NeuroOne Medical Technologies Corporation (Nasdaq: NMTC) announced the peer-reviewed publication of 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.),” is available online in the journal Stereotactic and Functional Neurosurgery and accessible via PubMed at https://pubmed.ncbi.nlm.nih.gov/41785222/.
The case series reports on four consecutive patients with drug-resistant epilepsy treated at a leading U.S. epilepsy center. The authors describe the OneRF Ablation System 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 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.
