Axonics Receives Regulatory Approval for Recharge-Free SNM System in Australia

Axonics, Inc. (Nasdaq: AXNX) today announced that it has received regulatory approval from the Therapeutic Goods Administration (TGA) for marketing the Axonics F15 recharge-free sacral neuromodulation (SNM) system in Australia to treat adults with overactive bladder.

“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 unique hydrogel indicated for female stress urinary incontinence.

“We are delighted to receive regulatory approval for our latest SNM system in Australia,” said Raymond W. Cohen, chief executive officer of Axonics. “Our mission-driven team remains committed to innovating, supporting our dedicated physician customers and their patients, and raising awareness of our best-in-class incontinence therapies in the United States, Europe and Australia.”

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

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. 2 on the 2023 Financial Times ranking of the fastest growing companies in the Americas after being ranked No. 1 in 2022.

Axonics 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 best-in-class urethral bulking hydrogel, Bulkamid, provides safe and durable symptom relief to women with stress urinary incontinence. In the U.S., moderate to severe urinary incontinence affects an estimated 28 million women and fecal incontinence affects an estimated 19 million adults. For more information, visit www.axonics.com.