BlinkLab Secures $7.66M to Fast-Track FDA Trials for Autism and ADHD Diagnostics

Placement Completion and Capital Raise

BlinkLab Limited (ASX:BB1), a digital healthcare innovator specialising in AI-powered neurodevelopmental diagnostics, announced the successful completion of a A$7.66 million placement to sophisticated and institutional investors. The placement was priced at A$0.30 per share, representing a discount of approximately 16.7% to the last traded price, reflecting strong investor appetite for the company’s growth prospects.

The capital raise included firm commitments from both domestic and international investors, with the Board and management also committing A$210,000, pending shareholder approval. The new shares are expected to be issued in early May 2025, with a general meeting planned for late June to approve director and management participation.

Strategic Use of Funds: Dual Regulatory Pathways

The funds raised will underpin BlinkLab’s ambitious growth strategy, primarily focused on accelerating the ongoing FDA registrational trial for its autism diagnostic platform, BlinkLab Dx1. Concurrently, the company will launch a second clinical program targeting ADHD with its Dx2 platform, initiating the FDA approval process for this novel diagnostic tool.

CEO Dr Henk Jan-Boele highlighted the strategic advantage of pursuing parallel regulatory pathways for both autism and ADHD diagnostics. This approach addresses a critical unmet medical need, as early and accurate differentiation between autism and ADHD remains a challenge for clinicians. By leveraging the same smartphone-based technology and app for both conditions, BlinkLab aims to efficiently expand its diagnostic reach without the need for new product development.

Market Opportunity and Technological Edge

The ADHD diagnostic market is notably larger than the autism diagnostic market, offering BlinkLab a significant opportunity to capture a broader share of neurodevelopmental diagnostics. The company’s existing operational groundwork from the Dx1 autism trial, including FDA regulatory experience, clinical site relationships, and CRO collaborations, provides a solid foundation to expedite the Dx2 ADHD trial.

Importantly, the Dx2 platform uses the same core technology that captures facial reflex responses via a smartphone app, but applies a different machine learning model to detect ADHD-specific biomarkers. This innovative approach positions BlinkLab at the forefront of digital diagnostics, potentially transforming early intervention strategies for children with neurodevelopmental conditions.

Regulatory and Market Implications

Beyond the US FDA trials, the capital will also support CE and MDR approval processes in Europe, further expanding BlinkLab’s regulatory footprint. Additional working capital will bolster ongoing operations, development efforts, and the extension of the company’s patent portfolio, reinforcing its intellectual property position in a competitive digital health landscape.

Chairman Brian Leedman expressed satisfaction with the strong demand for the placement, interpreting it as a vote of confidence in BlinkLab’s technological innovation and regulatory progress. The company’s rapid advancement since its ASX listing just 12 months ago underscores its potential to disrupt traditional neurodevelopmental diagnostics.

Looking Ahead

With the placement complete and regulatory trials underway, BlinkLab is poised to enter a critical phase of clinical validation and market positioning. The dual focus on autism and ADHD diagnostics could unlock substantial value if the FDA approvals are secured, offering scalable tools to address significant unmet needs in early childhood neurodevelopmental assessment.