IRVINE, Calif.– Axonics, Inc. (Nasdaq: AXNX), a global medical technology company that is developing and commercializing novel products for the treatment of bladder and bowel dysfunction, has filed a premarket approval supplement with the FDA for its fourth generation rechargeable sacral neuromodulation implantable neurostimulator (INS).
The fourth generation rechargeable INS reduces how frequently a patient needs to recharge their implanted device to only once every six months for one hour.1 This compares to the current recharging interval of once a month for one hour with the Axonics third generation rechargeable INS. The new INS utilizes the same small 5cc form factor as the Axonics R15™ and is paired with the same tined lead and intuitive, easy to use patient remote control. Axonics expects the new INS to receive FDA labeling for 20 years of useful life in the body.
Axonics anticipates receiving FDA approval for the fourth generation rechargeable INS in the fourth quarter of 2022 and expects to begin shipping the new device to customers in the first quarter of 2023. This filing follows the recent FDA approval of the Axonics F15™, the company’s newly developed, long-lived, recharge-free system, which commenced a comprehensive U.S. commercial launch in April.
“Since Axonics’ founding, delivering superior patient experiences has been at the forefront of the company’s development efforts,” said Raymond W. Cohen, chief executive officer of Axonics. “Our fourth generation INS, which requires recharging just twice per year, represents a significant breakthrough for rechargeable neuromodulation devices and underscores our commitment to continuous innovation for the benefit of patients and clinicians. We are confident that Axonics’ keen focus on enhancing the patient experience and increasing public awareness of sacral neuromodulation has the potential to drive significant market expansion in the years ahead.”
