BioCentury
ARTICLE | Company News

FDA wants more Augment Bone Graft data

January 4, 2012 2:16 AM UTC

BioMimetic Therapeutics Inc. (NASDAQ:BMTI) 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.

In May, an FDA panel voted in favor of the product to treat foot and ankle fractures despite FDA concerns about the product's safety and effectiveness. Augment Bone Graft is a combination of recombinant human platelet-derived growth factor BB ( rhPDGF-BB) and a resorbable synthetic bone matrix (see BioCentury Extra, May 12, 2011). ...