A little GEM

BioMimetic Therapeutics has recently initiated three clinical trials to evaluate GEM OS1 Bone Graft for use in foot and ankle fusion procedures and the treatment of unstable distal radius fractures.

GEM OS1 is a bioactive drug-device combination product that combines a tissue growth factor, recombinant human Platelet-Derived Growth Factor (rhPDGF), one of the principal wound healing stimulators in the body, with a synthetic bone matrix, Beta-tricalcium phosphate (Beta-TCP).

BioMimetic is leveraging the same combination drug-device technology for orthopaedic applications as it utilised in its FDA approved product, GEM 21S Growth-factor Enhanced Matrix for the treatment of periodontally related defects and gingival recession.

‘As a foot and ankle surgeon, I see a significant number of lower extremity fusion procedures that either do not heal or heal slowly, often leading to prolonged recovery times, increased patient morbidity, and greater cost to the patient and health care system,’ said lead US investigator, Dr. Christopher W. DiGiovanni, chief of foot and ankle in the department of orthopaedic surgery at Rhode Island Hospital and associate professor at Brown Medical School in Providence, RI.