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US MedTech leader Karen Holzberger appointed PainChek CEO

PainChek (ASX: PCK)

• Karen Holzberger appointed CEO of PainChek effective from 17 August 2026.
• Karen is a highly experienced leader who has grown both early-stage and large international medtech companies.
• This appointment supports PainChek’s drive for growth and development of our US market following FDA De Novo clearance.
• Andy Hoggan, who is serving as Interim CEO since 6 July 2026, will return to his role as Chief Operating Officer on 17 August 2026.

PainChek Ltd (ASX: PCK), developer of the world’s first AI-powered pain assessment and monitoring application, is pleased to announce the appointment of Karen Holzberger as CEO, effective from 17 August 2026. This appointment follows the Board’s announcement on 6 July 2026 of Mr Daffas’s departure as CEO. Ms Holzberger is based in the United States.

                        Newly appointed PainChek CEO Karen Holzberger

Karen Holzberger has 26 years of healthcare leadership, delivering revenue generation and strategic growth initiatives in US early stage and large international medtech companies.

She most recently served as President & Chief Executive Officer of SpinTech MRI, a US-based developer of the FDA-cleared STAGE™ MRI imaging platform, where she led a company focused on improving neurosurgery workflow, efficiency, throughput, and diagnostic decision-making through advanced MRI software.

Previously, Karen held senior leadership roles at Nuance Healthcare prior to Microsoft’s 2022 acquisition of Nuance Communications for approximately US$19.7 billion. She was Senior VP and General Manager of Nuance Healthcare’s Diagnostic Division, overseeing diagnostic imaging solutions and advancing adoption of AI-enabled tools within radiology workflows.

Earlier in her career, Karen served as VP and GM of GE Global Radiology Workflow, part of GE Healthcare, a global leader in medical imaging technology, with responsibility for service, implementation, and product management of mission-critical healthcare IT software.

Karen Holzberger holds a B.S. in Mechanical Engineering from Stevens Institute of Technology, USA.

The appointment comes as PainChek builds momentum in the US following FDA De Novo clearance in 2025, including a Master Services Agreement with Nasdaq-listed Sabra Health Care REIT covering up to 20,000 beds, with initial deployments now underway.

This complements continued growth in the Company’s established UK and ANZ markets.

Incoming CEO, Karen Holzberger, commented:

“I am excited to join PainChek as CEO. My focus will be on commercial outcomes, building the customer base in North America and expanding in Australia and the UK. I look forward to working with the team and Board to deliver our strategy.”

PainChek Chair, Lil Bianchi, commented:

“On behalf of the Board I am delighted to welcome Karen to PainChek, following an international search. Karen’s combination of strategic vision, operational leadership, product commercialisation, medical technology expertise and deep US healthcare experience positions her strongly to lead PainChek in our next phase of growth”.

                                                                           ENDS

About us:

ABOUT PAINCHEK

PainChek® is the world’s first regulatory-cleared medical device for the assessment of pain, enabling best-practice pain management for people living with pain in any environment, from those who cannot reliably self-report their pain, those who can, and for those whose ability to self-report their pain fluctuates.

Globally, PainChek® has attained regulatory clearance as a medical device in Australia, Canada, the European Union, New Zealand, Singapore, Malaysia, the United Kingdom and most recently FDA De Novo clearance in the United States.

PainChek® has contracts with over 2,000 aged care facilities, with more than 20,000,000 digital pain assessments conducted to date, and is trusted by thousands of nurses, carers, and clinicians.

PainChek® is setting a new benchmark for pain assessment. Being the first TGA-approved and FDA-cleared medical device for pain assessment, PainChek® combines AI and Human Intelligence to detect pain in people who cannot reliably self-report.

For more information, visit: https://painchek.com

Contact details:

David Tasker 
Chapter One Advisors 
T: +61 433 112 936 
E: [email protected]