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  • 29 July 2019
    Axonics® Announces Publication of ARTISAN Clinical Study Results in the Journal of Urology

    Axonics Modulation Technologies, Inc. (NASDAQ: AXNX) a medical technology company focused on the development and commercialization of novel implantable Sacral Neuromodulation (“SNM”) devices for the treatment of urinary and bowel dysfunction, today announced the results from its ARTISAN-SNM study were published online in the peer-reviewed Journal of Urology (https://doi.org/10.1097/JU.0000000000000458).

    This is the first journal publication to detail outcomes for patients in the United States treated with a rechargeable sacral neuromodulation system. The study, conducted under a U.S. Food & Drug Administration (FDA) Investigational Device Exemption (“IDE”), found that 90% of all implanted patients with the Axonics r-SNM® System had successful therapy outcomes.

    Rebecca McCrery, M.D., an ARTISAN-SNM study investigator and urogynecologist at Adult Pediatric Urology & Urogynecology in Omaha, NE, commented, “The ARTISAN-SNM results provide the highest response rate for Sacral Neuromodulation seen in the clinical literature. These results are reflective of the benefits of the Axonics miniaturized rechargeable system and recent improvements in Sacral Neuromodulation techniques. Publication of the results in the Journal of Urologyunderscores the quality of the study and the interest among the physician community in innovative treatment options for patients suffering from urinary incontinence and bowel dysfunction.”

    The ARTISAN-SNM study evaluated the safety and efficacy of the Axonics r-SNM System in 129 patients suffering from Urinary Urgency Incontinence. The article details the 6-month study results including:

    • 90% of the treated patients were therapy responders, defined as a ≥50% reduction in urgency incontinence episodes compared to their baseline
    • Urgency incontinence episodes across all patients reduced from an average of 5.6 per day at baseline to 1.3 per day at 6 months
    • 80% of the therapy responders had ≥75% reduction in their urgency incontinence episodes, and 34% were dry, having experienced a 100% reduction
    • Patients experienced a clinically meaningful improvement in quality of life as indicated by a 34-point improvement in their ICIQ-OABqol score
    • 93% of treated patients were satisfied with their r-SNM therapy and 98% said their charging experience was acceptable
    • There were no serious device-related adverse events

    “The Journal of Urology is the official journal of the American Urological Association and is widely read and cited,” said Raymond W. Cohen, CEO of Axonics. “Publication in this peer-reviewed journal means the ARTISAN-SNM results are now available to current SNM implanters and the urology community at large. As we anticipate FDA approval in the United States in the coming months, this publication will be an aid in helping us reach our target clinical audience regarding the performance of the Axonics r-SNM System.”