Highlights

  • PainChek has appointed US-based medical technology executive Karen Holzberger as Chief Executive Officer, effective 17 August 2026.
  • Ms Holzberger brings 26 years of healthcare leadership experience across early-stage and large international medical technology companies
  • Her appointment follows PainChek’s FDA De Novo clearance in the United States and supports the company’s focus on North American commercial growth.
  • PainChek has a Master Services Agreement with Sabra Health Care REIT covering up to 20,000 beds, with initial deployments underway.
  • Interim Chief Executive Officer Andy Hoggan will return to his position as Chief Operating Officer when Ms Holzberger commences.

PainChek Ltd (ASX:PCK) has appointed experienced US medical technology executive Karen Holzberger as Chief Executive Officer, effective 17 August 2026. The appointment follows an international recruitment process and comes as the company advances its United States commercial strategy after receiving FDA De Novo clearance for its artificial intelligence-powered pain assessment technology.

PainChek shares were trading flat at AUD 0.10 during the morning session on 20 July 2026. The stock remains down 74.39% over the past year, representing a decline of AUD 0.31. The company’s latest announcement focused on the leadership transition, Ms Holzberger’s healthcare commercialisation experience and PainChek’s plans to grow its customer base across North America, Australia and the United Kingdom.

US-Based Leadership Supports PainChek’s Next Commercial Phase

Karen Holzberger will take over as Chief Executive Officer on 17 August 2026, bringing 26 years of healthcare leadership and commercial experience to PainChek.

The company said her background includes generating revenue, developing strategic growth programs and leading both early-stage businesses and large international medical technology operations.

Her appointment is particularly relevant to PainChek’s development in the United States, where the company is building commercial momentum following FDA De Novo clearance received in 2025.

PainChek said the appointment supports its plans to expand in the US market while continuing to build its established operations in Australia, New Zealand and the United Kingdom.

Ms Holzberger is based in the United States, placing the incoming Chief Executive Officer close to the market that has become a central part of PainChek’s growth strategy.

The company’s Board believes her combination of medical technology knowledge, operational leadership and US healthcare experience provides the capabilities required for the company’s next stage of development.

Experienced Executive Brings 26 Years in Healthcare

Ms Holzberger has held senior positions across healthcare software, medical imaging and artificial intelligence-enabled clinical technology.

Most recently, she served as President and Chief Executive Officer of SpinTech MRI, a US-based developer of the FDA-cleared STAGE™ magnetic resonance imaging platform.

SpinTech MRI focuses on improving neurosurgery workflows, operational efficiency, patient throughput and diagnostic decision-making through advanced magnetic resonance imaging software.

Her responsibilities at SpinTech included leading a company operating within the regulated medical technology sector and progressing the commercial development of healthcare software designed for clinical environments.

This experience is relevant to PainChek’s own position as a developer of regulatory-cleared medical technology that uses artificial intelligence to support clinical decision-making.

Both companies operate in areas where product adoption depends on clinical utility, healthcare integration, regulatory requirements and the ability to demonstrate value to providers.

Nuance and GE Healthcare Roles Add Commercial Depth

Before joining SpinTech MRI, Ms Holzberger held senior leadership roles at Nuance Healthcare.

She served as Senior Vice President and General Manager of Nuance Healthcare’s Diagnostic Division, where she was responsible for diagnostic imaging solutions and the adoption of artificial intelligence-enabled tools within radiology workflows.

Her time at Nuance preceded Microsoft’s acquisition of Nuance Communications in 2022 for approximately US$19.7 billion.

The Nuance role provided experience in managing healthcare technology within a larger international organisation, including commercialisation of software used in clinical workflows.

Earlier in her career, Ms Holzberger worked at GE Healthcare as Vice President and General Manager of GE Global Radiology Workflow.

Her responsibilities included service, implementation and product management for healthcare information technology software used in mission-critical medical settings.

Together, these positions give the incoming CEO experience across product development, implementation, customer adoption and commercial growth in regulated healthcare markets.

Ms Holzberger holds a Bachelor of Science in Mechanical Engineering from Stevens Institute of Technology in the United States.

Appointment Follows Leadership Transition Announced in July

PainChek’s new CEO appointment follows the company’s announcement on 6 July 2026 regarding the departure of former Chief Executive Officer Philip Daffas.

Andy Hoggan has served as Interim Chief Executive Officer since 6 July 2026 while the Board completed the leadership transition.

Mr Hoggan will return to his role as Chief Operating Officer on 17 August 2026, coinciding with Ms Holzberger’s commencement.

This arrangement allows PainChek to retain operational continuity while appointing a permanent CEO with direct experience in the US healthcare and medical technology sectors.

The company did not announce broader changes to its management structure in the latest release.

Instead, the transition is focused on placing an experienced US-based executive in the CEO role as PainChek develops its North American commercial activities.

FDA Clearance Creates New US Commercial Opportunity

Ms Holzberger’s appointment comes after PainChek received FDA De Novo clearance in the United States during 2025.

The clearance provides an important regulatory foundation for the company’s expansion into the US healthcare market.

PainChek describes its technology as the world’s first regulatory-cleared medical device for pain assessment. The application combines artificial intelligence and human intelligence to identify and assess pain, including in people who cannot reliably communicate their discomfort.

The technology is intended for people who are unable to self-report pain, those who can communicate their pain and patients whose ability to self-report may vary over time.

Pain assessment can be particularly difficult in populations affected by cognitive impairment, communication limitations or changing clinical conditions.

PainChek’s application is designed to provide a digital assessment method that can be used by nurses, carers and clinicians in different healthcare environments.

Following US regulatory clearance, the company’s focus has shifted towards customer deployment, commercial adoption and expansion of its presence across American care settings.

Sabra Agreement Provides Initial US Deployment Pathway

PainChek has already established an initial commercial pathway in the United States through a Master Services Agreement with Nasdaq-listed Sabra Health Care REIT.

The agreement covers up to 20,000 beds, with initial deployments now underway.

The source announcement did not provide revenue guidance, a deployment timetable for all covered beds or financial terms associated with the Sabra arrangement.

However, the agreement gives PainChek access to a sizeable potential deployment base as it begins developing its US market presence.

Ms Holzberger’s background in healthcare software implementation and clinical technology adoption may support the company as it works to convert regulatory clearance and customer agreements into broader operational use.

Her immediate commercial priorities will include building PainChek’s customer base in North America while continuing expansion in Australia and the United Kingdom.

The incoming CEO said her focus would be on commercial outcomes and delivering the company’s strategy alongside the Board and management team.

Established International Markets Remain Part of Growth Strategy

Although the United States represents a developing market for PainChek, the company continues to operate across several established international regions.

PainChek has received regulatory clearance as a medical device in Australia, Canada, the European Union, New Zealand, Singapore, Malaysia, the United Kingdom and the United States.

This regulatory footprint provides the company with access to multiple healthcare markets, although the level of commercial development differs between regions.

The company said its US expansion complements continued growth across its established Australian, New Zealand and UK operations.

Ms Holzberger’s stated priorities include expanding PainChek’s presence in Australia and the United Kingdom alongside developing the North American customer base.

The approach indicates that the incoming CEO will oversee both the emerging US commercial opportunity and ongoing activity in the company’s more established markets.

PainChek Technology Reaches More Than 20 Million Assessments

PainChek reported that its technology is contracted across more than 2,000 aged-care facilities globally.

More than 20 million digital pain assessments have been conducted using the application to date.

The platform is used by thousands of nurses, carers and clinicians, providing PainChek with an existing operating base as it pursues further international expansion.

The application uses artificial intelligence-supported facial analysis alongside clinical observations entered by a care professional.

PainChek positions the technology as a tool for supporting consistent pain assessment and improving pain management for people across different care settings.

The platform’s use among people who cannot reliably self-report pain is an important part of its clinical purpose.

This may include individuals with communication difficulties or cognitive conditions that make traditional pain assessment challenging.

Board Highlights Commercialisation and Operational Experience

PainChek Chair Lil Bianchi said the appointment followed an international search process.

The Board identified Ms Holzberger’s strategic vision, operational leadership, product commercialisation background, medical technology expertise and understanding of the US healthcare market as relevant to the company’s next phase.

The appointment indicates that commercial execution is expected to be a key leadership priority.

PainChek has already completed an important regulatory milestone through FDA De Novo clearance, and the company is now working to develop customers and deployments in the United States.

The incoming CEO’s experience across early-stage businesses and large international healthcare companies may help PainChek manage the different requirements of market entry, customer implementation and organisational growth.

However, the announcement did not provide new revenue guidance, sales targets or financial forecasts linked to the CEO appointment.

CEO Remuneration Terms Disclosed

PainChek disclosed the principal remuneration terms for Ms Holzberger’s appointment.

She will receive annual remuneration of US$387,000 per annum.

The company said the package is consistent with market practice for an experienced US medical technology CEO and was benchmarked by the Board during the international recruitment process.

Ms Holzberger will also be eligible to participate in PainChek’s Short-Term Incentive and Long-Term Incentive plans.

The specific terms of those incentive arrangements will be determined by the Board and disclosed in the company’s next Remuneration Report.

The employment arrangement includes a three-month notice period.

PainChek did not disclose specific short-term or long-term incentive targets in the announcement.

About PainChek

PainChek develops an artificial intelligence-powered pain assessment and monitoring application.

The company describes PainChek® as the world’s first regulatory-cleared medical device developed for pain assessment.

It is designed to support pain management for people across a range of circumstances, including those unable to reliably communicate their pain and those whose ability to self-report changes over time.

PainChek has obtained medical device clearance across Australia, Canada, the European Union, New Zealand, Singapore, Malaysia, the United Kingdom and the United States.

The company’s technology has been adopted by more than 2,000 aged-care facilities, and over 20 million digital assessments have been completed.

PainChek combines artificial intelligence with observations made by healthcare professionals to support pain identification and monitoring.

The company is now pursuing further growth in North America following FDA De Novo clearance while continuing commercial development in its existing international markets.

What the Appointment Means for PainChek

Karen Holzberger’s appointment gives PainChek a US-based Chief Executive Officer with experience across regulated healthcare software, diagnostic imaging, artificial intelligence-enabled clinical tools and medical technology commercialisation.

The timing aligns with the company’s move from obtaining US regulatory clearance towards building customer adoption and executing initial deployments.

Her priorities will include expanding PainChek’s North American customer base, supporting commercial outcomes and continuing development in Australia and the United Kingdom.

The Sabra Health Care REIT agreement, covering up to 20,000 beds, provides an initial platform for US deployment, while PainChek’s existing presence across more than 2,000 aged-care facilities demonstrates established use of the technology internationally.

Investors are likely to monitor the pace of US customer growth, progress under the Sabra agreement and the company’s ability to convert regulatory approvals into commercial activity under its new leadership.