Orthovita to present comparative study data of its Cortoss product to polymethylmethacrylate

Oct 24 2009

Orthovita, Inc. (NASDAQ: VITA), an orthobiologics and biosurgery company, is pleased to announce that Dr. Pierce D. Nunley, Director of the Spine Institute of Louisiana, will present his abstract, “A Comparison of Clinical Outcomes and Adjacent Level Fractures in Patients Receiving Vertebroplasty for Osteoporotic Compression Fractures Using Cortoss^TM or PMMA: A Prospective, Randomized Trial,” at the 2009 Annual Meeting of the Congress of Neurological Surgeons (CNS). The presentation will take place in New Orleans on Monday, October 26, 2009, at 3:15 p.m.

The abstract was selected by CNS as a Top Ten Abstract for the meeting’s section on disorders of the spine and peripheral nerves. It is based on clinical data from Orthovita’s prospective, randomized, multi-center study comparing the efficacy of its Cortoss product to polymethylmethacrylate (PMMA) in the treatment of vertebral compression fractures (VCF). Dr. Nunley 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 a Visual Analogue Pain Scale (VAS) score success rate of 86.6%, the Cortoss patient group experienced a statistically significant benefit in pain success over the PMMA group, which had a VAS score success rate of 75.0%.
• Long-term patient outcomes assessed at 24 months: With an Oswestry Disability Index (ODI) function assessment success rate of 96.7%, the Cortoss patient group experienced a statistically significant benefit in function success over the PMMA group, which had an ODI success rate of 88.4%.

In addition, the Cortoss patient group experienced benefits over the PMMA cohort in the following outcomes:

• A 43.4% reduction in subsequent, adjacent level fractures in Cortoss patients treated for a primary fracture at one level, as measured at the end of the 24-month follow-up period;
• A 67.4% lower incidence of subsequent VCF procedures;
• A 74.6% lower incidence of re-hospitalization for spinal fracture; and
• The Cortoss patients required an average of 30% less material to achieve fracture fill.

“It is my sincere pleasure to have the opportunity to present the results of the Cortoss IDE study on behalf of all my colleague investigators at this important meeting,” Dr. Nunley stated. “These data are the culmination of many years of research and represent a sizeable and significant contribution to the scientific information surrounding vertebral augmentation for osteoporotic fractures. Given the recent attention these procedures have received in the popular media, we think that the quality of the design, execution and results of this particular study make it an important tool in establishing the proper role of vertebral augmentation in the optimal treatment of vertebral compression fractures. Furthermore, we believe the statistically significant improvements experienced by the Cortoss patient group constitute a powerful incentive for surgeons to evaluate this new technology in lieu of PMMA.”