NeuroOne(R) Achieves Major Milestone With ISO 13485 Certification

EQS-News: NeuroOne Medical Technologies / Key word(s): Financial NeuroOne(R) Achieves Major Milestone With ISO 13485 Certification 11.08.2026 / 14:35 CET/CEST The issuer is solely responsible for the content of this announcement. 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.”

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