NeuroOne Medical Technologies Corporation announced the peer-reviewed publication of clinical experience with its OneRF sEEG-guided radiofrequency ablation technology in the journal Stereotactic and Functional Neurosurgery. The article, accessible via PubMed at https://pubmed.ncbi.nlm.nih.gov/41785222/, details a case series of four consecutive patients with drug-resistant epilepsy treated at a leading U.S. epilepsy center.
The publication describes NeuroOne's OneRF Ablation System as the first and only FDA-cleared system capable of nervous tissue ablation using the same stereoelectroencephalography electrode for both diagnostic and therapeutic applications. This dual functionality represents a significant technological advancement in neurological treatment, allowing clinicians to perform diagnostic mapping and therapeutic ablation without removing or repositioning implanted electrodes.
According to the authors, the procedure proved safe and easily integrated into existing stereotactic neurosurgical workflows. The technology enabled treatment delivery either in the operating room or at the patient's bedside in the epilepsy monitoring unit, providing flexibility in clinical settings. Real-time temperature monitoring during radiofrequency ablation allowed for precise, controlled lesions while minimizing risk to surrounding brain structures.
The case series reported no adverse events among the four patients, with all experiencing reductions in seizure burden following treatment. Beyond therapeutic benefits, the procedure provided valuable information that helped guide subsequent surgical decision-making, highlighting its potential as both a diagnostic and prognostic tool. The authors noted in their publication that this development represents a significant advancement in the work-up of patients with intractable epilepsy undergoing sEEG for invasive evaluation.
For business and technology leaders, this development signals growth potential in the neurological device market. NeuroOne estimates the combined sEEG and brain ablation market to be at least $200 million worldwide and growing, with potential for multifold expansion based on large addressable patient populations with unmet clinical needs. The OneRF Ablation System represents NeuroOne's first device with a therapeutic indication and the company's third FDA 510(k)-cleared device, positioning the company with a full line of thin film electrode technology.
The implications for healthcare systems include potential reductions in hospitalizations and surgical procedures, lower treatment costs, and improved patient outcomes through combination diagnostic and therapeutic functions. As neurological disorders affect millions worldwide, technologies that streamline treatment while improving precision could transform standard care protocols and create new market opportunities for medical technology companies.
