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  • 28 July 2016
    Axonics Sacral Neuromodulation Systemô Receives MRI Conditional Labeling

    Irvine, CA, July 28, 2016 – Axonics® Modulation Technologies, Inc., developer of the first rechargeable implantable Sacral Neuromodulation (SNM) System for the treatment of urinary and fecal dysfunction, announced today that it has received magnetic resonance imaging (MRI) conditional labeling approval in Europe for its SNM System. Patients receiving implants of the Axonics SNM System are now able to safely undergo head and neck MRI scans in 1.5 Tesla and 3 Tesla environments.

    In early June, Axonics received a CE Mark for its SNM System to treat Overactive Bladder, Fecal Incontinence and Urinary Retention.

    Also in June, the Company announced that its first patients were successfully implanted as part of its RELAX-OAB 65-patient post-market clinical follow-up study. The study is currently enrolling patients at leading medical centers in England, Belgium, the Netherlands and France. The study is designed to confirm the performance of the Axonics SNM System as an aid in the treatment of the symptoms of Overactive Bladder, as well as to capture quantitative metrics, patient satisfaction and quality of life data.

    “This approval further illustrates that the Axonics technology platform is as robust as any implantable sacral neurostimulator and lead set on the market today,” said Raymond W. Cohen, Axonics’ Chief Executive Officer.

    About the Axonics Sacral Neuromodulation System™

    The Axonics SNM System is a rechargeable implantable neuromodulation system that modulates sacral nerve activity for the management of urinary and fecal dysfunction. The System includes, among other innovations, a miniaturized implantable pulse generator that is 60 percent smaller and is qualified to last at least 15 years in the body, more than three times longer than currently marketed non-rechargeable Sacral Neuromodulation technology. In addition, the Axonics SNM System features both a key-fob sized patient-friendly remote control and an intuitive clinician programmer that guides physician implanters throughout the procedure, from lead placement to programming.