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, announced the presentation of positive results from the ARTISAN-SNM pivotal study, designed to gain market approval from the U.S. Food & Drug Administration (FDA) for the Axonics r-SNM® System1.

ARTISAN-SNM study results were presented on May 5 at the 2019 American Urological Association(AUA) Annual Meeting in Chicago by Professor Howard Goldman, M.D., of the Cleveland Clinic.

The presentation, entitled “Treatment of urinary urgency incontinence using a novel rechargeable SNM system: 6-month results of the ARTISAN-SNM study,” summarized the clinical study 6-month outcomes demonstrating that patients implanted with the Axonics r-SNM System received clinically meaningful and statistically significant improvements in Urinary Urgency Incontinence symptoms and quality of life.

The ARTISAN-SNM study is a 129-patient single-arm, prospective, multi-center, unblinded pivotal clinical study approved under an FDA Investigational Device Exemption to evaluate the safety and efficacy of the Axonics r-SNM System for urinary dysfunction. The study is being conducted in 14 centers in the U.S. and five centers in Western Europe.

Key results at 6-months included:

• 90% of the treated patients were therapy responders, defined as a ≥50% reduction in urgency incontinence episodes compared to their baseline
• Urgency incontinence episodes across all patients reduced from an average of 5.6 per day at baseline to 1.3 per day at 6 months
• 80% of the therapy responders had ≥75% reduction in their urgency incontinence episodes, and 34% were dry, having experienced a 100% reduction
• Patients experienced a clinically meaningful improvement in quality of life as indicated by a 34-point improvement in their ICIQ-OABqol score
• 93% of treated patients were satisfied with their r-SNM therapy and 98% said their charging experience was acceptable
• There were no serious device-related adverse events

“The ARTISAN-SNM study has demonstrated that the Axonics r-SNM System is providing clinically significant symptom relief to patients,” said Karen Noblett, M.D., Chief Medical Officer of Axonics. “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.”