NeuroOne (Nasdaq:NMTC) announced today that it responded to FDA questions regarding the 510(k) submission of its OneRF ablation system.
Eden Prairie, Minnesota–based NeuroOne submitted OneRF for FDA clearance in June. It’s the company’s first therapeutic device.
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.
When the company announced its submission, it said it expected feedback from the FDA by Aug. 7, 2023. It said today that it expects to receive additional communications from the FDA in 30 days or less. NeuroOne retains hope for completed discussions soon followed by a commercial launch in the first half of 2024.
“We remain bullish on the potential for this technology to cause a paradigm shift in how patients are treated in ablation procedures,” said NeuroOne CEO Dave Rosa. “The potential to reduce hospital stays, additional procedures, complications and cost gives us confidence that this will have a meaningful impact in the market. We hope to complete discussions with the FDA in the near future as we prepare for a targeted commercial launch in the first half of 2024.”
More about NeuroOne and the neuro ablation opportunity
NeuroOne says FDA clearance would mark the first step in bringing an RF ablation system to market for neurology and neurosurgery. The company 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.
OneRF was 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.
NeuroOne estimates the current brain ablation market value sits around at least $100 million with rapid growth to come. The company believes it could expand that market based on large addressable patient populations with unmet clinical needs.
