Orthovita: FDA clears new version of Vitoss graft
Shares of Orthovita Inc. advanced Friday after the company said it received marketing clearance for a new version of its Vitoss bone graft product.
Orthovita said it plans to start selling the product in late 2011 or early 2012.
Late Thursday, the Malvern, Pa., company said the Food and Drug Administration approved its Vitoss bimodal graft, which is indicated to fill bone gaps in the spine, pelvis, and extremities. Vitoss contains bioreactive glass that is designed to encourage the growth of new bone, and the bimodal graft contains smaller particles that are designed to break down more quickly after bone growth has started.
Orthovita shares climbed 35 cents, or 15.9 percent, to $2.55 in morning trading. Earlier the shares rose as much as 28.2 percent.
In December, the company received FDA clearance for its Vitoss Bioactive Foam-2X bone graft substitute. Orthovita said it will launch that version of the product at a medical conference next week, and it plans to launch the bimodal version nine to 12 months later. Orthovita's partner Kensey Nash Corp. will be paid to make the graft, and Kensey will receive royalties based on sales.
Based on studies on animals, the company says the bioreactive glass particles in the Vitoss bimodal graft break down in 20 to 24 weeks.