Orthovita publishes clinical data from IDE pilot studies

Sep 21 2010

Orthovita, Inc. (NASDAQ: VITA), an orthobiologics and biosurgery company, is pleased to announce the publication of "Clinical Experience Using Cortoss for Treating Vertebral Compression Fractures with Vertebroplasty and Kyphoplasty" 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 Cortoss™ Bone Augmentation Material using the two different vertebral augmentation techniques of vertebroplasty and kyphoplasty.

“Clinical Experience Using Cortoss for Treating Vertebral Compression Fractures with Vertebroplasty and Kyphoplasty”

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 John's Health Center in Santa Monica, California, lead author of the article, stated, "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 Cortoss' clearance by FDA."