VITA - Orthovita Announces Podium Presentation of CORTOSS(R) for the Treatment of Vertebral Compression Fractures - Vertebral Augmentation to be Presented at the American Society of Neuroradiology (ASNR) Meeting in Chicago
Prospective Randomized Pivotal Trial of CORTOSS versus PMMA In the Treatment of Vertebral Compression Fractures;
Preliminary Results at a Single Institution in 57 Patients
Orthovita, Inc. (NASDAQ: VITA), a spine and biosurgery company, reported that H. Paul Hatten, Jr., M.D., from Vero Beach, Florida, will give a presentation entitled “Treatment of Osteoporotic VCF with CORTOSS®: Preliminary Results and Biomechanical Considerations from the First Prospective Trial at a Single Institution”, at the American Society of Neuroradiology (ASNR) meeting being held in Chicago, IL on Thursday June 14, 2007.
The podium presentation is on Thursday June 14, at 11:43 a.m. in Room Columbus I-L of the Hyatt Regency and will cover part of a prospective randomized controlled study being conducted under an FDA Investigational Device Exemption (IDE). The study assesses the safety and efficacy of CORTOSS compared to commercially available PMMA bone cements in osteoporotic compression fractures of the vertebra(e). A total of 256 patients have been enrolled at 19 sites using a 2:1 randomization with 162 patients assigned to CORTOSS and 94 patients assigned to PMMA. Patients are evaluated at pre-op, post-op, 72 hours, 1 week, 1, 3, 6, 12, and 24 months. Patient outcomes are assessed over time with the use of the Visual Analogue pain Scale (VAS), the Oswestry Disability Index (ODI), and the SF-12. Furthermore, maintenance of height and alignment of the level(s) treated are also monitored over time. Among the inclusion criteria are a minimum VAS pain score of 50/100, a minimum ODI score of 30% caused by recent (an) osteoporotic compression fracture(s) at one or two levels as evidenced by the presence of edema on MRI or bone scan. Exclusion criteria include greater than 70% vertebral collapse, spinal canal compromise, neurologic deficit at the level (s) to be treated, or tumors. Post-operative CT and radiographs are used to assess and quantify leakage. The results reported on this week were collected by Dr. Hatten at Indian River Radiology of Vero Beach, Florida, one of the 19 clinical sites involved in this IDE study.
At the Indian River Radiology site, 57 patients have been enrolled; 36 treated using CORTOSS and 21 treated using PMMA bone cement. The most striking difference between CORTOSS and PMMA seen in this subset of the larger IDE study is that the average volume of material injected per vertebra was 1.17 cc for CORTOSS and 2.41 cc for PMMA treated group.
“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 trabecular fill pattern obtained with CORTOSS, as opposed to the more homogenous “ball-like” fill seen with PMMA. This difference in fill pattern has the potential to reduce the risk of leakage. Early laboratory investigations also indicate that this fill pattern in combination with CORTOSS’ strength may result in a more favorable biomechanical environment.”
There are an estimated 700,000 osteoporotic vertebral compression fractures in the United States each year. Orthovita believes that the CORTOSS clinical study is the most rigorous trial ever enrolled for vertebral compression fractures of the spine. The prospective, randomized study protocol was developed in accordance with the FDA’s vertebral compression fracture guidance document.
CORTOSS has CE Certification for use in the European Union for screw augmentation and for vertebral augmentation. This enables CORTOSS to be sold in the European Union as well as in other countries that have adopted the European Union’s regulatory standards. 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® 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® 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® 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 synthetic-based biomaterial products, we market VITAGEL under a license granted by Angiotech Pharmaceuticals, Inc., and we continue to pursue similar relationships with other biomaterials companies.
