IRVINE, Calif.--(BUSINESS WIRE)--Axonics Modulation Technologies, Inc., developer of the first rechargeable implantable Sacral Neuromodulation System (SNM) for the treatment of urinary and fecal dysfunction, announced today that in compliance with the European Medical Device Directive for Active Implantable Medical Devices, it has received a Conformité Européenne (CE Mark) for its SNM System to treat Overactive Bladder (OAB), Fecal Incontinence and Urinary Retention.

The CE Mark confirms that the Axonics product meets the essential requirements of all European Medical Device Directives and enables Axonics to market its SNM System throughout the European Union.

Axonics has also received ethics committee approval from select centers in Western Europe to start a 65-patient post-market clinical follow up (PMCF) study.

The Company also announced that Neurourology and Urodynamics has published the results of a peer-reviewed study titled, “Cost Profiles and Budget Impact of Rechargeable Versus Non-Rechargeable Sacral Neuromodulation Devices in the Treatment of Overactive Bladder Syndrome.” The study assesses the potential cost impact to U.S. healthcare payers of a rechargeable SNM system. Findings determined that compared to non-rechargeable SNM systems for the treatment of OAB, a rechargeable SNM system with a long-lived battery could save the U.S. healthcare system more than $12 billion over the next 15 years. Physicians and researchers collaborating on the study included Karen L. Noblett, MD, University of California, Riverside; Roger R. Dmochowski, MD, Vanderbilt University; Sandip P. Vasavada, MD, Cleveland Clinic, and Abigail M. Garner, MS; Shan Liu, PhD; Jan B. Pietzsch, PhD of Wing Tech, Inc., Menlo Park, CA.

“The Axonics device promises increased patient comfort given its small size and moreover, the fact that it is rechargeable and can function three times longer in patients will eliminate the need for repeat surgeries to replace non-rechargeable devices that currently require replacement every four or five years,” said Prof. Karen L. Noblett, M.D., Chair of the Department of Obstetrics and Gynecology, University of California Riverside School of Medicine. “Our economic study findings clearly show the Axonics System has the ability to also lower healthcare costs potentially allowing more patients to benefit from SNM therapy that has been proven over many years to improve the quality of life of patients suffering from urinary and fecal dysfunction.”

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