NeuroOne Medical Technologies has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its OneRF trigeminal nerve ablation system to treat facial pain.
This clearance allows the company to market its system for procedures to generate radiofrequency (RF) lesions to alleviate pain or for lesioning nerve tissue in functional neurosurgical applications.
NeuroOne had previously indicated that the FDA submission was completed ahead of schedule and is now aiming for a limited commercial launch in the fourth quarter of this year.
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The OneRF ablation system RF generator platform treats trigeminal neuralgia, a chronic pain condition linked to the trigeminal primary sensory nerve in the face, associated with severe pain.
Typically, trigeminal neuralgia is managed through medication or various invasive procedures such as microvascular decompression (MVD), radiosurgery, or other percutaneous methods.
The system delivers targeted RF energy aimed at trigeminal nerve fibre ablation, interrupting pain signals.
Notably, the system includes a multi-contact RF probe that facilitates localisation and customised ablation of the pain-conducting nerve tissue, all while maintaining temperature-controlled conditions.
This technology may contribute to minimising procedural times, increasing patient comfort, and improving safety outcomes.
NeuroOne CEO Dave Rosa said: “One of the key aspects of the OneRF technology platform is its potential to be effective across multiple neurological disorders and pain management functions.
“This is our first venture in pain management therapies, and this newest technology aligns well with current commercial efforts with our OneRF brain ablation system. Some of the current users for the OneRF brain ablation system also perform nerve ablation procedures for facial pain, which may allow current medical practices to further justify the investment.”
Last year, NeuroOne announced an amendment to its agreement with Zimmer Biomet, granting the latter exclusive distribution rights for the OneRF system in exchange for an upfront payment of $3m.
