS™ Bone Augmentation Material, an injectable, polymer composite that mimics the structural characteristics of human bone, provides the basis for our fixation portfolio. Our hemostasis portfolio includes VITAGEL™ Surgical Hemostat, a unique, collagen-based matrix that controls bleeding and facilitates healing, and VITASURE™ Absorbable Hemostat, a plant-based product that can be deployed quickly throughout surgery.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s current expectations of future events that involve risks and uncertainties, including, without limitation, the demand and market acceptance of our products and other aspects of our business. Such statements are based on management’s current expectations and are subject to a number of substantial risks and uncertainties that could cause actual results or timeliness to differ materially from those addressed in the forward-looking statements. Factors that may cause such a difference are listed from time to time in reports filed by the Company with the U.S. Securities and Exchange Commission (SEC), including but not limited to risks described in our most recently filed Form 10-K under the caption “Risk Factors.” Further information about these and other relevant risks and uncertainties may be found in Orthovita’s filings with the SEC, all of which are available from the SEC as well as other sources. Orthovita undertakes no obligation to publicly update any forward-looking statements.
Source: Orthovita, Inc. |
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8/11/2010
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Orthovita Notes Publication by The Lancet of Study Demonstrating Efficacy of Vertebroplasty vs. Conservative Treatment
08112010 VITA - Lancet Publication of Vertebroplasty Study.pdf
• First large multicenter prospective study comparing efficacy of vertebroplasty to optimized conservative care in the treatment of acute vertebral compression fractures
• In the 202-patient randomized study, vertebroplasty resulted in greater pain relief than conservative treatment at all timepoints
• No serious complications or adverse events were reported
MALVERN, Pennsylvania, USA, Wednesday, August 11, 2010 – Orthovita, Inc. (NASDAQ: VITA), an orthobiologics and biosurgery company, notes that the August 10, 2010 online edition of The Lancet includes the largest peer-reviewed study to date demonstrating the efficacy of vertebroplasty in the treatment of acute vertebral compression fractures compared to conservative treatment. The article, titled “Vertebroplasty versus conservative treatment in acute osteoporotic vertebral compression fractures (Vertos II): an open label randomised trial,” was authored by Drs. Klazen and Lohle et al and described the methods and findings of a 202-patient study conducted in the Netherlands and Belgium between October 1, 2005 and June 30, 2008.
Vertebroplasty is a minimally invasive procedure involving the percutaneous injection of bone cement into a fractured vertebral body, effectively reducing pain. Orthovita received FDA clearance in June 2009 for Cortoss™ Bone Augmentation Material, a synthetic biomaterial, for use in vertebroplasty as an alternative to polymethylmethacrylate (PMMA) bone cement. Although PMMA and not Cortoss was used in the Vertos II study, in a 256-patient IDE vertebral augmentation study submitted to the FDA, Cortoss demonstrated non-inferiority to PMMA and statistically significant superiority in pain relief at 3 months and mobility at 24 months. In August 2009, the New England Journal of Medicine published two studies which seemed to indicate that a “sham” procedure and vertebroplasty were equally effective. According to the Vertos II investigators, the clinical interpretation of the NEJM studies is thwarted by the inclusion of patients with subacute and chronic fractures instead of acute fractures, and other methodological issues. The stated intention of the investigators in the Vertos II study was therefore “to clarify whether percutaneous vertebroplasty has additional value compared with optimum pain treatment in a well defined group of patients with acute vertebral compression fractures.”
The Vertos II study randomized 202 elderly patients with acute painful vertebral fractures who were treated with either vertebroplasty or conservative care and followed for one year. Conservative care included optimized analgesic regimens, bed rest and physical therapy. According to the authors, “Decrease in VAS score after vertebroplasty was signi¿cantly higher than with conservative treatment at all timepoints.” In addition, the vertebroplasty patients, who had significantly more disability and lower quality of life scores at baseline, showed significantly faster and greater improvements than conservatively treated patients for these parameters. The authors concluded that, “Pain relief after the procedure is immediate, sustained for 1 year, and is signi¿cantly better than that achieved with conservative treatment and at acceptable costs.” No serious complications or adverse events were reported in the study.
“Contrary to the conclusions published in the NEJM, the results of the Vertos II study show that vertebroplasty is an effective treatment of acute painful osteoporotic fractures in properly selected patients. Important differences between the studies are both the degree of pain and the number of weeks or months that the patients needed to be in pain before being considered for treatment,” said Dr. Maarten Persenaire, Chief Medical Officer of Orthovita. “One of the strengths of the Vertos II study is its applicability in routine care where patients with acute pain first undergo imaging and other tests to diagnose the cause and assess their overall state of health. By the time all results necessary for treatment selection have been received, about half of patients with fractures may have improved enough to warrant continued conservative measures. The study shows the remaining patients stand to gain significant benefits from vertebroplasty.”
About the Company
Orthovita, Inc. is a specialty spine and orthopedic company with a portfolio of orthobiologic and biosurgery products. Our products are based on novel and unique proprietary biomaterials that have innovative mechanisms of action in the body. Our orthobiologic platform offers products for the fusion, regeneration and fixation of human bone. Our biosurgery platform offers products for controlling intra-operative bleeding, also known as hemostasis. Our current fusion and regeneration products are based on our proprietary Vitoss(TM) Bone Graft Substitute technology and address the non-structural bone graft market with synthetic, bioactive alternatives to patient- and cadaver-derived bone tissue. Cortoss(TM) Bone Augmentation Material, an injectable, polymer composite that mimics the structural characteristics of human bone, provides the basis for our fixation portfolio. Our hemostasis portfolio includes Vitagel(TM) Surgical Hemostat, a proprietary, collagen-based matrix that controls bleeding and facilitates healing, and Vitasure(TM)Absorbable Hemostat, a plant-based product that can be deployed quickly throughout surgery.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s current expectations of future events that involve risks and uncertainties, including, without limitation, the demand and market acceptance of our products, and other aspects of our business. Such statements are based on management’s current expectations and are subject to a number of substantial risks and uncertainties that could cause actual results or timeliness to differ materially from those addressed in the forward-looking statements. Factors that may cause such a difference are listed from time to time in reports filed by the Company with the U.S. Securities and Exchange Commission (SEC), including but not limited to risks described in our most recently filed Form 10-K under the caption "Risk Factors.” Further information about these and other relevant risks and uncertainties may be found in Orthovita’s filings with the SEC, all of which are available from the SEC as well as other sources. Orthovita undertakes no obligation to publicly update any forward-looking statements.
Source: Orthovita, Inc. |
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8/2/2010
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Orthovita Reports 2010 Second Quarter Financial Results And Updates Full Year Financial Guidance
Orthovita Inc Second Quarter 2010 Press Release_2AUG2010_3pm.pdf
• Second quarter 2010 product sales were $23.9 million compared to $24.5 million in the second quarter of 2009
• Second quarter 2010 operating income of $0.4 million compared to a $0.1 million operating loss in the second quarter of 2009
• Second quarter 2010 net loss of $0.6 million, or $0.01 per common share, compared to a net loss of $0.7 million, or $0.01 per common share, in the second quarter of 2009
• 2010 financial guidance updated to reflect current expectations for product sales in the range of $96 million to $100 million and net income between $1 million and a net loss of $2 million
• Corporate restructuring implemented in June 2010 to reduce costs and streamline infrastructure in response to reduced 2010 product sales expectations
MALVERN, Pennsylvania, USA, August 2, 2010 – Orthovita, Inc. (NASDAQ: VITA), an orthobiologics and biosurgery company, reported financial results for the quarter ended June 30, 2010. Product sales for the second quarter of 2010 were $23.9 million compared to $24.5 million for the second quarter of 2009. Product sales for the second quarter of 2009 included $0.6 million from the sale of Vitomatrix™, a bone graft material used in dental products. There were no Vitomatrix sales in the second quarter of 2010 and no further sales of Vitomatrix are currently expected.
During the second quarter of 2010, Orthovita recorded $1.3 million in U.S. sales of Cortoss™, the Company’s novel synthetic biomaterial that was cleared by the FDA in June 2009 for the treatment of vertebral compression fractures, and Aliquot™, the Company’s Cortoss delivery device. Since Cortoss and Aliquot were not available for sale in the U.S. until July 2009, there were no U.S. sales of these products in the second quarter of 2009.
Sales of the Company’s biosurgery products increased 10% in the second quarter of 2010 compared to the second quarter of 2009. Sales of our Vitoss products, excluding $0.6 million from the sale of Vitomatrix in the second quarter of 2009, decreased 9% in the second quarter of 2010 compared to the second quarter of 2009. The decrease in our Vitoss sales resulted primarily from lower sales of our Vitoss Morsel and Foam products; sales of Vitoss Bioactive Foam products increased 7% in the second quarter of 2010 compared to the second quarter of 2009.
Antony Koblish, president and chief executive officer of Orthovita, said “U.S. sales of Cortoss and Aliquot increased from $0.9 million in the first quarter of 2010 to $1.3 million in the second quarter of 2010. In March 2010, we reduced our Cortoss and Aliquot pricing to be more closely aligned with the shift in vertebral augmentation procedures to the outpatient setting, and we have continued to experience monthly growth in Cortoss accounts. While our sales in dollars increased by 44% from the first to the second quarters of 2010, our Cortoss cartridge unit sales volume increased by 76%.”
Mr. Koblish also commented on the sequential growth in product sales from the first to the second quarter of 2010, stating that “excluding the effect of the $1.1 million from the sale of Vitomatrix in the first quarter of 2010, both our total product sales and our Vitoss sales in the second quarter of 2010 increased 4% compared to the first quarter of 2010. Within our Vitoss product family, sales of our Vitoss Bioactive Foam products, which accounted for 65% of total Vitoss sales in the second quarter of 2010, increased 13% from the first quarter of 2010 to the second quarter of 2010.”
“During 2010, our biosurgery and Vitoss product prices have remained relatively stable compared to 2009,” Mr. Koblish continued. “Our biosurgery product volumes have continued to increase. However, the rapid shift of many vertebral augmentation procedures away from the inpatient hospital market, where we have a strong sales presence among spine and neurosurgeons, to the outpatient market, where we are addressing a new physician target audience, has both slowed our expected rate of adoption of Cortoss and shifted sales force time away from the spine and neurosurgeons who use our Vitoss synthetic bone graft products. Because Vitoss is sold in a highly competitive environment requiring significant sales representative time in the operating room, our Vitoss volume growth has been adversely affected by the Cortoss launch.”
“To more effectively address this outpatient market, where procedures are primarily done by interventional radiologists and neuroradiologists, as well as allow our sales representatives to refocus on our Vitoss and biosurgery inpatient business, we plan to add distributors who specialize in these outpatient markets,” said Mr. Koblish. “We have streamlined our direct sales force, which will focus primarily on the inpatient spine and orthopedic market to leverage our customer relationships by marketing our biosurgery and orthobiologic products to all of our customers. Through an intense focus on our target physician audiences using a combination of our direct sales representatives, sales agents and distributors in a hybrid sales model, our goal is to regain sales momentum and growth in our Vitoss platform first while developing our hybrid selling model to increase penetration of Cortoss.”
Gross profit for the quarter ended June 30, 2010 was $15.7 million, or 66% of product sales, compared to $16.8 million, or 69% of product sales for the second quarter of 2009. The reduction in gross profit as a percentage of product sales was due to a more favorable product mix in the second quarter of 2009, primarily resulting from the Vitomatrix sale mentioned above, combined with higher charges in 2010 due to unused manufacturing capacity charges and increased reserves for expiring inventory.
During the second quarter of 2010, Orthovita recorded operating income of $0.4 million compared to an operating loss of $0.1 million in the second quarter of 2009. The improvement in operating income was due to lower sales and marketing and research and development expenses in the second quarter of 2010 compared to the second quarter of 2009, partially offset by higher general and administrative expenses, primarily related to information technology infrastructure. Sales and marketing expenses were lower in the second quarter of 2010 compared to the second quarter of 2009 primarily due to higher marketing expenses in the second quarter of 2009 in anticipation of the launch of Cortoss. Research and development expenses were lower in the second quarter of 2010 compared to the second quarter of 2009 primarily due to lower Cortoss and other product candidate research and development costs. The net loss for the second quarter of 2010 was $0.6 million, or $0.01 per common share, compared to a net loss of $0.7 million, or $0.01 per common share, in the second quarter of 2009.
Orthovita’s earnings before interest, taxes, depreciation and amortization and stock-based compensation expense, or Adjusted EBITDA, was $1.8 million in the second quarter of 2010, or $0.02 per common share compared to $1.1 million, or $0.01 per common share in the second quarter of 2009. A reconciliation of our reported GAAP net loss to Adjusted EBITDA is included with the Summary Financial Information included with this release.
For the first six months of 2010, product sales increased 4% to $47.9 million compared to $46.2 million for the first six months of 2009. This increase was primarily due to higher sales of our biosurgery products, which increased 11% in the first half of 2010 compared to the first half of 2009. During the first half of 2010, Orthovita recorded $2.2 million in U.S. sales of Cortoss and Aliquot. There were no sales of Cortoss or Aliquot in the U.S. during the first half of 2009. Product sales for the six months ended June 30, 2010 included $1.1 million from the sale of Vitomatrix compared to $0.6 million for the six months ended June 30, 2009. The supply agreement for this product was terminated in March 2010.
For the six months ended June 30, 2010, gross profit was $32.4 million, or 68% of product sales, compared to $31.5 million, or 68% of product sales, for the first six months of 2009.
During the first half of 2010, Orthovita recorded a nominal operating loss compared to a $0.5 million operating loss for the first half of 2009. The net loss for the first half of 2010 was $1.7 million, or $0.02 per common share, compared to a net loss of $1.9 million, or $0.02 per common share, for the first six months of 2009.
Adjusted EBITDA for the first half of 2010 was $2.7 million, or $0.04 per common share, compared to $1.9 million, or $0.03 per common share for the first half of 2009. A reconciliation of our reported GAAP net loss to Adjusted EBITDA is included with the Summary Financial Information included with this release.
Nancy Broadbent, chief financial officer of Orthovita, commented, “We have revised our financial guidance for 2010. Our original financial guidance, which we announced on March 10, 2010, included total product sales between $106 million and $112 million and net income between breakeven and $2 million. We now expect total product sales to be in the range of $96 million to $100 million and net income to be between $1 million and a net loss of $2 million. Our revised financial guidance for net income reflects a broader range than our original guidance primarily due to potentially higher charges for unused manufacturing capacity at the lower end of our sales range.”
“Due to our revised expectations for 2010 total product sales, we recently implemented a headcount reduction. We recorded a charge in the second quarter of 2010 of $0.1 million for severance costs, and we anticipate $2.4 million in annualized cost savings from our headcount reductions,” Ms. Broadbent continued. “We also selectively reduced other expenses, and we do not anticipate the need to raise additional capital to fund our operations for the foreseeable future.”
Cash, cash equivalents and short-term investments were $18.6 million at June 30, 2010, compared to $23.1 million at December 31, 2009. For the six months ended June 30, 2010 and 2009, the net cash and cash equivalents used in operating activities was $4.1 million and $3.4 million, respectively. We anticipate the level of cash utilization for the second half of 2010 will be below the cash utilized in the first half of the year.
Conference Call
Antony Koblish, President and Chief Executive Officer, and Nancy C. Broadbent, Senior Vice President and Chief Financial Officer of Orthovita, will host a conference call at 8:30 a.m. Eastern Time on August 3, 2010 to review and discuss the second quarter 2010 financial results. The phone number to join the conference call from within the U.S. is (888) 815-2919, and from outside the U.S. is (706) 643-3675; the conference identification number is 86671393. Listeners are advised to dial in ten minutes prior to the scheduled start time for the conference call. A replay of the conference call will be available for two weeks beginning August 3, 2010 at 11:30 a.m. Eastern Time, and ending August 17, 2010, at 11:59 p.m. Eastern Time. You may listen to the replay by dialing within the U.S. at (800) 642-1687 or by dialing from outside the U.S. (706) 645-9291. The replay identification number is 86671393.
About the Company
Orthovita, Inc. is a specialty spine and orthopedic company with a portfolio of orthobiologic and biosurgery products. Our products are based on novel and unique proprietary biomaterials that have innovative mechanisms of action in the body. Our orthobiologic platform offers products for the fusion, regeneration and fixation of human bone. Our biosurgery platform offers products for controlling intra-operative bleeding, also known as hemostasis. Our current fusion and regeneration products are based on our proprietary VitossTM Bone Graft Substitute technology and address the non-structural bone graft market with synthetic, bioactive alternatives to patient- and cadaver-derived bone tissue. CortossTM Bone Augmentation Material, an injectable, polymer composite that mimics the structural characteristics of human bone, provides the basis for our fixation portfolio. Our hemostasis portfolio includes VitagelTM Surgical Hemostat, a proprietary, collagen-based matrix that controls bleeding and facilitates healing, and Vitasure™ Absorbable Hemostat, a plant-based product that can be deployed quickly throughout surgery.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s current expectations of future events that involve risks and uncertainties, including, without limitation, our financial guidance, including product sales and net income/loss projections, the demand and market acceptance of our products, including Cortoss, sales growth of our products, our ability to manage and optimize our hybrid sales model, our utilization of cash, and other aspects of our business. Such statements are based on management’s current expectations and are subject to a number of substantial risks and uncertainties that could cause actual results or timeliness to differ materially from those addressed in the forward-looking statements. Factors that may cause such a difference are listed from time to time in reports filed by the Company with the U.S. Securities and Exchange Commission (SEC), including but not limited to risks described in our most recently filed Form 10-K under the caption "Risk Factors.” Further information about these and other relevant risks and uncertainties may be found in Orthovita’s filings with the SEC, all of which are available from the SEC as well as other sources. Orthovita undertakes no obligation to publicly update any forward-looking statements.
Source: Orthovita, Inc.
Summary Financial Information can be found on attached PDF document. |
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7/26/2010
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FDA Approves Orthovita’s New Collagen Facility
07262010-Collagen Facility PMA Approval.pdf
MALVERN, Pennsylvania, USA, Monday, July 26, 2010 – Orthovita, Inc. (NASDAQ: VITA), an orthobiologics and biosurgery company, reported today that the U.S. Food and Drug Administration (FDA) approved Orthovita’s PMA supplement for a new collagen processing facility in Malvern, Pennsylvania. Orthovita will use the new facility to process the highly purified form of collagen used in its VITAGEL™ Surgical Hemostat product. VITAGEL is a composite liquid hemostat used in surgical procedures as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical. VITAGEL is combined with the patient’s own plasma immediately prior to application to a bleeding site. A fibrin/collagen clot forms quickly to control bleeding and provide a three-dimensional matrix to facilitate healing.
The approval of the new facility not only gives Orthovita enhanced control over the supply and quality of a key raw material for its VITAGEL product, but also provides the Company with an opportunity to develop, manufacture and market additional collagen-based products. This technology processes collagen to retain crucial aspects of its natural molecular structure and the potent biological characteristics found in the collagen of living tissues. As a result, the collagen processed at the facility will be among the purest available on the market.
Orthovita’s President and Chief Executive Officer Antony Koblish stated, “We are very pleased to have further solidified our supply control over our VITAGEL product. The regulatory approval of our collagen facility also gives us another resource for executing on our goal to broaden our product offerings and increase sales force leverage. We are actively engaged in research and development work for products based on the versatile properties of the ultra pure collagen that can be made at our FDA-approved facility. We are also pursuing outside partnering and co-development arrangements to utilize our collagen facility and technical know-how.”
About the Company
Orthovita is an orthobiologics and biosurgery company that develops and markets novel medical devices. Our orthobiologics platform offers products for the fusion, regeneration and fixation of human bone. Our biosurgery platform offers products for controlling intra-operative bleeding, also known as hemostasis. Our current fusion and regeneration products are based on our proprietary VITOSS™ Bone Graft Substitute technology and address the non-structural bone graft market with synthetic, bioactive alternatives to patient- and cadaver-derived bone tissue. CORTOSS™ Bone Augmentation Material, an injectable, polymer composite that mimics the structural characteristics of human bone, provides the basis for our fixation portfolio. Our hemostasis portfolio includes VITAGEL™ Surgical Hemostat, a unique, collagen-based matrix that controls bleeding and facilitates healing, and VITASURE™ Absorbable Hemostat, a plant-based product that can be deployed quickly throughout surgery.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s current expectations of future events that involve risks and uncertainties, including, without limitation, our ability to successfully develop, manufacture and/or market products using our collagen processing technology and facility; the demand and market acceptance of our products and other aspects of our business. Such statements are based on management’s current expectations and are subject to a number of substantial risks and uncertainties that could cause actual results or timeliness to differ materially from those addressed in the forward-looking statements. Factors that may cause such a difference are listed from time to time in reports filed by the Company with the U.S. Securities and Exchange Commission (SEC), including but not limited to risks described in our most recently filed Form 10-K under the caption “Risk Factors.” Further information about these and other relevant risks and uncertainties may be found in Orthovita’s filings with the SEC, all of which are available from the SEC as well as other sources. Orthovita undertakes no obligation to publicly update any forward-looking statements.
Source: Orthovita, Inc. |
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7/22/2010
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Orthovita to Present at the
Canaccord Genuity 30th Annual Growth Conference
07222010-Canaccord Genuity Conf Aug 10.pdf
MALVERN, Pennsylvania, Thursday, July 22, 2010 – Orthovita, Inc. (NASDAQ: VITA), an orthobiologics and biosurgery company, announced today that it will present at the Canaccord Genuity 30th Annual Growth Conference in Boston. Antony Koblish, President and Chief Executive Officer of Orthovita, is scheduled to present on Tuesday, August 10, at 4:30 p.m. Eastern Time, at the InterContinental Boston Hotel, 510 Atlantic Avenue, Boston, Massachusetts. A live webcast of the presentation will be available, and can be accessed for 90 days following the conference, by visiting http://www.wsw.com/webcast/canaccord2/vita/.
About the Company
Orthovita is an orthobiologics and biosurgery company that develops and markets novel medical devices. Our orthobiologics platform offers products for the fusion, regeneration and fixation of human bone. Our biosurgery platform offers products for controlling intra-operative bleeding, also known as hemostasis. Our current fusion and regeneration products are based on our proprietary VITOSS™ Bone Graft Substitute technology and address the non-structural bone graft market with synthetic, bioactive alternatives to patient- and cadaver-derived bone tissue. CORTOSS™ Bone Augmentation Material, an injectable, polymer composite that mimics the structural characteristics of human bone, provides the basis for our fixation portfolio. CORTOSS received U.S. regulatory clearance in June 2009 for use in vertebral augmentation. Our hemostasis portfolio includes VITAGEL™ Surgical Hemostat, a unique, collagen-based matrix that controls bleeding and facilitates healing, and VITASURE™ Absorbable Hemostat, a plant-based product that can be deployed quickly throughout surgery.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s current expectations of future events that involve risks and uncertainties, including, without limitation, the demand and market acceptance of our products and other aspects of our business. Such statements are based on management’s current expectations and are subject to a number of substantial risks and uncertainties that could cause actual results or timeliness to differ materially from those addressed in the forward-looking statements. Factors that may cause such a difference are listed from time to time in reports filed by the Company with the U.S. Securities and Exchange Commission (SEC), including but not limited to risks described in our most recently filed Form 10-K under the caption “Risk Factors.” Further information about these and other relevant risks and uncertainties may be found in Orthovita’s filings with the SEC, all of which are available from the SEC as well as other sources. Orthovita undertakes no obligation to publicly update any forward-looking statements.
Source: Orthovita, Inc. |
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7/20/2010
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Orthovita Schedules Second Quarter 2010
Financial Results Conference Call
07202010-2Q2010 Earnings Call Announcement.pdf
MALVERN, Pennsylvania, Tuesday, July 20, 2010 – Orthovita, Inc. (NASDAQ: VITA), an orthobiologics and biosurgery company, will hold a conference call on Tuesday, August 3, 2010, at 8:30 a.m. Eastern Time, to review and discuss its financial results for the second quarter 2010. Antony Koblish, President and Chief Executive Officer, and Nancy C. Broadbent, Senior Vice President and Chief Financial Officer of Orthovita, will host the call.
The telephone number to join the conference call from within the U.S. is (888) 815-2919, and from outside the U.S. is (706) 643-3675. The conference identification number is 86671393. Participants should dial in ten minutes prior to the scheduled start time for the conference call.
A replay of the conference call will be available for two weeks beginning August 3, 2010, at 11:30 a.m. Eastern Time, and ending August 17, 2010, at 11:59 p.m. Eastern Time. You may listen to the replay by dialing within the U.S. (800) 642-1687 or by dialing from outside the U.S. (706) 645-9291. The replay identification number is 86671393.
About the Company
Orthovita is an orthobiologics and biosurgery company that develops and markets novel medical devices. Our orthobiologics platform offers products for the fusion, regeneration and fixation of human bone. Our biosurgery platform offers products for controlling intra-operative bleeding, also known as hemostasis. Our current fusion and regeneration products are based on our proprietary VITOSS™ Bone Graft Substitute technology and address the non-structural bone graft market with synthetic, bioactive alternatives to patient- and cadaver-derived bone tissue. CORTOSS™ Bone Augmentation Material, an injectable, polymer composite that mimics the structural characteristics of human bone, provides the basis for our fixation portfolio. CORTOSS received U.S. regulatory clearance in June 2009 for use in vertebral augmentation. Our hemostasis portfolio includes VITAGEL™ Surgical Hemostat, a unique, collagen-based matrix that controls bleeding and facilitates healing, and VITASURE™ Absorbable Hemostat, a plant-based product that can be deployed quickly throughout surgery.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s current expectations of future events that involve risks and uncertainties, including, without limitation, the demand and market acceptance of our products and other aspects of our business. Such statements are based on management’s current expectations and are subject to a number of substantial risks and uncertainties that could cause actual results or timeliness to differ materially from those addressed in the forward-looking statements. Factors that may cause such a difference are listed from time to time in reports filed by the Company with the U.S. Securities and Exchange Commission (SEC), including but not limited to risks described in our most recently filed Form 10-K under the caption “Risk Factors.” Further information about these and other relevant risks and uncertainties may be found in Orthovita’s filings with the SEC, all of which are available from the SEC as well as other sources. Orthovita undertakes no obligation to publicly update any forward-looking statements.
Source: Orthovita, Inc. |
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7/19/2010
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Orthovita Announces Presentations of Cortoss Clinical Study Results
at the 17th International Meeting of Advanced Spine Technologies
07192010-Cortoss iMAST presentations.pdf
MALVERN, Pennsylvania, Monday, July 19, 2010 – Orthovita, Inc. (NASDAQ: VITA), an orthobiologics and biosurgery company, is pleased to announce that Hyun W. Bae, M.D. of The Spine Institute at Saint John’s Health Center in Santa Monica, California, will present an abstract entitled “Correlation of Early Pain and Long-Term Functional Results from a Multi-Center, Prospective, Randomized, Controlled FDA-IDE Vertebroplasty Trial,” at the 17th International Meeting of the Advanced Spine Technologies (IMAST) being held from July 21 through July 24, 2010 at the Sheraton Centre Toronto in Toronto, Canada. The presentation will take place on Thursday, July 22, 2010, at 3:19 p.m.
The abstract has been nominated for the prestigious Whitecloud Award for Best Clinical Paper at the meeting. The winner of the award will be announced during the final general session on Saturday, July 24th. Dr. Bae’s abstract is based on clinical data from Orthovita’s multi-center, prospective, randomized, investigational device exemption (IDE) study comparing the safety and efficacy of Orthovita’s Cortoss™ Bone Augmentation Material to a polymethylmethacrylate (PMMA) control in the treatment of vertebral compression fractures (VCF). Dr. Bae participated in the study as a clinical investigator.
Key findings from the 256-patient clinical study include the following statistically significant benefits for the Cortoss patient group:
• Early patient outcomes assessed at 3 months: With 86.6% of Cortoss patients and 75.0% of PMMA patients achieving successful pain relief as measured by the Visual Analogue Pain Scale (VAS) the Cortoss patient group experienced a statistically significant benefit in pain success over the PMMA group.
• Long-term patient outcomes assessed at 24 months: With 96.7% of Cortoss patients and 88.4% of PMMA patients maintaining or improving their function as measured by the Oswestry Disability Index (ODI), the Cortoss patient group experienced a statistically significant benefit in function success over the PMMA group.
In addition, Dr. Bae will make a podium presentation of a paper entitled “Marked Improvement in Patients Treated with Vertebroplasty after Painful Osteoporotic Compression Fractures” at the IMAST meeting on Friday, July 23rd at 3:03 p.m. Dr. Bae will present data on the 44 patients treated at his institution with either Cortoss or PMMA. Improvement in the patients’ condition happened within 72 hours, and on average pain improved significantly by 55% and disability by 49%. These results clearly show the beneficial effects of vertebroplasty treatment for vertebral compression fractures.
Dr. Bae, the lead author of both manuscripts, stated, “The combined results of these studies show the effectiveness of vertebroplasty and that Cortoss has substantial clinical benefits as a vertebroplasty material to achieve the dual goals of immediate pain relief and long-term function.”
About the Company
Orthovita is an orthobiologics and biosurgery company that develops and markets novel medical devices. Our orthobiologics platform offers products for the fusion, regeneration and fixation of human bone. Our biosurgery platform offers products for controlling intra-operative bleeding, also known as hemostasis. Our current fusion and regeneration products are based on our proprietary VITOSS™ Bone Graft Substitute technology and address the non-structural bone graft market with synthetic, bioactive alternatives to patient- and cadaver-derived bone tissue. CORTOSS™ Bone Augmentation Material, an injectable, polymer composite that mimics the structural characteristics of human bone, provides the basis for our fixation portfolio. Our hemostasis portfolio includes VITAGEL™ Surgical Hemostat, a unique, collagen-based matrix that controls bleeding and facilitates healing, and VITASURE™ Absorbable Hemostat, a plant-based product that can be deployed quickly throughout surgery.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s current expectations of future events that involve risks and uncertainties, including, without limitation, the demand and market acceptance of our products and other aspects of our business. Such statements are based on management’s current expectations and are subject to a number of substantial risks and uncertainties that could cause actual results or timeliness to differ materially from those addressed in the forward-looking statements. Factors that may cause such a difference are listed from time to time in reports filed by the Company with the U.S. Securities and Exchange Commission (SEC), including but not limited to risks described in our most recently filed Form 10-K under the caption “Risk Factors.” Further information about these and other relevant risks and uncertainties may be found in Orthovita’s filings with the SEC, all of which are available from the SEC as well as other sources. Orthovita undertakes no obligation to publicly update any forward-looking statements.
Source: Orthovita, Inc. |
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6/14/2010
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Orthovita to Present at the Wells Fargo Securities Healthcare Conference
06142010-Wells Fargo Sec Conf Jun 23.pdf
MALVERN, Pennsylvania, Monday, June 14, 2010 – Orthovita, Inc. (NASDAQ: VITA), an orthobiologics and biosurgery company, announced today that it will present at the Wells Fargo Securities Healthcare Conference in Boston. Nancy Broadbent, Senior Vice President and Chief Financial Officer of Orthovita, is scheduled to present on Wednesday, June 23, at 4:00 p.m. Eastern Time, at the InterContinental Boston, 510 Atlantic Avenue, Boston, MA. A live webcast of the presentation will be available, and can be accessed for 90 days following the conference, by visiting http://www.wsw.com/webcast/wa61/vita.
About the Company
Orthovita is an orthobiologics and biosurgery company that develops and markets novel medical devices. Our orthobiologics platform offers products for the fusion, regeneration and fixation of human bone. Our biosurgery platform offers products for controlling intra-operative bleeding, also known as hemostasis. Our current fusion and regeneration products are based on our proprietary VITOSS™ Bone Graft Substitute technology and address the non-structural bone graft market with synthetic, bioactive alternatives to patient- and cadaver-derived bone tissue. CORTOSS™ Bone Augmentation Material, an injectable, polymer composite that mimics the structural characteristics of human bone, provides the basis for our fixation portfolio. CORTOSS received U.S. regulatory clearance in June 2009 for use in vertebral augmentation. Our hemostasis portfolio includes VITAGEL™ Surgical Hemostat, a unique, collagen-based matrix that controls bleeding and facilitates healing, and VITASURE™ Absorbable Hemostat, a plant-based product that can be deployed quickly throughout surgery.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s current expectations of future events that involve risks and uncertainties, including, without limitation, the demand and market acceptance of our products and other aspects of our business. Such statements are based on management’s current expectations and are subject to a number of substantial risks and uncertainties that could cause actual results or timeliness to differ materially from those addressed in the forward-looking statements. Factors that may cause such a difference are listed from time to time in reports filed by the Company with the U.S. Securities and Exchange Commission (SEC), including but not limited to risks described in our most recently filed Form 10-K under the caption “Risk Factors.” Further information about these and other relevant risks and uncertainties may be found in Orthovita’s filings with the SEC, all of which are available from the SEC as well as other sources. Orthovita undertakes no obligation to publicly update any forward-looking statements.
Source: Orthovita, Inc. |
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5/3/2010
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4/22/2010
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Orthovita Announces 2010 First Quarter Product Sales
VITA - Q1 2010 Sales Press Release.pdf
MALVERN, PA, USA, April 22, 2010 – Orthovita, Inc. (NASDAQ: VITA), a leading orthobiologics and biosurgery company, today announced that product sales for the first quarter of 2010 were $24.1 million, an 11% increase over product sales of $21.7 million in the first quarter of 2009. Product sales for the quarter ended March 31, 2010 included $1.1 million from the sale of Vitomatrix™, a bone graft material used in dental products, and $900,000 from U.S. sales of Cortoss™, the Company’s novel synthetic biomaterial that was cleared by the FDA in June 2009 for the treatment of vertebral compression fractures, and Aliquot™, the Company’s Cortoss delivery device. There were no Vitomatrix or U.S. Cortoss sales in the first quarter of 2009. The $1.1 million in Vitomatrix sales occurred in March 2010 as part of an agreement to terminate our supply agreement for this product.
“Our first quarter 2010 product sales reflected continued progress in our launch of Cortoss,” said Antony Koblish, president and chief executive officer of Orthovita. “Following our actions in early March to align more closely our Cortoss and Aliquot pricing strategy with the shift in vertebral augmentation procedures to the outpatient setting, we have seen both new customer accounts and monthly sales increase. Our U.S. Cortoss and Aliquot sales in March were 45% higher than January 2010, our highest month of Cortoss and Aliquot sales since launch, and our Cortoss customer accounts increased from 151 at the end of February to 186 at the end of March, with a 70% reorder rate.”
Mr. Koblish continued, “Compared to the first quarter of 2009, our biosurgery sales increased 11% in the first quarter of 2010, and our orthobiologic sales, which included Cortoss and and Vitomatrix, increased 11%. While we are gratified that the realignment of our Cortoss marketing strategy was successful in generating higher Cortoss growth at the end of the quarter, implementing this strategy reduced the amount of time our sales representatives could spend in the operating room on bone graft cases. As a result, our Vitoss™ sales, excluding the Vitomatrix sale, declined slightly in the first quarter of 2010 compared to the first quarter of 2009. However, we anticipate that the realignment of our Cortoss pricing strategy will reduce the time needed to obtain hospital approvals for Cortoss, freeing up our sales representatives’ time to refocus their efforts on our Vitoss products, and we expect that sales of our Vitoss products will increase in the coming quarters.”
The Company plans to release complete financial results for the first quarter of 2010 on May 3, 2010.
Conference Call
Antony Koblish, President and Chief Executive Officer, and Nancy C. Broadbent, Senior Vice President and Chief Financial Officer of Orthovita, will host a conference call at 8:30 a.m. Eastern Time on Tuesday, May 4, 2010 to review and discuss the first quarter 2010 financial results. The phone number to join the conference call from within the U.S. is (888) 815-2919, and from outside the U.S. is (706) 643-3675; the conference identification number is 67873938. Listeners are advised to dial in ten minutes prior to the scheduled start time for the conference call. A replay of the conference call will be available for two weeks beginning May 4, 2010 at 11:30 a.m. Eastern Time, and ending May 18, 2010, at 11:59 p.m. Eastern Time. You may listen to the replay by dialing within the U.S. (800) 642-1687 or by dialing from outside the U.S. (706) 645-9291. The replay identification number is 67873938.
About the Company
Orthovita is an orthobiologics and biosurgery company that develops and markets novel medical devices. Our orthobiologics platform offers products for the fusion, regeneration, and fixation of human bone. Our biosurgery platform offers products for controlling intra-operative bleeding, also known as hemostasis. Our current fusion and regeneration products are based on our proprietary VitossTM Bone Graft Substitute technology and address the non-structural bone graft market with synthetic, bioactive alternatives to patient- and cadaver-derived bone tissue. CortossTM Bone Augmentation Material, an injectable, polymer composite that mimics the structural characteristics of human bone, provides the basis for our fixation portfolio. Our hemostasis portfolio includes VitagelTM Surgical Hemostat, a unique, collagen-based matrix that controls bleeding and facilitates healing, and Vitasure™ Absorbable Hemostat, a plant-based product that can be deployed quickly throughout surgery.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s current expectations of future events that involve risks and uncertainties, including, without limitation, the demand and market acceptance of our products, including Cortoss, our ability to successfully launch Cortoss, our ability to achieve product revenue growth, and other aspects of our business. Such statements are based on management’s current expectations and are subject to a number of substantial risks and uncertainties that could cause actual results or timeliness to differ materially from those addressed in the forward-looking statements. Factors that may cause such a difference are listed from time to time in reports filed by the Company with the U.S. Securities and Exchange Commission (SEC), including but not limited to risks described in our most recently filed Form 10-K under the caption "Risk Factors.” Further information about these and other relevant risks and uncertainties may be found in Orthovita’s filings with the SEC, all of which are available from the SEC as well as other sources. Orthovita undertakes no obligation to publicly update any forward-looking statements.
Source: Orthovita, Inc. |
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4/16/2010
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Orthovita Schedules First Quarter 2010
Financial Results Conference Call
04162010-1Q2010 Earnings Call Announcement.pdf
MALVERN, Pennsylvania, Friday, April 16, 2010 – Orthovita, Inc. (NASDAQ: VITA), an orthobiologics and biosurgery company, will hold a conference call on Tuesday, May 4, 2010, at 8:30 a.m. Eastern Time, to review and discuss its financial results for the first quarter 2010. Antony Koblish, President and Chief Executive Officer, and Nancy C. Broadbent, Senior Vice President and Chief Financial Officer of Orthovita, will host the call.
The telephone number to join the conference call from within the U.S. is (888) 815-2919, and from outside the U.S. is (706) 643-3675. The conference identification number is 67873938. Participants should dial in ten minutes prior to the scheduled start time for the conference call.
A replay of the conference call will be available for two weeks beginning May 4, 2010, at 11:30 a.m. Eastern Time, and ending May 18, 2010, at 11:59 p.m. Eastern Time. You may listen to the replay by dialing within the U.S. (800) 642-1687 or by dialing from outside the U.S. (706) 645-9291. The replay identification number is 67873938.
About the Company
Orthovita is an orthobiologics and biosurgery company that develops and markets novel medical devices. Our orthobiologics platform offers products for the fusion, regeneration and fixation of human bone. Our biosurgery platform offers products for controlling intra-operative bleeding, also known as hemostasis. Our current fusion and regeneration products are based on our proprietary VITOSS™ Bone Graft Substitute technology and address the non-structural bone graft market with synthetic, bioactive alternatives to patient- and cadaver-derived bone tissue. CORTOSS™ Bone Augmentation Material, an injectable, polymer composite that mimics the structural characteristics of human bone, provides the basis for our fixation portfolio. CORTOSS received U.S. regulatory clearance in June 2009 for use in vertebral augmentation. Our hemostasis portfolio includes VITAGEL™ Surgical Hemostat, a unique, collagen-based matrix that controls bleeding and facilitates healing, and VITASURE™ Absorbable Hemostat, a plant-based product that can be deployed quickly throughout surgery.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s current expectations of future events that involve risks and uncertainties, including, without limitation, the demand and market acceptance of our products and other aspects of our business. Such statements are based on management’s current expectations and are subject to a number of substantial risks and uncertainties that could cause actual results or timeliness to differ materially from those addressed in the forward-looking statements. Factors that may cause such a difference are listed from time to time in reports filed by the Company with the U.S. Securities and Exchange Commission (SEC), including but not limited to risks described in our most recently filed Form 10-K under the caption “Risk Factors.” Further information about these and other relevant risks and uncertainties may be found in Orthovita’s filings with the SEC, all of which are available from the SEC as well as other sources. Orthovita undertakes no obligation to publicly update any forward-looking statements.
Source: Orthovita, Inc. |
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3/18/2010
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Orthovita to Present at the Sidoti & Company 14th Annual NY Emerging Growth Institutional Investor Forum
03182010- Sidoti Co Conf Mar 24.pdf
MALVERN, Pennsylvania, Thursday, March 18, 2010 – Orthovita, Inc. (NASDAQ: VITA), an orthobiologics and biosurgery company, announced today that it will present at the Sidoti & Company 14th Annual NY Emerging Growth Institutional Investor Forum in New York. Antony Koblish, President and Chief Executive Officer of Orthovita, is scheduled to present on Wednesday, March 24, at 11:20 a.m. Eastern Time, at the Grand Hyatt New York, 109 East 42nd Street at Grand Central Terminal, New York, New York. This presentation will not be webcast.
About the Company
Orthovita is an orthobiologics and biosurgery company that develops and markets novel medical devices. Our orthobiologics platform offers products for the fusion, regeneration and fixation of human bone. Our biosurgery platform offers products for controlling intra-operative bleeding, also known as hemostasis. Our current fusion and regeneration products are based on our proprietary VITOSS™ Bone Graft Substitute technology and address the non-structural bone graft market with synthetic, bioactive alternatives to patient- and cadaver-derived bone tissue. CORTOSS™ Bone Augmentation Material, an injectable, polymer composite that mimics the structural characteristics of human bone, provides the basis for our fixation portfolio. CORTOSS received U.S. regulatory clearance in June 2009 for use in vertebral augmentation. Our hemostasis portfolio includes VITAGEL™ Surgical Hemostat, a unique, collagen-based matrix that controls bleeding and facilitates healing, and VITASURE™ Absorbable Hemostat, a plant-based product that can be deployed quickly throughout surgery.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s current expectations of future events that involve risks and uncertainties, including, without limitation, the demand and market acceptance of our products and other aspects of our business. Such statements are based on management’s current expectations and are subject to a number of substantial risks and uncertainties that could cause actual results or timeliness to differ materially from those addressed in the forward-looking statements. Factors that may cause such a difference are listed from time to time in reports filed by the Company with the U.S. Securities and Exchange Commission (SEC), including but not limited to risks described in our most recently filed Form 10-K under the caption “Risk Factors.” Further information about these and other relevant risks and uncertainties may be found in Orthovita’s filings with the SEC, all of which are available from the SEC as well as other sources. Orthovita undertakes no obligation to publicly update any forward-looking statements.
Source: Orthovita, Inc |
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3/10/2010
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2/25/2010
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Orthovita Schedules Fourth Quarter and Year-End 2009
Financial Results Conference Call
02252010-4QYE2009 Earnings Call Announcement.pdf
MALVERN, Pennsylvania, Thursday, February 25, 2010 – Orthovita, Inc. (NASDAQ: VITA), an orthobiologics and biosurgery company, will hold a conference call on Thursday, March 11, 2010, at 8:30 a.m. Eastern Time, to review and discuss its financial results for the fourth quarter and year-end 2009. Antony Koblish, President and Chief Executive Officer, and Nancy C. Broadbent, Senior Vice President and Chief Financial Officer of Orthovita, will host the call.
The telephone number to join the conference call from within the U.S. is (888) 815-2919, and from outside the U.S. is (706) 643-3675. The conference identification number is 58246952. Participants should dial in ten minutes prior to the scheduled start time for the conference call.
A replay of the conference call will be available for two weeks beginning March 11, 2010, at 11:30 a.m. Eastern Time, and ending March 24, 2010, at 11:59 p.m. Eastern Time. You may listen to the replay by dialing within the U.S. (800) 642-1687 or by dialing from outside the U.S. (706) 645-9291. The replay identification number is 58246952.
About the Company
Orthovita is an orthobiologics and biosurgery company that develops and markets novel medical devices. Our orthobiologics platform offers products for the fusion, regeneration and fixation of human bone. Our biosurgery platform offers products for controlling intra-operative bleeding, also known as hemostasis. Our current fusion and regeneration products are based on our proprietary VITOSS™ Bone Graft Substitute technology and address the non-structural bone graft market with synthetic, bioactive alternatives to patient-and cadaver-derived bone tissue. CORTOSS™ Bone Augmentation Material, an injectable, polymer composite that mimics the structural characteristics of human bone, provides the basis for our fixation portfolio. CORTOSS received U.S. regulatory clearance in June 2009 for use in vertebral augmentation. Our hemostasis portfolio includes VITAGEL™ Surgical Hemostat, a unique, collagen-based matrix that controls bleeding and facilitates healing, and VITASURE™ Absorbable Hemostat, a plant-based product that can be deployed quickly throughout surgery.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s current expectations of future events that involve risks and uncertainties, including, without limitation, the demand and market acceptance of our products and other aspects of our business. Such statements are based on management’s current expectations and are subject to a number of substantial risks and uncertainties that could cause actual results or timeliness to differ materially from those addressed in the forward-looking statements. Factors that may cause such a difference are listed from time to time in reports filed by the Company with the U.S. Securities and Exchange Commission (SEC), including but not limited to risks described in our most recently filed Form 10-K under the caption “Risk Factors.” Further information about these and other relevant risks and uncertainties may be found in Orthovita’s filings with the SEC, all of which are available from the SEC as well as other sources. Orthovita undertakes no obligation to publicly update any forward-looking statements.
Source: Orthovita, Inc. |
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2/25/2010
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Orthovita to Present at the
Canaccord Adams Musculoskeletal Conference
02252010-Canaccord Adams Conf Mar 9.pdf
MALVERN, Pennsylvania, Thursday, February 25, 2010 – Orthovita, Inc. (NASDAQ: VITA), an orthobiologics and biosurgery company, announced today that it will present at the Canaccord Adams Musculoskeletal Conference in New Orleans. Antony Koblish, President and Chief Executive Officer of Orthovita, is scheduled to present on Tuesday, March 9, at 8:00 a.m. Central Time, at the Sheraton New Orleans Hotel, 500 Canal Street, New Orleans, Louisiana. A live webcast of the presentation will be available, and can be accessed for 60 days following the conference, by visiting http://www.newswire.ca/en/webcast/viewEvent.cgi?eventID=2953940.
About the Company
Orthovita is an orthobiologics and biosurgery company that develops and markets novel medical devices. Our orthobiologics platform offers products for the fusion, regeneration and fixation of human bone. Our biosurgery platform offers products for controlling intra-operative bleeding, also known as hemostasis. Our current fusion and regeneration products are based on our proprietary VITOSS™ Bone Graft Substitute technology and address the non-structural bone graft market with synthetic, bioactive alternatives to patient-and cadaver-derived bone tissue. CORTOSS™ Bone Augmentation Material, an injectable, polymer composite that mimics the structural characteristics of human bone, provides the basis for our fixation portfolio. CORTOSS received U.S. regulatory clearance in June 2009 for use in vertebral augmentation. Our hemostasis portfolio includes VITAGEL™ Surgical Hemostat, a unique, collagen-based matrix that controls bleeding and facilitates healing, and VITASURE™ Absorbable Hemostat, a plant-based product that can be deployed quickly throughout surgery.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s current expectations of future events that involve risks and uncertainties, including, without limitation, the demand and market acceptance of our products and other aspects of our business. Such statements are based on management’s current expectations and are subject to a number of substantial risks and uncertainties that could cause actual results or timeliness to differ materially from those addressed in the forward-looking statements. Factors that may cause such a difference are listed from time to time in reports filed by the Company with the U.S. Securities and Exchange Commission (SEC), including but not limited to risks described in our most recently filed Form 10-K under the caption “Risk Factors.” Further information about these and other relevant risks and uncertainties may be found in Orthovita’s filings with the SEC, all of which are available from the SEC as well as other sources. Orthovita undertakes no obligation to publicly update any forward-looking statements.
Source: Orthovita, Inc. |
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2/25/2010
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Orthovita to Present at the Roth Capital Partners 22nd Annual OC Growth Stock Conference
02252010-Roth Capital Conf Mar 15.pdf
MALVERN, Pennsylvania, Thursday, February 25, 2010 – Orthovita, Inc. (NASDAQ: VITA), an orthobiologics and biosurgery company, announced today that it will present at the Roth Capital Partners 22nd Annual OC Growth Stock Conference in Dana Point. Nancy Broadbent, Senior Vice President and Chief Financial Officer of Orthovita, is scheduled to present on Monday, March 15, at 1:00 p.m. Pacific Time, at the Ritz-Carlton Laguna Niguel, One Ritz-Carlton Drive, Dana Point, California. A live webcast of the presentation will be available, and can be accessed for 90 days following the conference, by visiting http://www.wsw.com/webcast/roth23.vita/.
About the Company
Orthovita is an orthobiologics and biosurgery company that develops and markets novel medical devices. Our orthobiologics platform offers products for the fusion, regeneration and fixation of human bone. Our biosurgery platform offers products for controlling intra-operative bleeding, also known as hemostasis. Our current fusion and regeneration products are based on our proprietary VITOSS™ Bone Graft Substitute technology and address the non-structural bone graft market with synthetic, bioactive alternatives to patient- and cadaver-derived bone tissue. CORTOSS™ Bone Augmentation Material, an injectable, polymer composite that mimics the structural characteristics of human bone, provides the basis for our fixation portfolio. CORTOSS received U.S. regulatory clearance in June 2009 for use in vertebral augmentation. Our hemostasis portfolio includes VITAGEL™ Surgical Hemostat, a unique, collagen-based matrix that controls bleeding and facilitates healing, and VITASURE™ Absorbable Hemostat, a plant-based product that can be deployed quickly throughout surgery.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s current expectations of future events that involve risks and uncertainties, including, without limitation, the demand and market acceptance of our products and other aspects of our business. Such statements are based on management’s current expectations and are subject to a number of substantial risks and uncertainties that could cause actual results or timeliness to differ materially from those addressed in the forward-looking statements. Factors that may cause such a difference are listed from time to time in reports filed by the Company with the U.S. Securities and Exchange Commission (SEC), including but not limited to risks described in our most recently filed Form 10-K under the caption “Risk Factors.” Further information about these and other relevant risks and uncertainties may be found in Orthovita’s filings with the SEC, all of which are available from the SEC as well as other sources. Orthovita undertakes no obligation to publicly update any forward-looking statements.
Source: Orthovita, Inc. |
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12/22/2009
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Orthovita to Present at the
J. P. Morgan 28th Annual Healthcare Conference
12-22-2009 Orthovita To Present at J.P. Morgan Healthcare Conference.pdf
MALVERN, Pennsylvania, Tuesday, December 22, 2009 – Orthovita, Inc. (NASDAQ: VITA), an orthobiologics and biosurgery company, announced today that it will present at the J. P. Morgan 28th Annual Healthcare Conference in San Francisco. Antony Koblish, chief executive officer of Orthovita, is scheduled to present on Thursday, January 14th, at 10:00a.m. Pacific Time, at the Westin St. Francis Hotel, 335 Powell Street, San Francisco, California. A live webcast of the presentation will be available, and can be accessed for 90 days following the conference, by visiting HUhttp://metameetings.com/webcasts/jpmorgan/healthcare10/directlink?ticker=VITAUH..
About the Company
Orthovita is an orthobiologics and biosurgery company that develops and markets novel medical devices. Our orthobiologics platform offers products for the fusion, regeneration and fixation of human bone. Our biosurgery platform offers products for controlling intra-operative bleeding, also known as hemostasis. Our current fusion and regeneration products are based on our proprietary VITOSS™ Bone Graft Substitute technology and address the non-structural bone graft market with synthetic, bioactive alternatives to patient- and cadaver-derived bone tissue. CORTOSS™ Bone Augmentation Material, an injectable, polymer composite that mimics the structural characteristics of human bone, provides the basis for our fixation portfolio. CORTOSS received U.S. regulatory clearance in June 2009 for use in vertebral augmentation. Our hemostasis portfolio includes VITAGEL™ Surgical Hemostat, a unique, collagen-based matrix that controls bleeding and facilitates healing, and VITASURE™ Absorbable Hemostat, a plant-based product that can be deployed quickly throughout surgery.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s current expectations of future events that involve risks and uncertainties, including, without limitation, the demand and market acceptance of our products and other aspects of our business. Such statements are based on management’s current expectations and are subject to a number of substantial risks and uncertainties that could cause actual results or timeliness to differ materially from those addressed in the forward-looking statements. Factors that may cause such a difference are listed from time to time in reports filed by the Company with the U.S. Securities and Exchange Commission (SEC), including but not limited to risks described in our most recently filed Form 10-K under the caption “Risk Factors.” Further information about these and other relevant risks and uncertainties may be found in Orthovita’s filings with the SEC, all of which are available from the SEC as well as other sources. Orthovita undertakes no obligation to publicly update any forward-looking statements.
Source: Orthovita, Inc. |
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11/23/2009
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Orthovita to Present at the
Piper Jaffray 21st Annual Health Care Conference
11232009-Piper Jaffray Conf Dec 2.pdf
MALVERN, Pennsylvania, Monday, November 23, 2009 – Orthovita, Inc. (NASDAQ: VITA), an orthobiologics and biosurgery company, announced today that it will present at the Piper Jaffray 21st Annual Health Care Conference in New York City. Antony Koblish, chief executive officer of Orthovita, is scheduled to present on Wednesday, December 2nd, at 3:00 p.m. Eastern Time, at the New York Palace Hotel, 455 Madison Avenue, New York, New York. A live webcast of the presentation will be available, and can be accessed for 30 days following the conference, by visiting http://www.corporate-ir.net/ireye/confLobby.zhtml?ticker=***VITA&item_id=2539636.
About the Company
Orthovita is an orthobiologics and biosurgery company that develops and markets novel medical devices. Our orthobiologics platform offers products for the fusion, regeneration and fixation of human bone. Our biosurgery platform offers products for controlling intra-operative bleeding, also known as hemostasis. Our current fusion and regeneration products are based on our proprietary VITOSS™ Bone Graft Substitute technology and address the non-structural bone graft market with synthetic, bioactive alternatives to patient- and cadaver-derived bone tissue. CORTOSS™ Bone Augmentation Material, an injectable, polymer composite that mimics the structural characteristics of human bone, provides the basis for our fixation portfolio. CORTOSS received U.S. regulatory clearance in June 2009 for use in vertebral augmentation. Our hemostasis portfolio includes VITAGEL™ Surgical Hemostat, a unique, collagen-based matrix that controls bleeding and facilitates healing, and VITASURE™ Absorbable Hemostat, a plant-based product that can be deployed quickly throughout surgery.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s current expectations of future events that involve risks and uncertainties, including, without limitation, the demand and market acceptance of our product. Such statements are based on management’s current expectations and are subject to a number of substantial risks and uncertainties that could cause actual results or timeliness to differ materially from those addressed in the forward-looking statements. Factors that may cause such a difference are listed from time to time in reports filed by the Company with the U.S. Securities and Exchange Commission (SEC), including but not limited to risks described in our most recently filed Form 10-K under the caption “Risk Factors.” Further information about these and other relevant risks and uncertainties may be found in Orthovita’s filings with the SEC, all of which are available from the SEC as well as other sources. Orthovita undertakes no obligation to publicly update any forward-looking statements.
Source: Orthovita, Inc. |
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11/13/2009
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Orthovita to Participate in the
Lazard Capital Markets 6th Annual Healthcare Conference
11132009 - Lazard Capital Markets Conf Nov 18.pdf
MALVERN, Pennsylvania, Friday, November 13, 2009 – Orthovita, Inc. (NASDAQ: VITA), an orthobiologics and biosurgery company, announced today that it will present at the Lazard Capital Markets 6th Annual Healthcare Conference in New York City. Antony Koblish, chief executive officer of Orthovita, is scheduled to present on Wednesday, November 18th, at 2:15 p.m. Eastern Time, at the St. Regis Hotel, Two East 55th Street at Fifth Avenue, New York, New York. A live webcast of the presentation will be available, and can be accessed for 90 days following the conference, by visiting http://www.wsw.com/webcast/lz6/vita/.
About the Company
Orthovita is an orthobiologics and biosurgery company that develops and markets novel medical devices. Our orthobiologics platform offers products for the fusion, regeneration and fixation of human bone. Our biosurgery platform offers products for controlling intra-operative bleeding, also known as hemostasis. Our current fusion and regeneration products are based on our proprietary VITOSS™ Bone Graft Substitute technology and address the non-structural bone graft market with synthetic, bioactive alternatives to patient- and cadaver-derived bone tissue. CORTOSS™ Bone Augmentation Material, an injectable, polymer composite that mimics the structural characteristics of human bone, provides the basis for our fixation portfolio. CORTOSS received U.S. regulatory clearance in June 2009 for use in vertebral augmentation. Our hemostasis portfolio includes VITAGEL™ Surgical Hemostat, a unique, collagen-based matrix that controls bleeding and facilitates healing, and VITASURE™ Absorbable Hemostat, a plant-based product that can be deployed quickly throughout surgery.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s current expectations of future events that involve risks and uncertainties, including, without limitation, the demand and market acceptance of our products, including Cortoss, our ability to successfully launch Cortoss, our ability to achieve our sales and net loss forecast for 2009, and other aspects of our business. Such statements are based on management’s current expectations and are subject to a number of substantial risks and uncertainties that could cause actual results or timeliness to differ materially from those addressed in the forward-looking statements. Factors that may cause such a difference are listed from time to time in reports filed by the Company with the U.S. Securities and Exchange Commission (SEC), including but not limited to risks described in our most recently filed Form 10-K under the caption "Risk Factors." Further information about these and other relevant risks and uncertainties may be found in Orthovita’s filings with the SEC, all of which are available from the SEC as well as other sources. Orthovita undertakes no obligation to publicly update any forward-looking statements.
Source: Orthovita, Inc. |
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11/5/2009
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Orthovita Reports 2009 Third Quarter Financial Results
11042009-Orthovita Reports 2009 Third Quarter Financial Results..pdf
• Third quarter 2009 sales increased 8% to $22.3 million; operating loss was $1.0 million compared to an operating loss of $1.2 million in the third quarter of 2008
• Controlled Cortoss launch in the U.S. generated $400,000 in Q3 2009 sales; Cortoss launch expanded to entire sales force for fourth quarter of 2009
MALVERN, PA, USA, November 5, 2009 – Orthovita, Inc. (NASDAQ: VITA), a leading orthobiologics and biosurgery company, today reported its financial results for the quarter ended September 30, 2009. Product sales for the third quarter of 2009 were $22.3 million, an 8% increase over product sales of $20.6 million in the third quarter of 2008. The 2009 third quarter results included $400,000 in U.S. sales of Cortoss™, the Company’s new and innovative synthetic biomaterial that was cleared by the FDA in June 2009 for the treatment of vertebral compression fractures. In July 2009, Orthovita initiated a limited, controlled launch of Cortoss in the U.S. using a small group of its highly trained direct sales representatives, and expanded the launch to its entire sales force for the fourth quarter of 2009.
Gross profit during the third quarter of 2009 was $15.1 million, or 68% of sales, compared to $13.9 million, or 68% of sales, in the third quarter of 2008. Operating expenses in the third quarter of 2009 were $16.1 million, a 7% increase over operating expenses of $15.1 million in the third quarter of 2008.
The operating loss for the third quarter of 2009 decreased to $1.0 million compared to an operating loss of $1.2 million in the third quarter of 2008. The net loss for the quarter ended September 30, 2009 was $1.7 million, or $0.02 per common share, which was unchanged from the third quarter of 2008.
“The most significant news of the third quarter was our controlled launch of Cortoss in the United States,” said Antony Koblish, President and Chief Executive Officer of Orthovita. “There are subtle but important differences in the application of the Cortoss technology compared to standard polymethylmethacrylate (PMMA) bone cement, and we wanted to ensure the best possible clinical outcomes as we introduced this innovative new technology to surgeons and patients. I am very pleased to report that surgeons adapted readily to the use of Cortoss, and many were impressed with the product’s ease of use, therapeutic fill and flow characteristics and strong clinical benefit. Several surgeons have commented that these features allow them to complete cases in less time than previously required. A number of surgeons are also using Cortoss in their more difficult cases and achieving favorable outcomes for their patients.”
“In September, following additional clinical training, all of our direct sales representatives began targeting surgeons for potential Cortoss use. Cortoss is a new technology, so our representatives need to spend quite a bit of time addressing new technology committees in hospitals before the product is approved and ordered. We are gratified to see that nearly two-thirds of the hospitals that have ordered Cortoss have already placed reorders for the product.”
“Total sales in the third quarter of 2009 increased over the corresponding 2008 quarter at a slower rate than in previous quarters,” commented Nancy Broadbent, Senior Vice President and Chief Financial Officer of Orthovita. “The third quarter is typically affected by summer seasonality, but we believe this had less of an impact in 2008 because of the rapid uptake of Vitoss Bioactive Foam launched earlier in 2008. We believe that sales force productivity in the 2009 quarter was also adversely affected by the launch of Cortoss in the U.S. and the time required educating physicians and hospital new technology committees about Cortoss.”
For the first nine months of 2009, product sales increased 22% to $68.5 million, compared to $56.1 million for the first nine months of 2008. This increase was due primarily to higher sales of Vitoss Bioactive Foam. Gross profit for the nine months ended September 30, 2009 was $ 46.7 million, or 68% of product sales, compared to $37.2 million, or 66% of product sales, in the nine months ended September 30, 2008. This improvement in gross margin was largely due to a more favorable product mix.
The operating loss in the first nine months of 2009 was $1.5 million compared to an operating loss of $8.5 million in the first nine months of 2008. This improvement resulted from higher sales and gross margins, which were partially offset by higher (5.0%) operating expenses in the first nine months of 2009 compared to the first nine months of 2008. The net loss for the first nine months of 2009 was $3.6 million, or $0.05 per common share, compared to a net loss of $9.5 million, or $0.13 per common share, in the first nine months of 2008.
Cash, cash equivalents and short-term investments were $22.5 million at September 30, 2009, compared to $32.3 million at December 31, 2008. For the nine months ended September 30, 2009, the net cash and cash equivalents used in operating activities was $5.9 million, compared to $11.7 million for the nine months ended September 30, 2008. Net cash and cash equivalents used in operating activities for the nine months ended September 30, 2009 decreased as compared with the nine months ended September 30, 2008, primarily due to a decrease in the operating loss.
Conference Call
Antony Koblish, President and Chief Executive Officer, and Nancy C. Broadbent, Senior Vice President and Chief Financial Officer of Orthovita, will host a conference call at 8:30 a.m. Eastern Time on Thursday, November 5, 2009 to review and discuss the third quarter 2009 financial results. The phone number to join the conference call from within the U.S. is (888) 815-2919, and from outside the U.S. is (706) 643-3675; the conference identification number is 35689143. Listeners are advised to dial in ten minutes prior to the scheduled start time for the conference call. A replay of the conference call will be available for two weeks beginning November 5, 2009 at 11:30 a.m. Eastern Time, and ending November 19, 2009, at 11:59 p.m. Eastern Time. You may listen to the replay by dialing within the U.S. (800) 642-1687 or by dialing from outside the U.S. (706) 645-9291. The replay identification number is 35689143.
About the Company
Orthovita is an orthobiologics and biosurgery company that develops and markets novel medical devices. Our orthobiologics platform offers products for the fusion, regeneration, and fixation of human bone. Our biosurgery platform offers products for controlling intra-operative bleeding, also known as hemostasis. Our current fusion and regeneration products are based on our proprietary VITOSS(TM) Bone Graft Substitute technology and address the non-structural bone graft market with synthetic, bioactive alternatives to patient- and cadaver-derived bone tissue. CORTOSS(TM) Bone Augmentation Material, an injectable, polymer composite that mimics the structural characteristics of human bone, provides the basis for our fixation portfolio. CORTOSS received clearance in June 2009 for vertebral augmentation. Our hemostasis portfolio includes VITAGEL(TM) Surgical Hemostat, a unique, collagen-based matrix that controls bleeding and facilitates healing, and VITASURE(TM) Absorbable Hemostat, a plant-based product that can be deployed quickly throughout surgery.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s current expectations of future events that involve risks and uncertainties, including, without limitation, the demand and market acceptance of our products, including CORTOSS, our ability to successfully launch Cortoss, our ability to achieve our sales and net loss forecast for 2009, and other aspects of our business. Such statements are based on management’s current expectations and are subject to a number of substantial risks and uncertainties that could cause actual results or timeliness to differ materially from those addressed in the forward-looking statements. Factors that may cause such a difference are listed from time to time in reports filed by the Company with the U.S. Securities and Exchange Commission (SEC), including but not limited to risks described in our most recently filed Form 10-K under the caption "Risk Factors.” Further information about these and other relevant risks and uncertainties may be found in Orthovita’s filings with the SEC, all of which are available from the SEC as well as other sources. Orthovita undertakes no obligation to publicly update any forward-looking statements.
Source: Orthovita, Inc. |
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11/4/2009
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Orthovita to Host Investor Breakfast on Wednesday, November 11, 2009, in San Francisco, CA
VITA - NASS Investor Breakfast_11 09 (3).pdf
MALVERN, PA, November 4, 2009 --- Orthovita, Inc. (Nasdaq: VITA) today announced that it will be hosting an investor breakfast from 7:00 A.M. to 9:00 A.M. PST on Wednesday, November 11, 2009, at the W Hotel in San Francisco, CA. This event will coincide with the annual meeting of the North American Spine Society (NASS) and will feature presentations by prominent surgeons on the practice of managing vertebral compression fractures (VCFs), including the role of Cortoss™, Orthovita’s novel biomaterial for the treatment of VCFs. Orthovita’s senior management will also provide an update on the commercialization of Cortoss.
Institutional buy side investment professionals and sell side analysts are invited to attend in person. The event will be available to the public via live Webcast at http://www.orthovita.com/investors/. To listen to the live event and view the corresponding presentation, please go to the Web site at least 15 minutes early to register, download and install any necessary audio software. A replay of the event will be available within 24 hours after the event. A replay of the webcast will be available for 90 days at the same location.
Pre-registration for the event is required. To pre-register, please contact Robert Stanislaro at (212) 850-5657 or robert.stanislaro@fd.com. Location and event details will be e-mailed to eligible professionals who pre-register. To enable Orthovita to make the necessary arrangements, pre-registration will close on November 9, 2009.
About the Company
Orthovita is an orthobiologics and biosurgery company that develops and markets novel medical devices. Our orthobiologics platform offers products for the fusion, regeneration, and fixation of human bone. Our biosurgery platform offers products for controlling intra-operative bleeding, also known as hemostasis. Our current fusion and regeneration products are based on our proprietary VITOSS(TM) Bone Graft Substitute technology and address the non-structural bone graft market with synthetic, bioactive alternatives to patient- and cadaver-derived bone tissue. CORTOSS(TM) Bone Augmentation Material, an injectable, polymer composite that mimics the structural characteristics of human bone, provides the basis for our fixation portfolio. CORTOSS received FDA clearance in June 2009 for vertebral augmentation. Our hemostasis portfolio includes VITAGEL(TM) Surgical Hemostat, a unique, collagen-based matrix that controls bleeding and facilitates healing, and VITASURE(TM) Absorbable Hemostat, a plant-based product that can be deployed quickly throughout surgery.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s current expectations of future events that involve risks and uncertainties, including, without limitation, the demand and market acceptance of our products, including CORTOSS, our ability to successfully launch Cortoss, our ability to achieve our sales and net loss forecast for 2009, and other aspects of our business. Such statements are based on management’s current expectations and are subject to a number of substantial risks and uncertainties that could cause actual results or timeliness to differ materially from those addressed in the forward-looking statements. Factors that may cause such a difference are listed from time to time in reports filed by the Company with the U.S. Securities and Exchange Commission (SEC), including but not limited to risks described in our most recently filed Form 10-K under the caption "Risk Factors.” Further information about these and other relevant risks and uncertainties may be found in Orthovita’s filings with the SEC, all of which are available from the SEC as well as other sources. Orthovita undertakes no obligation to publicly update any forward-looking statements. |
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10/23/2009
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Orthovita Announces Presentation of Cortoss Clinical Study Results
at the 2009 Congress of Neurological Surgeons Annual Meeting
10232009-Cortoss Presentation at CNS Annual Mtg.pdf
MALVERN, Pennsylvania, Friday, October 23, 2009 – Orthovita, Inc. (NASDAQ: VITA), an orthobiologics and biosurgery company, is pleased to announce that Dr. Pierce D. Nunley, Director of the Spine Institute of Louisiana, will present his abstract, “A Comparison of Clinical Outcomes and Adjacent Level Fractures in Patients Receiving Vertebroplasty for Osteoporotic Compression Fractures Using CortossTM or PMMA: A Prospective, Randomized Trial,” at the 2009 Annual Meeting of the Congress of Neurological Surgeons (CNS). The presentation will take place in New Orleans on Monday, October 26, 2009, at 3:15 p.m.
The abstract was selected by CNS as a Top Ten Abstract for the meeting’s section on disorders of the spine and peripheral nerves. It is based on clinical data from Orthovita’s prospective, randomized, multi-center study comparing the efficacy of its Cortoss product to polymethylmethacrylate (PMMA) in the treatment of vertebral compression fractures (VCF). Dr. Nunley participated in the study as a clinical investigator.
Key findings from the 256-patient clinical study include the following statistically significant benefits for the Cortoss patient group:
• Early patient outcomes assessed at 3 months: With a Visual Analogue Pain Scale (VAS) score success rate of 86.6%, the Cortoss patient group experienced a statistically significant benefit in pain success over the PMMA group, which had a VAS score success rate of 75.0%.
• Long-term patient outcomes assessed at 24 months: With an Oswestry Disability Index (ODI) function assessment success rate of 96.7%, the Cortoss patient group experienced a statistically significant benefit in function success over the PMMA group, which had an ODI success rate of 88.4%.
In addition, the Cortoss patient group experienced benefits over the PMMA cohort in the following outcomes:
• A 43.4% reduction in subsequent, adjacent level fractures in Cortoss patients treated for a primary fracture at one level, as measured at the end of the 24-month follow-up period;
• A 67.4% lower incidence of subsequent VCF procedures;
• A 74.6% lower incidence of re-hospitalization for spinal fracture; and
• The Cortoss patients required an average of 30% less material to achieve fracture fill.
“It is my sincere pleasure to have the opportunity to present the results of the Cortoss IDE study on behalf of all my colleague investigators at this important meeting,” Dr. Nunley stated. “These data are the culmination of many years of research and represent a sizeable and significant contribution to the scientific information surrounding vertebral augmentation for osteoporotic fractures. Given the recent attention these procedures have received in the popular media, we think that the quality of the design, execution and results of this particular study make it an important tool in establishing the proper role of vertebral augmentation in the optimal treatment of vertebral compression fractures. Furthermore, we believe the statistically significant improvements experienced by the Cortoss patient group constitute a powerful incentive for surgeons to evaluate this new technology in lieu of PMMA.”
About the Company
Orthovita is an orthobiologics and biosurgery company that develops and markets novel medical devices. Our orthobiologics platform offers products for the fusion, regeneration and fixation of human bone. Our biosurgery platform offers products for controlling intra-operative bleeding, also known as hemostasis. Our current fusion and regeneration products are based on our proprietary Vitoss(TM) Bone Graft Substitute technology and address the non-structural bone graft market with synthetic, bioactive alternatives to patient- and cadaver-derived bone tissue. Cortoss(TM) Bone Augmentation Material, an injectable, polymer composite that mimics the structural characteristics of human bone, provides the basis for our fixation portfolio. Cortoss received U.S. regulatory clearance in June 2009 for use in vertebral augmentation. Our hemostasis portfolio includes Vitagel(TM) Surgical Hemostat, a unique, collagen-based matrix that controls bleeding and facilitates healing, and Vitasure(TM) Absorbable Hemostat, a plant-based product that can be deployed quickly throughout surgery.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s current expectations of future events that involve risks and uncertainties, including, without limitation, the demand and market acceptance of our products, including Cortoss, our ability to successfully launch Cortoss, and other aspects of our business. Such statements are based on management’s current expectations and are subject to a number of substantial risks and uncertainties that could cause actual results or timeliness to differ materially from those addressed in the forward-looking statements. Factors that may cause such a difference are listed from time to time in reports filed by the Company with the U.S. Securities and Exchange Commission (SEC), including but not limited to risks described in our most recently filed Form 10-K under the caption "Risk Factors.” Further information about these and other relevant risks and uncertainties may be found in Orthovita’s filings with the SEC, all of which are available from the SEC as well as other sources. Orthovita undertakes no obligation to publicly update any forward-looking statements.
Source: Orthovita, Inc. |
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10/22/2009
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Orthovita Announces 2009 Third Quarter Sales
10222009-Q3 09 Sales Press Release.pdf
MALVERN, PA, USA, October 22, 2009 – Orthovita, Inc. (NASDAQ: VITA), a leading orthobiologics and biosurgery company, today announced that product sales for the third quarter of 2009 were $22.3 million, an 8% increase over product sales of $20.6 million in the third quarter of 2008. For the first nine months of 2009, product sales increased 22% to $68.5 million compared to $56.1 million for the first nine months of 2008. Results for the three and nine months ended September 30, 2009 include $400,000 from the sale of Cortoss(TM), the Company’s novel synthetic biomaterial that was cleared by the FDA in June 2009 for the treatment of vertebral compression fractures. Orthovita initiated a limited, controlled launch of Cortoss in July 2009 using a small group of its highly trained direct sales representatives and broadened the launch to its entire sales force for the fourth quarter of 2009.
The Company plans to release complete financial results for the third quarter of 2009 on November 4, 2009.
Conference Call
Antony Koblish, President and Chief Executive Officer, and Nancy C. Broadbent, Senior Vice President and Chief Financial Officer of Orthovita, will host a conference call at 8:30 a.m. Eastern Time on Thursday, November 5, 2009 to review and discuss the third quarter 2009 financial results. The phone number to join the conference call from within the U.S. is (888) 815-2919, and from outside the U.S. is (706) 643-3675; the conference identification number is 35689143. Listeners are advised to dial in ten minutes prior to the scheduled start time for the conference call. A replay of the conference call will be available for two weeks beginning November 5, 2009 at 11:30 a.m. Eastern Time, and ending November 19, 2009, at 11:59 p.m. Eastern Time. You may listen to the replay by dialing within the U.S. (800) 642-1687 or by dialing from outside the U.S. (706) 645-9291. The replay identification number is 35689143.
About the Company
Orthovita is an orthobiologics and biosurgery company that develops and markets novel medical devices. Our orthobiologics platform offers products for the fusion, regeneration, and fixation of human bone. Our biosurgery platform offers products for controlling intra-operative bleeding, also known as hemostasis. Our current fusion and regeneration products are based on our proprietary Vitoss(TM) Bone Graft Substitute technology and address the non-structural bone graft market with synthetic, bioactive alternatives to patient- and cadaver-derived bone tissue. Cortoss(TM) Bone Augmentation Material, an injectable, polymer composite that mimics the structural characteristics of human bone, provides the basis for our fixation portfolio. Cortoss received clearance in June 2009 for vertebral augmentation. Our hemostasis portfolio includes Vitagel(TM) Surgical Hemostat, a unique, collagen-based matrix that controls bleeding and facilitates healing, and Vitasure(TM)Absorbable Hemostat, a plant-based product that can be deployed quickly throughout surgery.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s current expectations of future events that involve risks and uncertainties, including, without limitation, the demand and market acceptance of our products, including Cortoss, our ability to successfully launch Cortoss, our ability to achieve our sales and net loss forecast for 2009, and other aspects of our business. Such statements are based on management’s current expectations and are subject to a number of substantial risks and uncertainties that could cause actual results or timeliness to differ materially from those addressed in the forward-looking statements. Factors that may cause such a difference are listed from time to time in reports filed by the Company with the U.S. Securities and Exchange Commission (SEC), including but not limited to risks described in our most recently filed Form 10-K under the caption "Risk Factors.” Further information about these and other relevant risks and uncertainties may be found in Orthovita’s filings with the SEC, all of which are available from the SEC as well as other sources. Orthovita undertakes no obligation to publicly update any forward-looking statements.
Source: Orthovita, Inc. |
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10/19/2009
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Orthovita Schedules Third Quarter 2009
Financial Results Conference Call
10192009-3Q2009 Earnings Call Announcement.pdf
MALVERN, Pennsylvania, Monday, October 19, 2009 – Orthovita, Inc. (NASDAQ: VITA), a leading orthobiologics and biosurgery company, will hold a conference call on Thursday, November 5, 2009, at 8:30 a.m. Eastern Time, to review and discuss its financial results for the third quarter 2009. Antony Koblish, President and Chief Executive Officer, and Nancy C. Broadbent, Senior Vice President and Chief Financial Officer of Orthovita, will host the call.
The telephone number to join the conference call from within the U.S. is (888) 815-2919, and from outside the U.S. is (706) 643-3675. The conference identification number is 35689143. Participants should dial in ten minutes prior to the scheduled start time for the conference call.
A replay of the conference call will be available for two weeks beginning November 5, 2009, at 11:30 a.m. Eastern Time, and ending November 19, 2009, at 11:59 p.m. Eastern Time. You may listen to the replay by dialing within the U.S. (800) 642-1687 or by dialing from outside the U.S. (706) 645-9291. The replay identification number is 35689143.
About the Company
Orthovita is an orthobiologics and biosurgery company that develops and markets novel medical devices. Our orthobiologics platform offers products for the fusion, regeneration and fixation of human bone. Our biosurgery platform offers products for controlling intra-operative bleeding, also known as hemostasis. Our current fusion and regeneration products are based on our proprietary Vitoss(TM)Bone Graft Substitute technology and address the non-structural bone graft market with synthetic, bioactive alternatives to patient- and cadaver-derived bone tissue. Cortoss(TM)Bone Augmentation Material, an injectable, polymer composite that mimics the structural characteristics of human bone, provides the basis for our fixation portfolio. Cortoss received U.S. regulatory clearance in June 2009 for use in vertebral augmentation. Our hemostasis portfolio includes Vitagel(TM)Surgical Hemostat, a unique, collagen-based matrix that controls bleeding and facilitates healing, and Vitasure(TM) Absorbable Hemostat, a plant-based product that can be deployed quickly throughout surgery.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s current expectations of future events that involve risks and uncertainties, including, without limitation, the demand and market acceptance of our products, including Cortoss, our ability to successfully launch Cortoss, our ability to achieve our sales and net loss forecast for 2009, and other aspects of our business. Such statements are based on management’s current expectations and are subject to a number of substantial risks and uncertainties that could cause actual results or timeliness to differ materially from those addressed in the forward-looking statements. Factors that may cause such a difference are listed from time to time in reports filed by the Company with the U.S. Securities and Exchange Commission (SEC), including but not limited to risks described in our most recently filed Form 10-K under the caption "Risk Factors.” Further information about these and other relevant risks and uncertainties may be found in Orthovita’s filings with the SEC, all of which are available from the SEC as well as other sources. Orthovita undertakes no obligation to publicly update any forward-looking statements.
Source: Orthovita, Inc. |
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9/15/2009
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Orthovita to Participate in the
UBS Global Life Sciences Conference
09152009-UBS Conf Sep 21.pdf
MALVERN, Pennsylvania, Tuesday, September 15, 2009 – Orthovita, Inc. (NASDAQ: VITA), an orthobiologics and biosurgery company, announced today that it will present at the UBS Global Life Sciences Conference in New York City. Antony Koblish, chief executive officer of Orthovita, is scheduled to present on Monday, September 21st, at 1:00 p.m. Eastern Time, at the Grand Hyatt New York, 109 East 42nd Street at Grand Central Terminal, New York, New York. A live webcast of the presentation will be available, and can be accessed for 90 days following the conference, by visiting http://cc.talkpoint.com/ubsx001/092109a_ke/?entity=67_MRUUVNQ.
About the Company
Orthovita is an orthobiologics and biosurgery company that develops and markets novel medical devices. Our orthobiologics platform offers products for the fusion, regeneration and fixation of human bone. Our biosurgery platform offers products for controlling intra-operative bleeding, also known as hemostasis. Our current fusion and regeneration products are based on our proprietary Vitoss(TM) Bone Graft Substitute technology and address the non-structural bone graft market with synthetic, bioactive alternatives to patient- and cadaver-derived bone tissue. Cortoss(TM) Bone Augmentation Material, an injectable, polymer composite that mimics the structural characteristics of human bone, provides the basis for our fixation portfolio. Cortoss received U.S. regulatory clearance in June 2009 for use in vertebral augmentation. Our hemostasis portfolio includes Vitagel(TM) Surgical Hemostat, a unique, collagen-based matrix that controls bleeding and facilitates healing, and Vitasure(TM)Absorbable Hemostat, a plant-based product that can be deployed quickly throughout surgery.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s current expectations of future events that involve risks and uncertainties, including, without limitation, the demand and market acceptance of our products, including Cortoss, our ability to successfully launch Cortoss, our ability to achieve our sales and net loss forecast for 2009, and other aspects of our business. Such statements are based on management’s current expectations and are subject to a number of substantial risks and uncertainties that could cause actual results or timeliness to differ materially from those addressed in the forward-looking statements. Factors that may cause such a difference are listed from time to time in reports filed by the Company with the U.S. Securities and Exchange Commission (SEC), including but not limited to risks described in our most recently filed Form 10-K under the caption "Risk Factors.” Further information about these and other relevant risks and uncertainties may be found in Orthovita’s filings with the SEC, all of which are available from the SEC as well as other sources. Orthovita undertakes no obligation to publicly update any forward-looking statements.
Source: Orthovita, Inc. |
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8/10/2009
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Orthovita to Present at the
Canaccord Adams Global Growth Conference
08102009-Canaccord Adams Conf Aug 11.pdf
MALVERN, Pennsylvania, Monday, August 10, 2009 – Orthovita, Inc. (NASDAQ: VITA), an orthobiologics and biosurgery company, announced today that it will present at the Canaccord Adams Global Growth Conference in Boston, Massachusetts. Antony Koblish, chief executive officer of Orthovita, is scheduled to present on Tuesday, August 11th, at 1:30 p.m. Eastern Time, at the InterContinental Hotel, 510 Atlantic Avenue, Boston, MA. An audio webcast of the presentation will be available, and can be accessed for 90 days following the conference, by visiting http://www.wsw.com/webcast/canaccord/vita/.
About the Company
Orthovita is an orthobiologics and biosurgery company that develops and markets novel medical devices. Our orthobiologics platform offers products for the fusion, regeneration and fixation of human bone. Our biosurgery platform offers products for controlling intra-operative bleeding, also known as hemostasis. Our current fusion and regeneration products are based on our proprietary VitossTM Bone Graft Substitute technology and address the non-structural bone graft market with synthetic, bioactive alternatives to patient- and cadaver-derived bone tissue. Cortoss™ Bone Augmentation Material, an injectable, polymer composite that mimics the structural characteristics of human bone, provides the basis for our fixation portfolio. Cortoss received U.S. regulatory clearance in June 2009 for use in vertebral augmentation. Our hemostasis portfolio includes Vitagel™ Surgical Hemostat, a unique, collagen-based matrix that controls bleeding and facilitates healing, and Vitasure™ Absorbable Hemostat, a plant-based product that can be deployed quickly throughout surgery. |
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8/5/2009
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7/27/2009
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Orthovita Schedules Second Quarter 2009
Financial Results Conference Call
Orthovita Schedules Second Quarter 2009 Financial Results Conference Call.pdf
MALVERN, Pennsylvania, Monday, July 27, 2009 – Orthovita, Inc. (NASDAQ: VITA), a leading orthobiologics and biosurgery company, will hold a conference call on Thursday, August 6, 2009, at 8:30 a.m. Eastern Time, to review and discuss its financial results for the second quarter 2009 and update full year guidance. Antony Koblish, President and Chief Executive Officer, and Nancy C. Broadbent, Senior Vice President and Chief Financial Officer of Orthovita, will host the call.
The telephone number to join the conference call from within the U.S. is (888) 815-2919, and from outside the U.S. is (706) 643-3675. The conference identification number is 18137278. Participants should dial in ten minutes prior to the scheduled start time for the conference call.
A replay of the conference call will be available for two weeks beginning August 6, 2009, at 11:30 a.m. Eastern Time, and ending August 20, 2009, at 11:59 p.m. Eastern Time. You may listen to the replay by dialing within the U.S. (800) 642-1687 or by dialing from outside the U.S. (706) 645-9291. The replay identification number is 18137278.
About the Company
Orthovita is an orthobiologics and biosurgery company that develops and markets novel medical devices. The orthobiologics platform offers products for the fusion, regeneration and fixation of human bone. The biosurgery platform offers products for controlling intra-operative bleeding, also known as hemostasis. Our current fusion and regeneration products are based on our proprietary VITOSS™ Bone Graft Substitute technology and address the non-structural bone graft market with synthetic, bioactive alternatives to patient- and cadaver-derived bone tissue. CORTOSS™ Bone Augmentation Material, an injectable, polymer composite that mimics the structural characteristics of human bone, provides the basis for our fixation portfolio. Our hemostasis portfolio includes VITAGEL™ Surgical Hemostat, a unique, collagen-based matrix that controls bleeding and facilitates healing, and VITASURE™ Absorbable Hemostat, a plant-based product that can be deployed quickly throughout surgery.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s current expectations of future events that involve risks and uncertainties, including, without limitation, demand and market acceptance of CORTOSS and our other products, the ability of our sales force to market CORTOSS, and other aspects of our business. Such statements are based on management’s current expectations and are subject to a number of substantial risks and uncertainties that could cause actual results or timeliness to differ materially from those addressed in the forward-looking statements. Factors that may cause such a difference are listed from time to time in reports filed by the Company with the U.S. Securities and Exchange Commission (SEC), including but not limited to risks described in our most recently filed Form 10-K under the caption "Risks Factors,” as well as other matters such as our ability to manufacture sufficient quantities of CORTOSS to meet demand for the product. Further information about these and other relevant risks and uncertainties may be found in Orthovita’s filings with the SEC, all of which are available from the SEC as well as other sources. Orthovita undertakes no obligation to publicly update any forward-looking statements.
Source: Orthovita, Inc. |
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7/13/2009
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6/8/2009
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Orthovita Receives FDA Clearance for CORTOSS™ Bone Augmentation Material in Treatment of Vertebral Compression Fractures
Press Release - Orthovita Receives FDA Clearance For Cortoss.2009 06 08.pdf
MALVERN, Pennsylvania, USA, Monday, June 8, 2009 – Orthovita, Inc. (NASDAQ: VITA), a leading orthobiologics and biosurgery company, announced today that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market CORTOSS Bone Augmentation Material for treatment of vertebral compression fractures.
CORTOSS is an injectable, bioactive composite that mimics the physiological properties of human cortical bone and is the first alternative to polymethylmethacrylate (PMMA) cement that has been evaluated in a large-scale, multi-center, randomized, controlled clinical study and cleared in the United States for the treatment of vertebral compression fractures. “Every year roughly 250,000 people in the United States undergo augmentation procedures such as vertebroplasty and kyphoplasty for painful fractures in the spine. Since the inception of the vertebroplasty procedure in the mid 1980s, PMMA has been the only viable implant for vertebral augmentation,” stated Antony Koblish, President and CEO of Orthovita. “CORTOSS is the first FDA-cleared alternative in this product category. Our experience and research to date shows that physicians and their staff are pleased with the innovative handling and biomechanical characteristics that CORTOSS offers. We believe these features, supported by our extensive human clinical data demonstrating safety and effectiveness, offer physicians and facilities substantial value and a clear rationale for adopting CORTOSS.”
In April 2009, Orthovita submitted the 2-year follow-up clinical data for patients enrolled in the company’s prospective, randomized, multi-center study comparing the efficacy of PMMA to CORTOSS. In this 256-patient pivotal trial conducted under an investigational device exemption, CORTOSS achieved its primary end-point of non-inferiority to the PMMA control at 24-months using a composite endpoint success rate reflecting improvement in the Visual Analogue Pain Scale (VAS) pain score, maintenance or improvement in Oswestry Disability Index (ODI) function assessment, maintenance of vertebral height and alignment, and no subsequent device-related surgical intervention at the index treatment level. In the pivotal study at 24 months:
• The composite endpoint success rate was 76.9% for patients treated with CORTOSS and 73.4% for PMMA patients.
• With an ODI success rate of 96.7%, the CORTOSS patient group experienced a statistically significant benefit in function success over the PMMA group, which had an ODI success rate of 88.4%.
Early patient outcomes were also assessed in the pivotal study at 3 months:
• The composite endpoint success rate was 82.8% for patients treated with CORTOSS and 73.7% for PMMA patients.
• With a VAS success rate of 86.6%, the CORTOSS patient group experienced a statistically significant benefit in pain success over the PMMA group, which had a VAS success rate of 75.0%.
In addition to the statistically significant benefit in pain success at three months and function success at 24 months, the CORTOSS population experienced measurable benefits over the PMMA cohort in the following outcomes:
-A 43.4% reduction in subsequent, adjacent level fractures in CORTOSS patients treated for a primary fracture at one level, as measured at the end of the 24-month follow-up period.
-The CORTOSS patients required an average of 30% less material to achieve fracture fill.
John Mathis, M.D. of The Center for Advanced Imaging in Roanoke, Virginia, and editor of the original textbook entitled “Percutaneous Vertebroplasty and Kyphoplasty,” commented: “For over 20 years, the treatment of vertebral fractures relied on the application of a foreign material without much consideration for the mechanical, and none for the biological conditions. CORTOSS is a material that was designed to restore mechanical conditions and match the properties of natural bone. I believe that its introduction marks the beginning of the next phase in the treatment of vertebral fractures which will be concentrated on the patients’ physiology.”
With 83% follow-up at the 24-month time point, the study also represents a significant piece of clinical research in this field. The pivotal study, in combination with various clinical trials previously completed in the U.S. and Europe, brings the total number of patients studied for CORTOSS in vertebral compression fractures to 527.
“In the evolution of vertebroplasty, development has focused largely on the different tools to deliver PMMA, instead of improving the implant that remains in the patient forever. Years ago, Orthovita had the vision to change this. After investing a tremendous amount of work and effort, the company is now ready to introduce this new and unique implant material. In addition, the exceptional quality of the clinical study that Orthovita designed and executed is an asset to the entire spinal community, ” said Pierce D. Nunley, M.D., Director of the Spine Institute of Louisiana, who participated in the trial.
CORTOSS Bone Augmentation Material is a blend of cross-linking resins and reinforcing fillers, which include the proprietary bioactive glass found in Orthovita’s VITOSS™ Bioactive FOAM products. Unlike PMMA, CORTOSS does not contain a methylmethacrylate monomer. The composite has a constant, paste-like consistency when being injected and sets quickly to create a load bearing implant with the mechanical properties of human cortical bone. In the pivotal study, CORTOSS demonstrated flow and fill into the existing intra-vertebral anatomy rather than displacing it like PMMA, which may reduce the volume of material required for clinical success. Pre-clinical in vitro and in vivo studies show that, after implantation, a bioactive response occurs at the implant’s surface which promotes the deposition of calcium phosphate, thereby strengthening the implant-bone interface. The unique flow characteristics of CORTOSS allow low-pressure, manual delivery through Orthovita’s ALIQUOT™ Delivery System. CORTOSS’ mix-on-demand preparation allows clinicians to stop material injection for an indeterminate amount of time, thus providing a high degree of procedural flexibility.
Commercialization for CORTOSS in the U.S. will be conducted through Orthovita’s orthobiologics and biosurgical sales forces. “Orthovita’s commercial success has been grounded in our ability to effectively present the value of our basic science and human clinical data throughout a hospital,” stated Christopher Smith, Senior Vice President of Sales and Marketing. “VITOSS Bone Graft Substitute is now the leading synthetic bone graft for spine surgery and our hemostat business, led by our VITAGEL™ product, has experienced brisk growth since its inception in 2005. We believe that CORTOSS will benefit significantly from the commercial infrastructure, core competencies and call patterns we have established. Further, we estimate that our current coverage addresses roughly 80% of the surgical market for vertebral compression fractures, which gives us a strong position to launch CORTOSS while we continue plans to grow our current product lines.”
Orthovita will focus its initial commercialization strategy on supporting and ensuring continued clinical success with CORTOSS in vertebral compression fractures. “We owe our clinical investigator and coordinator teams a debt of gratitude for their tireless efforts in executing the pivotal study,” said Maarten Persenaire, M.D., Chief Medical Officer for Orthovita. “It is from their experiences and thoughtful feedback that we have planned this launch. Reproducing their clinical success with every physician who uses CORTOSS is our singular objective,” Dr. Persenaire added.
Orthovita will hold a conference call today, June 8, 2009, at 11:00 a.m. Eastern Time, to review the CORTOSS
510(k) clearance and planned commercial launch of the product in the U.S. Antony Koblish, President and Chief Executive Officer, Nancy Broadbent, Senior Vice President and Chief Financial Officer, and Maarten Persenaire, M.D., Chief Medical Officer of Orthovita, will host the call.
The telephone number to join the conference call from within the U.S. is (888) 815-2919, and from outside the U.S. is (706) 643-3675. The conference identification number is 14027161. Participants should dial in ten minutes prior to the scheduled start time for the conference call.
A replay of the conference call will be available for one month beginning June 8, 2009, at 2:30 p.m. Eastern Time, and ending July 8, 2009, at 11:59 p.m. Eastern Time. You may listen to the replay by dialing within the U.S. (800) 642-1687 or by dialing from outside the U.S. (706) 645-9291. The replay identification number is 14027161.
About the Company
Orthovita is an orthobiologics and biosurgery company that develops and markets novel medical devices. The orthobiologics platform offers products for the fusion, regeneration, and fixation of human bone. The biosurgery platform offers products for controlling intra-operative bleeding, also known as hemostasis. Our current fusion and regeneration products are based on our proprietary VITOSS(TM) Bone Graft Substitute technology and address the non-structural bone graft market with synthetic, bioactive alternatives to patient- and cadaver-derived bone tissue. CORTOSS(TM) Bone Augmentation Material, an injectable, polymer composite that mimics the structural characteristics of human bone, provides the basis for our fixation portfolio. Our hemostasis portfolio includes VITAGEL(TM) Surgical Hemostat, a unique, collagen-based matrix that controls bleeding and facilitates healing, and VITASURE(TM)Absorbable Hemostat, a plant-based product that can be deployed quickly throughout surgery.
Disclosure Notice
This press release contains forward-looking statements regarding Orthovita’s current expectations of future events that involve risks and uncertainties, including, without limitation, demand and market acceptance of CORTOSS and our other products, the ability of our sales force to market CORTOSS, and other aspects of our business. Such statements are based on management’s current expectations and are subject to a number of substantial risks and uncertainties that could cause actual results or timeliness to differ materially from those addressed in the forward-looking statements. Factors that may cause such a difference are listed from time to time in reports filed by the Company with the U.S. Securities and Exchange Commission (SEC), including but not limited to risks described in our most recently filed Form 10-K under the caption "Risk Factors,” as well as other matters such as our ability to manufacture sufficient quantities of CORTOSS to meet demand for the product. Further information about these and other relevant risks and uncertainties may be found in Orthovita’s filings with the SEC, all of which are available from the SEC as well as other sources. Orthovita undertakes no obligation to publicly update any forward-looking statements.
Source: Orthovita, Inc. |
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6/2/2009
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Orthovita Announces Upcoming VITOSS Bone Graft Substitute Presentations Scheduled for the 2009 American College of Spine Surgery Annual Meeting and the 2009 Global Spine Congress
2009 06 02 Press Release - McConnell ACSS (2).pdf
MALVERN, Pennsylvania, USA, June 2, 2009 –Orthovita, Inc. (NASDAQ: VITA), a leading orthobiologics and biosurgery company, announced today two upcoming presentations related to its VITOSS™ Bone Graft Substitute product. These presentations are based on research conducted independently from Orthovita.
Jeffrey McConnell, M.D., of the Pennsylvania Spine and Scoliosis Institute at OAA Orthopaedic Specialists in Allentown, Pennsylvania, will present his abstract “A Comparison Of ß-TCP+BMA vs. RhBMP-2 In Anterior Lumbar Interbody Fusion: A Prospective, Randomized Trial With One And Two Year Clinical And Radiographic Outcomes,” at the 2009 Annual Meeting of the American College of Spine Surgery (ACSS) to be held in Newport Beach, California, from June 4 through 6, 2009. Dr. McConnell’s presentation is scheduled for Thursday, June 4, at 1:00 p.m., in the Laguna Sunset meeting room of the Newport Beach Marriott Hotel & Spa.
Charis Mitchell, Dr. McConnell’s research assistant, will present the data at the Global Spine Congress to be held in San Francisco, California, from June 23 through 26.
Dr. McConnell’s work is in contention for Best Abstract at both meetings.
“To my knowledge, our study represents the first direct, randomized comparison between VITOSS enriched with bone marrow aspirate and recombinant human bone morphogenic protein in anterior lumbar fusion procedures,” said Dr. McConnell. “Our results show no difference in radiological and clinical outcomes between the two groups. The data from this study can help physicians choose the best bone graft composition for an individual patient, taking both physiologic and economic factors into consideration.”
About the Company
Orthovita is an orthobiologics and biosurgery company that develops and markets novel medical devices. The orthobiologics platform offers products for the fusion, regeneration, and fixation of human bone. The biosurgery platform offers products for controlling intra-operative bleeding, also known as hemostasis. Our current fusion and regeneration products are based on our proprietary VITOSS(TM)Bone Graft Substitute technology and address the non-structural bone graft market with synthetic, bioactive alternatives to patient-and cadaver-derived bone tissue. CORTOSS(TM) Bone Augmentation Material, an injectable, polymer composite that mimics the structural characteristics of human bone, provides the basis for our fixation portfolio. Our hemostasis portfolio includes VITAGEL(TM) Surgical Hemostat, a unique, collagen-based matrix that controls bleeding and facilitates healing, and VITASURE(TM)Absorbable Hemostat, a plant-based product that can be deployed quickly throughout surgery.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s current expectations of future events that involve risks and uncertainties, including, without limitation, the development, regulatory clearance or approval, demand and market acceptance of our products, including CORTOSS, the ability of our sales force to market CORTOSS, and other aspects of our business. Such statements are based on management’s current expectations and are subject to a number of substantial risks and uncertainties that could cause actual results or timeliness to differ materially from those addressed in the forward-looking statements. Factors that may cause such a difference are listed from time to time in reports filed by the Company with the U.S. Securities and Exchange Commission (SEC), including but not limited to risks described in our most recently filed Form 10-K under the caption “Risk Factors.” Further information about these and other relevant risks and uncertainties may be found in Orthovita’s filings with the SEC, all of which are available from the SEC as well as other sources. Orthovita undertakes no obligation to publicly update any forward-looking statements.
Source: Orthovita, Inc. |
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5/18/2009
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Nancy C. Broadbent to Join Orthovita
as Senior Vice President and Chief Financial Officer
Nancy C. Broadbent to Join Orthovita - May 18 2009.pdf
MALVERN, Pennsylvania, USA, Monday, May 18, 2009 – Orthovita, Inc. (NASDAQ: VITA), an orthobiologics and biosurgery company, today announced that Nancy C. Broadbent will join the Company as Senior Vice President and Chief Financial Officer effective May 26, 2009. Concurrently with the appointment of Ms. Broadbent, Mr. Albert J. Pavucek, Jr. will be appointed Principal Financial Consultant of Orthovita.
“We are very pleased to welcome Nancy to Orthovita,” said Antony Koblish, President and Chief Executive Officer. “With several years of strong historical sales growth for our existing products and a regulatory submission for our CORTOSS product candidate under review by the FDA, Orthovita is at an exciting stage of its development. Nancy’s 25 years of financial experience, including 15 years as the chief financial officer of several emerging growth companies in the healthcare industry, will be an important asset as we continue our efforts to build and expand our orthobiologics and biosurgery businesses.”
Most recently, Ms. Broadbent was Senior Vice President and Chief Financial Officer of CollaGenex Pharmaceuticals, Inc., a publicly-held dermatology company that was acquired by Galderma Pharma S.A. in February 2008. Ms. Broadbent joined CollaGenex in 1996 as its first finance employee and developed and managed all accounting, financial, investor relations and information technology functions, which included the execution of CollaGenex’s initial public offering and numerous subsequent financings. Ms. Broadbent’s background includes more than 10 years of corporate finance experience at prominent Wall Street investment banks, including Salomon Brothers and PaineWebber Incorporated, where she advised clients primarily in the area of mergers and acquisitions.
About the Company
Orthovita is an orthobiologics and biosurgery company that develops and markets novel medical devices. The orthobiologics platform offers products for the fusion, regeneration, and fixation of human bone. The biosurgery platform offers products for controlling intra-operative bleeding, also known as hemostasis. Our current fusion and regeneration products are based on our proprietary VITOSS(TM) Bone Graft Substitute technology and address the non-structural bone graft market with synthetic, bioactive alternatives to patient- and cadaver-derived bone tissue. CORTOSS(TM) Bone Augmentation Material, an injectable, polymer composite that mimics the structural characteristics of human bone, provides the basis for our fixation portfolio. Our hemostasis portfolio includes VITAGEL(TM) Surgical Hemostat, a unique, collagen-based matrix that controls bleeding and facilitates healing, and VITASURE(TM)Absorbable Hemostat, a plant-based product that can be deployed quickly throughout surgery.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s current expectations of future events that involve risks and uncertainties, including, without limitation, the development, regulatory clearance or approval, demand and market acceptance of our products, including CORTOSS; and other aspects of our business. Such statements are based on management’s current expectations and are subject to a number of substantial risks and uncertainties that could cause actual results or timeliness to differ materially from those addressed in the forward-looking statements. Factors that may cause such a difference are listed from time to time in reports filed by the Company with the U.S. Securities and Exchange Commission (SEC), including but not limited to risks described in our most recently filed Form 10-K under the caption "Risk Factors.” Further information about these and other relevant risks and uncertainties may be found in Orthovita’s filings with the SEC, all of which are available from the SEC as well as other sources. Orthovita undertakes no obligation to publicly update any forward-looking statements.
Source: Orthovita, Inc. |
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5/6/2009
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4/23/2009
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Orthovita Schedules First Quarter 2009
Financial Results Conference Call
04232009-1Q2009 Earnings Call Announcement.pdf
MALVERN, Pennsylvania, Thursday, April 23, 2009 – Orthovita, Inc. (NASDAQ: VITA), an orthobiologics and biosurgery company, will hold a conference call on Thursday, May 7, 2009, at 8:30 a.m. Eastern Time, to review and discuss its financial results for the first quarter 2009. Antony Koblish, President and Chief Executive Officer, and Albert J. Pavucek, Jr., Chief Financial Officer of Orthovita, will host the call.
The telephone number to join the conference call from within the U.S. is (888) 815-2919, and from outside the U.S. is (706) 643-3675. The conference identification number is 94416118. Participants should dial in ten minutes prior to the scheduled start time for the conference call.
A replay of the conference call will be available for one week beginning May 7, 2009, at 11:30 a.m. Eastern Time, and ending May 14, 2009, at 11:59 p.m. Eastern Time. You may listen to the replay by dialing within the U.S. (800) 642-1687 or by dialing from outside the U.S. (706) 645-9291. The replay identification number is 94416118.
About the Company
Orthovita is an orthobiologics and biosurgery company that develops and markets novel medical devices. The orthobiologics platform offers products for the fusion, regeneration, and fixation of human bone. The biosurgery platform offers products for controlling intra-operative bleeding, also known as hemostasis. Our current fusion and regeneration products are based on our proprietary VITOSS® Bone Graft Substitute technology and address the non-structural bone graft market with synthetic, bioactive alternatives to patient- and cadaver-derived bone tissue. CORTOSS® Bone Augmentation Material, an injectable, polymer composite that mimics the structural characteristics of human bone, provides the basis for our fixation portfolio. CORTOSS Bone Augmentation Material is approved in certain countries outside the U.S. and is under review for clearance in the U.S. for vertebral augmentation. Our hemostasis portfolio includes VITAGEL® Surgical Hemostat, a unique, collagen-based matrix that controls bleeding and facilitates healing, and VITASURE™ Absorbable Hemostat, a plant-based product that can be deployed quickly throughout surgery. |
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4/1/2009
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Orthovita Submits Additional Data to FDA in Support of its
510(k) Application for the Use of CORTOSS® Bone Augmentation Material in Vertebral Augmentation
Two-Year Follow-Up Period Has Been Completed
for Patients Enrolled in the CORTOSS Pivotal Study
2009 04 01 CORTOSS 510_k_ submission.pdf
MALVERN, Pennsylvania, Wednesday, April 1, 2009 –Orthovita, Inc. (NASDAQ: VITA) announced today that it has submitted additional data to the U.S. Food and Drug Administration in support its 510(k) filing for the use of its CORTOSS Bone Augmentation Material in vertebral augmentation. This 510(k) application is intended to demonstrate that the performance of CORTOSS is substantially equivalent to polymethylmethacrylate (PMMA) bone cement.
The data submitted today includes two-year follow-up data from Orthovita’s pivotal, prospective, randomized, multi-site clinical study conducted under an FDA investigational device exemption (IDE). In the pivotal study, a total of 162 patients were treated with CORTOSS and 94 patients were treated with PMMA. The two-year follow-up period has now been completed for the pivotal study. In addition to two-year follow-up clinical data for patients enrolled in the pivotal study, Orthovita has submitted to FDA data on patients from two pilot U.S. clinical investigations conducted under FDA IDEs and from several European studies with follow-up ranging from 11 months to over 4 years.
“To our knowledge, the CORTOSS 510(k) filing contains the largest prospective, randomized, controlled clinical dataset ever assembled in the treatment of vertebral compression fractures. We are pleased with the high rate of follow-up that we obtained in the geriatric patient population that was enrolled in our pivotal study. We recognize and very much appreciate the diligence and tremendous effort shown by our clinical investigators and their staff in obtaining this critical, long-term data,” said Dr. Maarten Persenaire, Orthovita’s Chief Medical Officer.
FDA clearance of CORTOSS would permit Orthovita to market and sell the material in the United States for vertebral augmentation. CORTOSS has CE Certification for use in the European Union for screw augmentation and for vertebral augmentation. This enables CORTOSS to be sold in the European Union as well as in other countries that have adopted the European Union’s regulatory standards.
About the Company
Orthovita is an orthobiologics and biosurgery company that develops and markets novel medical devices. The orthobiologics platform offers products for the fusion, regeneration and fixation of human bone. The biosurgery platform offers products for controlling intra-operative bleeding, also known as hemostasis. Our current fusion and regeneration products are based on our proprietary VITOSS® Bone Graft Substitute technology and address the non-structural bone graft market with synthetic, bioactive alternatives to patient- and cadaver-derived bone tissue. CORTOSS® Bone Augmentation Material, an injectable, polymer composite that mimics the structural characteristics of human bone, provides the basis for our fixation portfolio. CORTOSS Bone Augmentation Material is approved in certain countries outside the U.S. and is under review for clearance in the U.S. for vertebral augmentation. Our hemostasis portfolio includes VITAGEL® Surgical Hemostat, a unique, collagen-based matrix that controls bleeding and facilitates healing, and VITASURE™ Absorbable Hemostat, a plant-based product that can be deployed quickly throughout surgery.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s current expectations of future events that involve risks and uncertainties, including, without limitation, the development, regulatory approval, demand and market acceptance of our products; our ability to obtain FDA clearance for CORTOSS in the United States; and other aspects of our business. Such statements are based on management’s current expectations and are subject to a number of substantial risks and uncertainties that could cause actual results or timeliness to differ materially from those addressed in the forward-looking statements. Other factors that may cause such a difference are listed from time to time in reports filed by the Company with the U.S. Securities and Exchange Commission (SEC), including but not limited to risks described in our most recently filed Form 10-K under the caption "Risks Factors.” Further information about these and other relevant risks and uncertainties may be found in Orthovita’s filings with the SEC, all of which are available from the SEC as well as other sources. Orthovita undertakes no obligation to publicly update any forward-looking statements.
Source: Orthovita, Inc. |
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3/18/2009
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Orthovita to Participate in the
Lazard Capital Markets Medical Technology Conference
03182009-Lazard Conf Mar 26.pdf
MALVERN, Pennsylvania, Wednesday, March 18, 2009 – Orthovita, Inc. (NASDAQ: VITA), an orthobiologics and biosurgery company, announced today that it will participate in the Lazard Capital Markets Medical Technology Conference in Snowbird, Utah. Antony Koblish, chief executive officer of Orthovita, is scheduled to participate in a series of one-on-one meetings with institutional investors on Thursday, March 26th, from 9:00 a.m. to 5:00 p.m. Mountain Time, at The Cliff Lodge at Snowbird Ski & Summer Resort, Highway 210, Little Cottonwood Canyon, Snowbird, UT.
About the Company
Orthovita is an orthobiologics and biosurgery company that develops and markets novel medical devices. The orthobiologics platform offers products for the fusion, regeneration, and fixation of human bone. The biosurgery platform offers products for controlling intra-operative bleeding, also known as hemostasis. Our current fusion and regeneration products are based on our proprietary VITOSS® Bone Graft Substitute technology and address the non-structural bone graft market with synthetic, bioactive alternatives to patient- and cadaver-derived bone tissue. CORTOSS® Bone Augmentation Material, an injectable, polymer composite that mimics the structural characteristics of human bone, provides the basis for our fixation portfolio. CORTOSS Bone Augmentation Material is approved in certain countries outside the U.S. and is under review for clearance in the U.S. for vertebral augmentation. Our hemostasis portfolio includes VITAGEL® Surgical Hemostat, a unique, collagen-based matrix that controls bleeding and facilitates healing, and VITASURE™ Absorbable Hemostat, a plant-based product that can be deployed quickly throughout surgery.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s current expectations of future events that involve risks and uncertainties, including, without limitation, the development, regulatory approval, demand and market acceptance of our products; our ability to obtain FDA clearance for CORTOSS in the United States; and other aspects of our business. Such statements are based on management’s current expectations and are subject to a number of substantial risks and uncertainties that could cause actual results or timeliness to differ materially from those addressed in the forward-looking statements. Other factors that may cause such a difference are listed from time to time in reports filed by the Company with the U.S. Securities and Exchange Commission (SEC), including but not limited to risks described in our most recently filed Form 10-K under the caption "Risks Factors”. Further information about these and other relevant risks and uncertainties may be found in Orthovita’s filings with the SEC, all of which are available from the SEC as well as other sources. Orthovita undertakes no obligation to publicly update any forward-looking statements.
Source: Orthovita, Inc. |
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3/11/2009
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3/10/2009
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Orthovita to Present at the Cowen and Company 29th Annual Health Care Conference
03102009-Cowen Conf Mar 16.pdf
MALVERN, Pennsylvania, Tuesday, March 10, 2009 – Orthovita, Inc. (NASDAQ: VITA), an orthobiologics and biosurgery company, announced today that it will present at the Cowen and Company 29th Annual Health Care Conference in Boston, Massachusetts. Antony Koblish, chief executive officer of Orthovita, is scheduled to present on Monday, March 16th, at 3:10 p.m. Eastern Time, at the Boston Marriott Copley Place, 110 Huntington Avenue, Boston, MA. A live webcast of the presentation will be available, and can be accessed for 90 days following the conference, by visiting http://www.corporate-ir.net/ireye/conflobby.zhtml?ticker=
***VITA&item_id=2110791.
About the Company
Orthovita is an orthobiologics and biosurgery company that develops and markets novel medical devices. The orthobiologics platform offers products for the fusion, regeneration, and fixation of human bone. The biosurgery platform offers products for controlling intra-operative bleeding, also known as hemostasis. Our current fusion and regeneration products are based on our proprietary VITOSS® Bone Graft Substitute technology and address the non-structural bone graft market with synthetic, bioactive alternatives to patient- and cadaver-derived bone tissue. CORTOSS® Bone Augmentation Material, an injectable, polymer composite that mimics the structural characteristics of human bone, provides the basis for our fixation portfolio. CORTOSS Bone Augmentation Material is approved in certain countries outside the U.S. and is under review for clearance in the U.S. for vertebral augmentation. Our hemostasis portfolio includes VITAGEL® Surgical Hemostat, a unique, collagen-based matrix that controls bleeding and facilitates healing, and VITASURE™ Absorbable Hemostat, a plant-based product that can be deployed quickly throughout surgery.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s current expectations of future events that involve risks and uncertainties, including, without limitation, the development, regulatory approval, demand and market acceptance of our products; our ability to obtain FDA clearance for CORTOSS in the United States; and other aspects of our business. Such statements are based on management’s current expectations and are subject to a number of substantial risks and uncertainties that could cause actual results or timeliness to differ materially from those addressed in the forward-looking statements. Other factors that may cause such a difference are listed from time to time in reports filed by the Company with the U.S. Securities and Exchange Commission (SEC), including but not limited to risks described in our most recently filed Form 10-K under the caption "Risks Factors”. Further information about these and other relevant risks and uncertainties may be found in Orthovita’s filings with the SEC, all of which are available from the SEC as well as other sources. Orthovita undertakes no obligation to publicly update any forward-looking statements.
Source: Orthovita, Inc. |
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3/4/2009
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Orthovita Board of Directors Elects William Tidmore
Chairman of the Board
030409_chairman.pdf
MALVERN, Pennsylvania, Wednesday, March 4, 2009 – The Board of Directors of Orthovita, Inc. (NASDAQ: VITA) has named William Tidmore Chairman of the Board of the Company effective March 3, 2009, following the resignation on March 1, 2009 of David Fitzgerald as Chairman of the Board and a director of Orthovita.
Mr. Tidmore has served as a member of Orthovita’s Board of Directors since 2007 and has over 20 years of experience in the spine and orthopedic industry. He was formerly President and Chairman of DePuy Acromed, as well as President of DePuy, which was acquired by Johnson & Johnson in 1999. Mr. Tidmore held various senior management positions during his tenure of over 14 years with Depuy, including leadership roles for international businesses with direct operational responsibilities across Europe, Latin America, Japan and Canada. Prior to that, Mr. Tidmore held several management positions at Ethicon, Inc., including Vice President of Sales and Marketing in Canada.
Mr. Fitzgerald, who had served since 2003 as Orthovita’s Chairman of the Board and as a member of the Board of Directors of ArthroCare Corp. (OTC:ARTC.PK), submitted his resignation to the Company due to his recent appointment as Acting President and Chief Executive Officer of ArthroCare. His decision to resign from Orthovita’s Board was based on the change in his role at ArthroCare to a senior executive, in recognition of the time commitment and possible business conflicts associated with this position.
“Dave has been an outstanding Chairman at Orthovita who has played an important role in the Company’s success throughout the years,” said Antony Koblish, President and Chief Executive Officer of Orthovita. “Under his guidance, Orthovita significantly increased sales, completed several key equity and debt financings, acquired marketing rights for two hemostasis products and made substantial progress in product development. We appreciate Dave’s contributions and he will be missed. We look forward to solid leadership from Bill Tidmore and the contributions that his extensive experience in the orthopedic and spine industry will bring.”
About the Company
Orthovita is an orthobiologics and biosurgery company that develops and markets novel medical devices. The orthobiologics platform offers products for the fusion, regeneration and fixation of human bone. The biosurgery platform offers products for controlling intra-operative bleeding, also known as hemostasis. Our current fusion and regeneration products are based on our proprietary VITOSS® Bone Graft Substitute technology and address the non-structural bone graft market with synthetic, bioactive alternatives to patient- and cadaver-derived bone tissue. CORTOSS® Bone Augmentation Material, an injectable, polymer composite that mimics the structural characteristics of human bone, provides the basis for our fixation portfolio. CORTOSS Bone Augmentation Material is approved in certain countries outside the U.S. and is under review for clearance in the U.S. for vertebral augmentation. Our hemostasis portfolio includes VITAGEL® Surgical Hemostat, a unique, collagen-based matrix that controls bleeding and facilitates healing, and VITASURE™ Absorbable Hemostat, a plant-based product that can be deployed quickly throughout surgery.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s current expectations of future events that involve risks and uncertainties, including, without limitation, the development, regulatory approval, demand and market acceptance of our products; our ability to obtain FDA clearance for CORTOSS in the United States; and other aspects of our business. Such statements are based on management’s current expectations and are subject to a number of substantial risks and uncertainties that could cause actual results or timeliness to differ materially from those addressed in the forward-looking statements. Other factors that may cause such a difference are listed from time to time in reports filed by the Company with the U.S. Securities and Exchange Commission (SEC), including but not limited to risks described in our most recently filed Form 10-K under the caption "Risks Factors”. Further information about these and other relevant risks and uncertainties may be found in Orthovita’s filings with the SEC, all of which are available from the SEC as well as other sources. Orthovita undertakes no obligation to publicly update any forward-looking statements.
Source: Orthovita, Inc. |
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2/26/2009
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Orthovita Schedules Fourth Quarter and Year-End 2008 Financial Results Conference Call
4Q YE 2008 Earnings Conf Call Announcement_022609.pdf
MALVERN, Pennsylvania, Thursday, February 26, 2009 – Orthovita, Inc. (NASDAQ: VITA), an orthobiologics and biosurgery company, will hold a conference call on Thursday, March 12, 2009, at 8:30 a.m. Eastern Time, to review and discuss its financial results for the fourth quarter and year-end 2008, and provide guidance for 2009. Antony Koblish, President and Chief Executive Officer, and Albert J. Pavucek, Jr., Chief Financial Officer of Orthovita, will host the call.
The telephone number to join the conference call from within the U.S. is (888) 815-2919, and from outside the U.S. is (706) 643-3675. The conference identification number is 86646129. Participants should dial in ten minutes prior to the scheduled start time for the conference call.
A replay of the conference call will be available for one week beginning March 12, 2009, at 11:30 a.m. Eastern Time, and ending March 19, 2009, at 11:59 p.m. Eastern Time. You may listen to the replay by dialing within the U.S. (800) 642-1687 or by dialing from outside the U.S. (706) 645-9291. The replay identification number is 86646129.
About the Company
Orthovita is an orthobiologics and biosurgery company that develops and markets novel medical devices. The orthobiologics platform offers products for the fusion, regeneration, and fixation of human bone. The biosurgery platform offers products for controlling intra-operative bleeding, also known as hemostasis. Our current fusion and regeneration products are based on our proprietary VITOSS® Bone Graft Substitute technology and address the non-structural bone graft market with synthetic, bioactive alternatives to patient- and cadaver-derived bone tissue. CORTOSS® Bone Augmentation Material, an injectable, polymer composite that mimics the structural characteristics of human bone, provides the basis for our fixation portfolio. CORTOSS Bone Augmentation Material is approved in certain countries outside the U.S. and is under review for clearance in the U.S. for vertebral augmentation. Our hemostasis portfolio includes VITAGEL® Surgical Hemostat, a unique, collagen-based matrix that controls bleeding and facilitates healing, and VITASURE™ Absorbable Hemostat, a plant-based product that can be deployed quickly throughout surgery.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s current expectations of future events that involve risks and uncertainties, including, without limitation, the development, regulatory approval, demand and market acceptance of our products; our ability to obtain FDA clearance for CORTOSS in the United States; and other aspects of our business. Such statements are based on management’s current expectations and are subject to a number of substantial risks and uncertainties that could cause actual results or timeliness to differ materially from those addressed in the forward-looking statements. Other factors that may cause such a difference are listed from time to time in reports filed by the Company with the U.S. Securities and Exchange Commission (SEC), including but not limited to risks described in our most recently filed Form 10-K under the caption "Risks Factors”. Further information about these and other relevant risks and uncertainties may be found in Orthovita’s filings with the SEC, all of which are available from the SEC as well as other sources. Orthovita undertakes no obligation to publicly update any forward-looking statements.
Source: Orthovita, Inc. |
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2/20/2009
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Orthovita to Present at the
Canaccord Adams Musculoskeletal Conference
Canaccord Adams Conf Feb 24 2009.pdf
MALVERN, Pennsylvania, Friday, February 20, 2009 – Orthovita, Inc. (NASDAQ: VITA), an orthobiologics and biosurgery company, announced today that it will present at the Canaccord Adams Musculoskeletal Conference in Las Vegas, Nevada. Antony Koblish, chief executive officer of Orthovita, is scheduled to present on Tuesday, February 24h, at 12:40 p.m. Pacific Time, at the University of Nevada, Las Vegas, 4505 Maryland Parkway, Las Vegas, NV. An audio webcast of the presentation will be available, and can be accessed for 90 days following the conference, by visiting http://www.newswire.ca/en/webcast/viewEvent.cgi?eventID=2550240.
About the Company
Orthovita is an orthobiologics and biosurgery company that develops and markets novel medical devices. The orthobiologics platform offers products for the fusion, regeneration, and fixation of human bone. The biosurgery platform offers products for controlling intra-operative bleeding, also known as hemostasis. Our current fusion and regeneration products are based on our proprietary VITOSS® Bone Graft Substitute technology and address the non-structural bone graft market with synthetic, bioactive alternatives to patient- and cadaver-derived bone tissue. CORTOSS® Bone Augmentation Material, an injectable, polymer composite that mimics the structural characteristics of human bone, provides the basis for our fixation portfolio. CORTOSS Bone Augmentation Material is approved in certain countries outside the U.S. and is under review for clearance in the U.S. for vertebral augmentation. Our hemostasis portfolio includes VITAGEL® Surgical Hemostat, a unique, collagen-based matrix that controls bleeding and facilitates healing, and VITASURE™ Absorbable Hemostat, a plant-based product that can be deployed quickly throughout surgery.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s current expectations of future events that involve risks and uncertainties, including, without limitation, the development, regulatory approval, demand and market acceptance of our products; our ability to obtain FDA clearance for CORTOSS in the United States; and other aspects of our business. Such statements are based on management’s current expectations and are subject to a number of substantial risks and uncertainties that could cause actual results or timeliness to differ materially from those addressed in the forward-looking statements. Other factors that may cause such a difference are listed from time to time in reports filed by the Company with the U.S. Securities and Exchange Commission (SEC), including but not limited to risks described in our most recently filed Form 10-K under the caption "Risks Factors”. Further information about these and other relevant risks and uncertainties may be found in Orthovita’s filings with the SEC, all of which are available from the SEC as well as other sources. Orthovita undertakes no obligation to publicly update any forward-looking statements.
Source: Orthovita, Inc. |
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2/13/2009
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Orthovita to Present at the Roth Capital Partners 21st Annual Growth Stock Conference
02122009-Roth Capital Conf Feb 18.pdf
MALVERN, Pennsylvania, Friday, February 13, 2009 – Orthovita, Inc. (NASDAQ: VITA), an orthobiologics and biosurgery company, announced today that it will present at the Roth Capital Partners 21st Annual Growth Stock Conference in Dana Point, California. Antony Koblish, chief executive officer of Orthovita, is scheduled to present on Wednesday, February 18th, at 2:00 p.m. Pacific Time, at The Ritz Carlton Laguna Niguel, One Ritz-Carlton Drive, Dana Point, CA. An audio webcast of the presentation will be available, and can be accessed for 90 days following the conference, by visiting http://www.wsw.com/webcast/roth20/vita/.
About the Company
Orthovita is an orthobiologics and biosurgery company that develops and markets novel medical devices. The orthobiologics platform offers products for the fusion, regeneration, and fixation of human bone. The biosurgery platform offers products for controlling intra-operative bleeding, also known as hemostasis. Our current fusion and regeneration products are based on our proprietary VITOSS® Bone Graft Substitute technology and address the non-structural bone graft market with synthetic, bioactive alternatives to patient- and cadaver-derived bone tissue. CORTOSS® Bone Augmentation Material, an injectable, polymer composite that mimics the structural characteristics of human bone, provides the basis for our fixation portfolio. CORTOSS Bone Augmentation Material is approved in certain countries outside the U.S. and is under review for clearance in the U.S. for vertebral augmentation. Our hemostasis portfolio includes VITAGEL® Surgical Hemostat, a unique, collagen-based matrix that controls bleeding and facilitates healing, and VITASURE™ Absorbable Hemostat, a plant-based product that can be deployed quickly throughout surgery.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s current expectations of future events that involve risks and uncertainties, including, without limitation, the development, regulatory approval, demand and market acceptance of our products; our ability to obtain FDA clearance for CORTOSS in the United States; and other aspects of our business. Such statements are based on management’s current expectations and are subject to a number of substantial risks and uncertainties that could cause actual results or timeliness to differ materially from those addressed in the forward-looking statements. Other factors that may cause such a difference are listed from time to time in reports filed by the Company with the U.S. Securities and Exchange Commission (SEC), including but not limited to risks described in our most recently filed Form 10-K under the caption "Risks Factors”. Further information about these and other relevant risks and uncertainties may be found in Orthovita’s filings with the SEC, all of which are available from the SEC as well as other sources. Orthovita undertakes no obligation to publicly update any forward-looking statements.
Source: Orthovita, Inc. |
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12/2/2008
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Orthovita to Participate in the RBC Capital Markets 2008 Healthcare Conference
12022008-RBC Capital Markets Conf Dec 11.pdf
MALVERN, Pennsylvania, Tuesday, December 2, 2008 – Orthovita, Inc. (NASDAQ: VITA), a spine and orthopedic biosurgery company, announced today that it will participate in the RBC Capital Markets 2008 Healthcare Conference in New York. Antony Koblish, president and chief executive officer of Orthovita, will participate in a panel discussion entitled “Showing Some Spine–With Innovation” on Thursday, December 11th, at 11:00 a.m. Eastern Time, at The Westin New York at Times Square, 270 West 43rd Street, New York, NY. An audio-only webcast of the panel discussion will be available and can be accessed for thirty days following the conference by visiting http://www.wsw.com/webcast/rbc95/panel25.
About the Company
Orthovita is a spine and orthopedic biosurgery company with proprietary biomaterials and biologic technologies for the development and commercialization of synthetic, biologically active, tissue engineering products. We develop and market synthetic-based biomaterials products for use in spine surgery, the repair of fractures and a broad range of clinical needs in the trauma, joint reconstruction, revision and extremities markets. Our near-term commercial business is based on our VITOSS(R) Bone Graft Substitute technology platforms, which are designed to address the non-structural bone graft market by offering synthetic alternatives to the use of autograft or cadaver-based bone material, VITAGEL(R) Surgical Hemostat, which is an adherent matrix and an impermeable barrier to blood flow, and VITASURE™ Absorbable Hemostat. Our longer-term U.S. clinical development program is focused on our internally developed CORTOSS(R) Bone Augmentation Material technology platform, which is primarily designed for injections in osteoporotic spines to treat vertebral compression fractures. We work jointly with Kensey Nash Corporation to develop and commercialize certain products based on our VITOSS platform, we market VITAGEL under a license agreement, we market VITASURE Absorbable Hemostat under a distribution rights agreement, and we continue to pursue similar relationships.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s current expectations of future events that involve risks and uncertainties, including, without limitation, the development, regulatory approval, demand and market acceptance of our products; our ability to obtain FDA clearance for CORTOSS in the United States; and other aspects of our business. Such statements are based on management’s current expectations and are subject to a number of substantial risks and uncertainties that could cause actual results or timeliness to differ materially from those addressed in the forward-looking statements. Other factors that may cause such a difference are listed from time to time in reports filed by the Company with the U.S. Securities and Exchange Commission (SEC), including but not limited to risks described in our most recently filed Form 10-K under the caption "Risks Factors”. Further information about these and other relevant risks and uncertainties may be found in Orthovita’s filings with the SEC, all of which are available from the SEC as well as other sources. Orthovita undertakes no obligation to publicly update any forward-looking statements.
Source: Orthovita, Inc. |
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11/12/2008
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Orthovita to Present at the Lazard Capital Markets 5th Annual Healthcare Conference
11122008-Lazard Conf Nov 19.pdf
MALVERN, Pennsylvania, Wednesday, November 12, 2008 – Orthovita, Inc. (NASDAQ: VITA), a spine and orthopedic biosurgery company, announced today that it will present at the Lazard Capital Markets 5th Annual Healthcare Conference in New York. Antony Koblish, chief executive officer of Orthovita, is scheduled to present on Wednesday, November 19th, at 3:30 p.m. Eastern Time, at the St. Regis New York Hotel, 2 East 55th Street at Fifth Avenue, New York, NY. A live audio webcast of the presentation will be available, and can be accessed for 90 days following the conference, by visiting http://www.wsw.com/webcast/lz5/vita.
About the Company
Orthovita is a spine and orthopedic biosurgery company with proprietary biomaterials and biologic technologies for the development and commercialization of synthetic, biologically active, tissue engineering products. We develop and market synthetic-based biomaterials products for use in spine surgery, the repair of fractures and a broad range of clinical needs in the trauma, joint reconstruction, revision and extremities markets. Our near-term commercial business is based on our VITOSS(R) Bone Graft Substitute technology platforms, which are designed to address the non-structural bone graft market by offering synthetic alternatives to the use of autograft or cadaver-based bone material, VITAGEL(R) Surgical Hemostat, which is an adherent matrix and an impermeable barrier to blood flow, and VITASURE™ Absorbable Hemostat. Our longer-term U.S. clinical development program is focused on our internally developed CORTOSS(R) Bone Augmentation Material technology platform, which is primarily designed for injections in osteoporotic spines to treat vertebral compression fractures. We work jointly with Kensey Nash Corporation to develop and commercialize certain products based on our VITOSS platform, we market VITAGEL under a license agreement, we market VITASURE Absorbable Hemostat under a distribution rights agreement, and we continue to pursue similar relationships.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s current expectations of future events that involve risks and uncertainties, including, without limitation, the development, regulatory approval, demand and market acceptance of our products; our ability to obtain FDA clearance for CORTOSS in the United States; and other aspects of our business. Such statements are based on management’s current expectations and are subject to a number of substantial risks and uncertainties that could cause actual results or timeliness to differ materially from those addressed in the forward-looking statements. Other factors that may cause such a difference are listed from time to time in reports filed by the Company with the U.S. Securities and Exchange Commission (SEC), including but not limited to risks described in our most recently filed Form 10-K under the caption "Risks Factors”. Further information about these and other relevant risks and uncertainties may be found in Orthovita’s filings with the SEC, all of which are available from the SEC as well as other sources. Orthovita undertakes no obligation to publicly update any forward-looking statements.
Source: Orthovita, Inc. |
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11/4/2008
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Orthovita to Present at the Rodman & Renshaw 10th Annual Healthcare Conference
110408_Rodman Renshaw Conf Nov 10.pdf
MALVERN, Pennsylvania, Tuesday, November 4, 2008 – Orthovita, Inc. (NASDAQ: VITA), a spine and orthopedic biosurgery company, announced today that it will present at the Rodman & Renshaw 10th Annual Healthcare Conference in New York. Antony Koblish, chief executive officer of Orthovita, is scheduled to present on Monday, November 10th, at 2:50 p.m. Eastern Time, at the New York Palace Hotel, 455 Madison Avenue, New York, NY. A live audio webcast of the presentation will be available, and can be accessed for 90 days following the conference, by visiting http://www.wsw.com/webcast/rrshq14/vita.
About the Company
Orthovita is a spine and orthopedic biosurgery company with proprietary biomaterials and biologic technologies for the development and commercialization of synthetic, biologically active, tissue engineering products. We develop and market synthetic-based biomaterials products for use in spine surgery, the repair of fractures and a broad range of clinical needs in the trauma, joint reconstruction, revision and extremities markets. Our near-term commercial business is based on our VITOSS(R) Bone Graft Substitute technology platforms, which are designed to address the non-structural bone graft market by offering synthetic alternatives to the use of autograft or cadaver-based bone material, VITAGEL(R) Surgical Hemostat, which is an adherent matrix and an impermeable barrier to blood flow, and VITASURE™ Absorbable Hemostat. Our longer-term U.S. clinical development program is focused on our internally developed CORTOSS(R) Bone Augmentation Material technology platform, which is primarily designed for injections in osteoporotic spines to treat vertebral compression fractures. We work jointly with Kensey Nash Corporation to develop and commercialize certain products based on our VITOSS platform, we market VITAGEL under a license agreement, we market VITASURE Absorbable Hemostat under a distribution rights agreement, and we continue to pursue similar relationships.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s current expectations of future events that involve risks and uncertainties, including, without limitation, the development, regulatory approval, demand and market acceptance of our products; our ability to obtain FDA clearance for CORTOSS in the United States; and other aspects of our business. Such statements are based on management’s current expectations and are subject to a number of substantial risks and uncertainties that could cause actual results or timeliness to differ materially from those addressed in the forward-looking statements. Other factors that may cause such a difference are listed from time to time in reports filed by the Company with the U.S. Securities and Exchange Commission (SEC), including but not limited to risks described in our most recently filed Form 10-K under the caption "Risks Factors”. Further information about these and other relevant risks and uncertainties may be found in Orthovita’s filings with the SEC, all of which are available from the SEC as well as other sources. Orthovita undertakes no obligation to publicly update any forward-looking statements.
Source: Orthovita, Inc. |
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11/3/2008
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10/14/2008
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Orthovita Schedules Third Quarter 2008 Financial Results Conference Call
3Q2008 Earnings Conf Call.pdf
MALVERN, Pennsylvania, USA, Tuesday, October 14, 2008 – Orthovita, Inc. (NASDAQ: VITA), a spine and orthopedic biosurgery company, will hold a conference call on Tuesday, November 4, 2008, at 8:30 a.m. Eastern Time, to review and discuss its financial results for the third quarter 2008. Antony Koblish, President and Chief Executive Officer, and Albert J. Pavucek, Jr., Chief Financial Officer of Orthovita, will host the call.
The telephone number to join the conference call from within the U.S. is (888) 815-2919, and from outside the U.S. is (706) 643-3675. The conference identification number is 67743061. Participants should dial in ten minutes prior to the scheduled start time for the conference call.
A replay of the conference call will be available for one week beginning November 4, 2008, at 11:30 a.m. Eastern Time, and ending November 11, 2008, at 11:59 p.m. Eastern Time. You may listen to the replay by dialing within the U.S. (800) 642-1687 or by dialing from outside the U.S. (706) 645-9291. The replay identification number is 67743061.
About the Company
Orthovita is a spine and orthopedic biosurgery company with proprietary biomaterials and biologic technologies for the development and commercialization of synthetic, biologically active tissue engineering products. We develop and market synthetic-based biomaterials products for use in spine surgery, the repair of fractures and a broad range of clinical needs in the trauma, joint reconstruction, revision and extremities markets. Our near-term commercial business is based on our VITOSS® Bone Graft Substitute technology platforms, which are designed to address the non-structural bone graft market by offering synthetic alternatives to the use of autograft or cadaver-based bone material, VITAGEL® Surgical Hemostat, an adherent matrix and an impermeable barrier to blood flow, and VITASURE™ Absorbable Hemostat. Our longer-term U.S. clinical development program is focused on our internally developed CORTOSS® Bone Augmentation Material technology platform, which is primarily designed for injections in osteoporotic spines to treat vertebral compression fractures.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s current expectations of future events that involve risks and uncertainties, including, without limitation, the development, regulatory approval, demand and market acceptance of our products; our ability to obtain FDA clearance for CORTOSS® in the United States; and other aspects of our business. Such statements are based on management’s current expectations and are subject to a number of substantial risks and uncertainties that could cause actual results or timeliness to differ materially from those addressed in the forward-looking statements. Other factors that may cause such a difference are listed from time to time in reports filed by the Company with the U.S. Securities and Exchange Commission (SEC), including but not limited to risks described in our most recently filed Form 10-K under the caption "Risks Factors”. Further information about these and other relevant risks and uncertainties may be found in Orthovita’s filings with the SEC, all of which are available from the SEC as well as other sources. Orthovita undertakes no obligation to publicly update any forward-looking statements.
Source: Orthovita, Inc. |
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9/22/2008
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Orthovita Announces New VITOSS® Bioactive Foam Pack
Bone Graft Substitute
2008 09 22 Bioactive PACK clearance and launch.pdf
MALVERN, Pennsylvania, Monday, September 22, 2008 – Orthovita, Inc. (NASDAQ: VITA), a spine and orthopedic biosurgery company, today announced VITOSS Bioactive Foam Pack as the newest addition to its bone graft substitute product line. Orthovita plans to launch VITOSS Bioactive Foam Pack in September 2008.
The VITOSS Bioactive Foam Pack product has the same structure, porosity and handling properties as Orthovita’s VITOSS Foam Pack product, and both product lines contain Orthovita’s proprietary VITOSS beta-tricalcium phosphate bone graft substitute and Kensey Nash Corporation’s proprietary collagen. VITOSS Bioactive Foam Pack includes Orthovita’s proprietary bioactive glass and has been shown in pre-clinical studies to accelerate bone healing, as evidenced by increased bone strength, when compared to non-bioactive materials. With its putty-like handling properties, the product can be easily molded for bone grafting procedures. VITOSS Bioactive Foam Pack is Orthovita’s second bone graft substitute product that combines bioactivity with the company’s market-leading VITOSS synthetic bone scaffold technology. Orthovita launched the first of such products, VITOSS Bioactive Foam Strips, earlier this year. Each of the products has the ability to soak and hold its own volume in bone marrow aspirate while retaining these biological fluids in pliable and compression resistant forms.
VITOSS Bioactive Foam Pack received 510(k) clearance from the U.S. Food and Drug Administration for use in bone grafting procedures in the spine, pelvis and extremities.
VITOSS Bioactive Foam Pack is the latest innovative Orthovita product co-developed with Kensey Nash Corporation. Pursuant to its contract with Kensey Nash, Orthovita will pay Kensey Nash to manufacture the VITOSS Bioactive Foam Pack product as well as make certain royalty payments to Kensey Nash based on the net sales of the product.
About the Company
Orthovita is a spine and orthopedic biosurgery company with proprietary biomaterials and biologic technologies for the development and commercialization of synthetic, biologically active tissue engineering products. We develop and market synthetic-based biomaterials products for use in spine surgery, the repair of fractures and a broad range of clinical needs in the trauma, joint reconstruction, revision and extremities markets. Our near-term commercial business is based on our VITOSS® Bone Graft Substitute technology platforms, which are designed to address the non-structural bone graft market by offering synthetic alternatives to the use of autograft or cadaver-based bone material, VITAGEL® Surgical Hemostat, an adherent matrix and an impermeable barrier to blood flow, and VITASURE™ Absorbable Hemostat. Our longer-term U.S. clinical development program is focused on our internally developed CORTOSS® Bone Augmentation Material technology platform, which is primarily designed for injections in osteoporotic spines to treat vertebral compression fractures.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s current expectations of future events that involve risks and uncertainties, including, without limitation, the development, regulatory approval, demand and market acceptance of our products, including VITOSS Bioactive Foam Pack; our ability to obtain FDA clearance for CORTOSS in the United States; and other aspects of our business. Such statements are based on management’s current expectations and are subject to a number of substantial risks and uncertainties that could cause actual results or timeliness to differ materially from those addressed in the forward-looking statements. Other factors that may cause such a difference are listed from time to time in reports filed by the Company with the U.S. Securities and Exchange Commission (SEC), including but not limited to risks described in our most recently filed Form 10-K under the caption "Risks Factors.” Further information about these and other relevant risks and uncertainties may be found in Orthovita’s filings with the SEC, all of which are available from the SEC as well as other sources. Orthovita undertakes no obligation to publicly update any forward-looking statements.
Source: Orthovita, Inc. |
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9/18/2008
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VITOSS Bone Graft Substitute Poster Presentation Scheduled for the 2008 CNS Annual Meeting
2008.09.18 McConnell.pdf
MALVERN, Pennsylvania, Thursday, September 18, 2008 – Orthovita, Inc. (NASDAQ: VITA), a spine and orthopedic biosurgery company, reported that Jeffrey McConnell, M.D., of the Pennsylvania Spine and Scoliosis Institute at OAA Orthopaedic Specialists in Allentown, will make a presentation related to Orthovita’s VITOSS Bone Graft Substitute product at the 2008 Annual Meeting of the Congress of Neurological Surgeons (CNS), Section on Disorders of the Spine and Peripheral Nerves, being held in Orlando, Florida from September 20-25, 2008.
Dr. McConnell will give an oral poster presentation of an abstract entitled, “A comparison of ß-TCP+BMA vs. RhBMP-2 in anterior lumbar interbody fusion: A prospective, randomized trial with 1-year interim clinical and radiographic outcomes.” In addition to the one-year data included in the abstract, Dr. McConnell will present two-year data. Dr. McConnell’s presentation is based on research conducted independently from Orthovita.
“This maturing data continues to show no difference in radiological and clinical outcomes,” Dr. McConnell reported. “The results of this study will help surgeons make better informed bone graft selections for optimizing patient care in a cost-conscious environment.”
Dr. McConnell’s presentation is scheduled for September 22, 2008, from 4:00 p.m. to 5:45 p.m. in the Select Abstract Session.
About the Company
Orthovita is a spine and orthopedic biosurgery company with proprietary biomaterials and biologic technologies for the development and commercialization of synthetic, biologically active tissue engineering products. We develop and market synthetic-based biomaterials products for use in spine surgery, the repair of fractures and a broad range of clinical needs in the trauma, joint reconstruction, revision and extremities markets. Our near-term commercial business is based on our VITOSS Bone Graft Substitute technology platforms, which are designed to address the non-structural bone graft market by offering synthetic alternatives to the use of autograft or cadaver-based bone material, VITAGEL Surgical Hemostat, an adherent matrix and an impermeable barrier to blood flow, and VITASURE™ Absorbable Hemostat. Our longer-term U.S. clinical development program is focused on our internally developed CORTOSS Bone Augmentation Material technology platform, which is primarily designed for injections in osteoporotic spines to treat vertebral compression fractures.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s current expectations of future events that involve risks and uncertainties, including, without limitation, the development, regulatory approval, demand and market acceptance of our products; our ability to obtain FDA clearance for CORTOSS in the United States; and other aspects of our business. Such statements are based on management’s current expectations and are subject to a number of substantial risks and uncertainties that could cause actual results or timeliness to differ materially from those addressed in the forward-looking statements. Other factors that may cause such a difference are listed from time to time in reports filed by the Company with the U.S. Securities and Exchange Commission (SEC), including but not limited to risks described in our most recently filed Form 10-K under the caption "Risks Factors.” Further information about these and other relevant risks and uncertainties may be found in Orthovita’s filings with the SEC, all of which are available from the SEC as well as other sources. Orthovita undertakes no obligation to publicly update any forward-looking statements.
Source: Orthovita, Inc. |
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9/16/2008
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Orthovita Files Response to FDA's Initial Review of the CORTOSS 510(k) Application
2008 09 16 CORTOSS response .pdf
MALVERN, Pennsylvania, Tuesday, September 16, 2008 – Orthovita, Inc. (NASDAQ: VITA), a spine and orthopedic biosurgery company, announced that it recently submitted its response to the initial set of comments received from the U.S. Food and Drug Administration to its 510(k) application for the use of CORTOSS Bone Augmentation Material in vertebral augmentation.
After receiving the FDA’s initial comment letter in March 2008, Orthovita requested a 180-day extension from the FDA for its response in order to collect and submit additional two-year follow-up patient data from its pivotal U.S. CORTOSS clinical study that was conducted under an FDA Investigational Device Exemption (IDE). FDA granted Orthovita’s request and Orthovita submitted its response to the FDA within the extension period. This response increases the number of patients in the pivotal study for whom two-year follow-up data has been submitted to approximately two-thirds of the original pivotal IDE study cohort. This data is in addition to the long-term follow-up data from Orthovita’s earlier pilot studies and European investigations that was previously submitted as part of the CORTOSS 510(k) application.
FDA clearance of CORTOSS would permit Orthovita to market and sell the material in the United States. CORTOSS has a CE Mark for use in the European Union for screw augmentation and for vertebral augmentation. This enables CORTOSS to be sold in the European Union as well as in other countries that have adopted the European Union’s regulatory standards.
About the Company
Orthovita is a spine and orthopedic biosurgery company with proprietary biomaterials and biologic technologies for the development and commercialization of synthetic, biologically active tissue engineering products. We develop and market synthetic-based biomaterials products for use in spine surgery, the repair of fractures and a broad range of clinical needs in the trauma, joint reconstruction, revision and extremities markets. Our near-term commercial business is based on our VITOSS Bone Graft Substitute technology platforms, which are designed to address the non-structural bone graft market by offering synthetic alternatives to the use of autograft or cadaver-based bone material, VITAGEL Surgical Hemostat, an adherent matrix and an impermeable barrier to blood flow, and VITASURE™ Absorbable Hemostat. Our longer-term U.S. clinical development program is focused on our internally developed CORTOSS Bone Augmentation Material technology platform, which is primarily designed for injections in osteoporotic spines to treat vertebral compression fractures.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s current expectations of future events that involve risks and uncertainties, including, without limitation, the development, regulatory approval, demand and market acceptance of our products; our ability to obtain FDA clearance for CORTOSS in the United States; and other aspects of our business. Such statements are based on management’s current expectations and are subject to a number of substantial risks and uncertainties that could cause actual results or timeliness to differ materially from those addressed in the forward-looking statements. These risks and uncertainties include the risk that the FDA will require the CORTOSS 510(k) application to contain two-year follow up data for a greater percentage of the patients in the pivotal study than that which has been submitted to the FDA to date or for all of the patients in the pivotal study. Other factors that may cause such a difference are listed from time to time in reports filed by the Company with the U.S. Securities and Exchange Commission (SEC), including but not limited to risks described in our most recently filed Form 10-K under the caption "Risks Factors”. Further information about these and other relevant risks and uncertainties may be found in Orthovita’s filings with the SEC, all of which are available from the SEC as well as other sources. Orthovita undertakes no obligation to publicly update any forward-looking statements.
Source: Orthovita, Inc. |
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9/10/2008
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Audio Webcast of Orthovita Presentation on September 22, 2008, at 9:30am ET, at the UBS 2008 Global Life Sciences Conference in New York
A live audio webcast of the presentation will be available as well as a replay which can be accessed three hours after the presentation and until October 25, 2008.
Link to webcast:
http://events.streamx.us/US/event/eventdetails.aspx?id=ubs20080922 |
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9/10/2008
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Orthovita to Present at the 2008 UBS Global Life Sciences Conference in New York
09102008-UBS Conf Sep 22.pdf
MALVERN, Pennsylvania, Wednesday, September 10, 2008 – Orthovita, Inc. (NASDAQ: VITA), a spine and orthopedic biosurgery company, announced today that it will present at the 2008 UBS Global Life Sciences Conference in New York. Antony Koblish, chief executive officer of Orthovita, is scheduled to present on Monday, September 22nd, at 9:30 a.m. Eastern Time, at the Grand Hyatt Hotel, 109 East 42nd Street at Grand Central Terminal, New York, NY. A live audio webcast of the presentation will be available as well as a replay which can be accessed three hours after the presentation and until October 25, 2008, by visiting Orthovita’s website, www.orthovita.com and clicking on the Investors/Press Releases section.
About the Company
Orthovita is a spine and orthopedic biosurgery company with proprietary biomaterials and biologic technologies for the development and commercialization of synthetic, biologically active tissue engineering products. We develop and market synthetic-based biomaterials products for use in spine surgery, the repair of fractures and a broad range of clinical needs in the trauma, joint reconstruction, revision and extremities markets. Our near-term commercial business is based on our VITOSS(R) Bone Graft Substitute technology platforms, which are designed to address the non-structural bone graft market by offering synthetic alternatives to the use of autograft or cadaver-based bone material, and VITAGEL(R) Surgical Hemostat, which is an adherent matrix and an impermeable barrier to blood flow. Our longer-term U.S. clinical development program is focused on our internally developed CORTOSS(R) Bone Augmentation Material technology platform, which is primarily designed for injections in osteoporotic spines to treat vertebral compression fractures. We work jointly with Kensey Nash Corporation to develop and commercialize certain products based on our VITOSS platform, we market VITAGEL under a license agreement, we market VITASURE™ Absorbable Hemostat under a distribution rights agreement, and we continue to pursue similar relationships with other biomaterials companies.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s current expectations of future events that involve risks and uncertainties, including, without limitation, the development, regulatory approval, demand and market acceptance of our products; our ability to obtain FDA clearance for CORTOSS in the United States; and other aspects of our business. Such statements are based on management’s current expectations and are subject to a number of substantial risks and uncertainties that could cause actual results or timeliness to differ materially from those addressed in the forward-looking statements. Other factors that may cause such a difference are listed from time to time in reports filed by the Company with the U.S. Securities and Exchange Commission (SEC), including but not limited to risks described in our most recently filed Form 10-K under the caption "Risks Factors”. Further information about these and other relevant risks and uncertainties may be found in Orthovita’s filings with the SEC, all of which are available from the SEC as well as other sources. Orthovita undertakes no obligation to publicly update any forward-looking statements.
Source: Orthovita, Inc. |
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8/8/2008
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Orthovita to Present at the Canaccord Adams 28th Annual Global Growth Conference
Canaccord Adams Conf Aug 13.pdf
MALVERN, Pennsylvania, Friday, August 8, 2008 – Orthovita, Inc. (NASDAQ: VITA), a spine and orthopedic biosurgery company, announced today that it will present at the Canaccord Adams 28th Annual Global Growth Conference in Boston. Antony Koblish, chief executive officer of Orthovita, is scheduled to present on Wednesday, August 13th, at 11:30 a.m. Eastern Time, at the Intercontinental Hotel Boston, 510 Atlantic Avenue, Boston, MA. A live webcast of the presentation will be available and can be accessed one hour after the presentation ends and for 90 days following the conference, by visiting the following website:
http://www.corporate-ir.net/ireye/conflobby.zhtml?ticker=***VITA&item_id=1887727.
About the Company
Orthovita is a spine and orthopedic biosurgery company with proprietary biomaterials and biologic technologies for the development and commercialization of synthetic, biologically active, tissue engineering products. We develop and market synthetic-based biomaterials products for use in spine surgery, the repair of fractures and a broad range of clinical needs in the trauma, joint reconstruction, revision and extremities markets. Our near-term commercial business is based on our VITOSS¿ Bone Graft Substitute technology platforms, which are designed to address the non-structural bone graft market by offering synthetic alternatives to the use of autograft or cadaver-based bone material,and VITAGEL¿ Surgical Hemostat, which is an adherent matrix and an impermeable barrier to blood flow. Our longer-term U.S. clinical development program is focused on our internally developed CORTOSS¿ Bone Augmentation Material technology platform, which is primarily designed for injections in osteoporotic spines to treat vertebral compression fractures. We work jointly with Kensey Nash Corporation to develop and commercialize certain products based on our VITOSS platform, we market VITAGEL under a license agreement, we market VITASURE™ Absorbable Hemostat under a distribution rights agreement, and we continue to pursue similar relationships with other biomaterials companies.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s current expectations of future events that involve risks and uncertainties, including, without limitation, the development, regulatory approval, demand and market acceptance of our products; our ability to obtain FDA clearance for CORTOSS in the United States; and other aspects of our business. Such statements are based on management’s current expectations and are subject to a number of substantial risks and uncertainties that could cause actual results or timeliness to differ materially from those addressed in the forward-looking statements. Other factors that may cause such a difference are listed from time to time in reports filed by the Company with the U.S. Securities and Exchange Commission (SEC), including but not limited to risks described in our most recently filed Form 10-K under the caption "Risks Factors”. Further information about these and other relevant risks and uncertainties may be found in Orthovita’s filings with the SEC, all of which are available from the SEC as well as other sources. Orthovita undertakes no obligation to publicly update any forward-looking statements.
Source: Orthovita, Inc. |
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8/6/2008
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Orthovita Reports 2008 Second Quarter Financial Results
Q2 2008 Financial Results.pdf
• Second Quarter 2008 Sales of $19.3 Million Reflect 30% Growth over Same Period
2007
• First Half 2008 Sales of $35.5 Million Reflect 27% Growth Over Same Period 2007
(Please see attached for full report.) |
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7/28/2008
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Orthovita Schedules Second Quarter 2008 Financial Results Conference Call
2Q2008 earnings conf call.pdf
MALVERN, Pennsylvania, USA, Monday, July 28, 2008 – Orthovita, Inc. (NASDAQ: VITA), a spine and orthopedic biosurgery company, will hold a conference call on Thursday, August 7, 2008, at 8:30 a.m. Eastern Time, to review and discuss its financial results for the second quarter 2008. Antony Koblish, President and Chief Executive Officer, and Albert J. Pavucek, Jr., Chief Financial Officer of Orthovita, will host the call.
The telephone number to join the conference call from within the U.S. is (888) 815-2919, and from outside the U.S. is (706) 643-3675. The conference identification number is 54484614. Participants should dial in ten minutes prior to the scheduled start time for the conference call.
A replay of the conference call will be available for one week beginning August 7, 2008, at 11:30 a.m. Eastern Time, and ending August 14, 2008, at 11:59 p.m. Eastern Time. You may listen to the replay by dialing within the U.S. (800) 642-1687 or by dialing from outside the U.S. (706) 645-9291. The replay identification number is 54484614.
About the Company
Orthovita is a spine and orthopedic biosurgery company with proprietary biomaterials and biologic technologies for the development and commercialization of synthetic, biologically active, tissue engineering products. We develop and market synthetic-based biomaterials products for use in spine surgery, the repair of fractures and a broad range of clinical needs in the trauma, joint reconstruction, revision and extremities markets. Our near-term commercial business is based on our VITOSS¿ Bone Graft Substitute technology platforms, which are designed to address the non-structural bone graft market by offering synthetic alternatives to the use of autograft or cadaver-based bone material, and VITAGEL¿ Surgical Hemostat, which is an adherent matrix and an impermeable barrier to blood flow. Our longer-term U.S. clinical development program is focused on our internally developed CORTOSS¿ Bone Augmentation Material technology platform, which is primarily designed for injections in osteoporotic spines to treat vertebral compression fractures. We work jointly with Kensey Nash Corporation to develop and commercialize synthetic-based biomaterial products, we market VITAGEL under a license agreement, we market VITASURE™ Absorbable Hemostat under a distribution rights agreement, and we continue to pursue similar relationships with other biomaterials companies.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s current expectations of future events that involve risks and uncertainties, including, without limitation, the development, regulatory approval, demand and market acceptance of our products; our ability to obtain FDA clearance for CORTOSS® in the United States; and other aspects of our business. Such statements are based on management’s current expectations and are subject to a number of substantial risks and uncertainties that could cause actual results or timeliness to differ materially from those addressed in the forward-looking statements. Other factors that may cause such a difference are listed from time to time in reports filed by the Company with the U.S. Securities and Exchange Commission (SEC), including but not limited to risks described in our most recently filed Form 10-K under the caption "Risks Factors”. Further information about these and other relevant risks and uncertainties may be found in Orthovita’s filings with the SEC, all of which are available from the SEC as well as other sources. Orthovita undertakes no obligation to publicly update any forward-looking statements.
Source: Orthovita, Inc. |
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6/3/2008
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Orthovita to Present at the Needham & Company, LLC Seventh Annual Biotechnology and Medical Technology Conference
Needham Co Conf Jun 12 2008.pdf
MALVERN, Pennsylvania, Tuesday, June 3, 2008 – Orthovita, Inc. (NASDAQ: VITA), a spine and orthopedic biosurgery company, announced today that it will present at the Needham & Company, LLC Seventh Annual Biotechnology and Medical Technology Conference in New York. Antony Koblish, chief executive officer of Orthovita, is scheduled to present on Thursday, June 12th, at 2:30 p.m. Eastern Time, at The New York Palace Hotel, 455 Madison Avenue, New York, NY. A live audio webcast of the presentation will be available, and can be accessed for 90 days following the conference, by visiting http://www.wsw.com/webcast/needham25/vita.
About the Company
Orthovita is a spine and orthopedic biosurgery company with proprietary biomaterials and biologic technologies for the development and commercialization of synthetic, biologically active, tissue engineering products. We develop and market synthetic-based biomaterials products for use in spine surgery, the repair of fractures and a broad range of clinical needs in the trauma, joint reconstruction, revision and extremities markets. Our near-term commercial business is based on our VITOSS¿ Bone Graft Substitute technology platforms, which are designed to address the non-structural bone graft market by offering synthetic alternatives to the use of autograft or cadaver-based bone material, and VITAGEL¿ Surgical Hemostat, which is an adherent matrix and an impermeable barrier to blood flow. Our longer-term U.S. clinical development program is focused on our internally developed CORTOSS¿ Bone Augmentation Material technology platform, which is primarily designed for injections in osteoporotic spines to treat vertebral compression fractures. We work jointly with Kensey Nash Corporation to develop and commercialize novel synthetic-based biomaterial products, we market VITAGEL under a license granted by Angiotech Pharmaceuticals, Inc., and we continue to pursue similar relationships with other companies in biomaterials.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s current expectations of future events that involve risks and uncertainties, including, without limitation, the development, regulatory approval, demand and market acceptance of our products; our ability to obtain FDA clearance for CORTOSS in the United States; and other aspects of our business. Such statements are based on management’s current expectations and are subject to a number of substantial risks and uncertainties that could cause actual results or timeliness to differ materially from those addressed in the forward-looking statements. Other factors that may cause such a difference are listed from time to time in reports filed by the Company with the U.S. Securities and Exchange Commission (SEC), including but not limited to risks described in our most recently filed Form 10-K under the caption "Risks Factors”. Further information about these and other relevant risks and uncertainties may be found in Orthovita’s filings with the SEC, all of which are available from the SEC as well as other sources. Orthovita undertakes no obligation to publicly update any forward-looking statements.
Source: Orthovita, Inc. |
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5/7/2008
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Orthovita Reports 2008 First Quarter Financial Results
Q1 Press Release 2008 V7.pdf
First Quarter 2008 Product Sales Reflect 23% Growth Over Same Period in 2007
(Please see attached for details.) |
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4/21/2008
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Orthovita Schedules First Quarter 2008 Financial Results Conference Call
04212008-1Q2008 earnings conf call.pdf
MALVERN, Pennsylvania, USA, Monday, April 21, 2008 – Orthovita, Inc. (NASDAQ: VITA), a spine and orthopedic biosurgery company, will hold a conference call on Thursday, May 8, 2008, at 8:30 a.m. Eastern Time, to review and discuss its financial results for the first quarter 2008. Antony Koblish, President and Chief Executive Officer, and Albert J. Pavucek, Jr., Chief Financial Officer of Orthovita, will host the call.
The telephone number to join the conference call from within the U.S. is (888) 815-2919, and from outside the U.S. is (706) 643-3675. The conference identification number is 43786887. Participants should dial in ten minutes prior to the scheduled start time for the conference call.
A replay of the conference call will be available for one week beginning May 8, 2008, at 11:30 a.m. Eastern Time, and ending May 15, 2008, at 11:59 p.m. Eastern Time. You may listen to the replay by dialing within the U.S. (800) 642-1687 or by dialing from outside the U.S. (706) 645-9291. The replay identification number is 43786887.
About the Company
Orthovita is a spine and orthopedic biosurgery company with proprietary biomaterials and biologic technologies for the development and commercialization of synthetic, biologically active, tissue engineering products. We develop and market synthetic-based biomaterials products for use in spine surgery, the repair of fractures and a broad range of clinical needs in the trauma, joint reconstruction, revision and extremities markets. Our near-term commercial business is based on our VITOSS® Bone Graft Substitute technology platforms, which are designed to address the non-structural bone graft market by offering synthetic alternatives to the use of autograft or cadaver-based bone material, and VITAGEL® Surgical Hemostat, which is an adherent matrix and an impermeable barrier to blood flow. Our longer-term U.S. clinical development program is focused on our internally developed CORTOSS® Bone Augmentation Material technology platform, which is primarily designed for injections in osteoporotic spines to treat vertebral compression fractures. We work jointly with Kensey Nash Corporation to develop and commercialize synthetic-based biomaterial products, we market VITAGEL under a license granted by Angiotech Pharmaceuticals, Inc., and we continue to pursue similar relationships with other companies in biomaterials.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s current expectations of future events that involve risks and uncertainties, including, without limitation, the development, regulatory approval, demand and market acceptance of our products; our ability to obtain FDA clearance for CORTOSS® in the United States; and other aspects of our business. Such statements are based on management’s current expectations and are subject to a number of substantial risks and uncertainties that could cause actual results or timeliness to differ materially from those addressed in the forward-looking statements. Other factors that may cause such a difference are listed from time to time in reports filed by the Company with the U.S. Securities and Exchange Commission (SEC), including but not limited to risks described in our most recently filed Form 10-K under the caption "Risks Factors”. Further information about these and other relevant risks and uncertainties may be found in Orthovita’s filings with the SEC, all of which are available from the SEC as well as other sources. Orthovita undertakes no obligation to publicly update any forward-looking statements.
Source: Orthovita, Inc. |
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4/14/2008
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Orthovita Introduces VITASURE™ Absorbable Hemostat as Part of its Strategy to Leverage its Biomaterials Sales Organization
Vitasure_press_release_2008_04_14.pdf
MALVERN, Pennsylvania, Monday, April 14, 2008 – Orthovita, Inc. (NASDAQ: VITA), a spine and orthopedic biosurgery company, announced today that it has obtained certain rights to distribute an absorbable hemostat product developed by Medafor, Inc., a Minneapolis-based medical device company. The product is approved for use as a hemostat in certain surgical procedures under a pre-market approval granted by the U.S. Food and Drug Administration in 2006 and a CE Mark granted in 2003. Orthovita plans to rebrand the product as VITASURE™ Absorbable Hemostat.
VITASURE’s hemostatic mechanism of action is based on Medafor’s exclusively licensed microporous polysaccharide hemosphere technology. Through this technology, VITASURE acts as a molecular sieve to instantly extract fluids from blood, creating a powerful osmotic action that causes the particles to swell and concentrates serum proteins, platelets, and other formed elements on its surface. The VITASURE particles and their coating of compacted cells then create a matrix for the formation of a tenacious fibrin clot. The VITASURE particles are fully absorbed and enzymatically cleared within 24-48 hours.
“VITASURE is an easy-to-use, cost-effective hemostat that can be used throughout the surgical procedure. Application of the product requires no mixing, reconstitution or preparation assembly. The addition of VITASURE complements our existing VITAGEL® Surgical Hemostat product, which is used primarily at the end of a surgical procedure to stop bleeding. The introduction of VITASURE to our specialized sales force will allow us to offer a complete hemostasis product portfolio to our customers,” said Antony Koblish, President and Chief Executive Officer of Orthovita. “We also believe VITASURE fits exceptionally well with our sales force’s call pattern focus on spine and orthopedic surgeries and will complement the use of our VITOSS® Bone Graft Substitute product line, including our newly-launched VITOSS Bioactive Foam Bone Graft Substitute product. We are pleased to have the opportunity to launch these two important new products into our specialized sales force in 2008.”
Under its distribution agreement with Medafor, Orthovita has the non-exclusive right to sell VITASURE in the spine and orthopedic field in the United States, and certain territories outside of the United States. Medafor has responsibility for manufacturing and maintaining regulatory approvals for the product. The initial term of the agreement is scheduled to expire in December 2013 and Orthovita has the right to renew the agreement for an additional three year period if certain purchase obligations are met during the fifth year of the agreement.
Orthovita expects to launch VITASURE by the third quarter of 2008 in the United States and during 2009 in its territories outside of the United States.
About the Company
Orthovita is a spine and orthopedic biosurgery company with proprietary biomaterials and biologic technologies for the development and commercialization of synthetic, biologically active, tissue engineering products. We develop and market synthetic-based biomaterials products for use in spine surgery, the repair of fractures and a broad range of clinical needs in the trauma, joint reconstruction, revision and extremities markets. Our near-term commercial business is based on our VITOSS® Bone Graft Substitute technology platforms, which are designed to address the non-structural bone graft market by offering synthetic alternatives to the use of autograft or cadaver-based bone material, and VITAGEL® Surgical Hemostat, which is an adherent matrix and an impermeable barrier to blood flow. Our longer-term U.S. clinical development program is focused on our internally developed CORTOSS® Bone Augmentation Material technology platform, which is primarily designed for injections in osteoporotic spines to treat vertebral compression fractures. We work jointly with Kensey Nash Corporation to develop and commercialize novel synthetic-based biomaterial products, we market VITAGEL under a license granted by Angiotech Pharmaceuticals, Inc., and we continue to pursue similar relationships with other companies in biomaterials.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s current expectations of future events that involve risks and uncertainties, including, without limitation, the development, regulatory approval, demand and market acceptance of our products; our ability to successfully launch VITASURE; our ability to obtain FDA clearance for CORTOSS in the United States; and other aspects of our business. Such statements are based on management’s current expectations and are subject to a number of substantial risks and uncertainties that could cause actual results or timeliness to differ materially from those addressed in the forward-looking statements. Other factors that may cause such a difference are listed from time to time in reports filed by the Company with the U.S. Securities and Exchange Commission (SEC), including but not limited to risks described in our most recently filed Form 10-K under the caption "Risks Factors”. Further information about these and other relevant risks and uncertainties may be found in Orthovita’s filings with the SEC, all of which are available from the SEC as well as other sources. Orthovita undertakes no obligation to publicly update any forward-looking statements.
Source: Orthovita, Inc. |
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3/18/2008
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CORTOSS Podium Presentation at 2008 SIR Meeting
CORTOSS podium presentation Beall 2008-3-18.pdf
MALVERN, Pennsylvania, Tuesday, March 18, 2008 – Orthovita, Inc. (NASDAQ: VITA), a spine and orthopedic biosurgery company, today announced an upcoming podium presentation related to its CORTOSS Bone Augmentation Material. The presentation will be held at the 33rd Annual Meeting of the Society of Interventional Radiology held in Washington, D.C., from March 15 through 20, 2008.
Douglas P. Beall, M.D., radiologist at the Edmond Medical Center in Oklahoma, will present a paper entitled “Prospective RCT Comparing Vertebroplasty Using Cortoss, a Novel Bioactive Material vs. PMMA – One Year Results.”
The presentation is based on the data of 69 patients treated and followed by Dr. Beall and Dr. Paul Hatten of Vero Beach, Florida, as part of a larger 256-patient Investigational Device Study conducted for regulatory submission by Orthovita to the FDA for the use of CORTOSS in vertebral augmentation.
“In these elderly patients with many co-morbidities, both materials achieved high clinical success rates,” Dr. Beall said. “Of interest, the frequency of subsequent fractures was almost twice as high for PMMA as for CORTOSS in this series. This could be either related to the different biomechanical properties of the CORTOSS material or its fill pattern within the vertebrae. Analysis of the complete study is expected to shed further light on this finding.”
The oral presentation of this paper is scheduled for March 19, 2008, between 1:30 and 3:30 p.m., in room 204 C of the Washington Convention Center.
About the Company
Orthovita is a spine and orthopedic biosurgery company with proprietary biomaterials and biologic technologies for the development and commercialization of synthetic, biologically active, tissue engineering products. We develop and market synthetic-based biomaterials products for use in spine surgery, the repair of fractures and a broad range of clinical needs in the trauma, joint reconstruction, revision and extremities markets. Our near-term commercial business is based on our VITOSS(R) Bone Graft Substitute technology platforms, which are designed to address the non-structural bone graft market by offering synthetic alternatives to the use of autograft or cadaver-based bone material, and VITAGEL(R) Surgical Hemostat, which is an adherent matrix and an impermeable barrier to blood flow. Our longer-term U.S. clinical development program is focused on our internally developed CORTOSS(R) Bone Augmentation Material technology platform, which is primarily designed for injections in osteoporotic spines to treat vertebral compression fractures. We work jointly with Kensey Nash Corporation to develop and commercialize novel synthetic-based biomaterial products, we market VITAGEL under a license granted by Angiotech Pharmaceuticals, Inc., and we continue to pursue similar relationships with other companies in biomaterials.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s current expectations of future events that involve risks and uncertainties, including, without limitation, the development, regulatory approval, demand and market acceptance of our products; our ability to obtain FDA clearance for CORTOSS in the United States; and other aspects of our business. Such statements are based on management’s current expectations and are subject to a number of substantial risks and uncertainties that could cause actual results or timeliness to differ materially from those addressed in the forward-looking statements. Other factors that may cause such a difference are listed from time to time in reports filed by the Company with the U.S. Securities and Exchange Commission (SEC), including but not limited to risks described in our most recently filed Form 10-K under the caption "Risks Factors”. Further information about these and other relevant risks and uncertainties may be found in Orthovita’s filings with the SEC, all of which are available from the SEC as well as other sources. Orthovita undertakes no obligation to publicly update any forward-looking statements.
Source: Orthovita, Inc. |
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3/14/2008
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Orthovita to Present at the Cowen and Company 28th Annual Health Care Conference
Cowen and Co Conf Mar 18.pdf
MALVERN, Pennsylvania, Friday, March 14, 2008 – Orthovita, Inc. (NASDAQ: VITA), a spine and orthopedic biosurgery company, announced today that it will present at the Cowen and Company 28th Annual Health Care Conference in Boston. Albert J. Pavucek, Jr., chief financial officer of Orthovita, is scheduled to present on Tuesday, March 18th, at 3:55 p.m. Eastern Time, at the Boston Marriott Copley Place, 110 Huntington Avenue, Boston, MA. A webcast of the presentation will not be available.
About the Company
Orthovita is a spine and orthopedic biosurgery company with proprietary biomaterials and biologic technologies for the development and commercialization of synthetic, biologically active, tissue engineering products. We develop and market synthetic-based biomaterials products for use in spine surgery, the repair of fractures and a broad range of clinical needs in the trauma, joint reconstruction, revision and extremities markets. Our near-term commercial business is based on our VITOSS Bone Graft Substitute technology platforms, which are designed to address the non-structural bone graft market by offering synthetic alternatives to the use of autograft or cadaver-based bone material, and VITAGEL Surgical Hemostat, which is an adherent matrix and an impermeable barrier to blood flow. Our longer-term U.S. clinical development program is focused on our internally developed CORTOSS Bone Augmentation Material technology platform, which is primarily designed for injections in osteoporotic spines to treat vertebral compression fractures. We work jointly with Kensey Nash Corporation to develop and commercialize novel synthetic-based biomaterial products, we market VITAGEL under a license granted by Angiotech Pharmaceuticals, Inc., and we continue to pursue similar relationships with other companies in biomaterials.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s current expectations of future events that involve risks and uncertainties, including, without limitation, the development, regulatory approval, demand and market acceptance of our products; our ability to obtain FDA clearance for CORTOSS in the United States; and other aspects of our business. Such statements are based on management’s current expectations and are subject to a number of substantial risks and uncertainties that could cause actual results or timeliness to differ materially from those addressed in the forward-looking statements. These risks and uncertainties include the risk that the FDA will require the CORTOSS 510(k) application to contain two-year follow up data for a greater percentage of the patients in the pivotal study than that which is reflected in the application as originally filed with the FDA or for all of the patients in the pivotal study. Other factors that may cause such a difference are listed from time to time in reports filed by the Company with the U.S. Securities and Exchange Commission (SEC), including but not limited to risks described in our most recently filed Form 10-K under the caption "Risks Factors”. Further information about these and other relevant risks and uncertainties may be found in Orthovita’s filings with the SEC, all of which are available from the SEC as well as other sources. Orthovita undertakes no obligation to publicly update any forward-looking statements.
Source: Orthovita, Inc. |
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3/4/2008
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Orthovita Announces New VITOSS® Bioactive Foam Bone Graft Substitute
2008 03 04 Bioactive FOAM clearance and launch .pdf
MALVERN, Pennsylvania, Tuesday, March 4, 2008 – Orthovita, Inc. (NASDAQ: VITA), a spine and orthopedic biosurgery company, today announced the launch of VITOSS Bioactive Foam as the newest addition to its bone graft substitute product line. VITOSS Bioactive Foam will be immediately available as part of a controlled rollout, with full launch at the beginning of the second quarter.
The VITOSS Bioactive Foam product has the same structure and porosity as Orthovita’s VITOSS Foam product, and both product lines contain Orthovita’s proprietary VITOSS beta-tricalcium phosphate bone graft substitute and Kensey Nash Corporation’s proprietary collagen material. VITOSS Bioactive Foam also contains bioactive glass that induces natural calcium phosphate growth onto the surface of the implant. Antony Koblish, President and Chief Executive Officer of Orthovita, said, “Our in-vivo data indicates that the integration of bioactive glass in VITOSS Bioactive Foam results in more rapid bone repair and healing. We are pleased to offer physicians and their patients a new, enhanced product that combines bioactivity with our market-leading synthetic bone scaffold technology.”
As with Orthovita’s VITOSS Foam products, the VITOSS Bioactive Foam product has the ability to soak and hold its own volume in bone marrow aspirate while retaining these biological fluids in pliable and compression resistant forms. VITOSS Bioactive Foam received 510(k) clearance from the U.S. Food and Drug Administration for use in bone grafting procedures in the spine, pelvis and extremities.
Pursuant to its contract with Kensey Nash Corporation, Orthovita will pay Kensey Nash to manufacture the VITOSS Bioactive Foam product as well as make certain royalty payments to Kensey Nash based on the net sales of such product.
About the Company
Orthovita is a spine and orthopedic biosurgery company with proprietary biomaterials and biologic technologies for the development and commercialization of synthetic, biologically active, tissue engineering products. We develop and market synthetic-based biomaterials products for use in spine surgery, the repair of fractures and a broad range of clinical needs in the trauma, joint reconstruction, revision and extremities markets. Our near-term commercial business is based on our VITOSS(R) Bone Graft Substitute technology platforms, which are designed to address the non-structural bone graft market by offering synthetic alternatives to the use of autograft or cadaver-based bone material, and VITAGEL(R) Surgical Hemostat, which is an adherent matrix and an impermeable barrier to blood flow. Our longer-term U.S. clinical development program is focused on our internally developed CORTOSS(R) Bone Augmentation Material technology platform, which is primarily designed for injections in osteoporotic spines to treat vertebral compression fractures. We work jointly with Kensey Nash Corporation to develop and commercialize novel synthetic-based biomaterial products, we market VITAGEL under a license granted by Angiotech Pharmaceuticals, Inc., and we continue to pursue similar relationships with other companies in biomaterials.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s current expectations of future events that involve risks and uncertainties, including, without limitation, the development, regulatory approval, demand and market acceptance of our products; our ability to obtain FDA clearance for CORTOSS in the United States; and other aspects of our business. Such statements are based on management’s current expectations and are subject to a number of substantial risks and uncertainties that could cause actual results or timeliness to differ materially from those addressed in the forward-looking statements. Other factors that may cause such a difference are listed from time to time in reports f... |
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3/3/2008
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Orthovita Schedules Fourth Quarter and Year-End 2007 Financial Results Conference Call
3-3-2008-4QYE2007 earnings conf call announcement.6.pdf
MALVERN, Pennsylvania, USA, Monday, March 3, 2008 – Orthovita, Inc. (NASDAQ: VITA), a spine and orthopedic biosurgery company, will hold a conference call on Thursday, March 13, 2008, at 8:30 a.m. Eastern Time, to review and discuss its financial results for the fourth quarter and year-end 2007. Antony Koblish, President and Chief Executive Officer, and Albert J. Pavucek, Jr., Chief Financial Officer of Orthovita, will host the call.
The phone number to join the conference call from within the U.S. is (888) 815-2919, and from outside the U.S. is (706) 643-3675. The conference identification number is 34776172. Participants should dial in ten minutes prior to the scheduled start time for the conference call.
A replay of the conference call will be available for one week beginning March 13, 2008, at 11:30 a.m. Eastern Time, and ending March 20, 2008, at 11:59 p.m. Eastern Time. You may listen to the replay by dialing within the U.S. (800) 642-1687 or by dialing from outside the U.S. (706) 645-9291. The replay identification number is 34776172.
About the Company
Orthovita is a spine and orthopedic biosurgery company with proprietary biomaterials and biologic technologies for the development and commercialization of synthetic, biologically active, tissue engineering products. We develop and market synthetic-based biomaterials products for use in spine surgery, the repair of fractures and a broad range of clinical needs in the trauma, joint reconstruction, revision and extremities markets. Our near-term commercial business is based on our VITOSS(R) Bone Graft Substitute technology platforms, which are designed to address the non-structural bone graft market by offering synthetic alternatives to the use of autograft or cadaver-based bone material, and VITAGEL(R) Surgical Hemostat, which is an adherent matrix and an impermeable barrier to blood flow. Our longer-term U.S. clinical development program is focused on our internally developed CORTOSS(R) Bone Augmentation Material technology platform, which is primarily designed for injections in osteoporotic spines to treat vertebral compression fractures. We work jointly with Kensey Nash Corporation to develop and commercialize synthetic-based biomaterial products, we market VITAGEL under a license granted by Angiotech Pharmaceuticals, Inc., and we continue to pursue similar relationships with other companies in biomaterials.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s current expectations of future events that involve risks and uncertainties, including, without limitation, the development, regulatory approval, demand and market acceptance of our products; our ability to obtain FDA clearance for CORTOSS in the United States; and other aspects of our business. Such statements are based on management’s current expectations and are subject to a number of substantial risks and uncertainties that could cause actual results or timeliness to differ materially from those addressed in the forward-looking statements. These risks and uncertainties include the risk that the FDA will require the CORTOSS 510(k) application to contain two-year follow up data for a greater percentage of the patients in the pivotal study than that which is reflected in the application as originally filed with the FDA or for all of the patients in the pivotal study. Other factors that may cause such a difference are listed from time to time in reports filed by the Company with the U.S. Securities and Exchange Commission (SEC), including but not limited to risks described in our most recently filed Form 10-K under the caption "Risks Factors”. Further information about these and other relevant risks and uncertainties may be found in Orthovita’s filings with the SEC, all of which are available from the SEC as well as other sources. Orthovita undertakes no obligation to publi... |
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