NeuroOne(R) Achieves Major Milestone With ISO 13485 Certification 11.08.2026, 14:35 Uhr von EQS News Jetzt kommentieren: 0

Certification Provides Key Step for the Company Towards Commercializing Internationally and Offering a New Opportunity for Revenue Growth

Achievement Highlights the Company's Robust Quality System and Strong Compliance Capabilities

EDEN PRAIRIE, MINN. - August 11, 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 it has received ISO 13485-2016 certification.

ISO 13485 is the international standard for Quality Management Systems in the Medical Device Industry; with particular emphasis on risk management, design controls, and continuous improvement. In achieving this certification, NeuroOne has demonstrated the continued capability to ensure safe product design, quality and traceability in manufacturing, and compliance with regulatory requirements; thereby reducing the likelihood of product failures.

Specific to NeuroOne, the certification includes the design and development, manufacture and distribution of electrosurgical generators and electrosurgical lesioning instruments, as well as diagnostic neurophysiological instruments, anchor bolts, and cable assemblies used for recording, monitoring, stimulation, and radiofrequency lesioning of nervous system tissue. This certification will allow the Company to pursue international marketing opportunities for the Company’s Evo® Cortical and Evo® sEEG Electrodes, as well as the OneRF® Brain Ablation System. Some geographies may have additional requirements before the Company can commercialize the products.

“Yet again, the team at NeuroOne delivers on another critical milestone earlier than planned," said Dave Rosa, President and Chief Executive Officer of NeuroOne. "We are excited to have received ISO 13485 certification as it opens the door for international revenue growth. While we have other technologies to help accelerate growth, this provides us nearer term revenue potential. We will begin working with our distribution partner, Zimmer Biomet, to formulate a plan for entering markets that have short-term paths to entry. For those geographies that are currently held solely by NeuroOne, we will also explore independent distributor partnerships. We hope to add to this certification as we execute on our current technologies in development.”

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 potential international expansion, both through our distribution partner Zimmer Biomet and the potential to explore independent distributor partnerships, the ability to receive revenue in the short term for international sales, and the ability to add to the current certification. 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, our partnerships may not facilitate the commercialization or market acceptance of our technology; whether due to supply chain disruptions, labor shortages, 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.

IR Contact
MZ Group – MZ North America
NMTC@mzgroup.us

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