FDA schedules panel meeting date for BioMimetic Therapeutics's Augment Bone Graft PMA

Feb 1 2011

BioMimetic Therapeutics, Inc. (NASDAQ: BMTI), a biotechnology company specializing in the development and commercialization of innovative drug-device combination products to promote the healing of musculoskeletal injuries and diseases, today announced that the U.S. Food and Drug Administration (FDA) has tentatively scheduled an Orthopedic and Rehabilitation Devices Panel meeting on May 12, 2011 to review the Company's Premarket Approval (PMA) application for Augment™ Bone Graft for the treatment of foot and ankle fusions in the U.S. If the panel determines the product's benefits outweigh any potential risks, the Company expects approval of Augment by the FDA within three to six months after the panel date.

"We are pleased that the date for the FDA advisory panel meeting has been set and look forward to the opportunity to present our findings from the Augment clinical program. To date, nearly 650 patients have been treated in Augment orthopedic clinical trials over the past four years. Moreover, GEM 21S^®, a nearly identical product, has proven safe and effective for treatment of periodontal bone and soft tissue defects during its five years of commercial use," commented Dr. Samuel Lynch, president and CEO of BioMimetic Therapeutics. "We are confident that, if approved, Augment will provide U.S. physicians and patients with a safe and important new therapeutic option for the treatment of foot and ankle fusions without the pain and morbidity associated with the current gold standard which requires taking autogenous bone from elsewhere in the patient's body. If approved, Augment will be the first new recombinant bone and tissue growth factor technology to be introduced for orthopedic uses in nearly a decade."

Confirmation and details of the meeting will be published in the Federal Register approximately six to eight weeks prior to the scheduled meeting date. Please note that until this panel meeting is announced in the Federal Register, it is considered tentative and could be postponed or cancelled. The Federal Register notice will be available at the following website: http://www.fda.gov/RegulatoryInformation/Dockets/FR/default.htm.