Axonics (Nasdaq:AXNX) announced today that Health Canada approved its fourth-generation rechargeable sacral neuromodulation (SNM) system.
Irvine, California-based Axonics’ R20 neurostimulator received labeling for a functional life in the body of at least 20 years. It reduces how frequently a patient must recharge their implanted device to once every six to 10 months. The devices charge for only one hour.
The previous generation of the device had a recharging interval of once a month for one hour. R20 utilizes the same small 5cc form factor as that device and pairs to the same tined lead and patient remote control.
“Since Axonics’ founding, delivering superior patient experiences has been at the forefront of our development efforts,” said Raymond W. Cohen, CEO of Axonics. “Patients with overactive bladder want efficacy and a long-lived solution to address their chronic condition. The Axonics R20 represents a significant breakthrough for rechargeable neuromodulation devices and underscores our commitment to continuous innovation. We are confident that Axonics’ keen focus on the incontinence patient population and increasing public awareness of sacral neuromodulation has the potential to drive significant market expansion in the years ahead.”
Axonics said it commenced sales of the R20 SNM system to customs in Canada. The system remains under review by the FDA in the U.S. The company expects approval and a commercial launch in the U.S. in the first quarter of 2023.