Axonics Modulation Technologies (NSDQ:AXNX) announced today that it won FDA premarket approval for its r-SNM sacral neuromodulation system for the treatment of overactive bladder and urinary retention.
The implantable, rechargeable sacral neuromodulation device is the first of its kind approved for sale in the U.S., Europe, Canada and Australia. It is also the only SNM device approved for full-body MRI scans without needing the device explanted, according to a news release.
The device, a neurostimulator about the size of a USB drive designed to last 15 years in the body, features a wireless charging system, a key-fob remote control and a clinician programmer designed to facilitate lead placement and stimulation programming.
Axonics’ latest indications for overactive bladder and urinary retention follow the FDA approval its SNM device won in September for fecal incontinence. The FDA approval includes the claim of 15-year functional life and was supported by data from Axonics’ Artisan-SNM 129-patient pivotal trial that met all primary and secondary endpoints while demonstrating 90% efficacy for all implanted urinary incontinence patients at six months.
“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,“ Axonics CEO Raymond Cohen said in the news release. ”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.”
The approval comes a week after Medtronic (NYSE:MDT) filed a lawsuit against Axonics in the U.S. District Court for the Central District of California, alleging infringements with four patents for Medtronic’s SNM technologies indicated for bowel and bladder conditions.
In response to the lawsuit, Cohen issued a statement in which he said: “Axonics believes that this lawsuit is the kind of response that is all too predictable from Medtronic signaling that it is lacking the wherewithal to compete fairly. It is ironic that the largest medical device company in the world, with over a 20-year long monopoly in the SNM market, failed to introduce any meaningful innovation for the sake of patients or their physician customers. Instead, they have chosen to employ legal tactics to engage in clear anticompetitive behavior and yet another attempt to change the dialogue with physicians and U.S. institutional investors.”
Medtronic issued a statement to MassDevice following Axonics’ FDA approval win, saying: “Medtronic is the leader in minimally invasive technology innovations in the field of sacral neuromodulation, making meaningful treatment options for people affected by bladder and bowel dysfunction. … Medtronic believes competition drives innovation and broader market awareness, which is good for the industry and for patients, and we welcome competitors who play by the rules and existing laws. Also, we are committed to protecting our proprietary technology and intellectual property, which drives our continued innovation.”
Medtronic described its InterStim II, which is not recharged, as the current standard of care used to treat more than 300,000 patients. Medtronic recently submitted for FDA approval for the InterStim Micro neurostimulator — a rechargeable system — and also its InterStim SureScan MRI leads for both the InterStim II and InterStim Micro.