Axonics® Announces 1-Year Top-Line Clinical Results from its ARTISAN-SNM Pivotal Study
The study results at 1-year 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 1-year, 89% of all implanted subjects were therapy responders, consistent with the 90% therapy responder rate reported at 6-months. There were no serious adverse device related events or unanticipated device related events. The results at 1-year show consistent symptom decrease, quality of life improvement, and patient satisfaction as the previously reported 6-month study results.
Detailed study results are planned to be presented at the
ARTISAN-SNM: 1-Year Responder Rate
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
About Overactive Bladder and Sacral Neuromodulation
Overactive bladder (OAB) includes urinary urge incontinence and urinary frequency and affects an estimated 87 million adults in the U.S. and
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 r-SNM System is currently under PMA review by the
Axonics Modulation Technologies, Inc.
Dan Dearen, +1-949-396-6320
President & Chief Financial Officer
Investor & Media Contact
Matt Clawson, +1-949-370-8500