Orthovita Submits PMA To FDA For Approval To Transfer Commercial Manufacturing Of VITAGEL(TM)

Malvern, PA - Orthovita announced today that it has submitted a PMA for VITAGEL(TM) Surgical Hemostat to the FDA. FDA approval of the PMA submitted by Orthovita will allow Orthovita to sell VITAGEL product that is manufactured on-site at its Malvern, PA facility. Orthovita has been distributing VITAGEL since January, 2005 through a distribution agreement with Angiotech Pharmaceuticals. Orthovita will continue to distribute VITAGEL product made to date by Angiotech Biomaterials (a division of Angiotech Pharmaceuticals) until Orthovita receives FDA approval for its own PMA, which approval is expected in the second half of 2006.

"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," said Antony Koblish president and chief executive officer at Orthovita, Inc. "Orthovita will work closely with the FDA to secure the final approval to commercially manufacture VITAGEL during the second half of 2006. We look forward to fully integrating our manufacturing of VITAGEL together with our ongoing selling and marketing efforts. Orthovita is very committed and optimistic on the prospects for the VITAGEL product line."

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. VITAGEL stimulates hemostasis and healing through multiple mechanisms, amplifying the patient's own biology. Upon application, VITAGEL works by combining a thrombin / collagen suspension with the patient's own plasma. The resultant fibrin / collagen clot stems bleeding and provides a robust three- dimensional matrix for soft tissue healing.

SOURCE: Orthovita