Axonics Modulation Technologies is an Irvine, CA company founded in 2013 that developed a novel implantable sacral nerve stimulator to treat patients with urinary and bowel dysfunction disorders.
The Axonics r-SNM system is a miniaturized rechargeable implantable stimulator with a longevity of at least 15 years. The system also features a charging system designed for quick charge times and a user-friendly remote control and programming interface.
The r-SNM device won CE Mark approval in June 2016. Axonics announced today that it had received FDA approval for the clinical indication of fecal 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 pre-market 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.