IRVINE, Calif.–(BUSINESS WIRE)–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
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
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%
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.”
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 Wednesday, May 8, 2019, at 4:30 p.m. Eastern Time.
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
bladder (OAB) includes urinary urge incontinence and urinary frequency
and affects an estimated 85 million adults in the U.S. and Europe. OAB
is caused by a miscommunication between the bladder and the brain and
significantly impacts quality of life. SNM therapy is a well-established
treatment that has been widely employed to reduce symptoms and restore
bladder function and is also employed to treat urinary retention and
fecal incontinence. Reimbursement for SNM is well established in the
United States and is a covered service in Europe, Canada and Australia.
About Axonics Modulation Technologies, Inc.
in Irvine, CA, is focused on the development and commercialization of a
novel implantable SNM system for patients with urinary and bowel
dysfunction. The Axonics r-SNM® System is the first rechargeable Sacral
Neuromodulation system approved for sale in Europe, Canada and
Australia. Premarket approval for the r-SNM System is currently pending
with the U.S. Food & Drug Administration. For more information, visit
the Company’s website at www.axonicsmodulation.com.
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 Securities and Exchange Commission, all of
which are available online at www.sec.gov.
Readers are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date hereof.
Except as required by law, Axonics undertakes no obligation to update or
revise any forward-looking statements to reflect new information,
changed circumstances or unanticipated events.
1 The Axonics
r-SNM System is currently designated as an investigational medical device
Axonics Modulation Technologies, Inc.
President & Chief Financial Officer
Investor & Media Contact