BioMimetic Therapeutics (NSDQ:BMTI) clawed back a chunk of the share value it lost earlier this week after the FDA released a dim review of BMTI’s Augment bone graft product, as an advisory panel for the federal watchdog agency recommended approving the treatment.
BMTI shares were up about 8 percent in pre-market trading today, to $9.91, after plunging more than 35 percent from a May 9 close of $13.39.
Investors were spooked by an FDA summary of the pre-market approval application for Augment ahead of a special panel review yesterday. A clinical study of the product, which is used to stimulate bone growth in foot and ankle fusion procedures, showed that it was not as successful as grafts taken from patients’ own bones, according to the summary.
But the agency’s Orthopedic and Rehabilitation Devices panel voted to recommend that the agency approve Augment, which is a drug/device combination that uses a recombinant human platelet-derived growth factor called B homodimer (rhPDGF-BB) and a bioresorbable synthetic bone matrix called beta-tricalcium phosphate or β-TCP. The vote is not binding, but the FDA often follows the lead of its advisory panels.
BioMimetic won Health Canada approval from Health Canada in November 2009 for midfoot, hindfoot and ankle fusion indications. Augment has only been used in IDE studies in the U.S.; a PMA nod would make it the first new recombinant protein product to hit the orthopedics market in nearly 10 years.
President and CEO Dr. Samuel Lynch said BMTI is planning to get Augment on hospital shelves immediately after an FDA approval, "which we expect within the coming six months," according to a press release. In fact, the company has already laid the groundwork for a strong sales push, inking distribution contracts that will put 100 independent reps on the street. BMTI said it expects that number to reach 150 to 175 reps by the time Augment is cleared for launch, plus an internal sales management team.
BioMimetic Therapeutics posted its first-quarter results this week, reporting a revenue increase of 13.2 percent, to $399,000, for the three months ended March 31. BioMimetic also shaved its net losses by 6.7 percent, from $8.5 million during Q2 2010 to $8.0 million during the just-ended quarter.
