Axonics Modulation Technologies, Inc., developer of the first rechargeable Sacral Neuromodulation (r-SNM™) System for the treatment of urinary and bowel dysfunction, announced today that it has completed enrollment for ARTISAN-SNM, its pivotal clinical study designed to gain U.S. Food & Drug Administration (FDA) approval in the United States.
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ARTISAN-SNM is a 120-patient, single-arm, prospective clinical study designed to demonstrate the safety and effectiveness of the Axonics r-SNM System as an aid in the treatment of urinary dysfunction in patients who have failed or could not tolerate more conservative treatments. Patients were implanted at 14 centers across the United States and 5 centers located in Belgium, the Netherlands, the U.K. and France.
Raymond W. Cohen, Chief Executive Officer of Axonics, stated, “With ARTISAN-SNM fully enrolled and implants completed ahead of schedule, we expect to reach the primary endpoints by the end of 2018. The significant interest demonstrated by the Urology and Urogynecology communities in both the U.S. and Europe resulted in the participation of some of the world’s most experienced and prolific neuromodulation implanters as study investigators.”
“Nearly half of the study cohort has already reached the 3-month post-implant timepoint and, as we anticipated, patients are experiencing safe and clinically significant symptom relief from the Axonics r-SNM System. We will be analyzing, among other things, the proportion of responders to SNM therapy at 6-months post-implant based on reduction in urinary incontinence episodes and urinary frequency from the patient’s baseline diary as well as numerous quality of life measures,” said Karen L. Noblett, M.D., Chief Medical Officer of Axonics.
The Axonics r-SNM System is approved in Europe, Canada and Australia for the treatment of overactive bladder (urinary incontinence, urinary frequency), non-obstructive urinary retention and fecal incontinence.
Cohen continued, “The next major steps for Axonics include penetrating our first commercial market, the U.K., as well as preparing for our 2019 launch in the U.S.”