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

17 May 2024 | Friday | News


Axonics, 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.
Image Source : Public Domain

Image Source : Public Domain

 

 

“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.”

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