• U.S. autism pilot study achieves 83.7% sensitivity and 84.7% specificity
• Regulatory alignment with FDA secured for pivotal 510(k) autism study
• European ADHD study nearing completion, expanding diagnostic platform

BlinkLab's U.S. autism pilot study of 485 children delivered 83.7% sensitivity and 84.7% specificity, significantly exceeding the FDA's performance thresholds of >65% sensitivity and >65% specificity. The pilot study included children with autism, ADHD, other developmental conditions, and typically developing controls, demonstrating the BlinkLab Dx 1 system's robustness in diagnostically complex and borderline cases. Analysis of the pilot dataset also enabled the identification of additional quantitative neurobehavioural markers, which are being incorporated to further improve the Dx 1 model. During the quarter, BlinkLab continued the assembly of its pivotal U.S. clinical trial network, onboarding Rush University Medical Center and bringing the total number of participating sites to eight. These leading autism research and clinical centres will support the pivotal 510(k) study, which is expected to enrol approximately 528 children. BlinkLab's European ADHD clinical study, conducted in partnership with Mental Care Group, also progressed to its final stages, with 332 children assessed to date. The strong performance observed in the autism pilot, including in children with ADHD, provides confidence in the platform's applicability across neurodevelopmental conditions. The company also appointed Dr Henk-Jan Boele as Managing Director, strengthening leadership continuity as it transitions into pivotal clinical execution and early commercialisation.

Over the coming quarters, BlinkLab will focus on: initiation of the pivotal U.S. FDA 510(k) autism study, completion and analysis of the European ADHD dataset, continued regulatory alignment for U.S. and European pathways, and early engagement with clinicians, KOLs, and potential commercial partners.