Orthovita, an orthobiologics and biosurgery medical device company, has received FDA approval for the company's PMA supplement of a new collagen, Vitagel processing facility in Malvern, Pennsylvania.
Orthovita expects to 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.
Orthovita said that the 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.
Antony Koblish, president and chief executive officer Orthovita, said: “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 utilise our collagen facility and technical know-how.”