Axonics® Provides Full One-Year Results from ARTISAN-SNM Pivotal Study at AUGS/IUGA Joint Scientific Meeting
Durable Outcomes Highlighted in Plenary Session Presentation; Expanding on Positive Topline Data Released in August
More than 350 Physicians Attended a Symposium Highlighting Hands-on Physician Experience with the Recently FDA-Approved Axonics r-SNM® System1
During the meeting, more than 350 physicians of the approximate 2,000 at the Conference, attended a one-hour symposium at which experienced physician implanters from the ARTISAN-SNM pivotal study discussed their first-hand impressions of the Axonics r-SNM System and post-implant patient feedback. In addition, more than 550 urologists and urogynecologists from the U.S. and abroad, visited Axonics’ exhibit and requested follow-up contact from the Company.
ARTISAN-SNM study results were presented on
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 was conducted in 14 centers in the U.S. and five centers in
Key results at 12 months included:
- 89% of the treated patients were therapy responders, defined as a ≥50% reduction in urgency incontinence episodes compared to their baseline. These results are consistent with the six-month results.
- Urgency incontinence episodes across all patients reduced from an average of 5.6 per day at baseline to 1.3 per day at six months
- 77% of the therapy responders had ≥75% reduction in their urgency incontinence episodes, and approximately 30% 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
- 124 of the 129 patients remained in the study at one-year post-implant
- There were no serious device-related adverse events
“AUGS/IUGA was the first major medical conference at which our U.S. commercial team was on hand to present our system and meet physicians who are experienced at implanting SNM devices – a key milestone and a truly successful event for Axonics,” said
Axonics, based in
Statements made in this press release that relate to future plans, events, prospects or performance are forward-looking statements as defined under the Private Securities Litigation Reform Act of 1995. Words such as “planned,” “expects,” “believes,” “anticipates,” “designed,” and similar words are intended to identify forward-looking statements. While these forward-looking statements are based on the current expectations and beliefs of management, such forward-looking statements are subject to a number of risks, uncertainties, assumptions and other factors that could cause actual results to differ materially from the expectations expressed in this press release, including the risks and uncertainties disclosed in Axonics filings with the
1 The Axonics SNM System received
Axonics Modulation Technologies, Inc.
Dan Dearen, +1-949-396-6320
President & Chief Financial Officer
Investor & Media Contact
Matt Clawson, +1-949-370-8500