IsoTis Accell gains FDA clearance
This article was originally published in The Gray Sheet
Executive Summary
Integra LifeSciences' pending acquisition of orthobiologics firm IsoTis moves a step closer to completion with the Aug. 15 receipt of 510(k) clearance for IsoTis' Accell line of demineralized bone matrix products. Accell is a key asset of the $51 million deal, which was announced Aug. 7 and conditioned upon Accell market go-ahead. The Accell products are indicated for use as bone graft extenders in the spine, extremities and pelvis, or as bone void fillers in the extremities and pelvis (1"The Gray Sheet" Aug. 13, 2007, p. 10)...