Axonics Modulation Technologies (NSDQ:AXNX) said today that it submitted interim clinical data from the pivotal study of its implantable sacral neuromodulation system to the FDA.
The company is evaluating its r-SNM system as a therapy for people with urinary dysfunction.
Axonics’ interim analysis was submitted as a supplement to the company’s “literature-based” premarket approval application. The report contains safety and efficacy results based on 60 implanted participants, including 59 people who have reached the six-month primary endpoint and one explanted participant.
“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,” CEO Raymond Cohen said in prepared remarks.
Axonics filed its literature-based PMA on Dec. 3 – the FDA has at least 180 days to decide whether or not to approve the application. Also last year, the Irvine, Calif.-based company went public with a $138 million IPO.
