NeuroOne Medical Technologies Corporation (Nasdaq: NMTC) announced the peer-reviewed publication of a clinical case series on its OneRF Ablation System, the first and only FDA-cleared system capable of nervous tissue ablation using the same sEEG electrode for both diagnostic and therapeutic applications. The study, 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 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. The technology enabled RF ablation without removing or repositioning already implanted sEEG electrodes. Treatment was delivered directly through the implanted electrodes while monitoring temperature in real time, which allowed for 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." 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 boasts a full line of thin film electrode technology to address patients requiring diagnostic brain mapping procedures as well as 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 grow multifold based on large addressable patient populations with unmet clinical needs. The publication underscores the potential of the OneRF system to reduce the number of hospitalizations and surgical procedures, lower costs, and improve patient outcomes by offering combination diagnostic and therapeutic functions.
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