Healthcare Industry News: VITAGEL
News Release - May 1, 2006
Two CORTOSS(R) Scientific Papers Will Be Presented at the 44th Annual Meeting of the American Society for NeuroradiologyUltra-Low Injection Volume Vertebroplasty Using CORTOSS Bone Substitute; and
Clinical Experience Using a Novel Bio-Ceramic for Treating Compression Fractures in Vertebroplasty and Kyphoplasty; One Year Follow-up on the First 40 Patients
MALVERN, Pa.--(HSMN NewsFeed)--May 1, 2006--Orthovita, Inc. (NASDAQ NM:VITA ), a leading developer of orthopedic biomaterials, announced today that Dr. Verka Beric will make an oral presentation of a scientific paper "Ultra-Low Injection Volume Vertebroplasty Using CORTOSS Bone Substitute" on Tuesday, May 2, 2006, at 3:39 p.m. in Room 5AB during the "Spine: Injections and Vertebroplasty" session that runs from 3:15 p.m. until 4:45 p.m. at the 44th Annual Meeting of the American Society for Neuroradiology. The presentation will review her results using CORTOSS® with an ultra-low injection volume vertebroplasty technique in twenty patients at the Frenchay Hospital in Bristol, United Kingdom. The American Society for Neuroradiology is holding its 44th Annual Meeting from April 29, 2006 through May 4, 2006 at the San Diego Convention Center in San Diego, CA.
The twenty patients in the study were treated minimally invasively for osteoporotic vertebral fracture with CORTOSS using the vertebroplasty technique, where CORTOSS is injected directly into the fractured vertebra. A maximum of three levels were injected during each procedure, with an average of 1.9 vertebrae injected per procedure. The average volume of CORTOSS injected was 0.5 ml per vertebra, which compares with 5-10 ml volumes of PMMA commonly used in each vertebra. Based upon pre-vertebroplasty, 1 week and 1 month post-vertebroplasty questionnaires that were completed, immediate pain relief was noted in the majority of patients, with average Visual Analog Score improvement of 49 points, and improvements in SF-36 and Oswestry Disability Index were also observed. The Visual Analog Score, Oswestry Disability Index and the SF-36 are validated tests commonly used to assess the benefits of treatment for spinal fractures. One clinically nonsignificant leak occurred that was asymptomatic.
"Unlike PMMA, CORTOSS appears to interdigitate with the trabeculae providing a scaffold-like filling pattern, and thereby allowing lower volumes of material to be injected than traditionally administered with PMMA," said Dr. Beric. "Even with ultra-low injection volumes of CORTOSS, there still appears to be significant clinical improvement in patient symptoms. CORTOSS seemed easier to use than PMMA, and as effective even at ultra-low volume, therefore suggesting that it may be safer than PMMA for use in vertebroplasty."
A second oral presentation of a scientific paper will be made regarding the preliminary results of an ongoing study, "Clinical Experience Using a Novel Bio-Ceramic for Treating Compression Fractures in Vertebroplasty and Kyphoplasty; One Year Follow-up on the First 40 Patients," conducted by Orthovita, Inc., and involving patients with vertebral compression fractures. The presentation will be given by Erik Westerlund, M.D., from CORE Orthopedic Medical Center in Encinitas, CA, on Monday, May 1, 2006, at 3:15 p.m. during the "Spine: Neoplasms, Spinal Injections/Vertebroplasty" session in Room 1AB, Presentation #88.
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 using CORTOSS®, 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 76 pre-op to 44 at one week, 32 at one month, 24 at three months and 33 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, 36% at one month, 30% at three months and 25% 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 38 at one week, 27 at one month, 22 at three months, 23 at six months and 13 at twelve months. These patients also seemed to show improvement in their Oswestry Disability Index as it decreased from 61% pre-op to 50% at one week, 38% at one month, 33% at three months, 34% at six months and 37% at twelve 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.
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 Erik Westerlund, M.D., from CORE Orthopedic Medical Center in Encinitas, CA, the other authors of this abstract include Hyun Bae, M.D., at The Spine Institute at St John's Health Center, Santa Monica, CA; Dr. Philip Maurer, who is a partner in 3B Orthopaedics at Pennsylvania Hospital, University of Pennsylvania Health System, Philadelphia, PA; Walter Peppelman, M.D. and William Beutler, M.D., at the Pennsylvania Spine Institute in Harrisburg, PA; Raymond Linovitz, 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 and soft tissue healing. Our near-term commercial business is based on our internally developed 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 internally developed 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 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.
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