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FDA Approves Further Changes To CORTOSS(R) IDE Pivotal Study Protocol |
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18 Apr 2006 |
MALVERN, PA, USA | Apr 17, 2006 | Orthovita, Inc. Orthovita, Inc. (NASDAQ NM:VITA), a leading developer of orthopedic biomaterials, announced today that the FDA has approved further changes to the protocol for its CORTOSS(R) IDE pivotal study. The changes include a reduction in the number of total patients to be enrolled from 300 down to 243, as well as an increase in the randomization ratio of patients treated with CORTOSS to patients in the control group treated with an approved PMMA bone cement. The protocol now provides for the enrollment of 162 patients in the CORTOSS arm of the study and 81 patients in the control group, for an overall randomization of 2:1. The prospective randomized controlled multi-center IDE study is underway in the U.S. and is designed to demonstrate that CORTOSS is safe and effective for the treatment of osteoporotic vertebral compression fractures. Patients in the study are being treated minimally invasively with CORTOSS using the vertebroplasty technique, where CORTOSS is injected directly into the fractured vertebra. CORTOSS is not available for sale in the United States and is limited to investigational use.
"This latest development is expected to shorten the enrollment phase of the study and we believe the 2:1 randomization will provide further positive impetus to all who are involved in this clinical program," said Antony Koblish, president and chief executive officer of Orthovita, Inc.
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 healing. 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 an 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 synthetic-based biomaterial products, and continues to pursue similar relationships with other companies in biomaterials.
Cautionary Note Regarding Forward-Looking Statements
This press release may contain forward-looking statements regarding Orthovita's current expectations of future events that involve risks and uncertainties as listed from time to time in reports we file with the U.S. Securities and Exchange Commission (SEC), including but not limited to risks described in our most recently filed Form 10-K. 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 upon request. Orthovita undertakes no obligation to publicly update any forward-looking statements.
CONTACT: Orthovita, Inc |
