BlinkLab

Quarterly Activities Report and Appendix 4C for the Period Ended 31 December 2024

BlinkLab Limited (ASX:BB1) (“BlinkLab”, or the “Company”) an innovative digital healthcare company leveraging smartphones, computer vision, Artificial Intelligence (“AI”), and Machine Learning (“ML”) to diagnose neurodevelopmental conditions such as autism and ADHD, is pleased to release its Appendix 4C and Quarterly Activity Report for the period ended 31 December 2024 (the “Quarter”).


Highlights

  • BlinkLab initiated its FDA registrational study, which aims to revolutionise the diagnostics and care for autism, making it more accessible and reliable.
    • The initial phase will recruit up to 100 participants (children aged between 2-11 years old), with the main study recruiting up to 1,000 subjects.
    • Four clinical sites have been selected, with six additional sites to be added; the sites are spread across the US to ensure diversity of the population.
    • Final results are expected by the end of CY 2025 and will be used for the 510(k) Food and Drug Administration (“FDA”) approval.
  • BlinkLab received positive feedback from a Pre-Submission meeting with the US Federal Drug Administration (“FDA”) regarding the regulatory pathway for BlinkLab Dx 1 diagnostic app.
  • Final results from the pivotal autism study (announced in November of 2024) bolster confidence that BlinkLab Dx 1 will surpass the accuracy parameters that are required for regulatory approval in the upcoming FDA registration trial.
  • BlinkLab and Monash University have partnered on the large-scale Monash Autism-ADHD Genetics and Neurodevelopment (“MAGNET”) study, which aims to conduct deep phenotyping in children on the autism spectrum, with ADHD, or both. The study will also work towards further improvements to BlinkLab’s Machine Learning (“ML”) algorithm to better distinguish between autism- and ADHD-specific clinical features.
  • As at 31 December 2024, the Company had a cash balance of A$4.4 million.

Following the positive outcome from the recent FDA pre-submission meeting, as well as positive final data from the pivotal preliminary study (ASX Announcement 19 November 2024), BlinkLab is confident in the success of its registrational study, as well as the subsequent 510(k) regulatory approval for our first diagnostic tool for autism, called “Blinklab Dx 1”.

US FDA Registrational Study in Autism Now Underway

The FDA registrational study program will consist of a pilot study, followed by the primary study. The pilot study will recruit up to 100 participants (children aged between 2-11 years) and will continue into a registrational study, which will be conducted with up to 1,000 subjects across ten clinical sites in the US. The pilot study will be used to train the investigators and personnel at clinical sites, as well as to test the procedures of subject screening and data collection. These steps are part of BlinkLab’s considered strategy for mitigating risk leading up to the main FDA study and are aimed at ensuring the highest quality of data and diagnostic accuracy of the BlinkLab tests.


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
The Conversation (0)
BlinkLab Limited

BlinkLab Limited


Keep reading...Show less

Revolutionising Mental Health Care Through Mobile Solutions

Syntheia (CSE:SYAI)

Syntheia Announces Closing of Private Placement

Syntheia Corp. (CSE: SYAI) (syntheia.ai) (the "Company"), is pleased to announce that further to its press releases dated July 23, 2025, and September 2, 2025 the Company has closed the second tranche of its non-brokered private placement financing for gross proceeds of $709,677.48 through the issuance of 5,913,979 units (each, a "Unit") at a price of $0.12 per Unit (the "Offering").

Each Unit was comprised of one common share in the capital of the Company (each, a "Common Share") and one Common Share purchase warrant (each, a "Warrant"). Each Warrant is exercisable to acquire one Common Share at a price of $0.16 until September 2, 2030 (the "Expiry Date"), subject to an accelerated expiry in the event the volume weighted average trading price of the Common Shares exceeds $0.20 for 20 consecutive trading days, the Company may, within 10 business days of the occurrence of such event, deliver a notice to the holders of the Warrants accelerating their Expiry Date to a date that is not less than 30 days following the date of such notice and the issuance of a press release by the Company announcing the acceleration notice (the "Accelerated Exercise Period"). Any unexercised Warrants shall automatically expire at the end of the Accelerated Exercise Period.

Keep reading...Show less
Circuit board forming a brain shape on a digital blue background.

Nebius Shares Soar on US$17.4 Billion Microsoft AI Deal

Nebius Group (NASDAQ:NBIS) surged on Tuesday (September 9) after announcing a multibillion-dollar deal with Microsoft (NASDAQ:MSFT) to provide dedicated artificial intelligence (AI) infrastructure.

Valued at US$17.4 billion over five years and expandable to US$19.4 billion if demand increases, the arrangement will see Nebius supply Microsoft with computing capacity from a new data center under construction in Vineland, New Jersey.

The news sent Nebius shares up 43.3 percent to US$91.75, their highest level on record.

Keep reading...Show less
OpenAI logo on a dark screen with a soft blue gradient background.

OpenAI Taps Broadcom to Build Custom AI Chips in Face of GPU Supply Concerns

OpenAI, the company behind ChatGPT, is reportedly set to begin large-scale production of its own artificial intelligence (AI) chips through a partnership with Broadcom (NASDAQ:AVGO).

Experts in the space see the move as a bid to cut reliance on chip giant NVIDIA (NASDAQ:NVDA) and ease the global shortage of processors driving platforms like ChatGPT.

The news came after Broadcom CEO Hock Tan told analysts in a September 4 call that the company had secured a fourth major customer that has committed to a US$10 billion order.

Keep reading...Show less
Person using laptop with generative AI, ChatGPT and other symbols floating between them.

10 Generative AI Stocks to Watch as ChatGPT Soars

The launch of OpenAI’s ChatGPT created a major buzz around artificial intelligence (AI) stocks.

ChatGPT is an AI chatbot software application that uses machine-learning techniques to emulate human-written conversations. This technology is called generative AI, and it's been making an impact on myriad industries, including marketing, security, healthcare, gaming, communication, customer service and software development.

The potential behind generative AI has been the primary driver behind a major stock rally that has helped the S&P 500 (INDEXSP:.INX) and Nasdaq Composite (INDEXNASDAQ:.IXIC) reach multiple new highs since 2023.

Keep reading...Show less
RemSense CEO and Managing Director Warren Cook

RemSense Eyes More Strategic Partnerships for Global Growth

RemSense (ASX:REM) is looking to secure more strategic partnerships as the company eyes global expansion, according to CEO and Managing Director Warren Cook.

“We have a strong pipeline of services to deliver to our existing clients that's going to take us right up through to the end of the year and into the early new year. For our global growth, we see partnerships as a critical part of our strategy to give us scale and capacity to grow throughout other parts of the region,” Cook said in an interview with the Investing News Network.

RemSense’s 3D visualisation technology — called virtualplant — is used by some major companies, including Woodside Energy Group (ASX:WDS,NYSE:WDS) and Chevron (NYSE:CVX).

Keep reading...Show less
Glowing red maple leaf on digital circuit board background.

Canada's Stealthy AI Strategy: Why the Future is B2B, Not Just Chatbots

As global giants chase consumer-facing artificial intelligence (AI), Canada has adopted a different approach.

The northern nation has excelled in developing B2B AI solutions for enterprises, governments and research institutions. This discreet strategy aims to cultivate a trusted AI environment, fostering innovation and economic growth within Canada, while building a resilient ecosystem safeguarded from external influences.

While the spotlight often falls elsewhere, Canada’s AI strategy could present a unique opportunity for investors seeking long-term growth in the evolving AI landscape.

Keep reading...Show less

Latest Press Releases

Related News

×