IRVINE, Calif.--(BUSINESS WIRE)--Axonics, Inc. (Nasdaq: AXNX), a global medical technology company that is developing and commercializing novel products for the treatment of bladder and bowel dysfunction, today announced the first patient implants in Canada with the Axonics F15™, the company’s newly developed, long-lived, fully recharge-free sacral neuromodulation (SNM) system.
The University of Alberta implanted four patients this week with the Axonics F15. The four patients were programmed at stimulation amplitudes between 0.95mA and 0.30mA, resulting in an expected battery longevity in the body ranging from 18 years to over 22 years.
The Axonics F15 received regulatory approval from Health Canada following U.S. FDA approval. The comprehensive U.S. commercial launch of the Axonics F15 commenced in the second quarter of 2022.
“The approval of the Axonics recharge-free system is welcome news for patients in Canada suffering from bladder and bowel dysfunction,” 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. “I am excited to now offer patients a recharge-free option that significantly increases device longevity in the body alongside the rechargeable Axonics SNM system that has helped so many of my patients.”
Karen Noblett, M.D., FPMRS, chief medical officer of Axonics, said, “Millions of adults in North America suffer from incontinence and struggle to find long-term symptom relief. SNM began experiencing a renaissance a few years ago when Axonics introduced the world’s first long-lived, miniaturized, full-body MRI compatible, rechargeable SNM system. Similarly, our long-lived, fully recharge-free SNM system has the potential to increase adoption of SNM therapy and significantly improve the quality of life for adults with bladder and bowel dysfunction.”
About the Axonics F15 SNM system
The Axonics F15 SNM system utilizes a recharge-free implantable neurostimulator (INS) that is relatively small and thin at only 10 cubic centimeters in volume. The INS employs a primary cell battery and has an expected life in the body of over 15 years at typical stimulation parameters and over 20 years at lower energy settings. Constant current stimulation allows the device to automatically adjust the magnitude of stimulation to maintain symptom relief with minimal reprogramming. The F15 is MRI compatible with 1.5 and 3.0T whole-body MRI scanners and utilizes an intuitive, easy to use recharge-free patient remote control.
About Axonics
Based in Irvine, Calif., Axonics is a global medical technology company that is developing and commercializing novel products for adults with bladder and bowel dysfunction. Axonics recently ranked No. 1 on the 2021 Deloitte Technology Fast 500™ and the 2022 Financial Times ranking of the 500 fastest growing companies in the Americas.
Axonics sacral neuromodulation (SNM) systems provide patients suffering from overactive bladder and/or fecal incontinence with long-lived, easy to use, safe, clinically effective therapy. In addition, the company’s best-in-class urethral bulking hydrogel, Bulkamid®, provides safe and durable symptom relief to women with stress urinary incontinence (SUI). Overactive bladder affects an estimated 87 million adults in the U.S. and Europe, with an additional 40 million adults estimated to suffer from fecal incontinence. SUI affects an estimated 29 million women in the U.S. alone. Axonics’ clinically proven products are offered at hundreds of medical centers across the U.S. and abroad. Reimbursement coverage is well established in the U.S. and is a covered service in most European countries. For more information, visit www.axonics.com.
