PainChek Ltd (ASX: PCK) has delivered a strong quarterly update, with notable progress in its US FDA regulatory approval, a growing global user base, and a strategic push into home care and infant pain assessment markets. With a $5.1 million capital raise secured, the company is well-positioned for its next phase of expansion.
US FDA Clearance on Track
A major milestone for PainChek is its US FDA De Novo regulatory submission, which, if approved, will make its adult pain assessment app the first FDA-regulated tool of its kind in the US. The company received confirmation from the FDA that its submission was complete, with a decision expected by May 2025.
CEO Philip Daffas expressed confidence in the PainChek application, noting the strength of the clinical validation results and was pleased that the same FDA executive who initially reviewed PainChek’s application in 2019 and the subsequent pre-submission supplements will oversee the review. “This provides us with confidence PainChek will soon become the first and only FDA regulated pain assessment app for this patient cohort to enter the US market,” Daffas said.
The US aged care market represents a $100 million annual opportunity, and PainChek is already working with potential US partners to establish market entry strategies.
Expanding Market Reach and Adoption
PainChek has continued its strong growth trajectory, with 100,000 contracted licences globally, an increase of 22% on the prior year. The company now has 68,458 implemented licences, translating to an annual recurring revenue (ARR) of $3.3 million, an 18% increase on the prior year.
Customer retention remains high, with 85-90% of customers maintaining their contracts, and over half of PainChek’s clients have been using the platform for more than three years.
In Australia, the company signed a significant home care deal with Anglicare SA, securing 2,100 home care licences. This marks a strategic shift into the home care sector, where over 272,000 potential licences exist.
PainChek has also expanded its partnership with AlayaCare, the leading home care software provider in Australia and Canada. With AlayaCare set to launch its AlayaCare Cloud Home Care solution in February, PainChek expects accelerated adoption in the home care market.
In the UK, PainChek’s contracted licences surged by 49% year-on-year to 37,000, with 23,000 implemented licences, marking a 110% annual growth in the region. Key new clients include Bracebridge Care Group (1,062 beds), and pilot programs have commenced with major operators such as Avery Healthcare and Methodist Homes.
Notably, the Scottish Government is conducting a cost-benefit analysis of PainChek’s impact in care homes, which could pave the way for broader adoption across Scotland’s 30,000 aged care beds.
Infant App Gains Traction
PainChek’s Infant App, designed for pre-verbal children aged 1-12 months, has been launched on the Apple App Store and will soon be available on Google Play. The company has conducted early consumer testing, with over 50 participants engaging in the Early Access Program.
This sector represents a massive opportunity, with 400 million pre-verbal children globally and 150 million first-time parents annually. PainChek is working with marketing specialists and parent-focused platforms like Kiindred and Mamamia to fine-tune its go-to-market strategy.
Financials & Capital Position
PainChek recorded customer receipts of $717,000 for the quarter and recognised revenue of $1.66 million for the half-year, up 27% from the prior year.
To support its expansion, the company raised $5.1 million in a fully underwritten rights issue in December. Cash reserves stood at $2.9 million at the end of the quarter, bolstered by the capital raise and expected R&D tax incentives of $1.3 million in Q1 2025.
While operating cash burn was $2.77 million, PainChek expects a stronger cash position next quarter, with further receipts and reduced one-off expenses related to FDA trials and staff incentive payments.
What’s Next?
With FDA approval pending, PainChek is on the cusp of a major US expansion, while its home care and infant app segments are emerging as significant growth drivers. The company’s strong client retention and increasing regulatory support in the UK and Australia suggest it is well-positioned for sustained growth.
For investors, the coming months will be critical as PainChek looks to translate its regulatory success into commercial traction, particularly in the lucrative US market.
