Medtronic (MDT) Gets FDA Nod for Revised Neuromodulation Labeling

Medtronic (NYSE:MDT) plc MDT announced a major regulatory advancement in the fast-growing neuromodulation space. Per the announcement, the company received revised commercial labeling approval from the FDA for its Intellis Platform that works with Differential Target (NYSE:TGT) Multiplexed (DTM) Spinal Cord Stimulation (SCS) programming.

This revised labeling shows superior outcome in the treatment of chronic, intractable back and leg paincompared to conventional SCS.

Intellis and DTM SCS Therapy at a Glance

The Intellis platform is the world's smallest implantable neurostimulator powered by proprietary Overdrive battery technology. It helps provide effective long-term pain relief for patients.

DTM is a SCS therapy delivered via the Intellis SCS platform used for the treatment of chronic, intractable pain.

Revised Labeling

For investors’ note, the revised labeling approval was supported by favorable study outcomes from a multicenter randomized control trial that shows DTM SCS’s superiority over conventional SCS for the treatment of intractable chronic back pain. A 3-month data showed that 80% of patients treated with DTM SCS reported back pain relief by at least 50%. This compares favorably with 51% of patients treated with conventional SCS.

The labeling update came close on the heels of the presentation of 12-month clinical trial outcomes during a late-breaking clinical trial session at NANS 2021. This 12-month data showed that 84% of patients with chronic back pain treated with DTM SCS reported at least 50% pain relief compared with 51% of patients treated with conventional SCS.

Medtronic expects the revised labeling to strengthen the credibility of outcomes from the DTM SCS procedure. The latest development is expected to contribute to the company’s pain therapy business in the coming months.

Industry Prospects

Per a report by Market Data Forecast, the global spinal cord stimulation market was estimated at $1871.6 million for 2018 and is expected to reach $2827.4 million in 2023, witnessing a CAGR of 8.6% between 2018 and 2023. Factors like aging population and increasing prevalence of chronic pain are expected to drive the market.

Given the rising potential of the market, the labeling update has been timed well.

Medtronic's recent updates within Neuromodulation

Within Neuromodulation, the company’s recent product rollouts are leading to share gains in both brain modulation and pain therapies. In brain modulation, the Percept PC launch has led to significant share gains from the company’s peers in this field Boston Scientific (NYSE:BSX) and Abbott. The company currently expects deep brain stimulation (DBS) share gains to be a multi-year trend.

In pain therapy, the company is gaining strong momentum from the DTM launch, with nearly a year-over-year point of share gain. In third-quarter fiscal 2021, DTM trials surged, following the release of the earlier-stated 12-month data in late October.

Price Performance

Shares of the company have gained 59% in a year’s time compared with the industry’s growth of 46.4%.

Zacks Rank and Key Picks

Currently, Medtronic carries a Zacks Rank #3 (Hold).

Some better-ranked stocks from the broader medical space are Align (NASDAQ:ALGN) Technology ALGN, Abbott Laboratories (NYSE:ABT) ABT and Hologic (NASDAQ:HOLX) HOLX. While Align Technology currently sports a Zacks Rank #1 (Strong Buy), the other two presently carry a Zacks Rank #2 (Buy). You can see the complete list of Zacks #1 Rank stocks here.

Align Technology has a projected long-term earnings growth rate of 19%.

Abbott has a projected long-term earnings growth rate of 14.1%.

Hologic has an estimated long-term earnings growth rate of 15.4%.

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