NeuroOne Medical Technologies (Nasdaq:NMTC) announced today that the FDA granted 510(k) clearance to its OneRF ablation system.
Clearance makes OneRF the first FDA-cleared, thin-film, sEEG-guided radiofrequency (RF) system capable of recording electrical activity and ablating nervous tissue. The system, which also features temperature control, became the third FDA-cleared device at NeuroOne. It’s the first therapeutic device made by the Eden Prairie, Minnesota-based company.
The 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. They utilize a much less invasive process that eliminates the need to remove the top portion of the skull, though.
NeuroOne initially submitted OneRF for FDA clearance in June. Last month, the company said it responded to FDA questions regarding the 510(k) submission. At that point, NeuroOne expected FDA clearance in 2024, but it appears to have come earlier than projected. The company now expects a commercial launch — either direct or through a strategic partner — in the first half of 2024.
“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,” NeuroOne CEO Dave Rosa said in a news release. “This may also reduce hospital stays, number of surgeries, and adverse events, while offering significant benefits from a clinical perspective. The addition of temperature control at the point of ablation also may enhance patient safety. Our team’s achievement in reaching this milestone was the culmination of years of perseverance, and I could not be more excited for our future.”
More about NeuroOne and the neuro ablation opportunity
NeuroOne previously suggested that FDA clearance would mark the first step in bringing an RF ablation system to market for neurology and neurosurgery. The company also commercially launched its Evo sEEG electrode line in the U.S. earlier this year. The electrodes provide up to 30 days of recording, monitoring and stimulation of electrical signals at the subsurface level of the brain.
It also hopes to enter into the field of drug delivery using neural probes. Last month, NeuroOne received a patent for novel electrodes that can operate as a standard neural electrode that delivers a treatment agent to a target area of the brain.
The company’s OneRF systemwas designed to combine both diagnostic and therapeutic capabilities. Its customized RF generator features real-time temperature monitoring capabilities, enabling 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.
The company values the current brain ablation market around at least $100 million with rapid growth expected.