Healthcare Industry News: vertebral compression fractures
News Release - September 14, 2006
Orthovita Announces First Public Podium Presentation of CORTOSS(R) IDE Pivotal Clinical Data in the Treatment of Vertebral Compression Fractures at the European Society of Neuroradiology Meeting in GenevaMALVERN, Pa.--(HSMN NewsFeed)--Sept. 14, 2006--Orthovita, Inc. (NASDAQ:VITA ), a developer of orthopedic biomaterials, 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 "Comparison Of CORTOSS® To PMMA In The Treatment Of vertebral compression fractures; Characteristics And Preliminary Clinical Results At A Single Institution" at the European Society of Neuroradiology meeting being held in Geneva from September 13 through September 16, 2006. The presentation of this paper number 39.3 can be seen in the Main Session SS39: Spine Intervention (Room: ICS/Interventional: 8:30-10:00 a.m.) on Saturday, September 16, 2006 from 8:40-8:50 a.m. Indian River Radiology is one of approximately 19 clinical sites involved in an ongoing prospective, randomized controlled pivotal study to examine the use of CORTOSS vertebroplasty in patients with osteoporotic compression fractures.
The results reported in the scientific paper by this clinical site cover 42 patients, of which 24 patients were treated using CORTOSS and 18 patients were treated using a PMMA bone cement. A total of 55 levels were treated; 34 in the CORTOSS treated group and 24 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 6 months. The average volume of material injected in the CORTOSS treated group was 2.1cc using a low-injection volume Cortoplasty(TM) technique, as compared to 3.5cc 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 results appear to be consistent with those obtained in the prospective vertebroplasty study using CORTOSS conducted in Europe.
"These preliminary results suggest CORTOSS may provide pain relief similar to PMMA while using about 40% less CORTOSS than PMMA," said Dr. Hatten. "In my experience performing vertebroplasties using CORTOSS as compared to PMMA, CORTOSS is easier to use and is superior in its interdigitated fill pattern to provide biomechanical stabilization of vertebral body compression fractures."
The purpose of this study is to assess the safety and efficacy of CORTOSS compared to commercially available PMMA bone cement via an FDA IDE pivotal, prospective, randomized clinical study. A total of 243 patients are to be enrolled in the pivotal study with a 2:1 randomization (162 patients treated using CORTOSS and 81 patients treated using a PMMA bone cement) at 19 sites. Patients are 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 greater than 70% collapse, canal compromise, neurologic deficit at the level(s) to be treated, and tumors. Post-operative CT and radiographs are being used to assess and quantify leakage.
A prospective, randomized, controlled multi-center IDE study underway in the U.S. is 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 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 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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