Axonics® Announces ARTISAN-SNM Pivotal Study Results Presented at the American Urological Association Annual Meeting
ARTISAN-SNM study results were presented on
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
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
Conference Call and Webcast
As previously announced, the
Company will host a conference call with the investment community to
discuss 2019 first quarter financial results and recent business
developments on
Interested parties may access the live call via telephone by dialing (866) 687-5771 (U.S.) or (409) 217-8725 (International) and using passcode 7475517. A live webcast of the call may be accessed by visiting the Events & Presentations page of the investors section of the Company’s website at ir.axonicsmodulation.com. A replay of the webcast will be available shortly after the conclusion of the call and will be archived on the Company’s website for 90 days.
About Overactive Bladder and Sacral Neuromodulation
Overactive
bladder (OAB) includes urinary urge incontinence and urinary frequency
and affects an estimated 85 million adults in the U.S. and
About
Axonics, based
in
Forward-Looking Statements
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 designated as an investigational medical device
View source version on businesswire.com: https://www.businesswire.com/news/home/20190506005099/en/
Source:
Axonics’ Contact
Axonics Modulation Technologies, Inc.
Dan
Dearen, +1-949-396-6320
President & Chief Financial Officer
ir@axonics.com
Investor & Media Contact
W2Opure
Matt Clawson,
+1-949-370-8500
mclawson@w2ogroup.com