PainChek’s Growth Hinges on Imminent FDA Clearance and US Expansion Risks
PainChek Limited has secured a A$7.5 million placement to fuel its international expansion, with US FDA clearance for its adult pain assessment app expected imminently. The company reports strong license growth and a 26% revenue increase year-on-year.
- 110,000 contracted licenses globally with $5.4M ARR
- A$7.5 million placement completed to fund US and Infant App growth
- US FDA De Novo clearance expected by late September/early October 2025
- Customer receipts exceed $1 million for the first time in a quarter
- Infant App marketing launched in Australia with staged rollout
Global Growth Momentum
PainChek Limited (ASX – PCK), the developer of the world’s first smart device-based pain assessment application, has reported a robust quarter ending June 2025. The company now boasts 110,000 contracted licenses across more than 1,900 aged care facilities worldwide, representing a 10% increase over the prior quarter. This translates to an annual recurring revenue (ARR) of $5.4 million once fully implemented, underscoring steady adoption in Australia, New Zealand, the UK, and Canada.
Implemented licenses stand at 71,000, generating $3.6 million ARR, marking a 17% increase year-on-year. Customer retention remains strong at over 85%, with a net retention rate of 106%, reflecting expanding deployments by existing large clients.
Capital Raise to Accelerate US Entry and Infant Market
In July 2025, PainChek completed a strongly supported A$7.5 million placement aimed at accelerating its growth plans in North America and supporting the rollout of its PainChek Infant App in Australia. The capital injection positions the company to capitalise on the imminent US market entry, pending regulatory approval.
The company has submitted its final US FDA De Novo regulatory application for the PainChek Adult App, with clearance expected between late September and early October 2025. This approval would open access to the $582 million US long-term care market, where PainChek has already secured partnerships with PointClickCare and ElderMark, collectively providing access to over 1.3 million beds.
Expanding Product Portfolio and Market Penetration
Alongside adult care, PainChek is advancing its Infant App, targeting a global market of over 400 million pre-verbal children. Marketing efforts have commenced in Australia, supported by a free trial model and tiered pricing designed to encourage sustainable adoption. The company is prioritising user feedback and clinical relevance to build credibility among parents and healthcare professionals.
In the UK, PainChek has increased its market penetration to 8% of residential aged care beds, with 42,000 contracted licenses and 26,000 implemented. Positive clinical evaluations and new multi-year agreements with major care providers underpin this growth. Similarly, in Canada, PainChek continues to expand with over 1,000 licenses under long-term agreements and plans to accelerate commercialization with the relocation of its Head of Business Development to North America.
Financial Performance and Operational Highlights
Customer receipts for the quarter surpassed $1 million for the first time, reaching $1.015 million, contributing to a total of $3.489 million for the year. Recognised customer revenue increased 26% year-on-year to $3.364 million. The company maintains a healthy cash position of $1.6 million as of June 2025, bolstered by the recent capital raise.
Operationally, PainChek continues to enhance integration with electronic health record systems and has achieved SOC2 Type 1 compliance, preparing for US market demands. Research and development efforts remain active, including projects focused on pediatric pain assessment and hospital-based applications.
Looking Ahead
With regulatory clearance on the horizon and fresh capital in hand, PainChek is poised for a pivotal phase of international expansion. The company’s strategic partnerships and product diversification, especially into the infant pain assessment market, offer multiple avenues for growth. However, the timing of FDA clearance and successful market penetration in the competitive US healthcare landscape remain key variables to watch.
Bottom Line?
PainChek’s upcoming US FDA clearance and capital raise set the stage for a transformative growth chapter, but execution risks remain.
Questions in the middle?
- Will PainChek secure FDA clearance within the projected timeframe?
- How quickly can PainChek scale its US market presence post-clearance?
- What adoption rates will the PainChek Infant App achieve amid competitive consumer health apps?