• Completed onboarding of 10 leading U.S. clinical sites for FDA 510(k) trial
• Enrolled and tested first participant, marking commencement of pivotal validation study
• Launched nationwide autism screening program in Morocco, a first-of-its-kind government deployment

BlinkLab Ltd, a leading digital healthcare company focused on AI-powered diagnostics, provided a Quarterly Activities Report highlighting significant progress in its FDA 510(k) validation trial for its autism diagnostic aid. During the quarter, the company completed onboarding of its full network of 10 leading U.S. clinical sites for the pivotal study and announced the enrollment and successful testing of the first participant, marking the formal commencement of the validation program. Execution of the study is being led by a global CRO, ensuring adherence to FDA-aligned protocols, data quality, and regulatory standards. The study builds on strong prior pilot data, where BlinkLab achieved high sensitivity and specificity relative to gold-standard clinical assessments. Separately, the company announced the launch of a nationwide, government-funded autism screening initiative in Morocco, representing the first large-scale deployment of a digital diagnostic platform for autism at a national healthcare system level. This positions BlinkLab as a leader in population-scale neurodevelopmental screening. The company also strengthened its position within the U.S. and global autism research ecosystem, with a peer-reviewed publication, a strategic partnership, and participation in a leading autism research initiative. The successful completion of a A$17.7 million capital raise after the reporting period further supports BlinkLab's next phase of growth, including the FDA pivotal study, European regulatory activities, and expansion into the ADHD market.

BlinkLab remains on track for FDA 510(k) submission by the end of CY2026, representing a major value inflection point for the company as it progresses toward regulatory approval and commercialisation. The nationwide screening program in Morocco is expected to generate one of the largest standardised datasets in autism screening globally, further strengthening BlinkLab's dataset and supporting ongoing improvements in model performance and clinical utility.