BioMimetic Therapeutics ($BMTI) can claim a victory. An expert FDA advisory committee supported the safety and effectiveness of the Franklin, TN-based biotech's bone graft treatment for foot and ankle surgeries by a slim margin on Thursday.
The company still faces the agency's scrutiny in its pursuit of U.S. marketing approval of Augment. The product involves a synthetic protein and is intended to be an alternative to using a patient's own tissue, or an autograft, in surgeries to repair broken foot and ankle bones. The advisory panel voted 12-6 in favor of the safety of the firm's product, even after FDA staff raised red flags in their own review earlier this week that a synthetic protein might spur growth of existing cancer cells. The panel also voted 10-8 on both questions of the product's effectiveness and that its benefits outweigh its risks.
The committee's votes came with recommendations that the company conduct additional studies of its bone graft treatment. The Tennessean reported that one topic the advisory panel discussed was the question about the potential cancer-growth side effect from the synthetic protein used in the treatment. The intended effect of the protein, a recombinant form of human platelet-derived growth factor, is to spur the regrowth of bone tissue to repair breaks.
"It's reasonable to expect that there's going to be additional work required, but I think there's now a path to approval for the product," said Greg Wade, an analyst at Wedbush Securities in San Francisco, told The Tennessean.
BioMimetic seems unfazed by its slim margin of victory. The company said last night that it's building up its commercial capabilities, adding it has upgraded its anticipated number of independent salespeople for the potential U.S. market launch from 80-100 to 150-175. While the product was approved in Canada in 2009, an FDA approval would open the company to the $2.5 billion annual bone graft market in this country.