PainChek Nears FDA Approval, Hits 100,000 Licences with Infant App Launch

FDA Clearance on Track

PainChek Ltd (ASX: PCK), the pioneer of AI-driven pain assessment technology, has taken a significant step forward with its US FDA De Novo regulatory submission for the PainChek Adult App. The company has received confirmation from the FDA that its submission is complete and is being reviewed by the same executive who initially engaged with PainChek in 2019. This continuity adds confidence that PainChek could become the first FDA-cleared pain assessment app in the US, with a decision anticipated by May 2025.

The US market represents a substantial opportunity, with an estimated $100 million annual potential in aged care alone. PainChek has already established US-based go-to-market partners and is actively expanding its network to accelerate market penetration upon clearance.

Strong Global Licence Growth and Market Penetration

Globally, PainChek has secured 100,000 contracted licences across nearly 1,820 aged care facilities, delivering an annual recurring revenue (ARR) of $4.8 million once fully implemented, a 22% increase compared to the prior year. Implemented licences stand at 68,458, marking an 18% year-on-year and 11% quarter-on-quarter increase, underscoring strong adoption momentum.

Customer retention remains robust at 85-90%, with over half of existing clients engaged for more than three years, reflecting deep integration into care processes and regulatory compliance. Market penetration in aged care is approximately 30% in Australia and 8% in the UK, with ongoing expansion into home care and hospital sectors.

Infant App Launch and New Market Frontiers

In a strategic move to diversify its product portfolio, PainChek has successfully launched the PainChek Infant App on the Apple App Store following a positive Early Access Program. Targeting a global market of 400 million pre-verbal children, including 150 million first-time parents annually, this app represents a world-first clinical tool for infant pain assessment.

The company is preparing for a broader commercial launch in Q2 2025, supported by updated websites, interactive videos, and partnerships with direct-to-consumer marketing specialists. This initiative opens a vast new consumer market beyond traditional aged care settings.

Financial Position and Capital Raising

Financially, PainChek reported unaudited recognised revenue of $1.658 million for the six months to December 2024, a 27% increase over the prior year. Quarterly customer receipts reached $717,000, reflecting seasonality in subscription renewals. The company strengthened its balance sheet by raising $5.1 million through a fully underwritten rights issue in December 2024, providing essential growth capital to support its US market entry and product expansion.

Operating expenses included increased staff costs due to performance bonuses and marketing spend related to the Infant App launch. Research and development payments declined following the completion of FDA clinical trials, signaling a shift from heavy investment to commercialisation.

Strategic Partnerships and Clinical Validation

PainChek continues to deepen its integration with key healthcare software providers such as PointClickCare in North America and AlayaCare in ANZ, facilitating seamless adoption across aged care and home care markets. Clinical studies and pilot programs are underway globally, including hospital trials in the UK and Singapore, and research collaborations targeting non-verbal children with disabilities.

These efforts reinforce PainChek’s position as a clinically validated, AI-powered pain assessment solution trusted by thousands of clinicians worldwide.