PainChek (ASX: PCK) is heading into a pivotal period, with a major U.S. regulatory decision expected by May 2025. If successful, the company could soon have the only AI-driven pain assessment tool cleared by the U.S. Food and Drug Administration (FDA), unlocking access to the 1.7 million-bed U.S. aged care market and beyond.
The Sydney-based medtech firm has spent years refining its artificial intelligence-powered pain assessment app, which detects facial cues to determine pain levels in patients who cannot self-report. Already commercialised in Australia, NZ, UK and Canada across 1800+ aged care facilities and 100,000+ beds, PainChek Adult App is now on the verge of securing its biggest prize yet—entry into the world’s largest healthcare market.
FDA Clearance: Years in the Making
PainChek isn’t simply throwing a last-minute submission at the FDA and hoping for the best. The company has been working closely with the regulator for years, conducting two pre-submissions before lodging its De Novo submission in November 2024.
The groundwork for this submission was extensive. PainChek engaged with the FDA as far back as 2019, holding meetings to determine the necessary clinical endpoints. These discussions shaped the U.S. validation study, which was completed in October 2024 across five aged care facilities in Iowa and New York, involving 105 participants. The results were consistent with previous studies in Australia and the UK, reinforcing the app’s accuracy in assessing pain for patients with moderate to severe dementia.
PainChek CEO Philip Daffas remains confident given the quality of the submission, and confirmation the same FDA executive who engaged with the company in 2019 is now overseeing the review. This continuity, along with addressing the requirements of the pre-submissions, increases the Company’s confidence of a timely and positive decision.
A green light from the FDA would not only give PainChek first-mover advantage in the U.S. aged care market but also set a predicate for future FDA clearances, including broader applications in hospitals and home care and its Infant App.
Additionally, existing US integration partnerships including PointClickCare, ensures rapid commercial access to more than 1,000,000 beds of the US aged care bed market.
PainChek CEO Philip Daffas
Beyond Aged Care: Hospitals, Home Care, and the Infant Market
While the FDA decision is the biggest immediate catalyst, PainChek isn’t putting all its eggs in one regulatory basket. The company has already expanded into home care, hospitals, and the consumer market, ensuring that revenue growth continues even as it awaits U.S. clearance.
In December 2024, Anglicare SA signed on as PainChek’s largest home care client, deploying 2,100 home care licenses. Given that Australia alone has over 272,000 home care clients, this represents a significant new revenue stream.
Meanwhile, in the UK, PainChek is making strides in hospitals, with a 16-week trial at the Royal Infirmary of Edinburgh currently underway. The hospital has integrated PainChek with InterSystems TrakCare, a widely used hospital information system, meaning successful results could lead to broader NHS adoption.
At the same time, PainChek’s Infant App is preparing for a commercial push. After a successful Early Access Program, the app is now being made available on the Apple App Store, with a direct-to-consumer launch targeted for Q2 C2025. The global market for infant pain assessment is enormous, with 150 million first-time parents annually potentially interested in using AI to detect pain in babies.
Financials: A Strong Base for Expansion
PainChek raised $5.1 million in December 2024 via a fully underwritten rights issue, ensuring it has the capital needed to fund expansion. With 100,000 contracted licenses and an annual recurring revenue (ARR) of $4.8 million, the company has built a solid foundation for long-term growth.
More than 50% of customers have been using the platform for over three years, demonstrating strong retention rates and the stickiness of the PainChek system. This is key, as the aged care sector moves towards greater regulation and compliance requirements for pain assessment.
The Investment Case: What Could Drive a Re-Rate?
The next few months could be a defining period for PainChek’s share price. A successful FDA clearance in May 2025 would provide a regulatory breakthrough, allowing rapid commercialisation in the U.S. aged care market. Meanwhile, expansion into home care, hospitals, and the infant consumer market ensures multiple pathways to growth.
PainChek’s long-standing engagement with the FDA, its rigorous U.S. validation study and existing US market partnerships make it a strong candidate for FDA clearance and a rapid US market entry. If the company secures FDA clearance and executes on its expansion plans, it could find itself on a much larger stage by mid-2025.
This article does not constitute financial advice and has been written for information purposes only. Before making any investment decision, readers should conduct their own research and consult their advisors.
