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)...
You may also be interested in...
BioMimetic Shifts Focus To Ortho Following Dental Combo Product Approval
BioMimetic Pharmaceuticals plans to initiate U.S. clinical studies for repairing bone fractures with device-biologic combination products in the first half of 2006
Abbott's ‘Bedrock Of Good Health’ Nutritionals Business Faces Mounting Infant Formula Litigation
Nutritional product business had 5.1% Q1 sales growth and is like Abbott’s other segments, “super well-aligned to the global demographics and trends in health care,” says CEO Ford. But as it defends complaints of damages from powder formulas made at facility found with unsafe levels of bacterial contaminants, Abbott’s also targeted in litigation alleging failure to warn about risk of infants born prematurely developing necrotizing enterocolitis if fed cow’s milk-based formula.
‘Core Pillars’ Of Safety And Innovation Take Center Stage In FDA Reports
The US FDA has issued a pair of reports focused on device safety and innovation. The reports describe recent steps the agency has taken to improve in the two areas, and what it plans to do next.