Healthcare Industry News: vertebral compression fractures
News Release - October 9, 2006
First U.S. Presentation of CORTOSS(R) IDE Pivotal Clinical Preliminary Data to Be Presented in a Poster at the Congress of Neurological Surgeons in ChicagoProspective Randomized Trial of CORTOSS(R) versus PMMA Bone Cement in the Treatment of vertebral compression fractures; Preliminary Results at a Single Institution in an FDA IDE Pivotal Clinical Study
MALVERN, Pa.--(HSMN NewsFeed)--Orthovita, Inc. (NASDAQ: VITA ), a developer of orthopedic biomaterials, reported that Hyun Bae, M.D., from The Spine Institute at Saint John's Health Center, Santa Monica, California, will present a scientific poster titled "Prospective Randomized Trial Of CORTOSS® Versus PMMA In The Treatment Of vertebral compression fractures; Preliminary Results At A Single Institution" at the Congress of Neurological Surgeons (CNS) meeting being held in Chicago from October 7 through October 12, 2006.
The results reported in the scientific paper cover 38 patients enrolled at this site; 22 treated with CORTOSS and 14 treated with PMMA. A total of 55 levels were treated; 35 in the CORTOSS treated group and 20 in the PMMA treated group. The average age is 81 for both the CORTOSS treated group and the PMMA treated group. Improvement in VAS and ODI scores was similar for both groups out to 6 months. The average volume of material injected was 2.3 cc in the CORTOSS treated group and 4.6 cc in the PMMA treated group. Leakages were asymptomatic and similar in both groups with no cardiac irregularities or pulmonary emboli.
"The preliminary results suggest that CORTOSS, with much lower injection volume per treated vertebra, may provide similar pain relief compared to PMMA bone cement," said Dr. Bae. "These results are consistent with those obtained in the prospective vertebroplasty study using CORTOSS conducted in Europe."
Ben P. Pradhan, MD, from The Spine Institute at Saint John's Health Center, Santa Monica, California, also contributed to this scientific paper.
The purpose of this study is to assess the safety and efficacy of CORTOSS® for the treatment of osteoporotic vertebral compression fractures as compared to commercially available PMMA bone cement via an FDA IDE pivotal, prospective, randomized clinical study. The total number of patients to be enrolled in the study is 243 with a 2:1 randomization (162 CORTOSS and 81 PMMA) at 19 sites. Patients are being evaluated at the following time points: pre-op, post-op, 72 hours, 1 week, 1, 3, 6, 12, and 24 months. Patient outcome will be assessed by Visual Analogue Scale (VAS), Oswestry Disability Index (ODI), SF-12 and maintenance of height and alignment at the level(s) treated. Among the inclusion criteria are a minimum VAS score of 50, a minimum ODI score of 30%, an osteoporotic compression fracture at one or two levels, presence of edema on MRI or bone scan and an informed patient consent. Among the exclusion criteria are a greater than 70% collapse, spinal canal compromise, neurologic deficit at the level(s) to be treated or tumors. CORTOSS is not available for sale in the United States and is limited to investigational use.
About the Company
Orthovita is a biosurgery company with proprietary biomaterial 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® 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 an adherent matrix and an impermeable barrier to blood flow. Our longer-term U.S. clinical development program is focused on our CORTOSS® 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 may contain forward-looking statements regarding Orthovita's current expectations of future events that involve risks and uncertainties, including, without limitation, our products, product safety, efficacy, regulatory approval, development and marketability, any future business relationships 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 "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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