IRVINE, Calif. - Axonics, Inc. (NASDAQ: AXNX), a medical technology firm specializing in bladder and bowel dysfunction treatments, has announced the receipt of CE Mark approval for its Axonics R20™ rechargeable sacral neuromodulation (SNM) system, a development poised to impact the European market.
The R20 neurostimulator, which boasts a functional life expectancy of at least 20 years, offers patients a significant reduction in the frequency of recharging, necessitating only a one-hour charge every 6 to 10 months. The device maintains the compact 5cc form factor of its predecessor, the Axonics R15™, and comes with a tined lead and a user-friendly patient remote control. Additionally, the R20 system introduces enhanced programming features and broader MRI compatibility.
Raymond W. Cohen, CEO of Axonics, emphasized that patient experience was a key focus in the development of the R20, aiming to provide a durable and effective solution for individuals with overactive bladder conditions. He expressed confidence that this innovation will contribute to market growth in the U.S. and internationally.
European sales of the R20 are expected to begin in mid-April. The system previously received approval from the U.S. Food and Drug Administration (FDA) in January 2023 and from Health Canada in December 2022.
Axonics is recognized for its growth, ranking second on the 2023 Financial Times list of the fastest-growing companies in the Americas. The company's neuromodulation systems and Bulkamid® hydrogel offer therapeutic options for adults suffering from urinary and fecal incontinence, addressing a significant need within the medical community.
This announcement is based on a press release statement.
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