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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. |
Earlier Releases |
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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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