Benzinga | Feb 16, 2021 06:09AM EST

Axonics Receives FDA Approval For Third-Generation Implantable Neurostimulator

Axonics Modulation Technologies, Inc. (NASDAQ:AXNX), a medical technology company that has developed and is commercializing novel implantable sacral neuromodulation (SNM) devices for the treatment of urinary and bowel dysfunction, has received PMA supplement approval from the U.S. Food & Drug Administration (FDA) for its third-generation implantable neurostimulator (INS).

This marks the sixth FDA approval Axonics has received for a significant product innovation since the company's U.S. commercial launch in November 2019. The FDA previously approved Axonics' second-generation rechargeable INS in April 2020, which extended the recharge interval to one hour each month.

The third-generation INS upgrades the embedded software in the INS and the functionality of the patient remote control. These modifications give patients the ability to make broader stimulation parameter adjustments at home, including selecting a second therapy program that was set post-operatively based on interoperative findings. These enhancements provide an appropriate level of flexibility to maximize symptom relief as patients settle into their everyday lives. This is accomplished while patients continue to benefit from an intuitive, easy to use therapy experience.

Axonics expects to begin shipping the third-generation INS and patient remote control on March 1, 2021.

Raymond W. Cohen, CEO of Axonics, said, "This is another significant upgrade we have made to the Axonics System, underscoring our commitment to continuous innovation that enhances the patient experience. While our long-lived INS device is as close to a 'set it and forget it' therapy, the new features will benefit physician practices in which patients have to travel long distances should they require therapy adjustments. We are confident that continuing to ensure excellent patient experiences will drive significant market expansion in the years ahead and result in SNM therapy becoming the preferred solution for urinary and bowel dysfunction."