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

Source: Osteohealth Company, www.osteohealth.com

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.

GEM 21S® Clinical Trial Results
FDA approval of GEM 21S® was based on results from a pivotal 180 patient double-blind, randomized, controlled multicenter, pivotal clinical trial involving subjects who required surgical intervention to treat periodontal bone defects. Patients were studied for six months following implantation of the product.
The study assessed both clinical attachment and bone regeneration, which was determined radiographically. The results of the study demonstrated that treatment with GEM 21S® (Growth-factor Enhanced Matrix) led to statistically significant benefits in bone growth and accelerated tissue attachment level gain compared to the control group that received the ß-TCP plus buffer, without the addition of the growth factor. Additionally, the study revealed no evidence of either local or systemic adverse effects resulting directly from placement of GEM 21S®.