Axonics today announced that it has received regulatory approval from the Therapeutic Goods Administration (TGA) for marketing the Axonics R20 rechargeable sacral neuromodulation (SNM) system in Australia to treat adults with overactive bladder and fecal incontinence.
The R20 neurostimulator is labeled for a functional life in the body of at least 20 years and reduces how frequently a patient needs to recharge their implanted device to once every 6 to 10 months for only one hour. The implant utilizes the same small 5cc form factor as the previous generation (Axonics R15) and is paired with the same tined lead and intuitive, easy to use patient remote control. The R20 also provides physicians and their patients with enhanced programming capabilities and expanded MRI labeling.
“Approval of the Axonics R20 is welcome news for Australians with bladder and bowel dysfunction,” said Dr. Janelle Brennan, a urologist at St. John of God Bendigo Hospital. “I am excited to offer my patients a therapy that provides durable symptom relief with a small rechargeable neurostimulator that can last over 20 years in the body.”
Axonics commenced SNM commercial activities in Australia in March 2023. In May 2024, Axonics received regulatory approval from the TGA to market its F15 recharge-free SNM system. In Australia, Axonics also markets Bulkamid, the company’s unique hydrogel indicated for female stress urinary incontinence.
“We are delighted to receive regulatory approval for our latest rechargeable SNM system in Australia,” said Raymond W. Cohen, chief executive officer. “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.”
Axonics expects to commence sales of the R20 to Australian customers in November.
