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Orthovita Announces Publication of 24-Month Data from Cortoss Clinical Pilot Studies in Vertebroplasty and Kyphoplasty

^{Published on 2010-09-20 05:11:33 - Market Wire}
 

MALVERN, Pa.--([ BUSINESS WIRE ])--Orthovita, Inc. (NASDAQ: VITA), an orthobiologics and biosurgery company, is pleased to announce the publication of aClinical Experience Using Cortoss for Treating Vertebral Compression Fractures with Vertebroplasty and Kyphoplastya in the September 15, 2010 edition of Spine. The article presents the clinical data from two FDA-approved investigational device exemption (IDE) pilot studies sponsored by Orthovita. These multi-center, prospective trials assessed the feasibility and clinical outcomes of Cortossa" Bone Augmentation Material using the two different vertebral augmentation techniques of vertebroplasty and kyphoplasty.

"These positive results formed the motivation and justification for us to continue to evaluate Cortoss in these patients, which we did with the prospective randomized IDE study we completed in 2009. The results of this study were the basis of Cortossa™ clearance by FDA."

Cortoss, an injectable, bioactive composite, was used to treat 40 patients with osteoporotic vertebral compression fractures (VCFs) in two multi-center studies. Key findings from the clinical studies include:

• Vertebral augmentation with Cortoss provides sustained postoperative relief of pain and improvement in disability and quality of life through 24 months of patient follow-up.
• Comparable pain relief and quality-of-life improvements were achieved with both vertebroplasty and kyphoplasty techniques, with approximately 50% less material volume required for vertebroplasty.
• Cortoss trabecular interdigitation and bone bonding were observed in histology obtained 6 months following vertebral augmentation with kyphoplasty.

The paper concludes that, based on the results of these pilot studies:

• Cortoss is safe and effective in treating osteoporotic VCFs using either vertebroplasty or kyphoplasty; and
• VCF pain relief and functional restoration achieved with Cortoss is comparable to the results reported in the literature for VCFs treated with polymethylmethacrylate (PMMA).

Dr. Bae of The Spine Institute at Saint Johna™s Health Center in Santa Monica, California, lead author of the article, stated, aThese positive results formed the motivation and justification for us to continue to evaluate Cortoss in these patients, which we did with the prospective randomized IDE study we completed in 2009. The results of this study were the basis of Cortossa™ clearance by FDA.a

About the Company

Orthovita is an orthobiologics and biosurgery company that develops and markets novel medical devices. Our orthobiologics platform offers products for the fusion, regeneration and fixation of human bone. Our biosurgery platform offers products for controlling intra-operative bleeding, also known as hemostasis. Our current fusion and regeneration products are based on our proprietary VITOSSa" Bone Graft Substitute technology and address the non-structural bone graft market with synthetic, bioactive alternatives to patient- and cadaver-derived bone tissue. CORTOSSa" Bone Augmentation Material, an injectable, polymer composite that mimics the structural characteristics of human bone, provides the basis for our fixation portfolio. Our hemostasis portfolio includes VITAGELa" Surgical Hemostat, a unique, collagen-based matrix that controls bleeding and facilitates healing, and VITASUREa" Absorbable Hemostat, a plant-based product that can be deployed quickly throughout surgery.

Disclosure Notice

This press release may contain forward-looking statements regarding Orthovitaa™s current expectations of future events that involve risks and uncertainties, including, without limitation, the demand and market acceptance of our products and other aspects of our business. Such statements are based on managementa™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 aRisk Factors.aFurther information about these and other relevant risks and uncertainties may be found in Orthovitaa™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.