NeuroOne Medical Technologies Corporation (Nasdaq: NMTC) announced its participation in the 2026 American Society for Stereotactic and Functional Neurosurgery (ASSFN) Biennial Meeting, taking place May 30-June 2, 2026, in Cleveland. The company will present its recently FDA 510(k)-cleared OneRF® Trigeminal Nerve Ablation System, which received clearance under K251243, and provide updates on its investigational SEEG-Drug Delivery System.
The OneRF® Trigeminal Nerve Ablation System is indicated for creating radiofrequency lesions to treat chronic facial pain or for lesioning nerve tissue in functional neurosurgical procedures. The system features an innovative multi-contact RF probe designed to enable precise mapping and ablation in fewer cycles without repositioning. Using the OneRF® Generator, the system may allow for reduced procedural time and improved patient comfort. NeuroOne recently completed the limited market release of this system.
In addition, the company will share details on its SEEG-Drug Delivery System, currently under development for investigational use. The system is designed to deliver drugs, record, and stimulate, support multiple trajectories, and enable repeated dosing through a single implant. This device is not yet approved or cleared by the FDA for sale.
NeuroOne will present a scientific presentation titled "Integrating Drug Delivery Capabilities into a SEEG-Based Recording, Stimulation, and Ablation Platform Technology" during Parallel Session 3 on Sunday, May 31, 2026. Additionally, two posters will be presented: "SEEG-Guided Radiofrequency Ablation with Real-Time Temperature Control: From Early Clinical Experience to the Development of a Post-Market Registry" and "New FDA-cleared Multi-Contact RF Probe for Trigeminal Neuralgia: Cadaveric Feasibility and Usability Evaluation." Multiple neurosurgeon presentations on clinical experiences with both the OneRF® Radiofrequency Ablation System (brain) and the OneRF® Trigeminal Nerve Ablation System are also expected.
The OneRF® Radiofrequency Ablation System (brain) was previously cleared under K231675 for creating radiofrequency lesions in nervous tissue for functional neurosurgical procedures. NeuroOne’s technology platform includes four FDA-cleared product families: Evo® Cortical Electrodes, Evo® sEEG Electrodes, OneRF® Ablation System, and OneRF® Trigeminal Nerve Ablation System. These solutions aim to reduce hospitalizations and surgical procedures, lower costs, and improve patient outcomes by offering diagnostic and therapeutic functions.
The implications of this announcement are significant for the field of functional neurosurgery. The ability to precisely map and ablate nerve tissue in fewer cycles, as offered by the OneRF® Trigeminal Nerve Ablation System, could enhance procedural efficiency and patient comfort. Furthermore, the development of an SEEG-based drug delivery system could open new avenues for treating neurological disorders by combining recording, stimulation, and drug delivery capabilities in a single implant. These advancements may improve outcomes for patients with chronic pain and other neurological conditions, while potentially reducing healthcare costs through fewer procedures and hospitalizations.
