Zimmer Biomet Reports Positive Update on Biologics Pipeline Following a Preliminary Analysis of Data from the First Pivotal Trial of Stem Cell Therapy for Critical Limb Ischemia to Reach Completion
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 (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)[1], and are therefore at higher risk of amputation of the affected limb (40 percent) or death (20 percent)[2].
"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[3]," 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.
About Zimmer Biomet
Founded in 1927 and headquartered in Warsaw, Indiana, Zimmer Biomet is a global leader in musculoskeletal healthcare. We design, manufacture and market orthopaedic reconstructive products; sports medicine, biologics, extremities and trauma products; office based technologies; spine, craniomaxillofacial and thoracic products; dental implants; and related surgical products.
We collaborate with healthcare professionals around the globe to advance the pace of innovation. Our products and solutions help treat patients suffering from disorders of, or injuries to, bones, joints or supporting soft tissues. Together with healthcare professionals, we help millions of people live better lives.
We have operations in more than 25 countries around the world and sell products in more than 100 countries. For more information, visit www.zimmerbiomet.com or follow Zimmer Biomet on Twitter at www.twitter.com/zimmerbiomet.
Cautionary Statement Regarding Forward-Looking Statements
This news release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements concerning Zimmer Biomet's expectations, plans, prospects, and product and service offerings, including new product launches and potential clinical successes. Such statements are based upon the current beliefs and expectations of management and are subject to significant risks and uncertainties that could cause actual outcomes and results to differ materially. For a list and description of some of such risks and uncertainties, see our periodic reports filed with the SEC. These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in Zimmer Biomet's filings with the SEC. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be set forth in our periodic reports. Accordingly, such forward-looking statements speak only as of the date made. Readers of this news release are cautioned not to place undue reliance on these forward-looking statements, since, while management believes the assumptions on which the forward-looking statements are based are reasonable, there can be no assurance that these forward-looking statements will prove to be accurate. This cautionary statement is applicable to all forward-looking statements contained in this news release.
[1] Fadini GP, et al. Autologous stem cell therapy for peripheral arterial disease meta-analysis and systematic review of the literature. Atherosclerosis. 2010 Mar;209(1):10-7.
[2] TASC Working Group. Management of Peripheral Arterial Disease. J Vasc Surg 2000; 31:S20-S34
[3] Gupta SK, et al. Cost Factors in Limb-threatening Ischaemia due to Infrainguinal Arteriosclerosis. Eur J Vasc Surg 1988; 2 (3):151-4
SOURCE Zimmer Biomet Holdings, Inc.
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