First Recombinant Growth Factor Approved by FDA for Use in Periodontal Applications

Osteohealth Company announced that GEM 21S® (Growth-factor Enhanced Matrix) has been approved by the U.S. Food and Drug Administration (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 (ß-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. The combination of the two components of GEM 21S ® are key to the overall effectiveness of the product. The rhPDGF-BB provides the biological stimulus for tissue repair by stimulating the proliferation and in-growth of osteoblasts, cells responsible for the formation of bone, while the ß-TCP provides the framework or scaffold for new bone growth to occur. In recognition of the unique treatment modality provided by GEM 21S®, the FDA has established it as a first-in-class product in its treatment category.