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Orthovita Reports CORTOSS Vertebroplasty Scientific Paper to be Presented at the ASNR 43rd Annual Meeting; A Prospective Multi-Center Pilot IDE Study on the Use of CORTOSS in Vertebroplasty
Business Wire, May 23, 2005
MALVERN, Pa. -- - Report on the First 20 Cases at Twelve Months -
Orthovita, Inc. (NASDAQ NM:VITA), a developer of orthopedic biomaterials, reported that Philip Maurer, M.D. will orally present today a scientific paper titled "Treatment of Compression Fractures with a Novel Bioceramic; 1-year Follow Up on the First 20 Patients" during the "Spine: Interventional and Innovative Techniques" session of the ASNR 43rd Annual Meeting in Toronto, Canada. The pilot IDE study was intended to provide preliminary information about the use of CORTOSS(R) Synthetic Cortical Bone to treat osteoporotic vertebral compression fractures. The one-year study results seemed to suggest that a relatively small volume of CORTOSS, averaging 1.9cc per treated vertebra, may be able to reinforce the vertebrae and achieve symptomatic relief, as compared to the larger volumes reported in the literature for polymethylmethacrylate (PMMA) bone cement. CORTOSS appeared to have an interdigitated fill pattern, which is intended to create trabecular reinforcement. In addition to Philip Maurer, M.D., who is associated with Booth, Bartolozzi, Balderston Orthopedics at the Pennsylvania Hospital in Philadelphia, PA, the other investigators involved in this study included Hyun Bae, M.D., at The Spine Institute at Saint John's Health Center, Santa Monica, CA, as well as Erik Westerlund, M.D., Timothy Peppers, M.D., and Raymond Linovitz, M.D., at CORE Orthopedic Medical Center in Encinitas, CA.
A larger, prospective, randomized, controlled multi-center IDE study is underway in the U.S. designed to demonstrate that CORTOSS is safe and effective for the treatment of osteoporotic vertebral compression fractures. CORTOSS is not available for sale in the United States and is limited to investigational use.
About the Company
Orthovita is a biomaterials company with proprietary technologies for the development and commercialization of synthetic, biologically active, tissue engineering products for orthopedic and neurosurgical applications. Our products are used in the regeneration of bone and soft tissue. Our near-term commercial business is based on our internally developed 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-derived bone material to meet a broad range of orthopedic clinical needs in the spine, trauma, joint reconstruction, revision surgery and extremities markets, and VITAGEL(TM) Surgical Hemostat, which is a safe 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) Synthetic Cortical Bone technology platform, which is designed for injections in osteoporotic spines to treat vertebral compression fractures. Orthovita works jointly with Kensey Nash Corporation and Angiotech Pharmaceuticals, Inc., to develop and market novel, synthetic-based, biomaterial products, and continues to pursue similar relationships with other companies in biomaterials.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements regarding Orthovita's current expectations of future events that involve risks and uncertainties, including, without limitations, 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 include, but are not limited to, our need to obtain and maintain regulatory approvals to sell our products, risks and uncertainties in clinical trial results, market acceptance of our products, competition and other risk factors 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 "Certain Risks Related to Our Business". 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 from Orthovita by request. Orthovita undertakes no obligation to publicly update any forward-looking statements.
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