5 February 2025 – Sydney, Australia | BlinkLab Limited (ASX: BB1) ("BlinkLab" or "the Company"), an innovative digital healthcare company leveraging AI-powered smartphone technology to transform autism and ADHD diagnostics, is pleased to announce the initiation of its first US-based clinical site for the autism diagnostic registrational trial.
The PriMED Clinical Research LLC ("PriMED") facility in Dayton, Ohio, has been selected as the first clinical site for the BlinkLab Dx 1 study, marking a major milestone in the Company’s FDA registrational study. The study is expected to commence with patient recruitment this month as part of the study’s initial 100-patient phase.
Highlights
-
PriMED Clinical Research LLC selected as the first U.S. clinical site.
-
Patient recruitment beginning immediately, with an enrollment target of 15-20 participants a month.
-
Institutional Review Board (IRB) approval secured.
-
Registrational trial aims to recruit 1,000 participants across multiple U.S. sites.
-
BlinkLab now progressing discussions with additional sites to accelerate trial expansion.
Advancing AI-Powered Autism Diagnosis
The BlinkLab Dx 1 study represents a breakthrough in early autism detection, using AI-driven smartphone technology to deliver accessible and rapid autism diagnoses. The trial is structured to support BlinkLab’s pathway toward FDA approval.
Comment from PriMED Clinical Research
Crystal Jackson, Clinical Research Site Manager, stated: “PriMED Physicians & PriMED Clinical Research Team, alongside Dr. Rogelio Amisola, Principal Investigator, are looking forward to our collaboration with BlinkLab. This partnership represents an exciting opportunity to integrate our clinical expertise with BlinkLab's innovative AI technology. We are dedicated to providing accurate and detailed data for the advancement in healthcare, paving the way for innovative approaches that enhance diagnostic accuracy and improve patient outcomes.”
Dr. Henk-Jan Boele - CEO, BlinkLab commented: “I am very excited to announce the official initiation of our FDA work. By partnering with the best clinical institutions, BlinkLab is committed to delivering breakthrough, accessible AIdriven technology that is expected to transform early autism detection and provide families with faster, more reliable diagnoses.”
Brian Leedman, Non-Executive Chairman commented: “Since our IPO in April 2024, BlinkLab has made significant strides in advancing the AI smartphone-based diagnostics application. During the December 2024 quarter, the initiation of our FDA registrational study for BlinkLab Dx 1, supported by positive results from pivotal studies, is a key milestone in bringing earlier and more accessible autism diagnosis to families. This partnership with PriMED represents another key milestone that highlights the enormous progress we’ve made over the past year. As we move forward, shareholders can look ahead to continued developments in our clinical programs and collaborations that support our long-term goals.”
For more information, visit www.blinklab.org.
For Further Information:
Dr. Henk-Jan Boele
Chief Executive Officer
BlinkLab Limited
Email: henkjan@blinklab.org
Phone: +31 (0) 611 132 247
Brian Leedman
Non-Executive Chairman
BlinkLab Limited
Email: brian@blinklab.org
Phone: +61 (0) 412 281 780
About us:
About BlinkLab Limited:
BlinkLab, a company founded by neuroscientists at Princeton University, over the past several years has fully developed a smartphone based diagnostic platform for autism, ADHD, schizophrenia, and other neurodevelopmental conditions. Our most advanced product is an autism diagnostic test that leverages the power of smartphones, AI and machine learning to deliver screening tests specifically designed for children as young as 18 months old. This marks a significant advancement, considering traditional diagnoses typically occur around five years of age, often missing the crucial early window for effective intervention. BlinkLab is led by an experienced management team and directors with a proven track record in building companies and vast knowledge in digital healthcare, computer vision, AI and machine learning. Our Scientific Advisory Board consists of leading experts in the field of autism and brain development allowing us to bridge most advanced technological innovations with groundbreaking scientific research.
Contact details:
Jane Morgan
Jane Morgan Management
Investor & Media Relations
jm@janemorganmanagement.com.au
