IRVINE, Calif.--(BUSINESS WIRE)--Axonics Modulation Technologies, Inc., developer of the first rechargeable Sacral Neuromodulation (r-SNM™) system for the treatment of urinary and fecal dysfunction, announced today that initial results from its prospective, multicenter clinical study will be presented for the first time at the International Neuromodulation Society (INS) World Congress on May 30, 2017 in Edinburgh, Scotland.
Professor Philip Van Kerrebroeck, MD, PhD, Chair of the Dept. of Urology, Maastricht University Medical Centre, The Netherlands, will present the data at the INS Congress on behalf of the study investigators.
Fifty-one (51) Overactive Bladder (OAB) patients with symptoms of urinary urgency incontinence and urgency-frequency, were enrolled and implanted in the RELAX-OAB study at leading medical centers in the Netherlands, Belgium, France and the UK.
“The Axonics r-SNM System was extremely well received by the patients, the study investigators and clinical staff,” said Raymond W. Cohen, Chief Executive Officer of Axonics. “The study, designed to confirm the safe and effective performance of the product, accomplished much more than its aim. While our focus now shifts to executing a U.S. pivotal study and gaining FDA approval, we look forward to making our product available to patients in select international centers in the interim.”
The Axonics r-SNM System received European CE Mark approval in June 2016 and Health Canada approval in December 2016 for the treatment of OAB, urinary retention, and fecal incontinence. These conditions affect over 100 million adults in the U.S. and Europe. SNM is a reimbursed FDA-approved therapy that has proven to be an effective and durable treatment widely used in Europe and the U.S. for the past two decades with more than 250,000 patients having benefited from the therapy to date.
Axonics anticipates initiating a U.S. FDA pivotal clinical study for OAB patients in select centers in the U.S., Canada and Europe in the second half of 2017.
About Axonics Modulation Technologies, Inc.
Axonics,
based in Irvine, CA, is a privately-held venture backed company that has
developed a novel implantable neuromodulation technology for patients
with urinary and fecal dysfunction and can be further directed towards
several clinical indications. The Axonics r-SNM System includes a
miniaturized rechargeable stimulator qualified to function at least 15
years, a charging system optimized for reduced charge time and minimal
heating, a patient-friendly remote control and an intuitive clinician
programmer that facilitates the lead placement procedure and
programming. Axonics 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.
