NeuroOne Medical Technologies Corporation (Nasdaq: NMTC) announced the peer-reviewed publication of clinical experience with its OneRF sEEG-Guided Radiofrequency Ablation System in the journal Stereotactic and Functional Neurosurgery. The article, available on PubMed at https://pubmed.ncbi.nlm.nih.gov/41785222/, describes a case series of four consecutive patients with drug-resistant epilepsy treated at a leading U.S. epilepsy center.
The OneRF Ablation System is the first and only FDA-cleared system capable of nervous tissue ablation using the same stereoelectroencephalography (sEEG) electrode for both diagnostic and therapeutic applications. The authors reported that the procedure was safe and easy to integrate into existing stereotactic neurosurgical workflows, allowing treatment either in the operating room or at the patient's bedside in the epilepsy monitoring unit. The technology enabled RF ablation without removing or repositioning already implanted sEEG electrodes, with real-time temperature monitoring to create precise, controlled lesions while minimizing risk to surrounding brain structures.
There were no adverse events, and all four patients experienced reductions in seizure burden following treatment. Additionally, the procedure provided information that guided subsequent surgical decision-making, highlighting its potential as a diagnostic and prognostic tool. The authors noted in their publication that "this development represents a significant advancement in the work-up of patients with intractable epilepsy, who are undergoing sEEG for invasive evaluation."
NeuroOne estimates the current combined sEEG and brain ablation market to be at least $200 million worldwide and growing, with potential for multifold growth based on large addressable patient populations with unmet clinical needs. The OneRF Ablation System is NeuroOne's first device with a therapeutic indication and the Company's third FDA 510(k)-cleared device. NeuroOne now offers a full line of thin film electrode technology for diagnostic brain mapping and RF ablation using the same sEEG electrode.
