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  • 7 November 2018
    Axonics® Receives Health Canada Approval for its Sacral Neuromodulation External Trial System

    Axonics Modulation Technologies, Inc., (NASDAQ: AXNX), developer of the first rechargeable Sacral Neuromodulation (r-SNM™) system for the treatment of urinary and bowel dysfunction, announced today that it has received Health Canadaapproval (Homologation d'un instrument medical) to market its External Trial System.

    Axonics previously received Health Canada approval for its miniaturized rechargeable implantable neurostimulator, tined lead, patient and clinician programmers, charger and related accessories.

    The External Trial System is an additional element of the Axonics r-SNM system used to help identify responders to Sacral Neuromodulation therapy prior to a permanent implant. It is composed of a temporary, single-use disposable external stimulator that is connected to either a Tined Lead or a temporary Peripheral Nerve Evaluation (PNE) Lead, depending on the preferred trial method.

    Raymond W. Cohen, Chief Executive Officer, said, “This approval comes at the right time, as we begin commercial activities in Canada. Whilst the Canadian SNM market has been limited historically, we believe that our small rechargeable neurostimulator, which features an expected in-body life of 15 years or more, will potentially spur market growth by bringing tangible benefits to patients and significant cost savings to the national health care system by eliminating the need to replace our competitor’s non-rechargeable device every three to five years.”

    Axonics is currently conducting a 129-patient pivotal clinical study for urinary incontinence patients under a U.S. FDA Investigational Device Exemption. The enrollment and implant phase was completed in late June 2018. The Company anticipates filing a pre-market approval (PMA) application for FDAapproval in the United States after the six-month post-implant endpoint has been reached.

    On November 2, 2018, Axonics completed an IPO raising $120 million in gross proceeds from the offering. Common stock is now trading on The Nasdaq Global Select Market under the ticker symbol “AXNX”.