Zimmer Biomet Holdings (ZBH) Updates on IDE Trial; Notes Improved AFS with cBMA Treatment
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Zimmer Biomet Holdings, Inc. (NYSE: ZBH) 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 (MarrOwStim™ PAD Kit for the Treatment of Critical LimB IschemIa in Subjects with Severe Peripheral ArteriaL DiseasE), 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).
"There is an urgent need for alternatives to amputations in patients with advanced critical limb ischemia, nearly 30 percent of whom never fully recover and require chronic professional assistance at home or in an institution," said Michael P. Murphy, M.D., the lead investigator of the MOBILE trial, and Associate Professor of Surgery, Associate Professor of Cellular and Integrative Physiology – Clinical, Director of the Vascular and Cardiac Center for Adult Stem Cell Therapy, and Director of the IU Center for Aortic Disease at the Indiana University School of Medicine in Indianapolis.
MOBILE is a prospective, randomized, double-blind, placebo-controlled clinical trial to evaluate the safety and efficacy of cBMA, injected intramuscularly into the affected limb, in preventing or delaying major amputation and/or death in patients with CLI who are unsuitable for revascularization. The primary efficacy endpoint of the study is Amputation Free Survival (AFS), time to major amputation and/or all cause mortality, at 1 year. For more information about the MOBILE trial, visit www.padstudy.org.
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