Axonics Files for FDA Premarket Approval for Neuromodulation System

Axonics Modulation Technologies, Inc. (NASDAQ:AXNX), a medical technology company focused on the design, development and commercialization of rechargeable implantable Sacral Neuromodulation (“SNM”) solutions for the treatment of urinary and bowel dysfunction, today announced that on December 3, 2018, the Company submitted a premarket approval application (“PMA”) to the U.S. Food & Drug Administration (“FDA”) for the Axonics r-SNM® System, an investigational medical device.

This PMA filing submitted by Axonics is referred to as a “literature-based PMA”. While most PMAs are supported by original clinical investigations, in rare cases, literature-based evidence may be accepted as the sole basis for approval of a PMA to establish reasonable assurance of safety and effectiveness when the literature is sufficient, detailed, objective, and directly applicable to the subject device. In this PMA filing, Axonics has submitted existing literature reporting on InterStim II®, manufactured by Medtronic plc, the only currently approved SNM device.

In addition to the technical specifications, testing data and published literature, Axonics included one-year follow-up data from its 51-patient RELAX-OAB European Post-Market Clinical Follow-up study to support the PMA. This PMA filing incorporates all elements of the Axonics r-SNM implantable system as well as the External Trial System and related accessories.

As is the case with a traditional PMA, the FDA has at least 180 days to review and decide whether or not to approve the PMA. Axonics anticipates that the FDA will complete a substantive review by early March 2019. Once the Company responds to any questions that may arise, the FDA will then have another 90 days to complete its review and issue a decision letter. Therefore, the earliest date a final determination is anticipated is June 2019.

Axonics is currently conducting a 129-patient pivotal clinical study, ARTISAN-SNM, under a U.S. Food & Drug Administration Investigational Device Exemption, for urinary dysfunction. On June 27, 2018, Axonics announced completion of the enrollment and implant phase. Axonics anticipates that substantially all patients will reach their 6-month post-implant endpoint on or about January 4, 2019.

https://www.biospace.com/article/releases/axonics-files-for-premarket-approval-with-u-s-food-and-amp-drug-administration-for-its-sacral-neuromodulation-system/