NeuroOne Medical Technologies announced today that it initiated a limited commercial launch for its OneRF ablation system.
The Eden Prairie, Minnesota–based company said its initial rollout comes earlier than it previously expected. It picked up FDA 510(k) clearance for the OneRF system just over three months ago in December 2023. Indications cover the creation of radiofrequency (RF) lesions in nervous tissue for functional neurosurgical procedures.
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NeuroOne first-to-market thin-film, sEEG-guided RF ablation system can both record electrical activity and ablate nervous tissue. The system, which also features temperature control, is the third FDA-cleared device at NeuroOne and the first therapeutic device made by the company. The company says the system could reduce hospital stays, total surgeries and adverse events while offering significant clinical benefits.
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. They utilize a much less invasive process that eliminates the need to remove the top portion of the skull, though.
NeuroOne expects to begin shipping systems this week to centers participating in the initial launch. The company said those centers already have cases scheduled beginning in April. It plans to leverage the system for other targeted ablation indications with additional FDA 510(k) applications.
“Today is an exciting day for NeuroOne as we begin the limited commercial launch of our OneRF ablation system,” CEO Dave Rosa said. “We are proud to be the first to market with a thin-film electrode technology capable of performing both diagnostic and therapeutic functions utilizing the same electrode.”
