US-based medical device company NeuroOne Medical Technologies has received approval from the US Food and Drug Administration (FDA) for its OneRF trigeminal nerve ablation system.
Designed to treat trigeminal neuralgia (chronic facial pain), the system offers a minimally invasive alternative to traditional medical and surgical treatments.
The OneRF system uses targeted radiofrequency (RF) energy to ablate trigeminal nerve fibres, interrupting pain signals.
Its unique RF probe allows precise localisation and custom ablation of nerve tissue under temperature-controlled conditions, enhancing both safety and accuracy.
NeuroOne said that its advanced ablation technology may potentially reduce procedural time and improve patient comfort and safety.
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 of 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.”
Trigeminal neuralgia is a chronic facial pain condition traditionally treated using medication, microvascular decompression, radiosurgery, and other techniques.
NeuroOne said that its OneRF trigeminal nerve ablation system offers a less invasive option for patients suffering from this debilitating condition.
The medical device company has completed the FDA submission ahead of schedule and plans a limited commercial launch in the fourth quarter of this year.
The FDA clearance leverages the company’s unique OneRF Ablation System RF generator platform, further validating its technological advancements in the field.
Last year, NeuroOne amended its distribution partnership with Zimmer Biomet, which specialises in orthopaedic and surgical instruments and other medical products.
Under the expanded partnership, Zimmer Biomet gets exclusive rights to distribute NeuroOne’s OneRF ablation system for brain use.
