NeuroOne® Announces Peer-Reviewed Publication of Initial Clinical Experience with OneRF® Trigeminal Nerve Ablation System
Fourteen of 15 patients were immediately pain-free, but the retrospective study lacked a direct comparison group.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Summary
NeuroOne Medical Technologies (Nasdaq: NMTC) announced peer-reviewed publication of initial clinical results for its OneRF Trigeminal Nerve Ablation System.
The retrospective study in Pain Management evaluated 15 patients whose facial nerve pain was not adequately controlled with medication. Fourteen patients (93.3%) were pain-free immediately; the remaining patient became pain-free approximately one week later. All had favorable pain outcomes at a mean six-month follow-up. At last follow-up, eight were pain-free without medication, six were pain-free while taking medication, and one had pain controlled with medication. Mapping succeeded in every case without probe repositioning. No off-target lesioning, ophthalmic complications or anesthesia dolorosa were observed. One patient developed a cheek hematoma and transient jaw-muscle weakness. The small study lacked a direct comparison group; larger studies and longer follow-up are needed.
Positive
- Minor pointImmediate pain freedom reached 93.3%: 14 of 15 patients; the remaining patient became pain-free approximately one week later.
- Minor pointAll 15 patients achieved favorable outcomes at a mean six-month follow-up.
- Minor pointEight patients (53.3%) were pain-free without medication at last follow-up; six more were pain-free while continuing medication.
- Minor pointContact-level mapping succeeded in every case, with no probe repositioning required to map and treat multiple nerve distributions.
- Minor pointNo off-target lesioning, ophthalmic complications or anesthesia dolorosa were observed.
Negative
- Minor pointOne patient developed a cheek hematoma that resolved after one week, plus transient jaw-muscle weakness.
- Minor pointOne patient had residual pain controlled with medication at last follow-up.
- Minor pointThe 15-patient retrospective study lacked a direct comparison group, limiting evidence on comparative effectiveness.
- Minor point. Forward-looking: it has not happened yet and may not happen.Long-term durability and contact-specific mapping's contribution require larger studies and longer follow-up.
Key Figures
- Immediate pain freedom
- 14 of 15 patients
- Immediately after treatment
- Favorable clinical outcome
- 15 of 15 patients
- Mean follow-up of six months; BNI pain score I–IIIB
- Pain-free without medication
- 8 patients (53.3%)
- At last follow-up
- Cheek hematoma
- 1 patient
- During needle insertion; resolved after 1 week, with transient masseter weakness also reported
Historical Context
-
OneRF patient feature reported immediate relief and pain-free status after treatment.
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Key Terms
trigeminal neuralgia medical
radiofrequency ablation medical
anesthesia dolorosa medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
Study Reports Immediate Pain Freedom in 14 of 15 Patients; all Patients Achieved Favorable Pain Outcomes at a Mean Six-Month Follow-Up
Multi-Contact Probe Technology Enabled Mapping and Treatment of Trigeminal Nerve Distributions without Repeated Probe Repositioning
EDEN PRAIRIE, Minn., Oct. 29, 2026 (GLOBE NEWSWIRE) -- NeuroOne Medical Technologies Corporation (Nasdaq: NMTC) (“NeuroOne” or the “Company”), a medical technology company focused on the surgical diagnosis and treatment of neurological disorders, today announced the publication of initial clinical results evaluating its OneRF® Trigeminal Nerve Ablation System in the peer-reviewed journal Pain Management.
The article, “OneRF radiofrequency ablation system for the minimally invasive treatment of trigeminal neuralgia: initial clinical experience,” was published online in October 2026. Authored by Michael D. Staudt, Theresa A. Elder, Marshall T. Holland and David P. Darrow, the retrospective study evaluated 15 patients with medically refractory trigeminal neuralgia treated during the system’s limited market release.
Trigeminal neuralgia causes sudden, severe, electric shock–like facial pain that can interfere with eating, speaking, and other daily activities. For patients whose pain cannot be adequately controlled with medication, percutaneous radiofrequency ablation of the trigeminal nerve offers a minimally invasive treatment option.
Conventional radiofrequency systems typically use a single active tip that must be repositioned to map and treat different trigeminal nerve distributions. OneRF’s thin-film, multi-contact probe allows physicians to perform multiple contact-level mapping and lesioning along a single fixed trajectory without repositioning. The lack of needing to reposition the probe may allow for reduced procedure times, lower number of anesthesia cycles and, most importantly, less discomfort for the patient during the procedure.
Key findings from the published study include*:
- Immediate pain freedom in
93.3% of patients: Fourteen of fifteen patients were pain-free immediately after treatment. The remaining patient experienced partial initial relief and became pain-free approximately one week later. - Favorable outcomes at follow-up: All 15 patients achieved a good clinical outcome, defined as a Barrow Neurological Institute pain score of I–IIIB, at a mean follow-up of six months.
- Pain freedom without medication: Eight patients, or
53.3% , were pain-free and taking no pain medication at their last follow-up. Six additional patients were pain-free while continuing medication; one had residual pain controlled with medication. - Mapping and treatment along a fixed trajectory: Contact-level mapping was achieved in every case, and no patient required probe repositioning to map and treat multiple trigeminal distributions.
- No observed off-target lesioning: The authors reported no off-target lesioning, ophthalmic complications, or anesthesia dolorosa.
- Complications: One patient developed a cheek hematoma during needle insertion and repositioning, which was treated with ice and resolved after 1 week; this same patient also developed transient masseter weakness.
“Treating trigeminal neuralgia requires careful localization of the nerve distributions responsible for each patient’s pain,” said Michael D. Staudt, MD, lead author of the publication. “In this initial series, the multi-contact probe allowed us to map and treat those distributions along a single fixed trajectory. The early pain outcomes are encouraging, and longer follow-up will help us understand the durability of relief.”
Dave Rosa, President and Chief Executive Officer of NeuroOne, added, “This publication adds peer-reviewed clinical evidence to our experience with OneRF for trigeminal neuralgia. We are encouraged by the pain relief reported in this initial cohort and by the ability to map and treat multiple nerve distributions without repeated probe repositioning. These findings support continued adoption of the platform and its potential to simplify the treatment workflow.”
The authors emphasized that this was a small, retrospective series without a direct comparison group. Larger studies and longer follow-up are needed to establish long-term durability, comparative effectiveness, and the contribution of contact-specific mapping to patient outcomes.
The publication is available at: https://doi.org/10.1080/17581869.2026.2748288.
About the OneRF® Trigeminal Nerve Ablation System
The OneRF® Trigeminal Nerve Ablation System leverages NeuroOne’s proprietary radiofrequency ablation technology and features a multi-contact probe designed to enable stimulation, mapping and ablation during trigeminal neuralgia procedures. The system is designed to streamline procedural workflow by potentially reducing the number of probe repositioning and anesthesia cycles while providing physicians with temperature-monitored radiofrequency ablation.
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.
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.
NeuroOne has also developed the StereoCED™ platform for targeted intracranial drug delivery, which is currently available for animal research and approved investigational clinical studies. StereoCED™ has not been cleared or approved by the FDA or any other regulatory agency. These solutions offer the potential to reduce the number of hospitalizations and surgical procedures, lower costs, and improve patient outcomes by offering diagnostic and therapeutic functions. The Company is engaged in research and development for basivertebral nerve ablation 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," "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 patient outcomes and the potential for lower procedure times, lower number of anesthesia cycles and less discomfort for the patient during the procedure. The distribution agreement does not provide for any guaranteed purchase orders, minimum purchase commitments or guaranteed sales, and there can be no assurance as to the level of sales, if any, that will be generated under the arrangement. 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 that our partnerships may not facilitate the commercialization or market acceptance of our technology; 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 our ability 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.
Clinician disclosure: Drs. Staudt, Holland and Darrow disclosed consulting relationships with NeuroOne. The publication reported no funding for the paper.
* Disclaimer: This recounts several patients’ experiences and may not be representative of all patient outcomes.
Caution: Federal law restricts this device to sale by or on the order of a physician.
Company Contact:
800-631-4030
ir@nmtc1.com
Investor Relations:
MZ Group - MZ North America
949-491-8235
NMTC@mzgroup.us
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What did NeuroOne's initial OneRF trigeminal neuralgia study show?
Fourteen of 15 patients (93.3%) were pain-free immediately after treatment, and the remaining patient became pain-free approximately one week later. All 15 achieved favorable pain outcomes at a mean follow-up of six months.
Did the authors of NeuroOne's OneRF study disclose consulting relationships or funding?
Drs. Staudt, Holland and Darrow disclosed consulting relationships with NeuroOne. The publication reported no funding for the paper.