The US Food and Drug Administration (FDA) has cleared NeuroOne’s radiofrequency ablation system, with a rollout of the device expected by the company in the first half of 2024.
The 510(k) clearance means the OneRF device can now be used by neurosurgeons on patients needing lesions of nervous tissue for functional neurosurgical procedures.
The system can ablate nervous tissue and record electrical activity in the brain. According to US-based NeuroOne, it has received the first clearance for a diagnostic and therapeutic combination device for both recording electrical brain activity and removing target regions of brain tissue to treat patients living with neurological conditions such as epilepsy, brain tumours, chronic back pain, and Parkinson’s disease.
NeuroOne CEO Dave Rosa said: “One of our ambitious goals was to be the first to develop and commercialise thin-film electrodes capable of performing both diagnostic and therapeutic functions and offer a better methodology to treat patients suffering from a variety of neurological conditions.”
NeuroOne’s minimally invasive electrodes are manufactured using polyimide thin film. They are designed to record electrical activity in the brain for less than 30 days.
Rosa added: “We believe we have the potential to dramatically change the way these surgeries are performed so that patients may only need to go through surgery once for both diagnostic and therapeutic procedures.”
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The company’s Evo cortical and stereoelectroencephalography (SEEG) electrodes were cleared by the FDA for monitoring, recording, and stimulating electrical signals at the subsurface level of the brain in October 2022.
NeuroOne estimates the brain ablation market is worth at least $100m globally. September 2023 saw a big move in the ablation treatment space when Boston Scientific acquired Relievant Medsystems for $850m. Relievant Medsystems had developed and commercialised a nerve ablation system for the treatment of a type of chronic back pain.
The market is growing rapidly alongside cardiovascular applications of ablation, where the treatment is also commonly used. In November this year, Medtronic secured a CE mark for its pulsed field ablation system.