Axonics Receives FDA Approval for Fourth-Generation Rechargeable Sacral Neuromodulation System
31 January 2023 - 10:00PM
Business Wire
Axonics, Inc. (Nasdaq: AXNX), a global medical technology
company that is developing and commercializing novel products for
the treatment of bladder and bowel dysfunction, today announced
that the U.S. Food and Drug Administration has approved the
company’s fourth-generation rechargeable sacral neuromodulation
system.
The newly approved Axonics R20™ neurostimulator is labeled for a
functional life in the body of at least 20 years and reduces how
frequently a patient needs to recharge their implanted device to
just once every 6 to 10 months for only one hour. This compares to
the third-generation’s recharge interval of once a month for one
hour. The Axonics R20 neurostimulator utilizes the same small 5cc
form factor as the Axonics R15™ and is paired with the same tined
lead and intuitive patient remote control. Axonics plans to
commercially launch the product in the United States in March.
“Delivering a superior patient experience has been at the
forefront of our sacral neuromodulation development efforts,” said
John Woock, Ph.D., executive vice president, chief marketing and
strategy officer of Axonics. “Patients with overactive bladder tell
us that first and foremost, they value efficacy and a long-lived
solution to address their chronic condition. The Axonics R20, which
requires recharging just twice per year, represents another
significant breakthrough for rechargeable neuromodulation devices
and underscores our commitment to continuous innovation. We are
confident that Axonics’ keen focus on the incontinence patient
population and increasing public awareness of sacral
neuromodulation has the potential to drive significant market
expansion in the years ahead.”
About Axonics®
Axonics is a global medical technology company that is
developing and commercializing novel products for adults with
bladder and bowel dysfunction. Axonics recently ranked No. 1 on the
2022 Financial Times ranking of the 500 fastest growing companies
in the Americas and No. 4 on the 2022 Deloitte Technology Fast 500™
following its No. 1 ranking in 2021.
Axonics sacral neuromodulation (SNM) systems provide patients
suffering from overactive bladder and/or fecal incontinence with
long-lived, easy to use, safe, clinically effective therapy. In
addition, the company’s best-in-class urethral bulking hydrogel,
Bulkamid®, provides safe and durable symptom relief to women with
stress urinary incontinence (SUI). Overactive bladder affects an
estimated 87 million adults in the U.S. and Europe, with an
additional 40 million adults estimated to suffer from fecal
incontinence. SUI affects an estimated 29 million women in the U.S.
alone. Axonics’ clinically proven products are offered at hundreds
of medical centers across the U.S. and abroad. Reimbursement
coverage is well established in the U.S. and is a covered service
in most European countries. For more information, visit
www.axonics.com.
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 “plans,” “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.
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version on businesswire.com: https://www.businesswire.com/news/home/20230131005339/en/
Axonics contact: Neil Bhalodkar 949-336-5293
ir@axonics.com
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