Augment Injectable Bone Graft: Phase III suspended enrollment

BioMimetic disclosed in its 4Q11 earnings that it voluntarily suspended screening and enrollment in a North American Phase III trial evaluating its Augment Injectable Bone Graft to focus on Augment Bone Graft. In January, the company received a response letter from FDA for a PMA for its Augment Bone Graft requesting additional information from a pivotal trial (see BioCentury, Jan. 9). The company is seeking approval of the product as an alternative to autograft in hindfoot and ankle fusion procedures. BioMimetic plans to submit an amendment to the PMA by mid-year. ...