PainChek Limited (ASX: PCK), a leader in digital pain assessment technology, has cleared a significant milestone in its path to US market entry. Following positive results from a validation study, PainChek announced it is on track to submit its Adult App for FDA De Novo clearance in November 2024. This clearance would mark PainChek’s official entry into the world’s largest aged care market, targeting the 1.7 million residents in US long-term care facilities, particularly those with moderate to severe dementia who cannot communicate their pain effectively.
Study Confirms Reliability of PainChek Technology
PainChek’s recent US validation study assessed 105 residents across five nursing homes in Iowa and New York, comparing results against the established Abbey Pain Scale. The study’s findings were consistent with previous research validating PainChek’s observational pain assessment tools, which have been widely used in Australia, the EU, and Canada. With the submission for FDA approval pending, CEO Philip Daffas highlighted that securing clearance would not only be a milestone for the company but would also set an important regulatory precedent.
“If successful, PainChek will be the first FDA-cleared pain assessment tool specifically designed for aged care residents with dementia,” said Daffas. “This clearance would also pave the way for the PainChek Infant App and support expansion of the Adult App into other US healthcare segments, such as hospitals and home care.”
Potential Market Impact
PainChek’s US market opportunity is vast. With an estimated 1.7 million individuals in US aged care facilities, the company projects a potential annual recurring revenue stream of approximately USD $85 million based on its US pricing model. To accelerate its expansion, PainChek has strategically aligned with major partners like PointClickCare, which provides access to over a million aged care beds across the US and Canada.
The FDA’s De Novo pathway, which PainChek is pursuing, is designed to evaluate novel devices without substantial equivalents. PainChek has already had two rounds of discussions with the FDA to confirm its endpoints, which could support a streamlined review process once the submission is completed. Typically, De Novo reviews take around 150 days, meaning PainChek could receive clearance by early 2025 if all goes as planned.
Looking Ahead: Expansion in Healthcare
PainChek’s strategy for US market entry doesn’t stop at aged care. If FDA approval is granted, the company plans to expand its footprint into home care and hospital segments, leveraging its data-driven assessment capabilities. With a US patent secured until 2038, PainChek is well-positioned to bring its AI-powered pain assessment solutions to multiple sectors across North America.
This FDA submission is the latest step in PainChek’s broader mission to redefine pain management across various demographics, including infants and adults with limited communication abilities. As part of its US strategy, PainChek also aims to publish the study’s findings in peer-reviewed journals and present at US medical conferences in 2025.
PainChek’s potential FDA clearance would not only be a milestone for the company but could also set a new standard for pain assessment in dementia care, opening the door for more comprehensive, technology-driven pain management solutions across the healthcare continuum.
