FRANKLIN, Tenn.--(BUSINESS WIRE)--BioMimetic Therapeutics, Inc. (NASDAQ: BMTI) today announced that the Food & Drug Administration (FDA) issued a letter to the Company confirming that its U.S. GEM OS1 pivotal study for the treatment of foot and ankle fusions should continue as designed and that the FDA has taken no action to change the study status. This letter follows several discussions between the Agency and BioMimetic regarding the posting on the FDA website of an Early Communication concerning the Agency’s ongoing safety review of Regranex®, a Johnson & Johnson product. Both GEM OS1 and Regranex contain recombinant human platelet-derived growth factor (rhPDGF-BB) (becaplermin) as the active ingredient.
