WARSAW, Ind., Nov. 15, 2016 /PRNewswire/ -- Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, today announced an update on its Investigational Device Exemption (IDE) clinical trial evaluating the use of autologous concentrated bone marrow aspirate (cBMA), prepared via the MarrowStim™ PAD Kit, for the treatment of critical limb ischemia (CLI). The trial, known as MOBILE ( Marr OwStim™ PAD Kit for the Treatment of Critical Lim B Ischem Ia in Subjects with Severe Peripheral Arteria L Diseas E), is the first pivotal study of its kind to complete enrollment and 1-year follow-up in a challenging patient population with a high mortality risk. A preliminary analysis of a partial data set found that treatment with cBMA improved amputation-free survival compared to placebo, while maintaining a safety profile comparable to placebo. The final analysis of the MOBILE data will form the basis of the Company's U.S. regulatory submission, which is currently being prepared. "We're excited to announce positive progress on our investigational treatment for critical limb ischemia that anchors our emerging biologics pipeline and highlights the breadth of our innovative research and development capability," said David Nolan, Group President, Biologics, Extremities, Sports Medicine, Surgical, Trauma, Foot and Ankle and Office Based Therapies for Zimmer Biomet. "The positive data from our IDE trial places Zimmer Biomet at the forefront of advancing our understanding of the clinical utility of autologous cell therapy, which is one of the most promising areas within biologics. We look forward to completing the analysis of the full data set, unveiling the final results, and finalizing our regulatory submission to the FDA." CLI, which affects an estimated 1.5 million patients in the U.S., is the most severe form of peripheral arterial disease whereby a severe obstruction of the arteries markedly reduces blood flow to the extremities (hands, feet and legs) causing severe pain, skin ulcers, sores or gangrene. Up to 30 percent of patients with CLI do not qualify for conventional interventions to restore blood flow (revascularization), and are therefore at higher risk of amputation of the affected limb (40 percent) or death (20 percent).