r-SNM

Axonics Modulation Technologies has announced the FDA approval of the Axonics r-SNM system. A press release reports that the Axonics system is the first rechargeable SNM system approved for sale in the USA, Europe, Canada and Australia. It is now approved, in the USA, for the management of faecal incontinence. The approval includes the claim of a 15-year functional life and the ability of patients to undergo full-body MRI scans without the necessity of having the device explanted.

The Axonics r-SNM system, according to the press release, offers a long-lived miniaturised neurostimulator that is approximately the size of a USB stick and is qualified to last 15 years in the body as compared to the incumbent’s device which is non-rechargeable and requires patients to undergo a surgical intervention to replace the device every three to five years. In addition to full body MRI conditional labelling, the Axonics r-SNM System features many differentiating attributes. These include a patented tined lead, user-friendly accessories, a wireless charging system optimised for infrequent charging, a small easy-to-use patient remote control, and an intuitive clinician programmer that facilitates lead placement and stimulation programming.

Raymond W Cohen, CEO of Axonics, comments: “If we consider the millions of women who are suffering in silence with bladder and bowel dysfunction, we believe the market opportunity for Axonics goes well beyond the existing approximately $650 million of revenue that is currently being generated by the incumbent’s non-rechargeable SNM device. We believe the number of patients seeking SNM treatment will expand dramatically over the next few years given our fuss-free, long-lived, full body MRI-compatible device. In the months prior to FDA approval, we invested significant time and resources in building inventory to support our fully trained, US commercial team which now includes 145 territory managers, clinical support specialists and sales managers strategically located around the country. We plan to begin shipping product to US physicians and hospitals during the fourth quarter of 2019, following the fulfilment of customary, pre-launch regulatory requirements.”

Axonics has an additional premarket approval (PMA) filing currently under review with the FDA for the clinical indications of overactive bladder (urinary urgency incontinence and urinary urgency frequency) as well as urinary retention for which the Company anticipates a determination in the near term.