NeuroOne's OneRF Technology Shows Promise in Treating Drug-Resistant Epilepsy Through Peer-Reviewed Case Series

The publication of a peer-reviewed case series in Stereotactic and Functional Neurosurgery supports the clinical utility of NeuroOne Medical Technologies Corporation's OneRF Ablation System for treating drug-resistant epilepsy. The article, accessible via PubMed at https://pubmed.ncbi.nlm.nih.gov/41785222/, details the initial clinical experience with this first FDA-cleared system capable of using the same stereoelectroencephalography electrode for both diagnostic mapping and therapeutic radiofrequency ablation.

The case series reports on four consecutive patients treated at a leading U.S. epilepsy center, describing the procedure as safe and easily integrated into existing stereotactic neurosurgical workflows. This integration allows treatment to occur either in the operating room or at the patient's bedside in the epilepsy monitoring unit, providing flexibility in clinical settings. The technology enables radiofrequency ablation without requiring removal or repositioning of already implanted sEEG electrodes, streamlining the treatment process.

Treatment was delivered directly through the implanted electrodes while monitoring temperature in real time, allowing for precise, controlled lesions while minimizing risk to surrounding brain structures. The authors reported no adverse events, and all four patients experienced reductions in seizure burden following treatment. Additionally, the procedure provided information that helped guide subsequent surgical decision-making, highlighting its potential value as both a diagnostic and prognostic tool in epilepsy management.

The authors note in their publication that this development represents a significant advancement in the work-up of patients with intractable epilepsy 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, positioning the company with a full line of thin film electrode technology to address patients requiring both diagnostic brain mapping and radiofrequency ablation procedures.

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 technology's ability to combine diagnostic and therapeutic functions in a single system addresses significant clinical challenges in treating neurological disorders, particularly for patients with drug-resistant epilepsy who have limited treatment options.