Axonics, a medical technology company that has developed and is commercialising a novel implantable rechargeable sacral neuromodulation (SNM) device for the treatment of urinary and bowel dysfunction, has announced the approval of the Axonics r-SNM system by the US Food & Drug Administration (FDA). The Axonics system is the first rechargeable SNM system approved for sale in the USA, Europe, Canada, and Australia.
The FDA approval grants Axonics the right to market its product in the USA for the clinical indication 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.
Axonics has an additional premarket approval 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.
Raymond W Cohen, CEO of Axonics, commented, “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 US$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.”