Axonics Modulation Technologies, Inc. (NASDAQ: AXNX), a medical technology company that has developed and is commercializing novel implantable sacral neuromodulation (SNM) devices for the treatment of urinary and bowel dysfunction, today announced completion of 2-year follow-ups and topline clinical results from its ARTISAN-SNM pivotal study that was conducted to evaluate the safety and efficacy of the Axonics r-SNM System®.

The 2-year study results demonstrate that patients implanted with the Axonics r-SNM System continue to receive clinically meaningful and statistically significant improvements in urinary urgency incontinence symptoms and quality of life. At 2 years, 88% of all implanted patients were therapy responders, consistent with the 89% therapy responder rate reported at 1-year. Eighty percent of patients achieved >75% improvement, with 37% being completely dry. There were no serious adverse or unanticipated device related events.

“The responder rate from the ARTISAN-SNM study continues to be the highest success rate reported in SNM literature and confirms sustained efficacy,” said Karen Noblett, M.D., a board-certified urogynecologist and chief medical officer of Axonics. “Americans with urgency incontinence are undertreated and struggle to find long-term relief. The persistent robust response and patient satisfaction with the Axonics r-SNM System demonstrates that there is an easy to use, highly efficacious treatment available to those suffering from this condition.”

Due to COVID-19, upcoming medical meetings and conferences have been cancelled or restricted to virtual meetings. Detailed study results will be presented to interested parties by study investigators via an Axonics-hosted webinar to be announced in the coming weeks.

ARTISAN-SNM study

The ARTISAN-SNM study is a 129-patient single-arm, prospective, multi-center, unblinded pivotal clinical study to evaluate the safety and efficacy of the Axonics r-SNM System. The study was conducted in 14 centers in the U.S. and five centers in Western Europe. All patients diagnosed with urinary urge incontinence were implanted with a tined lead and the Axonics miniaturized rechargeable neurostimulator in a non-staged procedure. Efficacy data was collected using a 3-day bladder diary, a validated quality of life questionnaire (ICIQ-OABqol), and a subject satisfaction questionnaire. Therapy responders at follow-up were identified as patients with at least a 50% reduction in urinary urgency incontinence episodes compared to baseline. Completion of 2-year follow-ups concludes the ARTISAN-SNM study.