FDA Approves Axonics’ Next-Gen Implantable Neurostimulator

Axonics Modulation Technologies Inc., a medical technology company that has developed and is commercializing novel implantable sacral neuromodulation (“SNM”) devices for the treatment of urinary and bowel dysfunction, today announced the U.S. Food & Drug Administration (“FDA”) approval of its next generation rechargeable implantable neurostimulator (“INS”) for its r-SNM System under a premarket approval (“PMA”) supplement.
 
This next generation INS decreases how frequently a patient needs to recharge their implanted device to once a month for about one hour1. This compares to the current recharging interval which is one hour every two weeks. This new feature will also give patients the option to customize their charging experience, for example, choosing to charge for only 15 minutes once a week or only one hour every two months for those patients at lower stimulation intensity levels. In addition to extending the recharging interval, the enhanced INS will experience virtually no battery degradation over the 15+ year life of the INS due to the reduced charging burden.
 
The FDA approved the long-lived, rechargeable, full-body MRI compatible Axonics r-SNM System in late 2019, with the first commercial sales occurring in November 2019. The next generation Axonics INS is expected to begin shipping to customers in the U.S. during the third quarter of 2020.
 
Raymond W. Cohen, CEO of Axonics, commented, “This FDA approval is another example of our commitment to innovation and to creating awareness, particularly among middle-aged women, that sacral neuromodulation is a safe and efficacious treatment for bladder and bowel dysfunction. From our inception, delivering a superior patient experience has been at the forefront of our development efforts. With this objective in mind, we developed a bespoke SNM device that is intuitive, fuss-free, long-lived, MRI full-body compatible, safe and clinically effective. The response by the SNM implanting community and their patients has been exceptional. This is evidenced by the fact that in just five months in the U.S. market, approximately one-third of centers offering SNM therapy are now implanting the Axonics System. We will continue to innovate by adding new embodiments and capabilities to our SNM product offering as well as working with the FDA to expand clinical indications.”