BlinkLab Raises $7.66M as Autism Pilot Hits 163 Children, ADHD Trial Grows
BlinkLab is advancing its FDA 510(k) clinical trials for autism and ADHD diagnostics, completing its U.S. autism pilot phase and expanding European ADHD recruitment. A recent $7.66 million capital raise supports these efforts as the company targets regulatory approvals in 2026.
- 163 children completed U.S. autism pilot trial; main phase to start soon
- European ADHD trial expanded to five sites, targeting 300 participants
- U.S. IRB approval secured for main FDA study phase
- $7.66 million capital raised to fund clinical and regulatory programs
- Recruitment strategy optimized to reduce costs and accelerate timelines
Clinical Trial Progress and Expansion
BlinkLab Limited (ASX – BB1) has reported significant progress in its clinical programs targeting neurodevelopmental disorders, notably autism and ADHD. The company’s U.S. autism trial pilot phase is nearing completion, with 163 children having completed all study procedures. This pilot phase, conducted at two clinical sites in Ohio and Illinois, is on track to finish recruitment by August 2025, with data unblinding and preliminary results expected in the third quarter.
Meanwhile, BlinkLab has expanded its ADHD clinical trial in Europe from a single site to five, aiming to enroll approximately 300 participants by year-end. This expansion is designed to capture the clinical heterogeneity of ADHD and support a robust regulatory submission under the European Medical Device Regulation (EU MDR).
Regulatory Milestones and Strategic Funding
A major regulatory milestone was achieved with the U.S. Institutional Review Board (IRB) granting approval to commence the main phase of the FDA 510(k) study. This approval clears the way for BlinkLab to begin enrolling participants in the main phase by the end of the current quarter, supported by an expanding network of clinical sites chosen for their geographic and socioeconomic diversity.
To underpin these clinical and regulatory initiatives, BlinkLab successfully raised $7.66 million in capital during the quarter. This funding strengthens the company’s financial position, with a cash balance of A$8.7 million as of June 30, 2025, providing a solid runway for ongoing development and commercialization efforts.
Innovative Diagnostic Platform and Operational Efficiencies
BlinkLab’s unique approach involves a unified digital diagnostic platform that addresses both autism and ADHD using the same core technology, mobile app, and clinician portal but with distinct diagnostic pathways. This strategy offers scalability and efficiency advantages over competitors who typically focus solely on autism diagnostics within the U.S. market.
Operationally, the company optimized its recruitment strategy for the FDA trial by broadening participant sources beyond autism specialty centers to include general pediatric offices, psychological practices, daycare centers, schools, and self-referrals. This shift reduces the required sample size, cuts costs, and accelerates timelines, while better reflecting real-world clinical use.
Feedback from the pilot phase also reinforced the viability of at-home testing, with strong parental support and low dropout rates, enhancing data quality and protocol compliance. Refinements to clinician standard operating procedures (SOPs) are underway to further improve model training and implementation.
Looking Ahead
As BlinkLab prepares to transition into the main phase of its FDA trial and continues to build its European clinical dataset, the company is positioning itself at the forefront of digital diagnostics for neurodevelopmental conditions. The upcoming release of pilot phase data and continued site onboarding will be critical indicators of progress toward regulatory approvals and commercialisation.
Bottom Line?
BlinkLab’s clinical and regulatory momentum, backed by fresh capital, sets the stage for pivotal data releases and potential market leadership in digital neurodevelopmental diagnostics.
Questions in the middle?
- How will the upcoming pilot phase data impact investor confidence and regulatory timelines?
- What are the prospects for BlinkLab’s platform to gain CE marking and FDA clearance in 2026?
- How will expanded recruitment strategies affect the diagnostic model’s accuracy and market adoption?
