Orthovita Announces Presentations Of Cortoss Clinical Study Results At The 17th International Meeting Of Advanced Spine Technologies

Main Category: Bones / Orthopedics
Also Included In: Pain / Anesthetics
Article Date: 20 Jul 2010 - 17:00 PDT

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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 John's Health Center in Santa Monica, California, will present an abstract entitled "Correlation of Early Pain and Long-Term Functional Results from a Multi-Center, Prospective, Randomized, Controlled FDA-IDE Vertebroplasty Trial," 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.

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. Bae's abstract is based on clinical data from Orthovita's multi-center, prospective, randomized, investigational device exemption (IDE) study comparing the safety and efficacy of Orthovita's Cortoss™ 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 "Marked Improvement in Patients Treated with Vertebroplasty after Painful Osteoporotic Compression Fractures" 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 patients' 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, "The 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."

Source:
Orthovita

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