Australian Regulators OK Axonics’ Recharge-Free SNM System

Axonics Inc. has received regulatory approval from Australia’s Therapeutic Goods Administration (TGA) for marketing the Axonics F15 recharge-free sacral neuromodulation (SNM) system to treat overactive bladder in adults.
 
“Approval of the Axonics recharge-free system is welcome news for Australians with bladder and bowel dysfunction,” said Dr. Ailsa Wilson Edwards, a urologist at Calvary North Adelaide Hospital. “I am excited to offer my patients a recharge-free option that significantly increases device longevity compared to legacy technology, provides constant current stimulation, and utilizes a simple remote control that is recharge-free and easy for patients to use.”
 
Axonics commenced SNM commercial activities in Australia in March 2023. In Australia, in addition to its SNM products, Axonics markets Bulkamid, the company’s hydrogel indicated for female stress urinary incontinence.

The Axonics F15 SNM system uses a recharge-free implantable neurostimulator (INS) that is relatively small and thin at 10 cubic centimeters in volume. The INS employs a primary cell battery and has an expected life in the body of mor than 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.
 
“We are delighted to receive regulatory approval for our latest SNM system in Australia,” Axonics CEO Raymond W. Cohen stated. “Our mission-driven team remains committed to innovating, supporting our physician customers and their patients, and raising awareness of our incontinence therapies in the United States, Europe, and Australia.”
 
Axonics is a global medical technology company that is developing and commercializing products for adults with bladder and bowel dysfunction. Axonics recently ranked No. 2 on the 2023 Financial Times ranking of the fastest-growing companies in the Americas after being ranked No. 1 in 2022. The company’s sacral neuromodulation systems provide adults with overactive bladder and/or fecal incontinence with long-lived, easy to use, safe, clinically effective therapy. In addition, the company’s urethral bulking hydrogel, Bulkamid, provides safe and durable symptom relief to women with stress urinary incontinence. In the United States, moderate to severe urinary incontinence affects an estimated 28 million women and fecal incontinence affects an estimated 19 million adults.