Augment Bone Graft regulatory update

BioMimetic said it received a response letter from FDA for a PMA for the company's Augment Bone Graft requesting additional information from a pivotal trial. The agency also requested further information related to postapproval studies to monitor the product's cancer safety, as well as additional pharmacokinetic evaluations in humans. 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. ...