NeuroOne Medical Technologies Corporation announced the peer-reviewed publication of a case series evaluating its OneRF Ablation System for treating drug-resistant epilepsy. 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 publication describes clinical experience with NeuroOne's OneRF Ablation System, which is the first and only FDA-cleared system capable of nervous tissue ablation using the same stereoelectroencephalography (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.
According to the authors, the procedure proved 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 radiofrequency 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 reported, and all four patients experienced reductions in seizure burden following treatment. The procedure also provided information that helped guide subsequent surgical decision-making, highlighting its potential value as both 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.
This development matters because drug-resistant epilepsy affects approximately one-third of epilepsy patients worldwide, creating significant unmet clinical needs. The ability to perform both diagnosis and treatment using the same implanted electrodes represents a paradigm shift in neurological care, potentially reducing the number of procedures patients must undergo while improving outcomes. The bedside treatment capability could also reduce hospital stays and associated healthcare costs.
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 technology's implications extend beyond epilepsy treatment, as the platform could potentially be adapted for other neurological conditions requiring precise brain mapping and targeted ablation.
The publication's findings suggest that integrating diagnostic and therapeutic functions into a single system could streamline treatment pathways for patients with complex neurological disorders. As healthcare systems worldwide seek more efficient and effective treatment options, technologies like NeuroOne's OneRF System that offer combination functions while maintaining safety profiles could see increased adoption in clinical settings.
