PainChek appoints US MedTech veteran Karen Holzberger as CEO to drive North American growth
PainChek Ltd (ASX: PCK) has appointed Karen Holzberger as Chief Executive Officer, effective 17 August 2026, in a move deliberately timed to accelerate the company’s US commercialisation following FDA De Novo clearance in 2025.
The appointment follows the Board’s 6 July 2026 announcement of Mr Daffas’s departure as CEO. Interim CEO Andy Hoggan, who has held the role since 6 July 2026, will return to his position as Chief Operating Officer on the same date.
Notably, Ms Holzberger is based in the United States, aligning the company’s top leadership with its North American growth focus.
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A US healthcare heavyweight steps in
Holzberger brings 26 years of healthcare leadership, with a track record of delivering revenue generation and strategic growth across both early-stage and large international medtech companies. Her deep US commercial experience answers a central question for investors: does PainChek now have the leadership to execute in its most significant market?
Career highlights include:
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Most recently President & Chief Executive Officer of SpinTech MRI, a US-based developer of the FDA-cleared STAGE™ MRI imaging platform focused on improving neurosurgery workflow and diagnostic decision-making.
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Former Senior VP and General Manager of Nuance Healthcare’s Diagnostic Division, prior to Microsoft’s 2022 acquisition of Nuance Communications for approximately US$19.7 billion, where she advanced adoption of AI-enabled tools within radiology workflows.
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Former VP and GM of GE Global Radiology Workflow, part of GE Healthcare, with responsibility for service, implementation, and product management of mission-critical healthcare IT software.
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Holds a B.S. in Mechanical Engineering from Stevens Institute of Technology, USA.
Her background in AI-enabled diagnostic tools and driving radiology workflow adoption maps closely onto PainChek’s own challenge: commercialising an AI pain-assessment platform across the US healthcare system.
PainChek Chair, Lil Bianchi
“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.”
Why the timing matters: PainChek’s US momentum
The appointment comes as PainChek builds momentum in the US following its FDA De Novo clearance. Central to that push is a Master Services Agreement with Nasdaq-listed Sabra Health Care REIT covering up to 20,000 beds, with initial deployments now underway.
The Sabra Health Care REIT agreement structured Sabra as the funding intermediary, covering subscription costs on behalf of its operating partners across 329 North American facilities, a model designed to remove individual facility budget barriers and compress the typical sales cycle for enterprise healthcare software.
This activity complements continued growth in the company’s established UK and ANZ markets. Placing a US-based, commercially focused CEO in-market strengthens execution against the FDA-cleared opportunity.
Incoming CEO, Karen Holzberger
“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.”
Understanding PainChek and why FDA clearance is pivotal
PainChek describes its product as the world’s first regulatory-cleared medical device for the assessment of pain. The technology combines AI and Human Intelligence to detect pain in people who cannot reliably self-report.
Why does regulatory clearance matter so much? The FDA De Novo clearance opens access to the United States.
The company’s global footprint and traction to date include:
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Regulatory clearance as a medical device across Australia, Canada, the European Union, New Zealand, Singapore, Malaysia, the United Kingdom and the United States.
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Contracts with over 2,000 aged care facilities.
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More than 20,000,000 digital pain assessments conducted to date.
Remuneration and terms of appointment
Holzberger’s remuneration package was benchmarked by the Board during the international recruitment process and is described as consistent with market practice for a highly experienced US MedTech CEO. Specific Short-Term and Long-Term Incentive terms will be set by the Board and disclosed in the company’s next Remuneration Report.
| Term | Detail |
|---|---|
| Position | Chief Executive Officer |
| Annual remuneration | US$387,000 per annum |
| Incentives | Eligible for Short-Term & Long-Term Incentive plans (terms to be set by the Board) |
| Notice period | 3 months |
| Effective date | 17 August 2026 |
What’s next for PainChek
Under Holzberger’s leadership, the company’s focus centres on commercial execution in North America, continued growth in the UK and ANZ markets, and scaling of the Sabra Health Care REIT deployment covering up to 20,000 beds.
The leadership transition takes effect on 17 August 2026, when Holzberger commences as CEO and Andy Hoggan returns to his role as Chief Operating Officer. With leadership now positioned in the market that offers the largest opportunity, the coming period will test how effectively the company converts its FDA-cleared platform into commercial outcomes.
For investors wanting to understand the full scope of the leadership rebuild PainChek has undertaken ahead of its US commercial push, our detailed coverage of Lil Bianchi’s appointment as Non-Executive Chair outlines her track record guiding 4DMedical from IPO to a $2 billion-plus market capitalisation and the strategic rationale the Board applied in reshaping governance ahead of the FDA-cleared launch.
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