Orthovita's Vitoss bone graft receives FDA clearance
This article was originally published in Clinica
Executive Summary
Vitoss BA Bimodal Bone Graft Substitute, developed by Orthovita, has received US 510(k) clearance as a non-structural bone void filler for use in the extremities, pelvis and posterolateral spine. The Malvern, Pennsylvania company plans to launch Vitoss BA Bimodal in the US in 9-12 months' time. Orthovita is currently concentrating on the US launch of Vitoss BA2X which is set for next week. The graft was produced under a development, manufacturing and supply agreement Orthovita has with Kensey Nash. It contains Orthovita’s Vitoss beta-tricalcium phosphate bone graft substitute scaffold and Kensey Nash's collagen material. When Orthovita launches Vitoss BA Bimodal, it will have to pay Kensey Nash to manufacture the product as well as pay royalties based on the net sales.