Shares of BioMimetic Therapeutics (NSDQ:BMTI) continued their slide today after plunging 35.3 percent yesterday on news of the FDA’s dim view of its Augment bone graft product.
The federal watchdog agency released its summary of the pre-market approval application for Augment ahead of a special panel review tomorrow. The FDA said 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. The agency’s Orthopedic and Rehabilitation Devices panel is set to meet tomorrow for a public hearing, after which it will vote whether to recommend that the FDA approve the device.
Augment 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. Surgeons mixequal amounts of the substances in a surgical bowl and pack the mixture into a bone void. 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.
The company 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 loss 6.7 percent, from $8.5 million during Q2 2010 to $8.0 million during the just-ended quarter.
BMTI shares were down nearly 6 percent today in early-morning trading, to $8.15. The stock was trading at $13.39 as of the market’s close May 9.
