Orthovita Reports Cortoss Vertebroplasty Data to be Presented at the American Academy of Orthopedic Surgeons

Business Wire, Feb 22, 2005

MALVERN, Pa. -- A Prospective Multi-Center Pilot IDE Study on the Use of Cortoss in Vertebroplasty - Report on the First 20 Cases at Twelve Months -

Orthovita, Inc. (NASDAQ NM:VITA), a leading developer of orthopedic biomaterials, today reported that a poster titled "A Prospective Multi-Center Pilot IDE Study on the use of Cortoss in Vertebroplasty - Report on the First 20 Cases" will be exhibited at the American Academy of Orthopedic Surgeons being held in Washington, D.C. from Wednesday, February 23, 2005 through Friday, February 25, 2005.

Hyun Bae, M.D. at The Spine Institute at Saint John's Health Center, Santa Monica, CA, led the study. Other investigators included Philip Maurer, M.D. at the Pennsylvania Hospital in Philadelphia, PA, as well as Erik Westerlund, M.D., Timothy Peppers, M.D. and Raymond Linovitz, M.D., at CORE Orthopedic Medical Center in Encinitas, CA.

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 study results seemed to suggest that a relatively small volume of Cortoss 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. The study results appear to be consistent with the results obtained in the prospective vertebroplasty study using Cortoss conducted in Europe. 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.

"In this study, the average volume of Cortoss injected was 1.9cc per vertebra treated, with the volume ranging from 0.7cc to 4.4cc per vertebra treated. Due to the engineered radiopacity of Cortoss, extravasations were easily detected intra-operatively and averaged 0.12cc as measured on post-op CT scans. All extravasations were anatomically close to the vertebra and remained asymptomatic, with no cardiac or pulmonary emboli observed," said Dr. Bae. "A larger, prospective randomized controlled IDE study to confirm these findings in under way."

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. Our products are used in the regeneration of bone and soft tissue. 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-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 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.

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 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.