Orthovita Announces Presentations of Cortoss Clinical Study Results at the 17th International Meeting of Advanced Spine Technol
MALVERN, Pa.--([ BUSINESS WIRE ])--Orthovita, Inc. (NASDAQ:VITA), an orthobiologics and biosurgery company, is pleased to announce that Hyun W. Bae, M.D. of The Spine Institute at Saint Johna™s Health Center in Santa Monica, California, will present an abstract entitled aCorrelation of Early Pain and Long-Term Functional Results from a Multi-Center, Prospective, Randomized, Controlled FDA-IDE Vertebroplasty Trial,a at the 17th International Meeting of the Advanced Spine Technologies (IMAST) being held from July 21 through July 24, 2010 at the Sheraton Centre Toronto in Toronto, Canada. The presentation will take place on Thursday, July 22, 2010, at 3:19 p.m.
"Correlation of Early Pain and Long-Term Functional Results from a Multi-Center, Prospective, Randomized, Controlled FDA-IDE Vertebroplasty Trial"
The abstract has been nominated for the prestigious Whitecloud Award for Best Clinical Paper at the meeting. The winner of the award will be announced during the final general session on Saturday, July 24th. Dr. Baea™s abstract is based on clinical data from Orthovitaa™s multi-center, prospective, randomized, investigational device exemption (IDE) study comparing the safety and efficacy of Orthovitaa™s Cortossa" Bone Augmentation Material to a polymethylmethacrylate (PMMA) control in the treatment of vertebral compression fractures (VCF). Dr. Bae participated in the study as a clinical investigator.
Key findings from the 256-patient clinical study include the following statistically significant benefits for the Cortoss patient group:
- Early patient outcomes assessed at 3 months: With 86.6% of Cortoss patients and 75.0% of PMMA patients achieving successful pain relief as measured by the Visual Analogue Pain Scale (VAS) the Cortoss patient group experienced a statistically significant benefit in pain success over the PMMA group.
- Long-term patient outcomes assessed at 24 months: With 96.7% of Cortoss patients and 88.4% of PMMA patients maintaining or improving their function as measured by the Oswestry Disability Index (ODI), the Cortoss patient group experienced a statistically significant benefit in function success over the PMMA group.
In addition, Dr. Bae will make a podium presentation of a paper entitled aMarked Improvement in Patients Treated with Vertebroplasty after Painful Osteoporotic Compression Fracturesa at the IMAST meeting on Friday, July 23rd at 3:03 p.m. Dr. Bae will present data on the 44 patients treated at his institution with either Cortoss or PMMA. Improvement in the patientsa™ condition happened within 72 hours, and on average pain improved significantly by 55% and disability by 49%. These results clearly show the beneficial effects of vertebroplasty treatment for vertebral compression fractures.
Dr. Bae, the lead author of both manuscripts, stated, aThe combined results of these studies show the effectiveness of vertebroplasty and that Cortoss has substantial clinical benefits as a vertebroplasty material to achieve the dual goals of immediate pain relief and long-term function.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.