NeuroOne Medical Technologies (Nasdaq:NMTC) announced today that it submitted an FDA 510(k) application for its OneRF ablation system.
This technology uses already-implanted sEEG electrodes to record brain activity and enable the ablation of nervous tissue. It connects to a proprietary radiofrequency (RF) generator. NeuroOne’s electrodes provide a similar function at the subsurface level of the brain compared to cortical electrodes. However, they utilize a much less invasive process. That process eliminates the need to remove the top portion of the skull.
NeuroOne said FDA clearance would mark the first step in bringing an RF ablation system to market for neurology and neurosurgery. It’s the company’s first therapeutic device. The company commercially launched its Evo sEEG electrode line in the U.S. earlier this month. The electrodes provide up to 30 days of recording, monitoring and stimulation of electrical signals at the subsurface level of the brain.
Eden Prairie, Minnesota-based NeuroOne developed OneRF to combine both diagnostic and therapeutic capabilities. It uses a customized RF generator with real-time temperature monitoring capabilities. The company said this allows clinicians to have greater control over temperature management during ablation. The system both records brain activity and ablates nervous tissue using the same electrode. NeuroOne said it could offer a safer clinical option for patients, plus lower costs.
“This is a monumental day for NeuroOne as it represents the first known FDA 510(k) submission of an sEEG electrode intended to record brain activity and also be used as an RF probe to ablate nervous tissue,” said Dave Rosa, NeuroOne CEO. “We also believe this system has applications beyond ablation of nervous tissue in the brain, offering a larger opportunity than we initially envisioned.”
NeuroOne expects to receive initial feedback from the FDA no later than Aug. 7, 2023.
