• Pilot Phase of U.S. Autism Trial Nears Completion with 163 Children Enrolled
• ADHD Trial Expanded in Europe to 5 Clinical Sites, Larger Dataset in Progress
• U.S. IRB Approval Secured for Main Phase of FDA Study

During the quarter, Blinklab made significant progress across its FDA clinical trial program and broader corporate objectives. Key highlights include the Pilot Phase of the U.S. autism trial nearing completion with 163 children enrolled, the expansion of the ADHD clinical program to five European sites, and the securing of U.S. Institutional Review Board (IRB) approval to initiate the Main Phase of the FDA 510(k) study. The company also strengthened its financial position with a successful $7.66M capital raise, enabling the launch of a parallel regulatory trial focused on both autism and ADHD diagnostics. Blinklab is the only company developing a unified digital diagnostic platform that addresses both autism and ADHD, leveraging the same core technology, mobile app, and clinician portal. The Pilot Phase has reinforced Blinklab's confidence in at-home testing, with positive feedback from participating families and only 3% of children unable to continue testing. Insights from the Pilot Phase will help define critical parameters for the Main Phase of the FDA study. Blinklab also expanded its network of clinical sites participating in the FDA autism study, with plans to onboard up to eight additional sites over the next three months to ensure broad representation across diverse populations.

The company expects to commence enrolment into the Main Phase of the FDA 510(k) study by the end of the current quarter, supported by an expanding site network. The resulting dataset from the ADHD clinical trial will form a critical part of Blinklab's clinical evidence package under the European regulatory framework, supporting both technical and clinical performance claims in preparation for CE marking under EU MDR.

Blinklab is positioning itself to deliver the highest level of confidence to its stakeholders and investors as it advances toward full-scale execution of the Main Phase of its FDA 510(k) trial. The company's broader vision targets both the U.S. and European healthcare markets, expanding the clinical utility of its platform to include ADHD in addition to autism.