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Results of CORTOSS(R) Vertebral Compression Fracture IDE Pilot Studies in Vertebroplasty and Kyphoplasty Presented at the 20th Annual Meeting of the North American Spine Society

Posted on: Wednesday, 28 September 2005, 09:00 CDT

A Preliminary Report on up to 12-Month Follow-Up of the First 40 Patients

The preliminary results of an ongoing study, "Characteristics and Clinical Experience Using A Novel Bioceramic For Treating Vertebral Compression Fractures in Vertebroplasty and Kyphoplasty; Report On The First 40 Patients," conducted by Orthovita, Inc., (NASDAQ NM:VITA) and involving patients with vertebral compression fractures will be presented in an abstract at the 20th Annual Meeting of the North American Spine Society being held in Philadelphia, PA. Hyun Bae, M.D., lead author of the study, will present the findings on Wednesday, September 28 at 4:17 p.m. during the Vertebral Augmentation Concurrent Session.

The purpose of the two pilot IDE studies, conducted in 20 patients each, was to obtain preliminary information for assessing the feasibility and clinical outcome in using CORTOSS(R), Orthovita's product to treat osteoporotic vertebral compression fractures. Patients in the study were treated minimally invasively with CORTOSS using either the vertebroplasty technique, where CORTOSS is injected directly into the fractured vertebra, or the kyphoplasty technique, where a balloon is first inserted into the fractured vertebra and inflated to create a void prior to injection of CORTOSS.

The preliminary study results suggest that patients treated with CORTOSS using the vertebroplasty technique show improvement as their Visual Analog Score for pain decreased from 73 pre-op to 36 at four days, 44 at one week, 24 at three months and 28 at twelve months. These patients also seemed to show improvement in their Oswestry Disability Index as it decreased from 52% pre-op to 42% at one week, 30% at three months and 23% at twelve months. Similarly, the preliminary study results suggest that patients treated with CORTOSS using the kyphoplasty technique show improvement as their Visual Analog Score for pain decreased from 78 pre-op to 43 at four days, 38 at one week, 22 at three months, and 20 at six months. These patients also seemed to show improvement in their Oswestry Disability Index as it decreased from 60% pre-op to 49% at one week, 33% at three months and 38% at six months. In both studies, the improvements in VAS and ODI were statistically significant. No statistically significant differences in pain and function follow-up results were seen between the two techniques in this preliminary analysis. The SF-12 scores improved or were maintained at each time point in both treatment groups. The Visual Analog Score, Oswestry Disability Index and the SF-12 are validated tests commonly used to assess the benefits of treatment for spinal fractures.

"These early-stage results from 40 patients in our studies treated with CORTOSS seem to indicate that this new synthetic biomaterial could potentially offer many important benefits to patients," said Dr. Bae.

The reported study results also seemed to suggest that a relatively small volume of CORTOSS, averaging 1.9cc per treated vertebra in vertebroplasty and 4.1cc in kyphoplasty, may be able to reinforce the vertebrae and achieve symptomatic relief, as compared to the larger volumes reported in the literature for polymethylmethacrylate (PMMA) bone cement. This observation is believed to be due to the ability of CORTOSS to interdigitate with the native bone within the treated vertebra. These overall results appear to be consistent with those obtained in the prospective vertebroplasty study conducted in Europe using CORTOSS. Leakages were analyzed on post-op CT scans and appeared to be similar in both treatment groups. All leakages observed in each treatment group were asymptomatic. A larger, 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.

In addition to Dr. Bae, who is associated with The Spine Institute at Saint John's Health Center, Santa Monica, CA, the other authors of this abstract include Philip Maurer, M.D., at the Pennsylvania Hospital in Philadelphia, PA, Walter Peppelman, M.D. and William Beutler, M.D. at the Pennsylvania Spine Institute in Harrisburg, PA, Raymond Linovitz, M.D., Erik Westerlund, M.D., and Timothy Peppers, M.D. at CORE Orthopedic Medical Center in Encinitas, CA, Isador Lieberman, M.D. at The Cleveland Clinic in Cleveland, OH, Choll Kim, M.D. at the University of California - San Diego, San Diego, CA, and Federico Girardi, M.D. at the Hospital for Special Surgery in New York City, NY.

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. 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 a safe 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 and Form 10-Q 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 from Orthovita upon request. Orthovita undertakes no obligation to publicly update any forward-looking statements.

Source: Business Wire

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