PainChek Expands Global Aged Care Reach as Clinical Trials Advance

3 min read | July 31, 2025 07:23 AM BST | By Team Kalkine Media

Highlights:

  • PainChek expands aged care reach across multiple global regions

  • New executive role created for US market expansion

  • Final submission made for FDA clearance of Adult App

The Australian health and biotech sector continues to evolve, with key updates from companies on the ASX Today 200, including digital health company PainChek (ASX:PCK). As the June quarter wraps up, fresh disclosures underline ongoing efforts to scale innovations and refine international strategies in aged care technology.

Global Expansion of PainChek Licences

PainChek (ASX:PCK) has reinforced its position in the global aged care market, supported by a growing base of technology licences across Australia, New Zealand, the United Kingdom and Canada. Its app-based platform is designed to enhance pain assessment accuracy and efficiency, particularly for non-verbal individuals in residential aged care settings.

The company's customer retention remains firm, with expanding partnerships among care providers contributing to consistent license implementation. A strong clinical usage database continues to build, showcasing the volume and scale of pain assessments conducted using the application. This ongoing activity indicates widespread acceptance among aged care providers in various geographies.

US Market Preparation and Senior Appointment

With a strategic focus on entering the long-term care space in the United States, PainChek has appointed a new executive to lead business development in the region. The newly appointed executive brings over a decade of leadership experience in the technology sector, with a focus on aged care and senior living services.

This appointment marks a key step in positioning the company within the US market, one of the largest globally for residential care services. The company plans to launch its PainChek Adult App in the United States, which is currently undergoing the regulatory approval process.

Final Submission Made for US Regulatory Clearance

A significant milestone was achieved with PainChek’s final submission to the US Food and Drug Administration for its Adult App. The application seeks de novo clearance for recognition as a medical device, marking a crucial stage in the company’s global strategy.

If successful, this approval would open a new market and further validate the company’s clinical technology. Meanwhile, new pricing models including upfront and fixed-payment contracts have been introduced, supporting faster deployment and improving cash flow.

Innovation and Product Development

In parallel with its Adult App push, PainChek continues to explore new frontiers with the release of its Infant App in Australia. This product complements its existing platform, expanding capabilities to a younger demographic in care environments. The development of multiple applications under the PainChek ecosystem showcases its broader vision for digital pain monitoring tools.

Continued innovation, along with structured growth plans and fresh funding allocation, has allowed the company to stay focused on new product rollouts while simultaneously expanding its established offering.

Frequently Asked Questions

  • What markets has PainChek (ASX:PCK) expanded into recently?
    PainChek has expanded into Australia, New Zealand, the United Kingdom, Canada, and is preparing for US entry.
  • What regulatory milestone has PainChek recently reached?
    PainChek has completed its final submission to the FDA for the Adult App's clearance in the United States.
  • How is PainChek improving its implementation strategy?
    New upfront and fixed activation models are helping speed up deployments and enhance cash flow outcomes.

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