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 case series, published in Stereotactic and Functional Neurosurgery and accessible via PubMed, 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 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. The publication's 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.” 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 company markets a minimally invasive and high-definition/high-precision electrode technology platform with four FDA-cleared product families: Evo Cortical Electrodes, Evo sEEG Electrodes, OneRF Ablation System (for brain), and OneRF Trigeminal Nerve Ablation System. These solutions offer the potential to reduce the number of hospitalizations and surgical procedures, lower costs, and improve patient outcomes by offering combination diagnostic and therapeutic functions. The Company is also engaged in research and development for drug delivery and spinal cord stimulation programs. For more information, visit nmtc1.com.
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements involve risks and uncertainties, including those described under the heading "Risk Factors" in the Company's filings with the Securities and Exchange Commission. Caution: Federal law restricts this device to sale by or on the order of a physician.
