BioMimetic Therapeutics, Inc. announced today that it has received approval from the U.S. Food and Drug Administration (FDA) for its lead product, GEM 21S(R). The first BioMimetic product to be PMA approved by the FDA, GEM 21S is a fully synthetic regeneration system for the treatment of periodontal bone defects and associated gingival recession. GEM 21S is composed of the tissue growth factor, recombinant human Platelet-Derived Growth Factor (rhPDGF-BB), and a synthetic bone matrix, Beta-tricalcium phosphate (a-TCP). It is the first totally synthetic product combining a purified recombinant growth factor with a synthetic bone matrix to be approved by the FDA for human application.
