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 submission of interim clinical data from the ARTISAN-SNM pivotal clinical study to the U.S. Food & Drug Administration (“FDA”).

The ARTISAN-SNM study is a 129-patient single-arm, prospective, multi-center, unblinded pivotal clinical study, approved under an FDA Investigational Device Exemption (“IDE”) to evaluate the safety and efficacy of the Axonics r-SNM® System1 for urinary dysfunction.

This interim clinical data was submitted as a supplement to the Company’s previously filed “literature-based” premarket approval application (“PMA”). The interim analysis was conducted in accordance with a revised statistical analysis plan using an Intent to Treat (“ITT”) analysis of a partial cohort of all implanted subjects that have reached their six-month post-implant time point. The clinical study report, filed with FDA, provides safety and efficacy results from an early-look analysis in 60 implanted subjects, including 59 patients that have reached the six-month primary endpoint and one explanted patient.

Enrollment for the ARTISAN-SNM study was completed in June 2018 and all patients have now reached their six-month, post-implant primary endpoint.

Raymond W. Cohen, CEO of Axonics, commented, “On December 7, 2018, the FDA authorized an interim analysis of a partial ITT cohort from our ARTISAN-SNM pivotal study. Given that, we determined it was advantageous to enrich our current literature-based PMA currently under review by the FDA. We are in the process of analyzing the full ARTISAN-SNM cohort of patients and maintain the option to submit a traditional PMA in Q1 2019. Our strategy is intended to obtain PMA approval of our r-SNM System through the most expeditious route.”

Axonics filed the literature-based PMA on December 3, 2018. 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 management responds to any questions that may arise, the FDA will then have another 90 days to complete its review and issue a decision letter.