BioCentury
ARTICLE | Clinical News

Osiris leaps on Grafix diabetic foot ulcer data

August 14, 2013 12:21 AM UTC

Osiris Therapeutics Inc. (NASDAQ:OSIR) jumped $14.78 (139%) to $25.44 on Tuesday after reporting data it believes will support payer approval of Grafix in the out-patient setting for diabetic foot ulcers. Osiris said weekly Grafix met the primary endpoint of improving the proportion of patients with complete wound closure, defined as 100% re-epithelialization, at 12 weeks vs. standard of care (SOC) in the Phase IV Protocol 302 trial to treat diabetic foot ulcers (62% vs. 21.3%, p<0.0001).

Osiris markets the 3D cellular matrix comprising endogenous mesenchymal stem cells (MSCs) and growth factors in the U.S. to treat chronic wounds, including diabetic foot ulcers and venous leg ulcers. The company has not been able to obtain full coverage by Medicare and private insurance for Grafix for outpatient treatment of diabetic foot ulcers. The company said it is conducting Protocol 302 to gain full reimbursement in the outpatient setting, which according to Osiris represents 80% of the market for diabetic foot ulcers. Osiris estimates the total U.S. market for diabetic foot ulcers is $2 billion. ...