12 Patients Successfully Treated Across Three Leading Centers, With All Patients Reporting Freedom From Pain*
Early Experience Highlights Improved Patient Comfort, Short Procedure Times and Precise Localization
EDEN PRAIRIE, MINN. - March 26, 2026 (NEWMEDIAWIRE) - NeuroOne Medical Technologies Corporation (Nasdaq: NMTC) ("NeuroOne" or the "Company"), a medical technology company dedicated to transforming the surgical diagnosis and treatment of neurological disorders, today announced the completion of the limited market release of its OneRF® Trigeminal Nerve Ablation System following FDA 510(k) clearance in August 2025.
Trigeminal neuralgia is a severely debilitating chronic pain condition affecting approximately 150,000 patients in the United States and is widely referred to as the “suicide disease” due to the extreme, intractable pain it can cause resulting in mental anguish. Patients often experience sudden, intense facial pain that disrupts even the most basic daily functions. While medications may provide temporary relief, many patients ultimately require surgical intervention.
A total of 12 patients were successfully treated across 3 centers during the limited market release. All 12 patients reported freedom from pain following treatment.* Physicians also reported that the majority of cases had short procedural times, with the fastest procedure completed in 16 minutes. These results highlight the advantages of NeuroOne’s multi-contact probe.
A key limitation of current ablative systems is the need for multiple sleep–wake cycles - which may require three or more cycles - as patients are repeatedly awakened to confirm pain localization, then re-anesthetized while the probe is repositioned to treat different segments of the nerve. NeuroOne’s multi-contact probe is designed to address this inefficiency by enabling precise mapping and ablation in a single cycle without repositioning.
“This type of surgery has been performed for many decades with a radiofrequency probe, although this requires waking the patient up multiple times during the surgery and is only capable of testing and treating one pain distribution at a time,” explained neurosurgeon Michael Staudt, MD, the Lincoln Endowed Chair in Brain Health at University Hospitals and an Associate Professor of Neurological Surgery at Case Western Reserve University School of Medicine. “This new ablation probe is a step forward for our patients. It is a multi-contact probe designed to test and treat multiple nerve distributions without the need for repositioning.”
The OneRF® Trigeminal Nerve Ablation Kit uses the same NeuroOne Radiofrequency Generator already used in epilepsy ablation procedures. This allows existing OneRF® Ablation System customers to quickly add trigeminal neuralgia treatment without additional capital investment, with each procedure utilizing a disposable kit. The ability to support multiple clinical applications, including epilepsy and trigeminal neuralgia, with a single system may also make the NeuroOne platform more attractive to hospitals evaluating new technology purchases.
“The results from our limited market release highlight the clinical and procedural advantages of our multi-contact probe, including the ability to perform mapping and ablation without repositioning, which may significantly improve patient comfort,” said Dave Rosa, President and Chief Executive Officer of NeuroOne. “To build on this momentum, we are expanding access to additional centers while simultaneously evaluating strategic partnership opportunities and broader go-to-market strategies.”
The NeuroOne OneRF® Trigeminal Nerve Ablation System is indicated for use in procedures to create radiofrequency lesions for the treatment of pain, or for lesioning nerve tissue for functional neurosurgical procedures. The system received FDA 510(k) clearance under K251243.
About NeuroOne
NeuroOne Medical Technologies Corporation is a medical technology company focused on improving surgical care options and outcomes for patients suffering from neurological disorders. NeuroOne 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 engaged in research and development for drug delivery and spinal cord stimulation programs. For more information, visit nmtc1.com.
Forward Looking Statements
This press release may include 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. Except for statements of historical fact, any information contained in this press release may be a forward looking statement that reflects NeuroOne's current views about future events and are subject to known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. In some cases, you can identify forward looking statements by the words or phrases "may," "might," "will," "could," "would," "should," "expect," "intend," "plan," "forecasts," "objective," "anticipate," "believe," "estimate," "predict," "project," "potential," "target," "seek," "contemplate," "continue, "focused on," "committed to" and "ongoing," or the negative of these terms, or other comparable terminology intended to identify statements about the future. Forward looking statements may include statements regarding the potential to expand access to additional centers, potential strategic partnership opportunities, market size and potential growth; business strategy, future operations, future efficiencies, and other financial and operating information. Although NeuroOne believes that we have a reasonable basis for each forward-looking statement, we caution you that these statements are based on a combination of facts and factors currently known by us and our expectations of the future, about which we cannot be certain. Our actual future results may be materially different from what we expect due to factors largely outside our control, including risks related to whether the Company will continue to maintain compliance with all Nasdaq continued listing requirements, risks that our strategic partnerships may not facilitate the commercialization or market acceptance of our technology whether due to supply chain disruptions, labor shortages or otherwise risks that our technology will not perform as expected based on results of our pre-clinical and clinical trials risks related to uncertainties associated with the Company's capital requirements to achieve its business objectives and ability to raise additional funds: the risk that we may not be able to secure or retain coverage or adequate reimbursement for our technology uncertainties inherent in the development process of our technology risks related to changes in regulatory requirements or decisions of regulatory authorities that we may not have accurately estimated the size and growth potential of the markets for our technology risks related to clinical trial patient enrollment and the results of clinical trials that we may be unable to protect our intellectual property rights and other risks, uncertainties and assumptions, including those described under the heading "Risk Factors" in our filings with the Securities and Exchange Commission. These forward looking statements speak only as of the date of this press release and NeuroOne undertakes no obligation to revise or update any forward looking statements for any reason, even if new information becomes available in the future.
Caution: Federal law restricts this device to sale by or on the order of a physician.
* Disclaimer: This recounts several patients' experiences and may not be representative of all patient outcomes.
IR Contact
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NMTC@mzgroup.us
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