IRVINE, Calif.--(BUSINESS WIRE)--Axonics Modulation Technologies, Inc. announced today that it received a Homologation d'un instrument médical (medical device approval) for the first rechargeable Sacral Neuromodulation (r-SNM™) System® to treat Overactive Bladder (OAB), Fecal Incontinence and Urinary Retention.
The Health Canada license confirms that the Axonics® product meets all of the Canadian Medical Devices Regulations, Section 36, for Active Implantable Medical Devices and enables Axonics to market its r-SNM System throughout Canada.
Axonics previously received ethics committee approval from the University of Toronto to treat patients in Canada as part of the Company’s post-market clinical follow-up study and anticipates treating patients in Canada in the first quarter of 2017.
“The Health Canada approval provides Axonics with another important marketing approval. Along with our European CE mark, it gives us the ability to sell our r-SNM System in two large international territories. Additionally, we anticipate IDE clearance from the US FDA to treat patients in the US in the near term,” said Raymond W. Cohen, Axonics’ Chief Executive Officer. “To date, Axonics has implanted nearly 40 patients in Europe with excellent clinical results. These results confirm that our miniaturized implantable neurostimulator is meeting its promise to advance the state of the art for sacral neuromodulation and 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 accounting for more than $600 million in revenue in 2016. 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.
About the Axonics rechargeable Sacral Neuromodulation (r-SNM) System®
The Axonics r-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 than currently marketed non-rechargeable SNM technology and promises to last at least 15 years. In addition, the Axonics r-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.