PainChek has completed its final FDA submission for the PainChek Adult App, targeting the US long-term care market with a potential $100 million annual opportunity. A regulatory decision is expected within 75 days, setting the stage for rapid commercialisation.
- Final FDA De Novo submission completed for PainChek Adult App
- Regulatory decision expected by late September to early October 2025
- Targeting US long-term care market for dementia pain assessment
- Existing US partner agreements support swift commercial rollout
- Initial US market opportunity projected to exceed $100 million annually
PainChek Advances Toward US Market Entry
PainChek Limited, an Australian medical device innovator, has taken a significant step toward entering the lucrative US healthcare market by completing its final submission to the US Food and Drug Administration (FDA) for De Novo clearance of its PainChek Adult App. This app is designed to assess pain in adults, particularly those living with moderate to severe dementia, a population that has long lacked effective, regulatory-approved pain assessment tools.
The FDA’s decision is anticipated within 75 days, potentially by late September or early October 2025. This timeline follows a productive meeting with the FDA in June, after which PainChek incorporated additional clinical data from recent US trials to address regulatory feedback. The company’s confidence in the approval pathway is bolstered by these developments and the groundwork laid through established US partnerships.
Tapping into a Large and Underserved Market
The US long-term care sector, encompassing skilled nursing and assisted living facilities, houses nearly 3 million people, many of whom suffer from dementia-related pain that is difficult to assess and manage. PainChek’s app leverages artificial intelligence to provide consistent, objective pain assessments, reducing reliance on subjective reporting and caregiver bias. This innovation meets a critical unmet need, with the initial market opportunity estimated to exceed $100 million USD annually based on projected pricing.
Beyond long-term care, PainChek plans to pursue additional FDA clearances to expand into home care, hospital, and infant care markets, broadening its addressable market in the US. The company’s existing contracts with over 1,900 aged care facilities worldwide and more than 12 million digital pain assessments conducted to date underscore its established credibility and operational scale.
Strategic Partnerships and Commercial Readiness
PainChek’s strategy includes leveraging US partner agreements and a recently appointed Head of Business Development to accelerate commercialisation upon regulatory approval. These partnerships are expected to facilitate rapid adoption across the US healthcare ecosystem, positioning PainChek for early revenue generation in the world’s largest healthcare market.
CEO Philip Daffas highlighted the company’s optimism, noting that the final FDA submission and ongoing US collaborations provide a strong foundation for success. The company’s innovative technology, combining AI-driven pain assessment with comprehensive reporting tools, aims to transform pain management practices for vulnerable populations.
As PainChek awaits the FDA’s verdict, the broader healthcare community will be watching closely to see if this pioneering app can deliver on its promise to improve pain assessment and care for millions of Americans.
Bottom Line?
FDA clearance could unlock a major new revenue stream for PainChek and reshape pain management in US long-term care.
Questions in the middle?
- Will the FDA grant De Novo clearance within the expected timeframe?
- How quickly can PainChek scale US commercial operations post-clearance?
- What are the prospects for expanding into home care and hospital markets?