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Axonics Receives Health Canada Approval for Fourth-Generation Rechargeable Sacral Neuromodulation System
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Axonics (NASDAQ: AXNX) has received approval from Health Canada for its fourth-generation rechargeable sacral neuromodulation system, the Axonics R20 neurostimulator. This innovative device offers a functional life of at least 20 years and extends recharge intervals to every 6 to 10 months, a significant improvement from the previous model's monthly requirement. The R20 is now being sold in Canada, with FDA review ongoing for potential approval in the U.S., anticipated in Q1 2023. This advancement demonstrates Axonics' commitment to enhancing patient experiences and expanding market reach.
Positive
FDA review in the U.S. indicates potential for future market expansion.
Significant improvement in device functionality with a 20-year life and extended recharge intervals.
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IRVINE, Calif.--(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 Health Canada 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 once every 6 to 10 months for only one hour. This compares to the third-generation’s recharging interval of once a month for one hour. The Axonics R20 neurostimulator utilizes the same small 5cc form factor as the third-generation device and is paired with the same tined lead and intuitive, easy to use patient remote control.
“Since Axonics’ founding, delivering superior patient experiences has been at the forefront of our development efforts,” said Raymond W. Cohen, chief executive officer of Axonics. “Patients with overactive bladder want efficacy and a long-lived solution to address their chronic condition. The Axonics R20 represents a 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.”
Axonics has commenced sales of the R20 sacral neuromodulation system to customers in Canada. The device is currently under review by the FDA in the United States. The company anticipates FDA approval and plans to commercially launch the product in the United States in the first quarter of 2023.
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 “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.
The Axonics R20 is a fourth-generation rechargeable sacral neuromodulation system designed to treat bladder and bowel dysfunction, featuring a functional life of at least 20 years.
When will the R20 neurostimulator be available in the U.S.?
The R20 is currently under FDA review, with commercial launch anticipated in the U.S. in the first quarter of 2023.
What are the recharge intervals for the Axonics R20?
The R20 allows for recharging every 6 to 10 months, significantly less frequent than the previous model, which required recharging once a month.
How does the Axonics R20 impact patient experience?
The R20 is designed to provide enhanced convenience and long-term efficacy for patients suffering from overactive bladder and other related conditions.
What company developed the R20 neurostimulator?
The Axonics R20 neurostimulator was developed by Axonics, a global medical technology company.
