BioMimetic Therapeutics Inc. (Nasdaq: BMTI) was dealt a setback Tuesday when it learned the Food and Drug Administration did not approve its application for the bone graft device Augment, and has requested additional clinical information from the company.
BioMimetic had been aiming for FDA approval of the device by the end of 2011. But the Nashville-based biotechnology company reported that the FDA said its pre-market approval application “must be considered not approvable” without additional information relating to Augment’s safety and effectiveness, as well as antibody safety and reproductive issues.
BioMimetic said it intends to answer the FDA by mid-2012, and that Augment approval could occur 15 to 24 months from now if the agency is satisfied with the responses.
The FDA also has requested additional information on post-approval studies to monitor the cancer safety of Augment, and to further evaluate its pharmacokinetic profile in humans.
“The company continues to believe in the safety and effectiveness of Augment and remains optimistic about obtaining FDA approval of Augment,” BioMimetic said in a statement.
Augment is a product that attempts to promote the healing of musculoskeletal injuries and diseases, thereby eliminating the need to harvest bone from a patient.
According to the Wall Street Journal, shares for BioMimetic were down 11 percent, at $2.60 in light after-hours trading. Through the close, the stock has dropped 78 percent in the last year.
