BlinkLab Limited (ASX:BB1) (“BlinkLab” or the “Company”) an innovative digital healthcare company leveraging smartphones, computer vision, Al and machine learning to diagnose neurodevelopmental conditions, is pleased to release its Appendix 4C and Quarterly Activity Report for the period ended 30 September 2024. During the quarter the Company made significant progress towards the launch of its upcoming FDA registration study, which is on-track to commence before the calendar year end.

Highlights

• FDA registration study on track to commence this calendar year.
• Strategic partnerships signed with leading outpatient mental healthcare providers in Europe, for Autism and ADM/
• Several clinical studies in Autism, ADI-D), Frontotemporal Dementia, Functional Neurological Disorders, Spinocerebellar Ataxia, with top European and US institutions are ongoing and results are expected next calendar year.
• Commenced regulatory work towards obtaining ISO/CE mark certifications in Europe to support future commercial launch.
• As at 30 September 2024, the Company had a cash balance of A$5.4 million following the $7 million IPO in April.

Strong progress towards initiation of FDA clinical study later this year for "BlinkLab Dx 1" We are pleased to report that, after a competitive selection process, BlinkLab are in the final stages of appointing a world-recognised Clinical Research Organisation ("CRO"), with a track record of obtaining regulatory approvals for digital healthcare and medical devices, to co­ordinate our upcoming FDA registration trial.

Throughout the quarter, the Company continued work on finalising the study protocol, engaging with FDA as well as reaching out and interacting with future US based clinical sites that will be conducting the registrational studies. Before the end of CY 2024, we expect to announce the outcomes of this work. We are excited about the progress that our regulatory and development team is making to start the FDA study that we believe will be the largest smartphone based clinical study in the world, in the field of autism diagnostics.

Strategic Partnerships with large European Mental Healthcare Providers

During the past quarter, we announced two major clinical and future commercialisation partnerships with large European mental healthcare providers. Together with Mental Care Group and INTER-PSY, BlinkLab has launched companion clinical studies in ADHD and autism, evaluating whether the Company's technology can enhance diagnostic accuracy and efficiency in clinical settings, with a future commitment to commercialise our products with these partners in Europe upon successful outcomes. With a national network of over 200 clinical centres serving over 100,000 patients annually, these partnerships are a huge endorsement of the BlinkLab smartphone-based tests and the potential to grow successfully outside the US.

Ongoing Work Towards Obtaining European Certifications of BlinkLab Product

As the Company continues to support the activities for the launch of FDA registrational study, the BlinkLab team has also initiated work towards obtaining applicable regulatory clearances to be able to launch the product outside the US.

Under the EU Medical Device Regulation (MDR) 2017/745, the BlinkLab diagnostic platform is classified as a class Ila medical device and will require CE marking of conformity before the device can be launched on the market. The conformity work will include implementation of quality management systems (IS013485 certification), usability engineering, labelling, adherence to general data protection regulation (GDPR), developing appropriate post-market surveillance plan and other activities. This work commenced during the prior quarter, and the Company will be providing ongoing updates as it moves forward towards EU certification and future launch in markets outside the US.

Ongoing Clinical Studies in Other Indications with World Leading Research Organisations

Since listing on the Australian Securities Exchange in April this year, BlinkLab has announced multiple clinical research collaborations with several world-renowned research institutions to conduct studies in mental and developmental conditions outside of autism and ADHD.

The data collected from these studies is fundamental to the Company's diagnostic platform and machine learning models, as distinguishing autism and ADHD from other psychiatric disorders in the real world is difficult due to their multidimensional phenotypes and significant overlap of symptoms and characteristics.

At BlinkLab we are trying to fundamentally change the diagnostic approach by collecting digital phenotype data from the broadest possible range of neurodevelopmental and neurodegenerative conditions. By training the model on large data sets from various diseases, we significantly improve future predictive performance of the BlinkLab application in real-world scenarios.

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