NeuroOne (Nasdaq:NMTC) announced today that it received FDA clearance for its OneRF trigeminal nerve ablation system.
The OneRF system creates radiofrequency (RF) lesions for the treatment of pain or for lesioning nerve tissue for functional neurosurgical procedures. Eden Prairie, Minnesota–based NeuroOne initially submitted the system ahead of schedule in April. It now targets a limited commercial launch in the fourth quarter of calendar year 2025.
Trigeminal nerve ablation, a minimally invasive procedure, uses RF energy to destroy abnormal tissue and relieve severe, chronic pain in the face caused by trigeminal neuralgia. Using its patented OneRF platform, NeuroOne designed its ablation procedure to provide pain relief for this condition.
The system’s multi-contact probe has differentiated features designed to use multi-point mapping of pain location, stimulation and ablation. All of this comes within the same electrode along with the safety of temperature-controlled ablation.
NeuroOne’s OneRF system previously picked up FDA 510(k) clearance in December 2023. This clearance covered the creation of radiofrequency (RF) lesions in nervous tissue for functional neurosurgical procedures. NeuroOne’s technology uses already-implanted sEEG electrodes to record brain activity and enable the ablation of nervous tissue. The company also has a distribution deal with Zimmer Biomet that covers the technology.
“One of the key aspects of the OneRF technology platform is its potential to be effective across multiple neurological disorders and pain management functions,” said Dave Rosa, CEO of NeuroOne. “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.
“Furthermore, we expect to pursue additional opportunities leveraging our technology platform in pain management and other therapeutic applications, such as treatment of lower back pain. With this clearance, we will continue our ongoing discussions with strategic partners and have the potential to begin generating revenues from trigeminal nerve ablation as soon as late calendar year 2025.”
