Axonics Modulation Technologies (NASDAQ:AXNX) received FDA premarket approval for its rechargeable-sacral neuromodulation (r-SNM) system for overactive bladder (OAB) and urinary retention indications.
The r-SNM system is the first rechargeable SNM system approved for sale in the U.S., Europe, Canada and Australia. The FDA approved the system for fecal incontinence in September 2019.
The FDA’s approval for the OAB indication was based on Axonics’ 129-patient pivotal clinical study that demonstrated 90% efficacy for all implanted urinary incontinence patients at six months.
“Based on feedback from U.S. physicians, we believe the SNM market is poised to dramatically expand over the next few years given our fuss-free, highly efficacious, long-lived, full-body MRI compatible device,” CEO Raymond Cohen said in a statement.
