Healthcare Industry News:  neuromodulation 

Devices Regulatory

 News Release - June 6, 2016

Axonics Receives CE Mark for its Sacral Neuromodulation System for the Treatment of Urinary and Fecal Dysfunction

Company also Announces Peer-reviewed Study Showing Healthcare Cost Savings of Rechargeable SNM Systems

IRVINE, Calif.--(Healthcare Sales & Marketing Network)--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.”

OAB affects an estimated 85 million adults in the US 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 US for the past two decades. Over 200,000 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.

“Axonics has successfully developed a unique product to deliver SNM therapy that we believe will greatly improve the patient and clinician experience,” said Raymond W. Cohen, Axonics’ Chief Executive Officer. “We look forward to treating patients in our upcoming PMCF study.”

About the Axonics Sacral neuromodulation System™

The Axonics SNM System is an implantable neuromodulation system that modulates sacral nerve activity for the management of urinary and fecal dysfunction. The System includes, among other innovations, a miniaturized implantable pulse generator that is 60% smaller and promises to last 15 years, which is more than three times longer in the body than currently marketed non-rechargeable SNM technology. In addition, the Axonics’ SNM System features a key-fob sized patient-friendly remote control and an intuitive clinician programmer that will guide and support physician implanters throughout the procedure, from lead placement to programming.

About Axonics Modulation Technologies, Inc.

Axonics, based in Irvine, CA, is a privately held company developing novel implantable neuromodulation technology directed toward a number of clinical indications. Investors include Edmond de Rothschild Investment Partners, Advent Life Sciences, NeoMed Management, Legend Capital, Cormorant Asset Management and The Alfred E. Mann Foundation. For more information, visit the Company’s website at www.axonicsmodulation.com.


Source: Axonics Modulation Technologies

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