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Medtronic (MDT) Completes 1st Patient Implant of Implantable TNM

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Medtronic plc (MDT - Free Report) recently announced the completion of the first patient implants in the TITAN 2 pivotal study. Notably, the pivotal study will assess the safety and efficacy of Medtronic's investigational implantable tibial neuromodulation (TNM) device in people with overactive bladder (OAB).

The recent development is likely to fortify Medtronic’s Pelvic Health business, which is part of the company’s Neuroscience Portfolio.

More on TITAN 2 Pivotal Study

The TITAN 2 study is a potential, multicenter, pivotal study that will include up to 130 patients from up to 30 sites in the United States. The included patients will be followed for 24 months with a primary endpoint of six months.

The TITAN 2 study will examine the safety and efficacy of the implantable TNM device in people with OAB. Medtronic will prepare its submission to the FDA for approval upon successfully completing the TITAN 2 pivotal trial.

About Implantable TNM

Implantable TNM is a minimally-invasive technology that stimulates the posterior tibial nerve near the ankle, transmitting electrical impulses that adjust the neural activity of the bladder.

Implantable TNM is designed to expand access to therapies for incontinence for more physicians and their patients. An implantable TNM device would decrease the burden on patients and physicians by providing ongoing treatments without the need for additional clinic visits. Additionally, the procedure is less invasive than the current standard of care -- sacral neuromodulation.

Benefits of the Implantable TNM Device

It is to be noted that more than 37 million adults in the United States suffer from OAB. Implantable TNM has the potential to provide relief to millions of patients who suffer from bladder incontinence through a new approach that will offer better convenience and more options for physicians and patients.

Zacks Investment Research

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Medtronic's experience with implantable neuromodulation, existing proprietary technology platforms and the proven effectiveness of its percutaneous tibial neuromodulation (PTNM) therapy distinctively positions the company to bring implantable TNM to the market. Per management, TITAN 2 represents the company’s commitment to investing in the future and expanding access to advanced therapies to treat incontinence.

Industry Prospects

Per a report by MARKETSANDMARKETS, the global market for overactive bladder treatment was $3.63 billion in 2017 and is expected to reach $4.19 billion by 2022 at a CAGR of 2.9%. The development of innovative intravesical therapies, aggressive marketing by pharma companies and favorable demographics are the key factors driving the market.

Progress in Neuroscience Portfolio

In March 2022, Medtronic launched the NuVent Eustachian tube dilation balloon. This development came on the heels of the FDA approval of this single-use device for the treatment of chronic, obstructive Eustachian Tube Dysfunction. Balloon dilation is an effective treatment option to treat Eustachian tube dysfunction. It restores proper Eustachian tube function and reduces symptoms like pain, pressure, and hearing difficulties.

In February 2022, Medtronic received FDA approval for InterStim X, the next generation of the InterStim portfolio's recharge-free device and it is available immediately. Notably, InterStim systems are the standard of care in advanced therapy options and the most personalized system to deliver sacral neuromodulation therapy. The device is designed to be used in the treatment of OAB, chronic fecal incontinence and non-obstructive urinary retention.

Price Performance

Shares of the company have lost 9% in a year compared with the industry's fall 16.8%.

Zacks Rank and Key Picks

Medtronic currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the broader medical space are McKesson Corporation (MCK - Free Report) , AMN Healthcare Services, Inc. (AMN - Free Report) and Bio-Rad Laboratories, Inc. (BIO - Free Report) .

McKesson, carrying a Zacks Rank #2 (Buy), reported third-quarter fiscal 2022 adjusted earnings per share (EPS) of $6.15, which beat the Zacks Consensus Estimate of $5.38 by 14.3%. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

McKesson has a long-term earnings growth rate of 11.8%. MCK has gained 58.4% compared with the industry’s 7.6% growth in the past year.

AMN Healthcare, flaunting a Zacks Rank #1, has a long-term earnings growth rate of 16.2%. The company surpassed earnings estimates in the trailing four quarters, delivering a surprise of 19.5%, on average.

AMN Healthcare has outperformed its industry in the past year. AMN has gained 38.5% versus the 53.4% industry decline.

Bio-Rad reported fourth-quarter 2021 adjusted EPS of $3.21, which surpassed the Zacks Consensus Estimate by 11.9%. It currently has a Zacks Rank #2.

Bio-Rad has an earnings yield of 2.3% versus the industry’s negative yield. BIO surpassed earnings estimates in the trailing four quarters, the average surprise being 66.9%.

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