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Zimmer Biomet (ZBH) Announces Positive Data from IDE Trial

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Zimmer Biomet Holdings, Inc. (ZBH - Free Report) , a major player in musculoskeletal healthcare, recently reported positive update on its Investigational Device Exemption (IDE) clinical trial assessing the use of autologous concentrated bone marrow aspirate (cBMA) for the treatment of critical limb ischemia (CLI). The trial dubbed as MOBILE (MarrowStim PAD Kit for the Treatment of Critical Limb Ischemia in Subjects with Severe Peripheral Arterial Disease) is said to be the first pivotal study to complete enrollment and a 1-year follow-up in a patient population with high mortality risk.

CLI is the acute form of peripheral arterial disease whereby a severe obstruction of the arteries drastically reduces blood flow to the extremities (hands, feet and legs), leading to severe pain, skin ulcers, sores or gangrene. Up to 30% 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%) or death (20%).

MOBILE evaluates the safety and efficacy of cBMA, by injecting intramuscularly into the affected limb of patients with CLI who are not fitted for revascularization. A preliminary investigation of a partial data set found that treatment with cBMA improved amputation-free survival and maintained a safety profile compared to placebo trial. The final analysis of the MOBILE data will form the basis of ZimmerBiomet's U.S. regulatory submission, which is currently being prepared.

Management claims that its investigational treatment would address the urgent need for alternatives to amputations in patients with advanced CLI, as majority of the patients never recover completely and require chronic professional assistance at home or at an institution. The positive trial data anchors the company’s emerging biologics pipeline and highlights innovative research and development capability.

According to a Transparency Market Research report, the global CLI treatment market is growing because of rising aged population and incidence of CLI along with the participation of a large number of companies to develop treatments. We believe Zimmer Biomet would be able to capture the untapped potential of this growing market. Meanwhile, the positive data from the IDE trial is expected to help Zimmer Biomet understand the clinical utility of autologous cell therapy, which is one of the most promising areas within biologics.

Zacks Rank & Key Picks

Zimmer Biomet currently carries a Zacks Rank #4 (Sell). Better-ranked medical stocks are Nxstage Medical Inc. (NXTM - Free Report) , Baxter International Inc. (BAX - Free Report) and Bovie Medical Corporation (BVX - Free Report) . Nxstage Medical and Baxter sport a Zacks Rank #1 (Strong Buy) while Bovie Medical carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Nxstage Medical surged 35.4% over the last one year compared to the S&P 500’s 6.3% over the same period. The company has a four-quarter average positive earnings surprise of 50.00%.

Baxter International rallied 21.9% in the past one year, much higher than the S&P 500’s 6.3%. It has a trailing four-quarter average positive earnings surprise of 27%.

Bovie Medical recorded a 124.2% gain in the past one year, way better than the S&P 500’s 6.3%. The company has a trailing four-quarter positive average earnings surprise of 28.7%.

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