PainChek Ltd (ASX: PCK) has delivered a robust quarterly update, highlighting strong momentum across regulatory approvals, global adoption, and market expansion. With its US FDA submission progressing, an expanding footprint in home care and infant pain assessment, and a $5.1 million capital raise secured, the company is primed for its next growth phase.
US FDA Clearance on Track
A major milestone for PainChek is its De Novo submission to the US FDA, which, if cleared, will make its adult pain assessment app the first FDA-regulated tool of its kind in the US. The FDA has confirmed that the submission is 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 overall quality of the submission. He was also pleased the same FDA executive who initially reviewed PainChek’s application in 2019 and the subsequent pre-submission supplements will oversee the review.
“We are confident PainChek will soon become the first and only FDA regulatory cleared pain assessment app for the long-term care patient cohort to enter the US market,” Daffas said.
Philip Daffas
The US aged care market alone represents a $100 million USD annual opportunity, but PainChek’s ambitions in North Americas go far beyond given the additional growth opportunities within Home Care, Hospital, and Infant Pain assessment markets. The PainChek adult app is already generating revenue in Australia, UK and Canada in the aged care, home care, and hospital sectors, with its Infant App set for commercial launch next quarter.
PainChek is already working with key US-based partners, including PointClickCare, the largest aged care software provider in North America, and InterSystems, a global leader in healthcare data solutions. These partnerships will be critical to scaling PainChek’s presence in the region.
Global Expansion Continues
PainChek’s growth trajectory remains strong, with 100,000 contracted licences globally, up 22% year-on-year. The company has 68,458 implemented licences, translating to an annual recurring revenue (ARR) of $3.3 million, an 18% increase from the prior year.
Customer retention is high at 85-90%, with over half of PainChek’s clients using the platform for more than three years.
In Australia, the company has made a strategic push into home care, securing a 2,100-licence deal with Anglicare SA—a small but important step into a 272,000-licence market. PainChek has also strengthened its partnership with AlayaCare, a leading home care software provider in Australia and Canada. With AlayaCare launching its Cloud Home Care solution in February, PainChek expects an acceleration in adoption.
The UK is emerging as another strong growth region, with contracted licences up 49% year-on-year to 37,000 and implemented licences surging 110% to 23,000. Key new clients include Bracebridge Care Group (1,062 beds), and pilot programs have commenced with major operators Avery Healthcare and Methodist Homes.
PainChek’s credibility in the UK is further bolstered by the Scottish Government conducting a cost-benefit analysis of its use in care homes. If successful, this could open the door to broader adoption across Scotland’s 30,000 aged care beds. This would mark the second government-backed PainChek initiative, following support from the Australian Government.
Infant App Gains Traction
PainChek’s Infant App, designed for pre-verbal children aged 1-12 months, has officially launched on the Apple App Store, with a Google Play release imminent.
Early consumer testing has been promising, with over 50 parents participating in the Early Access Program. The opportunity in this segment is vast, 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 refine its go-to-market strategy. Additionally, the company is engaging with hospitals, midwives, and early childhood care providers, further broadening its commercial reach.
Royal Infirmary of Edinburgh hospital live trial to start
The Royal Infirmary of Edinburgh has launched a live trial of PainChek within the hospital, integrating its pain assessment data with the InterSystems TrakCare health information system. This follows a successful collaboration with InterSystems to develop and test the integration process. TrakCare, a globally interoperable system used in hospitals worldwide, connects care teams across the healthcare ecosystem and provides a single source of truth for clinical information. The PainChek trial will run for 16 weeks, with the integrated process now accessible across the global TrakCare hospital network.
Financials & Capital Position
PainChek recorded $717,000 in customer receipts for the quarter and $1.66 million in half-year revenue, a 27% increase year-on-year.
The company raised $5.1 million in a fully underwritten rights issue in December, bolstering its cash reserves to $2.9 million at quarter-end. Additional funding will come from an expected $1.3 million R&D tax incentive in Q1 2025.
Operating cash burn was $2.77 million, though PainChek expects a stronger cash position next quarter as further receipts come in and one-off expenses—such as FDA trials and staff incentive payments—taper off.
What’s Next?
With FDA clearance pending, PainChek is on the brink of a major US expansion, while home care and the Infant App are shaping up as significant new revenue streams. Strong customer retention, regulatory tailwinds, and global partnerships suggest the company is well-placed for sustained growth.
For investors, the next few months will be pivotal as PainChek looks to convert regulatory success into commercial traction in the world’s largest healthcare market.
