FDA Gives Orthovita The Go Ahead To Manufacture VITAGEL
BY ARIELLA P. GOLOMB, MD, JUNE 16, 2006
Orthovita announced that it has obtained pre-market approval (PMA) from the FDA to market its VITAGEL(TM) surgical hemostat manufactured on-site at its Malvern, Pennsylvania facility. Orthovita has been distributing VITAGEL since the first quarter of 2005 through a distribution agreement with Angiotech. After a March 2006 License Agreement, manufacturing obligations shifted from Angiotech to Orthovita. In May the company announced that due to higher than anticipated sales, they did not expect to have sufficient VITAGEL inventory to sustain current sales levels for a period of time. VITAGEL revenues represented 16% of the company's revenues in 1Q:06, and today's news caused Orthovita stock to hit a 52 week high.
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 stimulates hemostasis and healing through multiple mechanisms, amplifying the patient's own biology. VITAGEL is approved for use only in conjunction with the CELLPAKER(R) plasma collection system. 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.
Despite the encouraging news about the VITAGEL approval, Orthovita is not in the clear yet- they still need to gain pre-marketing approval for the manufacturing of the CELLPAKER system. The company stated today that it believes it has sufficient CELLPAKER inventory purchased from Angiotech to meet sales demand through the end of 2006.
