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Orthovita Issued U.S. Patent for Aseptic Manufacturing Methods for Polymerizable Materials Such as CORTOSS.

MALVERN, Pa. -- Orthovita, Inc. (NASDAQ NM:VITA)

--U.S. Patent No. 6,800,245, Covering Ten New Claims for Methods of Manufacturing and Using Sterile Polymerizable Systems and Kits, Enhances Competitive Advantage for Orthovita in Development of New Synthetic Biomaterials for Bone Repair.

Orthovita, Inc. (NASDAQ NM:VITA), a leading developer of orthopedic biomaterials, announced today that it has been granted a U.S. patent for the company's proprietary method of aseptically sterilizing biologically compatible restorative compositions. The patent covers ten new claims for the production of sterile, polymerizable blends and sterile, biologically compatible restorative compositions that support the core technology used to develop CORTOSS(R), Orthovita's synthetic cortical bone void filler for use in bone repair. The patent also covers a method of restoring tissues using a sterile restorative composition prepared via specified aseptic processing procedures.

CORTOSS is a high-strength, self-setting composite engineered specifically to mimic the strength characteristics of human structural bone. CORTOSS is approved for sale under a CE Mark in Europe for use in vertebral augmentation procedures, including compression fractures caused by osteoporosis and invasive tumors. CORTOSS is currently being studied in U.S. clinical trials using a new FDA IDE protocol design for use in vertebral augmentation procedures. The new trial design is being conducted at up to 19 clinical sites and will compare CORTOSS to treatment with polymethylmethacrylate (PMMA) bone cement in treating vertebral compression fractures.

"Many initially promising biomaterials, with revolutionary characteristics for use in surgery, fail to be viable because of challenges in achieving the necessary sterility profile without altering the desired material properties," said Erik Erbe, Ph.D., chief science officer of Orthovita. He added, "This patent provides a significant competitive advantage for Orthovita and CORTOSS in the marketplace by protecting our proprietary state-of-the-art composite technology that allows us to achieve the sterility assurance level required for use in orthopedics."

About the Company

Orthovita is a leading biomaterials company with proprietary technologies for the development and commercialization of synthetic, biologically active, tissue engineering products for orthopedic and neurosurgical applications. We develop and market novel synthetic-based biomaterial products for use in spine surgery, the repair of osteoporotic fractures, and a broad range of clinical needs in the trauma, joint reconstruction, revision and extremities markets. Our products are used in the regeneration of bone and soft tissues.

Our near-term commercial business is based on our VITOSS(R) Scaffold technology platforms, which are designed to address the non-structural bone graft market, and VITAGEL(TM), which is a matrix for soft-tissue healing. Our longer-term clinical development program is focused on our CORTOSS(R) technology platform, which is designed for injections in osteoporotic spines to treat vertebral compression fractures. Orthovita also pursues opportunities to work jointly with other leaders in biomaterials, such as Kensey Nash Corporation and Angiotech Pharmaceuticals, Inc.

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 dependence on the commercial success of our approved products, our history of operating losses and our need for additional funds, our need to obtain and maintain regulatory approvals to sell our products, the rate at which we invest in our field sales network, the ability of our field sales network to generate new sales, our ability to enter into an agreement to commercialize and distribute VITOSS in Japan, our ability to manage commercial scale manufacturing capability and capacity, risks and uncertainties in pre-clinical and clinical trial results, market acceptance of our products, the sales levels of our products, our success in expanding our commercial product portfolio and distribution channel, research and development, 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 other sources. Orthovita undertakes no obligation to publicly update any forward-looking statements.
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Publication:Business Wire
Geographic Code:1USA
Date:Oct 21, 2004
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