Axonics Modulation Technologies, Inc. (NASDAQ: AXNX) a medical technology company focused on the development and commercialization of novel implantable Sacral Neuromodulation (“SNM”) devices for the treatment of urinary and bowel dysfunction, today announced the submission of pivotal clinical data from the ARTISAN-SNM pivotal clinical study designed to gain marketing approval from the U.S. Food & Drug Administration (“FDA”) for the Axonics r-SNM® System1.

The ARTISAN-SNM study is a 129-patient single-arm, prospective, multi-center, unblinded pivotal clinical study approved under an FDA Investigational Device Exemption (“IDE”) to evaluate the safety and efficacy of the Axonics r-SNM System for urinary dysfunction. The study was conducted in 14 centers in the U.S. and 5 centers in Western Europe. All patients reached their six-month, post-implant primary endpoint in January 2019.

As the Company announced on February 19, 2019, the clinical study demonstrated that patients implanted with the Axonics r-SNM System received clinically meaningful and statistically significant improvements in Urinary Urgency Incontinence (“UUI”) symptoms and quality of life. Additionally, the study met all primary and secondary endpoints. No serious device-related adverse events have been reported.

The Clinical Study Report (“CSR”) was submitted to the FDA on February 21, 2019 as an amendment to the Company’s premarket approval (“PMA”) application. The CSR provides safety and efficacy results and a detailed analysis of the full cohort of all implanted patients at the six-month post-implant endpoint.

Raymond W. Cohen, CEO of Axonics, commented, “The six-month clinical results from our ARTISAN-SNM pivotal study add to the significant body of evidence that we have submitted and is currently under review at the FDA. Based on ongoing dialogue with the agency, we determined it was advantageous to continue to enrich the current PMA. Our filing strategy is consistent with our primary objective which is to obtain U.S. FDA approval of our r-SNM System in the most efficient and expeditious manner.”

ARTISAN-SNM Top-Line Results

All patients diagnosed with UUI and meeting study criteria were implanted with a tined lead and the Axonics neurostimulator. Efficacy data was collected using a 3-day bladder diary, a validated quality of life questionnaire (ICIQ-OABqol), and a satisfaction questionnaire. Therapy responders were identified as patients with at least 50% reduction in urgency incontinence episodes at follow-up visits as compared to baseline. An as-treated analysis was performed for all 129 implanted patients. At six months, 90% of all implanted patients were therapy responders including 80% of therapy responders with a ≥75% reduction in urgency incontinence episodes of which 34% were completely dry. Across all patients, urgency incontinence episodes per day reduced from 5.6 ± 0.3 (mean ± standard error) at baseline to 1.3 ± 0.2 at six months (p<0.0001). Patients averaged statistically and clinically significant improvement on the composite ICIQ-OABqol score (34 points) at six months as compared to baseline and 93% of all implanted patients were satisfied with their r-SNM therapy.

Premarket Approval (PMA) Status with the U.S. FDA

Axonics filed a PMA application with the FDA in early December 2018 and interim clinical data from the ARTISAN-SNM study the same month. The ARTISAN-SNM CSR was submitted on February 21, 2019. The clinical data disclosed herein has not yet been reviewed by the FDA. Axonics does not anticipate that the filing of the full cohort of six-month clinical data will significantly impact the FDA’s standard 180-day PMA review timeline required to complete its review and issue a decision letter.