FRANKLIN, Tenn.--(BUSINESS WIRE)--BioMimetic Therapeutics, Inc. (NASDAQ: BMTI) today announced that the U.S. Food and Drug Administration (FDA) completed its evaluation and approval of the manufacturing facility that produces rhPDGF-BB, the key active ingredient in the Company’s lead product, GEM 21S, Growth-factor Enhanced Matrix. As part of the approval process of GEM 21S, the FDA required the review and approval of a manufacturing site owned and operated by Novartis in Vacaville, California which manufactures bulk supply of rhPDGF-BB. The current approval provides additional, large scale manufacturing capacity to ensure the adequate supply of rhPDGF-BB available for use in GEM 21S, which is marketed for the treatment of periodontal bone defects and gingival recession, and GEM OS1, which is currently being evaluated in three clinical trials for orthopedic indications.
