Axonics (Nasdaq:AXNX) announced that it filed a premarket approval (PMA) supplement with the FDA for its next-generation neurostimulator.
Irvine, California-based Axonics designed its fourth-generation rechargeable sacral neuromodulation implantable neurostimulator (INS) to reduce the frequency with which a patient needs to recharge their implanted device to just once every six months for one hour.
The current recharging interval comes once per month for one hour with Axonics’ third-generation rechargeable INS, according to a news release.
Axonics’ latest INS utilizes the same small 5cc form factor as its R15 system and pairs with the same tined lead and intuitive, easy-to-use patient remote control. The company expects the INS to receive FDA labeling for 20 years of useful life in the body, with projections for FDA approval set for the fourth quarter of 2022, followed by shipment of the new device to customers in the first quarter of 2023.
The regulatory filing follows last month’s U.S. commercial launch of the Axonics F15 long-lived, recharge-free system. The F15 system received FDA approval in March.
“Since Axonics’ founding, delivering superior patient experiences has been at the forefront of the company’s development efforts,” Axonics CEO Raymond W. Cohen said in the release. “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.”