Health Canada Approval for Axonics’ Implantable Neurostimulator

Axonics Modulation Technologies, Inc., a medical technology company that has developed and is commercializing novel implantable sacral neuromodulation devices for the treatment of urinary and bowel dysfunction, today announced that Health Canada has approved its next generation rechargeable implantable neurostimulator (INS) for the Axonics r-SNM System.

The next generation INS approved by Health Canada reduces how frequently a patient needs to recharge their implanted device to once a month for about one hour. Axonics received U.S. FDA approval for this version of its INS in April 2020. Health Canada previously approved the first generation Axonics r-SNM System in January 2017. Axonics is currently the only rechargeable SNM system available in Canada.

“This approval is welcome news for patients in Western Canada suffering from bladder and bowel dysfunction, and reinforces the notion that Axonics is committed to providing the latest technology to all of its customers,” said Gary J. Gray, M.D., FRCS, a urologist and clinical professor at the Kipnes Urology Centre in the Department of Surgery at the University of Alberta. “We have implanted over 85 Axonics SNM devices in our center prior to the pandemic and have achieved clinical results that have exceeded our expectations. There is significant unmet need for sacral neuromodulation therapy in Western Canada and we have barely scratched the surface of fulfilling this demand. We look forward to continuing our relationship with Axonics for many years to come.”

Raymond W. Cohen, CEO of Axonics, said, “Physician and patient response to our next generation INS has been exceptional since it began shipping to U.S. customers in August. This approval from Health Canada demonstrates our commitment to support Canadian patients who can now benefit from the latest SNM technology. Axonics will continue to invest in innovation and enhancing the patient experience, and given the exceptional clinical results being generated, we are confident our efforts will accrue to SNM becoming the preferred therapy for overactive bladder and bowel dysfunction patients in North America.”