NeuroOne Medical Technologies has announced the limited commercial launch of its OneRF Ablation System, a thin-film, stereoelectroencephalography (sEEG)-guided radiofrequency (RF) system.
The system received 510(k) clearance from the US Food and Drug Administration (FDA) in December 2023 for the creation of RF lesions in nervous tissue for functional neurosurgical procedures.
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The OneRF Ablation System is designed for both recording electrical activity and ablating nervous tissue and features temperature controls.
NeuroOne CEO Dave Rosa said: “Today is an exciting day for NeuroOne as we begin the limited commercial launch of our OneRF Ablation System. We are proud to be the first to market with a thin-film electrode technology capable of performing both diagnostic and therapeutic functions utilising the same electrode.
“We expect to start shipping systems this week to centres participating in our limited launch with cases already scheduled starting in April.”
Representing NeuroOne’s first therapeutic device and its third FDA-cleared product, the system complements NeuroOne’s existing portfolio that includes the Evo cortical and sEEG electrodes, mainly used to record electrical activity in the brain for less than 30 days.
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By GlobalDataRosa added: “We believe physicians and patients will benefit from our technology given it may reduce hospital stays, number of surgeries, and adverse events while offering significant clinical benefits, including temperature control to enhance patient safety.
“Looking ahead, we plan to leverage the system for other targeted ablation indications by submitting additional FDA 510(k) applications.”
The company anticipates the current global market for brain ablation to be at least $100m and expects significant growth.
