Axonics (Nasdaq:AXNX) announced today that it received CE mark approval for its R20 rechargeable sacral neuromodulation (SNM) system.
The implantable system provides therapy for patients suffering from overactive bladder or fecal incontinence. Axonics won FDA approval for this generation of the R20 in January 2023. The R20 neurostimulator uses the same small 5cc form factor as the previous-generation R15. It pairs with the same tined lead and intuitive patient remote control. It also features enhanced programming capabilities with expanded MRI labeling.
R20 has a functional life in the body of at least 20 years and reduces charging frequency to every 6-10 months for just one hour.
Axonics expects to begin selling R20 to European customers in mid-April.
“Delivering a superior patient experience has been at the forefront of our SNM development efforts,” said CEO Raymond W. Cohen. “Patients with overactive bladder tell us that first and foremost, they value efficacy and a long-lived solution to address their chronic condition. The R20 represents another significant breakthrough for rechargeable neuromodulation devices and underscores Axonics’ commitment to continuous innovation.
“We are confident that our keen focus on the incontinence patient population has the potential to drive significant market expansion in both the U.S. and international markets in the years ahead.”
News of CE mark comes amid an interesting time for Axonics. The company is in the midst of being acquired by Boston Scientific.
In January, Boston Scientific announced its plans to buy Axonics and its neuromodulation and hydrogel technologies. The companies said at the time that they expected the deal to close in the first half of this year.
However, questions arose over the status of the acquisition after reports suggested a longer look at the deal from the FTC. Bloomberg suggested that the combined offerings at the companies could cause antitrust concerns.