A recent peer-reviewed publication in Stereotactic and Functional Neurosurgery details the clinical experience with NeuroOne Medical Technologies Corporation's OneRF Ablation System, the first FDA-cleared system capable of using the same stereoelectroencephalography (sEEG) electrode for both diagnostic mapping and therapeutic radiofrequency ablation. The case series, authored by Zavala et al., is accessible via PubMed at https://pubmed.ncbi.nlm.nih.gov/41785222/ and reports on four consecutive patients treated at a leading U.S. epilepsy center.
The study found the procedure to be safe and easily integrated into existing stereotactic neurosurgical workflows. A key advantage highlighted is the system's flexibility, allowing treatment to be delivered either in the operating room or at the patient's bedside in the epilepsy monitoring unit. This capability enables RF ablation without the need to remove or reposition already implanted sEEG electrodes, streamlining the process. Treatment was administered directly through the implanted electrodes while monitoring temperature in real time, which the authors state allowed for precise, controlled lesions while minimizing risk to surrounding brain structures.
According to the publication, there were no adverse events reported among the four patients, and all experienced reductions in their seizure burden following the treatment. The authors note that the procedure also provided valuable information that helped guide subsequent surgical decision-making, underscoring its potential dual role as both a diagnostic and prognostic tool. They conclude that "this development represents a significant advancement in the work-up of patients with intractable epilepsy, who are undergoing sEEG for invasive evaluation."
The OneRF Ablation System is NeuroOne's first device with a therapeutic indication and the company's third FDA 510(k)-cleared device. It is part of a full line of thin film electrode technology designed to address patients requiring diagnostic brain mapping as well as RF ablation. The company estimates the current combined global market for sEEG and brain ablation procedures to be at least $200 million and growing, with potential for significant expansion given large addressable patient populations with unmet clinical needs. This clinical validation supports the technology's role in potentially reducing the number of surgical procedures and hospitalizations while improving outcomes for patients with neurological disorders.
