What happened

Shares of Axonics Modulation Technologies (NASDAQ:AXNX), a medical device company focused on bladder and bowel dysfunction, rose 15% as of 11:00 a.m. EST on Thursday. The double-digit jump is a response to the news that the company won FDA approval for its Axonics r-SNM (rechargeable sacral neuromodulation) System.

So what

The FDA granted premarket approval for the Axonics r-SNM System as a treatment for urinary urge incontinence, urinary urge frequency, as well as urinary retention (OAB).

Doctor giving double thumbs up.

Image source: Getty Images.

The Axonics r-SNM System offers several benefits over existing SNM systems, including:

  • It's fully rechargeable.
  • It's wearable during a full-body MRI scan.
  • Its functional life is 15 years, which is far more than most legacy SMN devices, which have to be replaced every four years.

This approval comes just two months after the SMN device won FDA approval as a treatment for fecal incontinence.

Axonics' CEO, Raymond Cohen, was thrilled with the approval and made it clear that his company will aggressively pursue the big opportunity it sees:

If we consider the millions of women who have tried and discontinued OAB pharmaceuticals, the market opportunity for Axonics goes well beyond the approximate $700 million of revenue that is currently being generated by the incumbent's non-rechargeable SNM device. Based on feedback from U.S. physicians, we believe the SNM market is poised to dramatically expand over the next few years given our fuss-free, highly efficacious, long-lived, full-body MRI compatible device. Our U.S. commercial team of 146 territory managers, clinical support specialists and sales managers rivals the size of the incumbent's field staff, and is focused on calling on the top 1,000 urologists, urogynecologists and colorectal surgeons who account for approximately 80% of the SNM implants in the U.S.

Traders bid up the stock in response to the regulatory win.

Now what

It is estimated that 87 million adults suffer from an overactive bladder in the U.S. and Europe. Another 40 million adults suffer from fecal incontinence. That gives Axonics a huge addressable market opportunity.

Of course, Axonics won't have this market all to itself. Medical device giant Medtronic has been in the space for years and won't take kindly to the new competition.

Only time will tell if the benefits of the Axonics r-SNM System will be strong enough to convince patients, providers, and payers to give it a try. The next few quarters will be critical for judging Axonics' success, which makes this an exciting healthcare stock for growth investors to watch.