Orthovita Submits 510(k) Application to FDA for the Use of CORTOSS(R) Bone Augmentation...

Orthovita Submits 510(k) Application to FDA for the Use of CORTOSS(R) Bone Augmentation Material in Vertebral Augmentation

MALVERN, Pa.--(Business Wire)--Orthovita, Inc. (NASDAQ:VITA), a spine and orthopedic biosurgery
company, announced today that it has submitted a 510(k) filing to the
U.S. Food and Drug Administration for the use of its CORTOSS Bone
Augmentation Material in vertebral augmentation. This filing is based
on data collected in three U.S. clinical investigations conducted
under FDA Investigational Device Exemptions (IDEs) and several
European studies, and is intended to demonstrate that the performance
of CORTOSS is substantially equivalent to polymethylmethacrylate
(PMMA) bone cement. The extensive clinical study of CORTOSS
demonstrates that the same degree of clinical improvement in pain and
function is achieved with approximately 40% less material than PMMA
when augmenting the vertebral body. CORTOSS also provides other
benefits, including consistent handling characteristics and viscosity.

The CORTOSS 510(k) filing includes data on 469 vertebral
compression fracture patients treated with CORTOSS and 94 patients
treated with PMMA with follow up ranging from 11 months to over 3
years. This data includes results from Orthovita's pivotal,
prospective, randomized clinical study conducted under an FDA IDE. In
the pivotal study, a total of 162 patients were treated with CORTOSS
and 94 patients were treated with PMMA. Two-year follow up for all 256
of the pivotal study patients will be completed in February 2009.

"The 510(k) filing is a key step toward the introduction of
CORTOSS to the U.S. market as an alternative to PMMA bone cement for
the treatment of vertebral compression fractures. To the Company's
knowledge, the CORTOSS 510(k) filing contains the largest prospective,
randomized, controlled clinical dataset ever assembled in the
treatment of vertebral compression fractures. We would like to express
our gratitude to all our investigators and their personnel for their
hard work and invaluable contributions that helped us achieve this
milestone," said Antony Koblish, President and Chief Executive Officer
of Orthovita.

FDA clearance of CORTOSS would permit Orthovita to market and sell
the material in the United States. CORTOSS has CE Certification for
use in the European Union for screw augmentation and for vertebral
augmentation. This enables CORTOSS to be sold in the European Union as
well as in other countries that have adopted the European Union's
regulatory standards.

About the Company

Orthovita is a spine and orthopedic biosurgery company with
proprietary biomaterials and biologic technologies for the development
and commercialization of synthetic, biologically active, tissue
engineering products. We develop and market synthetic-based
biomaterials products for use in spine surgery, the repair of
fractures and a broad range of clinical needs in the trauma, joint
reconstruction, revision and extremities markets. Our near-term
commercial business is based on our VITOSS(R) Bone Graft Substitute
technology platforms, which are designed to address the non-structural
bone graft market by offering synthetic alternatives to the use of
autograft or cadaver-based bone material, and VITAGEL(R) Surgical
Hemostat, which is an adherent matrix and an impermeable barrier to
blood flow. Our longer-term U.S. clinical development program is
focused on our internally developed CORTOSS(R) Bone Augmentation
Material technology platform, which is primarily designed for
injections in osteoporotic spines to treat vertebral compression
fractures. We work jointly with Kensey Nash Corporation to develop and
commercialize novel synthetic-based biomaterial products, we market
VITAGEL under a license granted by Angiotech Pharmaceuticals, Inc.,
and we continue to pursue similar relationships with other companies
in biomaterials.

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
development, regulatory approval, demand and market acceptance of our
products; our ability to obtain FDA clearance for CORTOSS in the
United States; 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. These risks and uncertainties include the
risk that the FDA will require the CORTOSS 510(k) application to
contain two-year follow up data for a greater percentage of the
patients in the pivotal study than that which is reflected in the
application as originally filed with the FDA or for all of the
patients in the pivotal study. Other 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 "Risks 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.

Orthovita, Inc.
Albert J. Pavucek, Jr.
Chief Financial Officer
610-640-1775 or 800-676-8482

Copyright Business Wire 2008