Axonics® Receives FDA Approval for Recharge-Free Sacral Neuromodulation System|||




Axonics sets recharge-free neuromodulation benchmark with FDA labeling for 15+ years

of functional life at typical stimulation parameters and 20+ years at lower energy settings

IRVINE, Calif.–(BUSINESS WIRE)–Axonics, Inc. (Nasdaq: AXNX), a global medical engineering visitor 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 (FDA) has approved its newly adult, long-lived, recharge-free sacral neuromodulation (SNM) implantable neurostimulator (INS).

The Axonics F15™ recharge-free SNM system has the following cardinal attributes:

  • INS type:
    master cell battery
  • INS longevity:
    functional life has been validated for over fifteen years at typical stimulation parameters and over 20 years at lower energy settings
  • INS volume:
    10 cubic centimeters (twenty% smaller than the market’s other non-rechargeable SNM device)
  • Stimulation:
    abiding current automatically adjusts stimulation output
  • MRI compatibility:
    total body with 1.5T and 3.0T whole-body scanners
  • Patient remote command:
    intuitive, recharge-gratis key fob featuring
    SmartMRI

    technology
  • Programming:
    proprietary algorithm recommends optimal stimulation parameters based on intraoperative responses

“Axonics is keenly focused on developing innovative, best-in-grade, patient-axial SNM solutions every bit well as expanding sensation and admission to this life-changing therapy,” said Raymond W. Cohen, chief executive officer of Axonics. “Our rechargeable organisation introduced innovations to the SNM category in late 2019 that clinicians and patients had been requesting for years – longevity in the body, full-body MRI compatibility, a miniaturized implant, fuss-free therapy and a patient remote control that is easy for patients to use. The new Axonics F15 recharge-gratis SNM organization is similarly groundbreaking – a small and thin INS with an expected life in the body of well over a decade that does not crave any element of the system to be recharged – and sets a new standard for what is possible in this category. We look to begin shipping the Axonics F15 arrangement in April.”

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Cohen continued, “Tens of millions of Americans suffer from 1 course or another of incontinence and struggle to observe long-term symptom relief. SNM was historically utilized as a therapy of final resort as it was only bachelor with a neurostimulator that had an average battery life of 4 years, requiring patients to undergo multiple replacement surgeries. We aim to change that paradigm and expect the Axonics F15 organization to increase adoption of SNM therapy. We will likewise launch a national television direct-to-consumer advertising entrada in the coming weeks to increase awareness for Axonics therapies, which treat all forms of bladder and bowel incontinence. We remain confident that our commitment to innovation, quality and providing physicians and patients strong support will continue to drive market place expansion and accelerate Axonics on its path to marketplace leadership.”

About Axonics

Based in Irvine, Calif., Axonics is a global medical engineering company that is developing and commercializing novel products for adults with bladder and bowel dysfunction. Axonics recently ranked No. i on the 2021 Deloitte Technology Fast 500™, a ranking of the 500 fastest-growing technology, media, telecommunications, life sciences, fintech, and energy tech companies in Northward America.

The visitor’south sacral neuromodulation (SNM) systems provide patients suffering from overactive bladder and/or fecal incontinence with long-lived, piece of cake to utilise, rubber, clinically effective therapy. In addition, Axonics’ 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 meg adults in the U.Southward. and Europe, with an additional twoscore million adults estimated to endure from fecal incontinence. SUI affects an estimated 29 one thousand thousand women in the U.Southward. 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 data, visit world wide web.axonics.com.

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Forward-Looking Statements

Statements made in this printing release that chronicle to time to come plans, events, prospects or performance are forward-looking statements equally defined under the Private Securities Litigation Reform Act of 1995. Words such as “planned,” “expects,” “believes,” “anticipates,” “designed,” and similar words are intended to place forward-looking statements. While these forwards-looking statements are based on the current expectations and beliefs of management, such forwards-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 bachelor online at www.sec.gov. Readers are cautioned not to identify undue reliance on these forrad-looking statements, which speak only as of the date hereof. Except as required past law, Axonics undertakes no obligation to update or revise whatsoever forward-looking statements to reflect new data, changed circumstances or unanticipated events.

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