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NeuroOne Releases CNS Drug Delivery White Paper Ahead of Planned Fiscal Year-End Availability of the StereoCED(TM) Platform

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White Paper Highlights How StereoCED™ is Designed to Address Key Barriers to the Scalable Commercial Delivery of Brain Therapeutics Through a Streamlined Robotic-Assisted Workflow

Device Availability for Research and Investigational Clinical Studies Expected by Fiscal Year-End

The white paper highlights how advances in cell and gene therapies, biologics, and other central nervous system (CNS) therapeutics are increasing the demand for efficient, reproducible methods of delivering therapies directly to the brain. While convection-enhanced delivery (CED) has demonstrated the ability to bypass the blood-brain barrier and achieve targeted drug distribution, many current approaches may present challenges as therapies expand into broader commercial use.

The StereoCED™ drug delivery platform is being designed to address these challenges by leveraging robotic stereotactic systems already established in neurosurgical operating rooms. Rather than requiring specialized workflows and lengthy sequential infusions, the platform is being designed to support simultaneous, multi-trajectory intracranial drug delivery through a streamlined robotic workflow. This approach has the potential to significantly reduce procedure time while enabling reproducible, scalable therapeutic delivery. The StereoCED™ drug delivery platform is currently under development and has not been cleared or approved by the U.S. Food and Drug Administration for commercialization.

“Brain-delivered therapeutics are approaching an important inflection point,” said Dave Rosa, President and Chief Executive Officer of NeuroOne. “As these therapies move toward commercialization, certain intracranial infusion procedures lasting 8 to 12 hours may become a significant bottleneck to commercial adoption. We believe healthcare systems will need solutions that leverage established neurosurgical workflows, significantly reduce procedure time, and support scalable delivery across hospitals. StereoCED™ is being designed with those needs in mind, and we look forward to device availability for research and investigational clinical studies by fiscal year-end.”

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 development of the StereoCED™ Drug Delivery Platform, including the potential for it to be available at fiscal year-end, its ability to support simultaneous, multi-trajectory intracranial drug delivery through a streamlined robotic workflow, and potential to significantly reduce procedure time while enabling reproducible, scalable therapeutic delivery. 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 the StereoCED™ Drug Delivery Platform may not receive any regulatory clearance or approval, or achieve its design goals, 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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