Axonics Modulation Technologies, Inc. announced the submission of interim clinical data from the ARTISAN-SNM pivotal clinical study to the U.S. Food & Drug Administration. The ARTISAN-SNM study is a 129-patient single-arm, prospective, multi-center, unblinded pivotal clinical study, approved under an FDA Investigational Device Exemption to evaluate the safety and efficacy of the Axonics r-SNM System for urinary dysfunction. This interim clinical data was submitted as a supplement to the Company's previously filed literature-based premarket approval application. The interim analysis was conducted in accordance with a revised statistical analysis plan using an Intent to Treat 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.