Healthcare Industry News: Surgical Hemostat
News Release - September 22, 2008
Orthovita Announces New VITOSS Bioactive Foam Pack Bone Graft SubstituteMALVERN, Pa.--(HSMN NewsFeed)--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.
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.
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.
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