NeuroOne Medical Technologies Corporation (Nasdaq: NMTC) announced the peer-reviewed publication of clinical experience with its OneRF sEEG-Guided Radiofrequency 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 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.)," is accessible via PubMed and published in the journal Stereotactic and Functional Neurosurgery.
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, with real-time temperature monitoring 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 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 offers a full line of thin film electrode technology for diagnostic brain mapping procedures and RF ablation using the same sEEG electrode. The company 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.
This publication underscores the clinical utility of NeuroOne's technology in improving outcomes for patients with drug-resistant epilepsy, offering a minimally invasive option that can be performed at the bedside, potentially reducing the number of hospitalizations and surgical procedures.
