Axonics Wins Australian Approval for Fourth-Generation Rechargeable SNM System

Australia’s Therapeutic Goods Administration (TGA) has approved the Axonics R20 rechargeable sacral neuromodulation (SNM) system for overactive bladder and fecal incontinence treatment.
 
Axonics Inc.’s R20 neurostimulator is labeled for a functional life in the body of at least 20 years and reduces the recharging frequency to once every six to 10 months for only one hour. The implant uses 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. This past spring, Axonics received regulatory approval from the TGA to market its F15 recharge-free SNM system. In Australia, Axonics also markets Bulkamid, the company’s hydrogel indicated for female stress urinary incontinence.
 
“We are delighted to receive regulatory approval for our latest rechargeable SNM system in Australia,” Axonics CEO Raymond W. Cohen stated. “Our mission-driven team remains committed to innovating, supporting our dedicated physician customers and their patients, and raising awareness of our incontinence therapies.”
 
Axonics expects to begin R20 neurostimulator sales to Australian customers in November.
 
Axonics is a global medical technology company developing and commercializing products for adults with bladder and bowel dysfunction. 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 urethral bulking hydrogel, Bulkamid, provides safe and durable symptom relief to women with stress urinary incontinence. Moderate to severe incontinence affects tens of millions of adults globally.