Axonics touts results from pivotal FDA IDE r-SNM urinary dysfunction trial

Axonics Modulation Technologies (NSDQ:AXNX) Monday released the results from the FDA investigational device exemption pivotal study of its r-SNM Sacral Neuromodulation system exploring its use in treating urinary dysfunction.

The Irvine, Calif.-based company said it presented results from the study, dubbed the ARTISAN-SNM study, at the 2019 American Urological Association’s Annual Meeting in Chicago this week.

Axonics presented six-month results from the 129-patient, unblinded pivotal clinical study, and said that it hopes the results will support FDA approval of the system.

Data at six months indicated that 90% of the treated patients responded to the therapy, experiencing a 50% or greater reduction in urgency incontinence episodes compared to the baseline. Urgency incontinence episodes in all patients were reduced from an average of 5.6 per day at baseline to 1.3 per day, the company said.

Results indicated that 80% of therapy responders had a 75% or greater reduction in episodes, with 34% experiencing a complete 100% reduction. Patients reported clinically meaningful improvements in quality of life rated on their ICIQ-QABqol scores, Axonics said.

A total of 93% of patients said they were satisfied with therapy received from the r-SNM device, and 98% reported acceptable charging experiences. No serious device related adverse events were reported.

“The ARTISAN-SNM study has demonstrated that the Axonics r-SNM System is providing clinically significant symptom relief to patients. The high levels of patient success and satisfaction exceed historical clinical results for Sacral Neuromodulation. The Axonics r-SNM System, designed to last a minimum of 15-years in the body, is a game-changing solution for physicians and patients as it significantly reduces the need for device replacement surgeries associated with the legacy non-rechargeable implant which has historically been the only SNM system available,” chief medical officer Dr. Karen Noblett said in a press release.

In March, Axonics took a hit after it posted fourth-quarter and 2018 losses that exceeded the consensus forecast on Wall Street.

Axonics touts results from pivotal FDA IDE r-SNM urinary dysfunction trial