NeuroOne Medical Technologies Corporation (Nasdaq: NMTC) announced the publication of a peer-reviewed case series detailing initial clinical experience with its OneRF sEEG-guided radiofrequency ablation system. The article, titled “Initial clinical experience with the first FDA-approved sEEG-guided radiofrequency ablation system featuring real-time temperature monitoring: A case series (Zavala et al.)”, appears in the journal Stereotactic and Functional Neurosurgery and is accessible via PubMed.
The OneRF Ablation System is the first and only FDA-cleared system capable of nervous tissue ablation using the same sEEG electrode for both diagnostic and therapeutic applications. The case series reports on four consecutive patients with drug-resistant epilepsy treated at a leading U.S. epilepsy center. The authors describe the procedure as 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.
Key features of the technology include the ability to perform RF ablation without removing or repositioning already implanted sEEG electrodes. Treatment is delivered directly through the implanted electrodes while monitoring temperature in real time, which enables 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 helped guide subsequent surgical decision-making, highlighting its potential value as a diagnostic and prognostic tool.
The authors note 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.” This underscores the importance of the OneRF system as a combined diagnostic and therapeutic device that could streamline epilepsy surgery workflows.
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 procedures and RF ablation using the same sEEG electrode. NeuroOne estimates the current combined sEEG and brain ablation market to be at least $200 million worldwide and growing, with the potential to expand multifold based on large addressable patient populations with unmet clinical needs.
This publication marks a significant milestone for NeuroOne as it provides clinical validation for the OneRF system’s safety and effectiveness. The ability to perform ablation at the bedside in the epilepsy monitoring unit could reduce the need for additional surgical procedures, lower costs, and improve patient outcomes. As the first published case series, it offers real-world evidence that may support broader adoption of this technology in epilepsy centers worldwide.
