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
CortossTM 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.”
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 VitossTM Bone Graft
Substitute technology and address the non-structural bone graft market
with synthetic, bioactive alternatives to patient- and cadaver-derived
bone tissue. CortossTM Bone Augmentation Material, an
injectable, polymer composite that mimics the structural characteristics
of human bone, provides the basis for our fixation portfolio. Cortoss
received U.S. regulatory clearance in June 2009 for use in vertebral
augmentation. Our hemostasis portfolio includes VitagelTM
Surgical Hemostat, a unique, collagen-based matrix that controls
bleeding and facilitates healing, and Vitasure™ Absorbable Hemostat, a
plant-based product that can be deployed quickly throughout surgery.
Disclosure Notice
This press release may contain forward-looking statements regarding
Orthovita’s current expectations of future events that involve risks and
uncertainties, including, without limitation, the demand and market
acceptance of our products, including Cortoss, our ability to
successfully launch Cortoss, and other aspects of our business. Such
statements are based on management’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 "Risk Factors.”
Further
information about these and other relevant risks and uncertainties may
be found in Orthovita’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.