Home Optimal energy Axonics® Receives FDA Clearance for No-Recharge Sacral Neuromodulation System

Axonics® Receives FDA Clearance for No-Recharge Sacral Neuromodulation System


IRVINE, Calif.–(BUSINESS WIRE)–Axonics, Inc. (Nasdaq: AXNX), a global medical technology company that develops and markets novel products for the treatment of bladder and bowel dysfunction, today announced that the Food and Drug Administration ( FDA) of the United States had approved its new developed implantable neurostimulator (INS) sacral neuromodulation (SNM) with long life and without recharging.

The Axonics F15™ Refillless SNM System has the following key attributes:

  • Type of INS: primary battery
  • INS longevity: functional lifetime has been validated for more than 15 years with typical stimulation parameters and more than 20 years with lower energy parameters
  • Volume INS: 10 cubic centimeters (20% smaller than other non-rechargeable SNM devices on the market)
  • Stimulation: constant current automatically adjusts stimulation output
  • MRI compatibility: full body with 1.5T and 3.0T full body scanners
  • Patient remote control: intuitive and refill-free key ring with SmartMRI Technology
  • Programming: proprietary algorithm recommends optimal stimulation parameters based on intraoperative responses

“Axonics is strongly focused on developing innovative, best-in-class, patient-centric SNM solutions, and expanding awareness and access to this life-changing therapy,” said Raymond. W. Cohen, CEO of Axonics. “Our rechargeable system introduced innovations to the SNM category in late 2019 that clinicians and patients have been asking for years – in-body longevity, full-body MRI compatibility, a miniaturized implant, hassle-free therapy, and an easy-to-use patient remote control. The new Axonics F15 refill-free SNM system is also revolutionary – a small and thin INS with an expected in-body life of over a decade that does not require any part of the system to be recharged – and sets a new standard for what is possible in this category.We expect to start shipping the Axonics F15 system in April.

Cohen continued, “Tens of millions of Americans suffer from one form or another of incontinence and struggle to find long-term relief from symptoms. SNM was historically used as a therapy of last resort because it was only available with a neurostimulator that had an average battery life of four years, requiring patients to undergo multiple replacement surgeries. Our goal is to change this paradigm and we expect the Axonics F15 system to increase adoption of SNM therapy. We will also launch a national direct-to-consumer television campaign in the coming weeks to increase awareness of Axonics therapies, which treat all forms of urinary and fecal incontinence. We remain confident that our commitment to innovation, quality, and providing strong support to physicians and patients will continue to drive market expansion and advance Axonics on the path to leadership in the Marlet.

About Axonics

Based in Irvine, Calif., Axonics is a global medical technology company that develops and markets new products for adults with bladder and bowel dysfunction. Axonics recently ranked #1 in the 2021 Deloitte Technology Fast 500™, a ranking of the 500 fastest growing technology, media, telecommunications, life sciences, fintech and energy technology companies in North America.

The Company’s Sacral Neuromodulation (SNM) systems provide patients with overactive bladder and/or fecal incontinence with long-lasting, easy-to-use, safe and clinically effective therapy. Plus, Axonics best-in-class urethral bulking hydrogel, Bulkamid®, provides safe and long-lasting symptom relief for women with stress urinary incontinence (SUI). Overactive bladder affects approximately 87 million adults in the United States and Europe, with an additional 40 million adults estimated to suffer from faecal incontinence. SUI affects approximately 29 million women in the United States alone. Axonics’ clinically proven products are offered in hundreds of medical centers in the United States and abroad. Reimbursement coverage is well established in the United States 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 by the Private Securities Litigation Reform Act of 1995. Words such as “anticipated”, “will expects, “believes”, “anticipates”, “intended” and similar words are intended to identify forward-looking statements. Although these forward-looking statements are based on management’s current expectations and beliefs, these forward-looking statements are subject to a number of risks, uncertainties, assumptions and other factors that could cause actual results Actual results 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 forward-looking statements to reflect new information, changed circumstances or unforeseen events.