NeuroOne Reports Real-World Evidence of Seizure Reduction with OneRF Ablation System

NeuroOne Medical Technologies Corporation (Nasdaq: NMTC) has announced physician-reported outcomes from a large single-center cohort of epilepsy patients treated with its OneRF Brain Ablation System at the Mayo Clinic in Jacksonville, Florida. The findings, based on 25 patients with drug-resistant focal epilepsy, suggest a potential paradigm shift in how these patients are treated, offering a minimally invasive option that combines diagnostic and therapeutic capabilities.

The procedures were led by neurologist Dr. Brin Freund and the late neurosurgeon Dr. Sanjeet Grewal. After diagnostic stereo-EEG (SEEG) monitoring with NeuroOne electrodes, physicians identified seizure foci and performed radiofrequency (RF) ablations. All patients were deemed appropriate candidates based on anatomy and seizure localization. The physicians evaluated safety, seizure outcomes, and patient-reported quality of life, with results showing that the procedure was well tolerated, with rare short-term effects and no serious long-term complications.

According to the report, the majority of patients experienced meaningful reductions in seizure frequency, with some achieving sustained seizure freedom either directly after RF ablation or after subsequent surgical or medical therapy guided by data from the ablation. Most patients also reported improved quality of life and satisfaction with the procedure. Ablation targets ranged from small, discrete seizure areas to multifocal or more extensively distributed epileptic networks.

Dr. Freund highlighted the advantages of the approach, stating, “NeuroOne SEEG-guided radiofrequency thermocoagulation is a minimally invasive procedure that can be performed at the bedside through the same implanted diagnostic electrodes used to localize a patient’s seizures.” He noted that after recording seizures and mapping critical brain regions, physicians can precisely target seizure-generating tissue while preserving normal brain function. “An important advantage of this technology is its ability to deliver a controlled, temperature-based treatment while allowing us to immediately resume recording afterward. This enables us to assess the effectiveness of the ablation in real time and, when appropriate, perform additional targeted ablations during the same monitoring period. This approach has changed how we treat drug-resistant focal epilepsy and is now part of the standard of care at Mayo Clinic Florida,” Dr. Freund added.

Dave Rosa, CEO of NeuroOne, expressed gratitude to the Mayo Clinic team and emphasized the broader implications. “These results validate our long-held belief that, for patients already undergoing diagnostic SEEG, the ability to potentially deliver meaningful therapeutic benefit through the same implanted electrodes represents a compelling clinical and economic value proposition.” Rosa noted that the company’s proprietary temperature monitoring technology provides real-time treatment feedback and an additional layer of confidence during ablation. “As the only FDA-cleared platform combining SEEG diagnosis and RF ablation using the same sEEG device, we believe NeuroOne is uniquely positioned to support this evolving diagnosis-to-therapy treatment paradigm,” he said.

The growing real-world evidence supports an emerging diagnosis-to-therapy paradigm, where patients can receive both diagnostic monitoring and therapeutic intervention in a single procedure, potentially reducing hospitalizations and surgical procedures. For more information about NeuroOne and its technologies, visit nmtc1.com.

NeuroOne markets a minimally invasive electrode technology platform with four FDA-cleared product families, including the OneRF Ablation System for brain and trigeminal nerve ablation. The company is also engaged in research and development for drug delivery, basivertebral nerve ablation, and spinal cord stimulation programs.

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