Axonics® Completes Enrollment of U.S. FDA Pivotal Study for its Sacral Neuromodulation System

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IRVINE, Calif.–()–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.

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.”

About Overactive Bladder (OAB) and Sacral Neuromodulation (SNM)

Overactive bladder affects an estimated 85 million adults in the U.S. and Europe. Another 40 million are reported to suffer from fecal incontinence. SNM therapy is an effective and durable treatment that has been widely used and reimbursed in Europe and the U.S. for the past two decades. It is estimated that over 300,000 patients have benefited from the therapy to date. SNM is the only OAB treatment with proven clinical superiority to standard medical therapy and OAB patients who receive SNM report significantly higher quality of life than patients undergoing drug treatment.

About Axonics Modulation Technologies, Inc.

Axonics, based in Irvine, CA, is a privately-held company that has developed a novel implantable sacral neuromodulation system for patients with urinary and bowel dysfunction. With the support of a number of the world’s highest profile venture firms located in the U.S., France, the United Kingdom, the Netherlands, Switzerland and China, Axonics has raised over $114 million in venture capital. The Company is focused on disrupting the SNM market that is estimated at $700 million in annual sales, growing to $1 billion by 2021. The Axonics r-SNM system includes a temporary disposable external trial system and implantable components such as a miniaturized rechargeable implantable stimulator qualified to function at least 15 years, tined lead, and patient-friendly items such as a charging system optimized for reduced charge time with no heating, a universal remote control and an intuitive clinician programmer that facilitates the lead placement procedure and programming. For more information, visit the Company’s website at www.axonicsmodulation.com.

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