"We are pleased to reach this important milestone to provide a potential therapy for patients that would likely progress to amputation," said Stuart Kleopfer, President of Biomet Biologics. "This is another step forward in making autologous, minimally manipulated, point-of-care stem cell therapies available to the U.S. patient population."

Jeffrey Binder, President and CEO of Biomet, stated, ""We are proud to be working with these prestigious surgeons and institutions on a landmark study that has the potential to demonstrate an important advance in the treatment of a significant unmet clinical need. This program is an important element of Biomet's emerging biologics platform."

Biomet Biologics recently completed a Phase I study of 30 subjects to evaluate the safety of autologous concentrated bone marrow aspirate for critical limb ischemia. The results of this Phase I study were used to advance the company's MarrowStim?„? concentration technology into the FDA-approved, pivotal IDE trial described here. Overall, the trial will enroll 152 subjects at up to 20 investigational sites. Subjects will be randomized to receive either the investigational treatment involving the MarrowStim?„? P.A.D. Kit, or a placebo control involving a sham procedure. The trial's primary end point of time to treatment failure, defined as major amputation or death, will be evaluated over a one-year follow-up period. Secondary end points, including rest pain, perfusion measurements, quality of life, and safety, will also be evaluated for one year. Completion of subject enrollment is estimated for September, 2011 and completion of one-year data collection for September, 2012.

SOURCE Biomet, Inc.