BlinkLab Expands U.S. Clinical Trial Network - University of Nebraska Medical Center Engaged as Second Site in Main Phase of FDA 510(k) Study

Jane Morgan Management

BlinkLab Limited (ASX:BB1) (“BlinkLab” or “the Company”) is pleased to announce the expansion of its U.S. clinical trial network with the University of Nebraska Medical Center (UNMC) engaged as the second site in the main phase of its FDA 510(k) study for BlinkLab Dx 1 – its smartphone-based diagnostic tool for early autism detection.

Highlights

• Second U.S. Site: University of Nebraska Medical Center (UNMC) selected as second site for BlinkLab’s pivotal FDA 510(k) autism diagnostic trial.

• Pilot Phase Near Completion: BlinkLab’s 100-participant pilot study has been progressing towards completion, with results expected this quarter.

• Main Study Scaling: An additional 750–900 children are intended to be enrolled during the main trial phase of the registrational trial.

• Multi-Site Strategy: For the main study phase of the trial, up to 10 U.S. clinical sites are planned to boost trial reach, diversity, and adoption.

• UNMC Activation Now Underway: Participant testing will begin following the final wrap-up of the pilot phase.

UNMC was selected for its outstanding research capabilities, established infrastructure, and proven success in executing multi-site clinical trials across varied pediatric populations. The site adds momentum as the Company nears completion of its 100-participant pilot phase, with results expected later this quarter.

The main study phase will enroll a further 750–900 children across multiple U.S. sites. BlinkLab intends to expand to up to 10 clinical locations across the United States to ensure geographic and demographic diversity in participant recruitment, which is essential for clinical validation and broad adoption following the appropriate regulatory clearance.

Site activation activities at UNMC have now commenced, and participant testing is scheduled to begin shortly after the pilot phase concludes.

Dr. Henk-Jan Boele, Co-founder and CEO of BlinkLab, commented: “We’re very pleased to welcome UNMC into our growing U.S. trial network. Their clinical research strength and access to diverse patient populations will help us ensure this study generates high-quality, generalisable data. Expanding to 10 sites, including institutions like UNMC, supports our strategy not just for regulatory clearance but for long-term clinical adoption.” 

Chairman of BlinkLab, Mr. Brian Leedman, added: “Insights gained from the ongoing pilot phase have helped us optimise both our protocol and user experience. Expanding to a broader trial network during the main phase of the study will allow us to validate the technology in a range of real-world settings and diverse population which is critical for FDA clearance and future uptake by clinicians.” 

UNMC becomes the second of up to ten planned U.S. sites participating in the main study phase. This distributed trial structure is key to ensuring a diverse, representative sample of participants and building the foundation for national deployment of the BlinkLab Dx 1 platform following regulatory clearance.

The Company expects to submit its final FDA 510(k) application during 2026.

About BlinkLab Limited (ASX:BB1) 

BlinkLab Limited, a company founded by neuroscientists at Princeton University, over the past several years has fully developed a smartphone based diagnostic platform for autism, ADHD, schizophrenia, and other neurodevelopmental conditions. Our most advanced product is an autism diagnostic test that leverages the power of smartphones, AI and machine learning to deliver screening tests specifically designed for children as young as 18 months old. This marks a significant advancement, considering traditional diagnoses typically occur around five years of age, often missing the crucial early window for effective intervention. BlinkLab is led by an experienced management team and directors with a proven track record in building companies and vast knowledge in digital healthcare, computer vision, AI and machine learning. Our Scientific Advisory Board consists of leading experts in the field of autism and brain development allowing us to bridge most advanced technological innovations with groundbreaking scientific research.

Jane Morgan
Jane Morgan Management
Investor & Media Relations
[email protected]