Digital health company BlinkLab (ASX:BB1) has completed a placement to both domestic and international sophisticated and institutional investors, raising $7.66 million before costs at $0.30 per share.
The company is developing AI-driven diagnostics for neurodevelopmental conditions like autism and ADHD. It said the funds raised will be used to progress the development of its FDA registrational trial for its autism diagnostic tool, BlinkLab Dx 1, and initiate a second clinical program targeting ADHD with its newly developed Dx 2 platform.
The funds will also support European regulatory approval processes, extend patent protections for the technology, and provide additional working capital, the company said.
Co-founder and CEO Dr Henk Jan-Boele said, “BlinkLab expresses its gratitude for the support received from both Australian and international investors. Importantly, the funding allows BlinkLab to initiate a second regulatory study for ADHD alongside our ongoing efforts in autism. There are several key compelling advantages to pursuing a parallel regulatory strategy for BlinkLab Dx1 (for autism) and Dx2 (for ADHD) in the US under the FDA 510(k) pathway.
"Firstly, it addresses a critical unmet medical need. Clinicians consistently highlight the challenge of distinguishing between autism and ADHD in young children, a distinction that is essential for timely and appropriate intervention. Current diagnostic tools often fall short in supporting accurate early differentiation. BlinkLab’s digital diagnostics have the potential to fill this gap, equipping healthcare providers and an overburdened system with accessible, scalable tools to identify neurodevelopmental conditions early. This is especially important for optimising developmental, educational, and social outcomes in children.
"Secondly, by targeting both ADHD and autism in parallel, BlinkLab is positioned to capture a larger share of the diagnostic market. The ADHD diagnostic market is more than four times the size of the autism diagnostic market. The operational groundwork laid during the Dx1 autism trial, including experience with FDA requirements, building relationships with US-based clinical sites, clinical trial design, CRO collaborations, and regulatory advisors, provides BlinkLab with a robust platform to efficiently launch and accelerate the Dx2 regulatory study for ADHD.
"It is important to emphasise that the Dx2 model leverages the exact same BlinkLab app to capture facial reflex responses, so there is no need to develop a new product. In essence, it is the same core product, but powered by a different machine-learning model that focuses on a distinct set of reflex biomarkers relevant to ADHD.”
