Former Apple Health Clinical Lead Appointed to Board

Highlights

• Former Clinical Lead for Mental Health at Apple Health joins BlinkLab Board: Dr Raphael Bernier joins the Board as a Non-Executive Director effective immediately. Dr Bernier brings first-hand experience translating clinical science into digital products at global scale, including leading clinical development of Apple’s Mental Wellbeing app for iPhone, iPad and Apple Watch.
• Leading autism clinician-scientist: Dr Bernier is the former Executive Director of the Seattle Children’s Autism Center, one of the largest autism clinical programs in the United States, and former William J. and Lydia N. Gumerman Endowed Chair in Child Psychiatry at the University of Washington, bringing direct experience of autism clinical care and the diagnostic pathway that BlinkLab Dx1 is designed to support.
• Extensive research and publication record: Dr Bernier has authored more than 200 scientific articles and two books, and has served as principal or co-investigator on more than 40 NIH and foundation-funded studies on the causes and neuroscience of autism and related neurodevelopmental disorders.
• Strategic appointment for U.S. market entry: This combination of clinical, research and commercial experience strengthens the Board as BlinkLab targets FDA 510(k) submission in Q1 CY 2027 and, subject to clearance, a specialist-first U.S. commercial launch.
• Board transition: Concurrently with Dr Bernier’s appointment, Dr Richard Hopkins has stepped down as Non-Executive Director after serving on the Board since May 2022.

BlinkLab Limited (ASX:BB1) (“BlinkLab” or the “Company”), a digital healthcare company developing AI-powered diagnostic tools, is pleased to announce the appointment of Dr Raphael Bernier, formerly Clinical Lead at Apple Health, as a Non-Executive Director, effective immediately. The Company also advises that Dr Richard Hopkins has stepped down from the Board.

Appointment of Dr Raphael Bernier

Dr Bernier brings a rare combination of clinical practice, internationally recognised research leadership and commercial product-development experience¹. His appointment is intended to deepen the Board’s expertise as BlinkLab progresses its pivotal U.S. FDA 510(k) program for BlinkLab Dx1 and prepares for clinical adoption and commercialisation in the United States, subject to regulatory clearance.

Dr Bernier recently retired from Apple Health, where he led the clinical development of the Mental Wellbeing app for iPhone, iPad and Apple Watch. He also conducted early-stage research across released and unreleased products in the Apple ecosystem and supported the rollout of additional products relating to child development and cognitive accessibility.

He is now a faculty member in the Department of Psychology at the University of Washington and remains an active clinician. Before joining Apple, Dr Bernier held the William J. and Lydia N. Gumerman Endowed Chair in Child Psychiatry at the University of Washington and served as Executive Director of the Seattle Children’s Autism Center, one of the largest autism clinical programs in the United States, serving thousands of patients each year, and as Associate Director of the University of Washington Center on Human Development and Disability.

Dr Bernier has authored more than 200 scientific articles² and two books, has been cited over 36,000 times, and has been principal or co-investigator on more than 40 studies funded by the U.S. National Institutes of Health and foundations, focused on the causes and neuroscience of neurodevelopmental disorders. He received his PhD from the University of Washington, completed clinical training at UCLA, and also holds degrees from the University of Wisconsin and Tufts University.

Strategic importance for BlinkLab

BlinkLab considers Dr Bernier’s appointment strategically important at a pivotal stage in the Company’s development. BlinkLab’s current corporate timetable targets completion of the pivotal U.S. study for BlinkLab Dx1 in Q4 CY 2026, submission of results to the FDA in Q1 CY 2027 and an FDA response on 510(k) clearance in Q2 CY 2027.

Dr Bernier’s experience spans the clinical, academic and technology sectors that will be central to this next phase. As a clinician who led one of the largest autism clinical programs in the United States, Dr Bernier brings direct understanding of the autism diagnostic pathway that BlinkLab Dx1 is designed to support, including the clinical workflows, specialist capacity constraints and waiting-list pressures that can delay diagnosis for families. His extensive relationships across autism and neurodevelopmental care, research institutions, health systems, digital health and technology are expected to support BlinkLab’s clinical strategy, engagement with key opinion leaders, product development, implementation planning and preparation for responsible commercial adoption.

Board transition: Dr Richard Hopkins

Dr Hopkins has served as a Non-Executive Director of BlinkLab since May 2022 and has contributed his experience in biotechnology leadership, corporate strategy, financing, business development and intellectual property during a period of significant growth for the Company. The Board would like to express their gratitude to  Dr Hopkins for his service and counsel, including his contribution as BlinkLab progressed from its ASX listing through the development and execution of its U.S. clinical and regulatory strategy.

Dr Raphael Bernier, Non-Executive Director of BlinkLab, commented:

I’m so very delighted to join BlinkLab. The strong scientific foundation and innovation underlying BlinkLab’s approach ensures a meaningful impact on children and families throughout the world. There is nothing more exciting and rewarding for me than being a part of that.

Brian Leedman, Non-Executive Chairman of BlinkLab, commented:

Raphael brings an exceptional combination of clinical insight, research leadership and commercial product experience. His recent work at Apple Health gives him a valuable perspective on translating rigorous clinical science into digital products that can be deployed at scale. As BlinkLab advances toward completion of its pivotal study and prepares for U.S. market entry following FDA clearance, Raphael’s judgement and extensive network across clinicians, researchers, health systems and technology leaders will be strategically valuable. On behalf of the Board, I also thank Richard for his important contribution to BlinkLab since before our ASX listing and throughout a formative period for the Company.

References

1) https://doi.org/10.53053/XEBD8379

2) https://scholar.google.com/citations?hl=en&user=i41kgM0AAAAJ