Orthovita’s surgical collagen facility gains FDA approval
10 August 2010
Orthovita, Inc. (NASDAQ: VITA), an orthobiologics and
biosurgery company, has received FDA approval for a new collagen
processing facility in Malvern, Pennsylvania. Orthovita will use the new
facility to process the highly purified form of collagen used in its
Vitagel Surgical Hemostat product.
Vitagel is a composite liquid hemostat used in surgical procedures
as an adjunct to hemostasis when control of bleeding by ligature or
conventional procedures is ineffective or impractical. Vitagel is
combined with the patient’s own plasma immediately prior to
application to a bleeding site. A fibrin/collagen clot forms quickly
to control bleeding and provide a three-dimensional matrix to
facilitate healing.
The approval of the new facility not only gives Orthovita
enhanced control over the supply and quality of a key raw material
for its Vitagel product, but also provides the company with an
opportunity to develop, manufacture and market additional
collagen-based products. This technology processes collagen to
retain crucial aspects of its natural molecular structure and the
potent biological characteristics found in the collagen of living
tissues. As a result, the collagen processed at the facility will be
among the purest available on the market.
Orthovita’s President and Chief Executive Officer Antony Koblish
stated, “We are very pleased to have further solidified our supply
control over our Vitagel product. The regulatory approval of our
collagen facility also gives us another resource for executing on
our goal to broaden our product offerings and increase sales force
leverage. We are actively engaged in research and development work
for products based on the versatile properties of the ultra pure
collagen that can be made at our FDA-approved facility. We are also
pursuing outside partnering and co-development arrangements to
utilize our collagen facility and technical know-how.”