CORTOSS(R) Podium Presentation Scheduled For The 32nd Annual Scientific Meeting Of The Society Of Interventional Radiology.
MALVERN, Pa. -- Orthovita, Inc. (NASDAQ:VITA), a spine and biosurgery company, reported that H. Paul Hatten, Jr., M.D., from Indian River Radiology, Vero Beach, Florida, will make a podium presentation of a scientific paper titled "Treatment of Vertebral Compression Fractures with Cortoss - Preliminary Results at a Single Institution in a Prospective Randomized Clinical Trial" at the 32nd Annual Scientific Meeting of the Society of Interventional Radiology being held in Seattle from March 1 through March 6, 2007.
The podium presentation is on Monday, March 5, 2007 at 2:45 p.m. Pacific Time in the Non-Vascular Interventions: Biopsy/Spine session. The presentation will cover part of a pivotal study being conducted under an FDA Investigational Device Exemption (IDE) to assess the safety and efficacy of CORTOSS compared to commercially available PMMA bone cements. A total of 256 patients have been enrolled in the pivotal study with a 2:1 randomization (162 patients treated using CORTOSS and 94 patients treated using a PMMA bone cement) at 22 clinical sites. Patients are evaluated at pre-op, post-op, 72 hours, 1 week, 1, 3, 6, 12, and 24 months. Patient outcome will be assessed by Visual Analog 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. Exclusionary criteria include greater than 70% collapse, spinal canal compromise, neurologic deficit at the level(s) to be treated, or tumors. Post-operative CT and radiographs are being used to assess and quantify leakage. The results reported in the podium presentation are from the Indian River Radiology site in Vero Beach, Florida, which is one of the clinical sites involved in the pivotal study.
At the Indian River Radiology site, 57 patients have been enrolled; 36 treated using CORTOSS and 21 treated using a PMMA bone cement. A total of 78 vertebral levels have been treated; 50 in the CORTOSS treated group and 28 in the PMMA treated group. The average age is 77 in the CORTOSS treated group and 78 in the PMMA treated group. Improvement in VAS and ODI scores was similar for both groups out to 12 months. The average volume of material injected in the CORTOSS treated group was 1.9 cc and 3.5 cc in the PMMA treated group. Leakages were observed on post-operative CT scans and found to be similar in both groups. All extravasations were asymptomatic with no cardio-pulmonary complications.
"These preliminary results suggest that CORTOSS may provide similar pain relief compared to PMMA bone cement with approximately 50% less material," said Dr. Hatten. "This may be due to the distinct interdigitated fill pattern obtained with CORTOSS, which may reduce the risk of leakage and emboli while employing a "start-stop" technique and precision delivery."
CORTOSS has CE Certification for use in the European Union for screw augmentation and for vertebral augmentation of VCFs of the spine, which enables it to be sold in the European Union as well as in other countries that have adopted the European Union's regulatory standards. A 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 spine and orthopedic biosurgery company with proprietary biomaterials and biologic technologies for the development and commercialization of synthetic, biologically active, tissue engineering products. We develop and market synthetic-based biomaterials products for use in spine surgery, the repair of fractures and a broad range of clinical needs in the trauma, joint reconstruction, revision and extremities markets. 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-based bone material, and VITAGEL([R]) 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]) Bone Augmentation Material technology platform, which is primarily designed for injections in osteoporotic spines to treat vertebral compression fractures. We work jointly with Kensey Nash Corporation to develop and commercialize novel synthetic-based biomaterial products, we market VITAGEL under a license granted by Angiotech Pharmaceuticals, Inc., and we continue 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, the development, regulatory approval, demand and market acceptance of our products; the development of our sales network; the adequacy of inventory; our ability to manufacture products; timing of any submissions to the FDA related to CORTOSS approval; the adequacy of available resources; 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 "Risks Factors". 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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|Date:||Mar 2, 2007|
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