Orthovita applies to FDA to make Vitagel at Pennsylvania plant

By E. Janene Geiss

Philadelphia, Dec. 5 - Orthovita said Monday that it has submitted a Pre-Market Approval for Vitagel Surgical Hemostat to the U.S. Food and Drug Administration.

FDA approval of the PMA would allow Orthovita to sell Vitagel product manufactured at its Malvern, Pa., facility, according to a company news release.

Orthovita has been distributing Vitagel since January 2005 through a distribution agreement with Angiotech Pharmaceuticals, officials said.

Orthovita will continue to distribute Vitagel product made by Angiotech Biomaterials, a division of Angiotech Pharmaceuticals, until Orthovita receives approval for its own PMA, which is expected in the second half of 2006, officials said.

"Filing our Vitagel PMA with the FDA is a significant step required in the process to transfer Vitagel manufacturing from Angiotech Biomaterials to Orthovita's Malvern, Pennsylvania facility," Antony Koblish, president and chief executive officer, said in the release.

Vitagel is a surgical hemostat used in surgical procedures as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical. It stimulates hemostasis and healing through multiple mechanisms, amplifying the patient's own biology, officials said.

Orthovita is a Malvern, Pa., biomaterials company with proprietary technologies for the development and commercialization of synthetic, biologically active, tissue-engineering products for orthopedic and neurosurgical applications.

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