BlinkLab raises $17.5m to fund FDA autism diagnostic trial and ADHD expansion

The placement was priced at 65c per share, representing a 17.2 per cent discount to BlinkLab's last traded price.

While the company's shares retreated 3.5c today, they closed at 75c, well above the placement issue price, valuing the company at $98.8 million.

The capital raise comes after BlinkLab last month enrolled its first participant in the registrational FDA validation study across a network of 10 leading US clinical sites, a milestone the company had flagged as a key near-term catalyst.

The pivotal study requires a minimum of 528 children aged two to 11, with recruitment expected to take about eight months and an FDA submission targeted by year-end 2026.

BlinkLab's core product, known as Dx1, uses a smartphone app to measure involuntary eye-blink responses and other sensory markers to screen for autism spectrum disorder.

A pilot study of 485 children demonstrated 83.7 per cent sensitivity and 84.7 per cent specificity - well above the FDA-agreed thresholds of greater than 65 per cent for both measures.

“This capital raise is another major milestone for BlinkLab," says CEO Dr Henk-Jan Boele.

"It is a direct result of the incredible dedication shown by our team and our clinical partners. They have worked tirelessly for several years to advance this technology to its current stage, from developing the foundational science to successfully executing complex clinical studies within the promised timelines, a particularly challenging feat in the medtech and clinical trial environment.

"It has required an extraordinary level of commitment to ensure we deliver a robust software product that meets the highest clinical and regulatory standards."

Proceeds from the placement will also fund development of Dx2, BlinkLab's ADHD diagnostic program, which the company says leverages the same smartphone-based sensory platform.

European CE/MDR approval for Dx1 is also being pursued as a parallel regulatory pathway.

Board and management committed $200,000 to the placement, with the directors' portion subject to shareholder approval at a general meeting expected in mid-2026.

Chairman Brian Leedman says the placement attracted strong interest from institutional and sophisticated investors.

"This capital raise not only strengthens our balance sheet but also establishes relationships with investors who understand the scale of the opportunity ahead and the significance of what BlinkLab is seeking to achieve," says Leedman.

"As we move closer to regulatory approval and commercialisation, having the right partners on the register becomes increasingly important."

Boel, a medical doctor, says he has seen first-hand the challenges families face in navigating the diagnostic journey for autism and other neurodevelopmental conditions.

"Long waiting times, subjective assessments and variability in access to specialists create a significant burden on both patients and healthcare systems," he says.

"BlinkLab Dx1 has been designed to directly address this unmet need by providing an objective, accessible, and scalable diagnostic tool that can support earlier identification and intervention.

"With this funding, we are now well positioned to complete our pivotal US study and progress toward FDA approval, while also advancing our European regulatory strategy.

"Importantly, it also enables us to expand into ADHD, where the need for better diagnostic tools is arguably even greater. We believe this is just the beginning of what our platform can achieve in transforming the way neurodevelopmental conditions are diagnosed and managed."

Today's announcement follows BlinkLab's selection in March for Morocco's government-funded nationwide autism screening program, which targets about 600,000 annual births.

Morocco estimates autism affects more than 400,000 people nationally, with the initial screening centres commencing from this month.