NeuroOne® Expands U.S. Commercialization of FDA-Cleared OneRF® Trigeminal Nerve Ablation System with New Southern California Distribution Agreement
NeuroOne (NMTC) entered a new Southern California distribution agreement for its FDA-cleared OneRF® Trigeminal Nerve Ablation System, expanding commercial access across key counties including the Los Angeles metropolitan area.
Rhea-AI Summary
NeuroOne (NMTC) entered a new Southern California distribution agreement for its FDA-cleared OneRF® Trigeminal Nerve Ablation System, expanding commercial access across key counties including the Los Angeles metropolitan area.
The deal advances the company’s strategy to build a U.S. distribution network for its minimally invasive radiofrequency solution for trigeminal neuralgia. The OneRF® system, cleared via FDA 510(k), is indicated for creating radiofrequency lesions to treat pain or lesion nerve tissue in functional neurosurgical procedures and is designed to streamline workflow with temperature-monitored ablation and a multi-contact probe enabling stimulation, mapping and ablation.
Positive
- New Southern California distributor adds coverage of key counties including Los Angeles metro
- Supports U.S. expansion strategy by building out a broader distribution network for OneRF®
- FDA 510(k)-cleared indication for pain treatment and functional neurosurgical lesioning underpins commercialization
Negative
- None.
Details
Market Reaction – NMTC
Following this news, NMTC has gained 0.71%, reflecting a mild positive market reaction. Our momentum scanner has triggered 7 alerts so far, indicating moderate trading interest and price volatility. The stock is currently trading at $1.42. Trading volume is exceptionally heavy at 13.5x the average, suggesting very strong buying interest.
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Key Figures
- FDA clearance
- 510(k)
- OneRF Trigeminal Nerve Ablation System
Key Terms
510(k) clearance regulatory
radiofrequency ablation technical
trigeminal neuralgia medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
Agreement Covers Key Southern California Counties Including Los Angeles Metro as NeuroOne Broadens Commercial Access in Key U.S. Markets
EDEN PRAIRIE, Minn., Sept. 17, 2026 (GLOBE NEWSWIRE) -- NeuroOne Medical Technologies Corporation (Nasdaq: NMTC) (“NeuroOne” or the “Company”), a medical technology company focused on transforming the surgical diagnosis and treatment of neurological disorders, today announced a new Southern California distribution agreement for its FDA-cleared OneRF® Trigeminal Nerve Ablation System. The agreement covers key counties, including the Los Angeles metropolitan area, expanding commercial access in an important U.S. market and advancing the Company’s strategy to build distribution across key U.S. markets.
Trigeminal neuralgia is a debilitating chronic pain condition affecting the trigeminal nerve, the primary sensory nerve of the face. It is characterized by sudden episodes of severe, electric shock-like facial pain that can significantly disrupt everyday activities and quality of life.
NeuroOne’s OneRF® Trigeminal Nerve Ablation System received U.S. Food and Drug Administration (FDA) 510(k) clearance for use in procedures to create radiofrequency lesions for the treatment of pain, or for lesioning nerve tissue for functional neurosurgical procedures. The system leverages NeuroOne’s proprietary OneRF® platform, and provides physicians with a less invasive radiofrequency option for treating trigeminal neuralgia and is designed to support a more streamlined procedural workflow.
“Southern California represents an important market for our OneRF® Trigeminal Nerve Ablation System, and this agreement marks another important step in expanding our commercial footprint,” said Dave Rosa, President and Chief Executive Officer of NeuroOne. “We believe this distribution relationship will help bring our technology to more physicians and ultimately help patients suffering from this extremely painful and debilitating condition. We look forward to identifying additional distributors in other key markets in the near future.”
The new Southern California agreement builds on NeuroOne’s initial commercialization efforts for the OneRF® Trigeminal Nerve Ablation System and supports the Company’s broader strategy to develop a distribution network across key U.S. markets. NeuroOne expects to continue evaluating additional distribution relationships as it works to expand commercial access to the system.
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. 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 drug delivery, 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 the potential of identifying additional distributors in other key markets in the near future, and the potential for this distribution agreement to increase physician awareness of the technology. 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.
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 region does NeuroOne’s new OneRF® distribution agreement cover?
The new distribution agreement covers key Southern California counties, including the Los Angeles metropolitan area, which the company identifies as an important U.S. market for the OneRF® Trigeminal Nerve Ablation System.
What is the OneRF® Trigeminal Nerve Ablation System designed to do?
The OneRF® Trigeminal Nerve Ablation System leverages proprietary radiofrequency ablation technology and a multi-contact probe to enable stimulation, mapping and ablation during trigeminal neuralgia procedures. It is designed to streamline workflow by potentially reducing probe repositioning and anesthesia cycles while providing temperature-monitored radiofrequency ablation.
For what indications is the OneRF® Trigeminal Nerve Ablation System cleared?
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.
How does this agreement fit into NeuroOne’s broader commercialization strategy?
The Southern California distribution agreement builds on initial commercialization efforts for the OneRF® Trigeminal Nerve Ablation System and supports NeuroOne’s broader strategy to develop a distribution network across key U.S. markets. The company expects to continue evaluating additional distribution relationships to expand commercial access.