PainChek Nears FDA Clearance, Launches Infant App, and Expands Global Reach
PainChek Limited reports strong progress toward FDA De Novo clearance for US market entry, launches its Infant App in Australia, and achieves robust global licence growth with a 30% year-on-year revenue increase.
- Positive FDA De Novo clearance progress with US market entry targeted by June 2025
- Infant App commercially launched on Apple Store in Australia with positive early user feedback
- Global contracted licences reach 101,000 with $4.9M annual recurring revenue
- Customer retention remains high at over 85%, with more than half of clients retained over 3 years
- Cash reserves at $1.6M, supported by R&D tax incentives and ongoing sales growth
Regulatory Milestone in Sight
PainChek Limited (ASX: PCK), a pioneer in AI-driven pain assessment technology, is advancing steadily toward a critical regulatory milestone with the US Food and Drug Administration (FDA). Following a positive review meeting in April 2025, the company is on track for De Novo clearance by the end of June, which would position PainChek as the first FDA-cleared pain assessment app for the US long-term care market. This market, with nearly 2 million beds, represents a significant expansion opportunity, estimated at US$100 million annually, especially given the new CMS mandates requiring validated pain assessment tools for reimbursement and compliance.
Commercial Launch of Infant App
In parallel with its adult-focused offerings, PainChek has launched its Infant App on the Apple App Store in Australia. This soft launch, conducted in partnership with parenting platform Kiindred, is designed to refine pricing, marketing, and user engagement strategies. Early feedback from parents highlights the app’s ease of use and its value in providing reassurance during stressful moments such as teething or inconsolable crying. The company is exploring flexible pricing models, including free trials and subscription options, to optimize market adoption ahead of a broader rollout planned for the second quarter of 2025.
Strong Licence Growth and Market Penetration
PainChek’s global footprint continues to expand with 101,000 contracted licences generating an annual recurring revenue (ARR) of $4.9 million once fully implemented, a 12% increase year-on-year. Implemented licences stand at 71,000, up 17% from the previous year, reflecting solid uptake across Australia, the UK, New Zealand, Canada, and growing interest in the home care and hospital sectors. Market penetration reaches approximately 30% in Australian aged care and 8% in the UK, with a robust sales pipeline exceeding 40,000 licences under negotiation. Customer retention remains a standout metric, exceeding 85% over the past year, with more than half of clients maintaining contracts for over three years.
Financial and Operational Highlights
The company reported customer receipts of $841,000 for the quarter and unaudited customer revenue of $2.54 million for the nine months to March 2025, marking a 30% increase over the prior corresponding period. PainChek’s cash reserves stood at $1.6 million at quarter-end, excluding a $1.41 million R&D tax incentive refund received post-quarter. Operating expenses reflect strategic investments in marketing, particularly for the Infant App, and a reduction in R&D spend following the completion of FDA clinical trials. The company continues to invest in integration partnerships with key healthcare platforms such as PointClickCare, AlayaCare Cloud, and BESTMED, enhancing scalability and market penetration.
Research and Market Development
PainChek is actively engaged in multiple research collaborations, including projects targeting pain assessment in children with disabilities and hospitalized older adults. The company is also expanding its presence in North America, with successful pilot conversions in Canada and ongoing recruitment for US business development roles. The upcoming presentation at the CHAA conference in Alberta underscores PainChek’s commitment to thought leadership and market education in the region.
Looking Ahead
With FDA clearance anticipated imminently, PainChek is well positioned to capitalize on the vast US long-term care market. The Infant App’s measured rollout strategy aims to build a strong foundation before scaling, while ongoing licence growth and high retention rates provide a stable revenue base. Strategic partnerships and continuous product innovation underpin the company’s expansion plans across multiple geographies and care settings.
Bottom Line?
As PainChek approaches FDA clearance and scales its Infant App, investors should watch for accelerating US market traction and evolving revenue streams.
Questions in the middle?
- Will PainChek secure FDA De Novo clearance by the targeted June 2025 deadline?
- How will pricing and user adoption evolve for the Infant App beyond the soft launch phase?
- What impact will US market entry have on PainChek’s overall revenue growth and cash flow?