Company Description

We are a medical device company preparing to commercialize breakthrough computerized analysis technology that enhances clinicians’ capabilities in diagnosing neurological and neurodevelopmental disorders. NSI’s first product, GyriCalc is a proprietary, patented software solution specifically designed to assist in the diagnosis of autism by identifying early structural markers of neurodevelopmental differences through the automated analysis of MRI images. NSI’s initial market focus will be the United States and Canada. In the U.S., we filed for marketing clearance with the FDA in early March 2025 and anticipate receiving approval during 2025. In Canada, where no regulatory approval is required, we recognize the political nature of the healthcare industry and will prioritize strategic discussions with influential government departments and non-profit organizations to ensure a successful market entry. Currently, NSI does not generate any revenue. Our primary focus is on successfully launching GyriCalc for autism and establishing a foothold in the U.S. and Canadian markets. While GyriCalc currently focuses on autism, NSI envisions expanding its applications to support clinicians in diagnosing other conditions, such as dyslexia, ADHD, and schizophrenia. Plans to develop GyriCalc for these additional markets will be considered in Q4 2025 after the successful launch of the product for autism. This phased approach underscores our commitment to delivering high-impact solutions that address critical clinical needs. The Company was incorporated in 2016 and in 2018 entered into an agreement with the University of Louisville, Kentucky, which awarded the Company an exclusive worldwide license to the technology underlying the Company’s product. Thereafter, activities were primarily focused on raising capital and developing the professional resources required for future commercialization. Software engineering efforts began in 2022 and accelerated throughout 2023 and 2024, accompanied by clinical trials in preparation for submission to the FDA. --- We were incorporated in Delaware on January 20, 2016 under the name of Autism Diagnostic Technologies, Inc. The original Certificate of Incorporation was restated on January 31, 2024 to change the name of the Company to NeuroSpectrum Insights, Inc. Our principal executive offices are located at 376 Main Street, Ste. 105, Bedminster, NJ 07921, and our telephone number is (908) 304-4858. Our corporate website address is https://neurospectruminsights.com/.