BioMimetic's GEM 21S shows long-term efficacy for periodontal treatment

By Elaine Rigoli

Tampa, Fla., Sept. 18 - BioMimetic Therapeutics, Inc. released 12- and 24-month follow-up results from the pivotal clinical trial for the company's lead product, GEM 21S Growth-factor Enhance Matrix, for the treatment of periodontal disease and gingival recession.

The company said the data demonstrate continued long-term efficacy for GEM 21S treatment, with improved bone growth observed throughout the 24-month observation period compared to control treatment.

The Franklin, Tenn., drug-device company said GEM 21S combines recombinant human platelet-derived growth factor BB (rhPDGF-BB), a principal wound healing stimulator in the body, with Beta-tricalcium phosphate (Beta-TCP), a synthetic bone matrix.

Radiographic (x-ray) analysis of bone growth showed that sites treated with GEM 21S demonstrated a statistically significant increase in bone fill throughout the 24-month observation period as compared to treatment with the Beta-TCP matrix alone, a material often used to treat bone injuries.

Further, bone formation in the Beta-TCP matrix alone group never achieved the degree of bone formation during the 24-month period as was observed at six months in the GEM 21S group, the company said in a news release.

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