BioMimetic encouraged by positive data
This article was originally published in The Gray Sheet
Executive Summary
Six-week data from BioMimetic Therapeutics' 19-patient pilot clinical study evaluating GEM OS1 bone graft in open surgery for wrist fractures shows that all patients receiving external fixation augmented with GEM OS1 achieved moderate to complete bone fill (50%-100%) across the fracture gap compared with 56% of patients receiving external fixation alone. Based on the promising results, the Franklin, Tenn., firm is enrolling patients in a pilot study for its next-generation injectable GEM OS2 in the closed treatment of wrist fractures. The firm plans to begin a U.S. pivotal trial for the GEM OS1 foot/ankle indication in the first half of this year. In 2005, BioMimetic received PMA approval for its GEM 21S to treat bone defects in the jaw (1"The Gray Sheet" Dec. 12, 2005, p. 15)...