BlinkLab

September 2024 Quarterly Activities Report and Appendix 4C

Advancing global neurodiagnostics with strategic partnerships and regulatory milestones on a pathway to commercialisation

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.
BlinkLab was also pleased to announce several new strategic partnerships which confirmed the continuing adoption of BlinkLab's products with world-renowned research institutions. The rapid progress in making the Company's cutting-edge technology available to healthcare practitioners, families and caregivers is exciting for the BlinkLab team.

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.


Click here for the full ASX Release

This article includes content from Blinklab Limited, licensed for the purpose of publishing on Investing News Australia. This article does not constitute financial product advice. It is your responsibility to perform proper due diligence before acting upon any information provided here. Please refer to our full disclaimer here.

BB1:AU
BlinkLab Limited

BlinkLab Limited Investor Kit

  • Corporate info
  • Insights
  • Growth strategies
  • Upcoming projects

GET YOUR FREE INVESTOR KIT

The Conversation (0)
BlinkLab Limited

BlinkLab Limited


Keep reading...Show less
BlinkLab

Positive Outcome from FDA Pre-Submission Meeting

BlinkLab Achieves Pivotal Step Towards FDA Approval for Autism Diagnostic App

BlinkLab Limited (ASX:BB1) (“BlinkLab”, or the “Company”), an innovative digital healthcare company is pleased to announce a positive outcome from its Pre-Submission meeting with the FDA yesterday. The FDA has confirmed the study design and data requirements in order to achieve 510(k) clearance and subsequently launch the diagnostic app in the U.S. The Company plans to complete both programs within 12-16 months after the necessary approvals and site engagements have been secured.

Keep reading...Show less
Man at laptop with AI symbols superimposed.

AI Market Forecast: Top Trends That Will Affect AI in 2025

The United Nations has designated 2025 as the year of quantum science and technology, highlighting the profound impact that technological advancements are poised to have on the world.

The increasing prevalence of artificial intelligence (AI) across a wide array of industries has spurred significant investment in the sector over the last two years as the world's largest tech firms jump in. As AI continues to evolve, many investors are wondering if 2025 will be a pivotal year when these investments begin to show significant returns.

From its impact on stock market valuations to its transformative potential across industries, here the Investing News Network delves into the key trends and developments that are shaping the future of AI.

Keep reading...Show less
Rocketboots Limited

RocketBoots Limited (ASX: ROC) – Reinstatement to Quotation

Description

The suspension of trading in the securities of RocketBoots Limited (‘ROC’) will be lifted immediately following the release by ROC of an announcement regarding the details of the capital raise, board changes and remuneration updates.

Keep reading...Show less
Rocketboots Limited

RocketBoots Successfully Completes Capital Raise and Board Changes; Positioned to Deliver International Expansion in 2025

Artificial Intelligence software company RocketBoots Limited (ASX:ROC) (RocketBoots or the Company), is pleased to announce the appointment of Mr Roy McKelvie as Chairman, to guide the company through a period of material scaling. Mr McKelvie will invest $200k in RocketBoots, subject to shareholder approval, and cornerstone a raise for $500k at $0.085 per share (before costs) with other sophisticated investors (Placement).

Keep reading...Show less
BlinkLab

BlinkLab Limited (ASX: BB1) – Trading Halt

Description

The securities of BlinkLab Limited (‘BB1’) will be placed in trading halt at the request of BB1, pending it releasing an announcement. Unless ASX decides otherwise, the securities will remain in trading halt until the earlier of the commencement of normal trading on Friday, 20 December 2024 or when the announcement is released to the market.

Keep reading...Show less
AI computer circuit.

AI Market 2024 Year-End Review

Competition in the artificial intelligence (AI) sector escalated dramatically in 2024, with major tech companies investing billions in a race to research and develop advanced AI technologies.

This surge in investment spurred rapid advancements, fierce competition and a wave of innovation that has the potential to reshape the technological landscape moving forward.

Here the Investing News Network delves into the trends that defined the AI sector in 2024.

Keep reading...Show less
BlinkLab Limited

BlinkLab Limited Investor Kit

  • Corporate info
  • Insights
  • Growth strategies
  • Upcoming projects

GET YOUR FREE INVESTOR KIT

Latest Press Releases

Related News

×