Can PainChek Turn FDA Clearance Into US Market Breakthrough?

Financial Performance and Operational Highlights

PainChek Limited has released its audited preliminary final report for the year ended 30 June 2025, revealing a 24% increase in total revenue to $4.8 million. This growth was driven by expanding subscription revenues and increased customer receipts, which rose to $3.5 million. Despite this progress, the company reported a net loss of $7.69 million, a 7% improvement compared to the previous year. Operational costs increased, notably in cost of sales and corporate administration, reflecting investments in staff for UK sales and capital raising activities.

Strategic US Market Entry and FDA Clearance Progress

The 2025 financial year marked a pivotal phase for PainChek’s US market ambitions. The company completed a comprehensive clinical validation study involving 105 nursing home residents across Iowa and New York, submitting data for FDA De Novo clearance of its Adult PainChek App. A final FDA meeting in June 2025 positioned PainChek on track for clearance, anticipated by October 2025 or sooner. This approval would make PainChek the first regulatory-cleared pain assessment app for people with moderate to severe dementia in the US, opening access to a $582 million annual market opportunity.

To support this expansion, PainChek established a US subsidiary and appointed a Head of Business Development with extensive senior living industry experience. Strategic partnerships with PointClickCare and ElderMark provide access to over 1.3 million beds in the US aged care sector, positioning the company for rapid commercial deployment post-clearance.

Growth in Established Markets and New Consumer Segment

Outside the US, PainChek’s Adult App continued to gain traction in Australia, New Zealand, the UK, and Canada, with contracted licenses increasing 16% to 110,000 beds and annual recurring revenue reaching approximately $3.6 million. The company is advancing toward operational break-even in its core ANZ and UK markets through cost optimisation and improved customer retention.

In a significant diversification, PainChek launched its Infant App on the Apple App Store in Australia during Q2 2025, targeting the direct-to-consumer market for pre-verbal children. This move taps into a global market of over 400 million children and represents a new growth pillar. Plans for broader international rollout and strategic partnerships with healthcare retailers and pediatric providers are underway to accelerate adoption.

Capital Raising and Future Outlook

In July 2025, PainChek successfully raised $7.5 million through a share placement at $0.034 per share, with proceeds earmarked for US commercialization, Canadian and US operations, and Infant App market penetration. This capital injection supports scaling the team and operations as the company prepares for FDA clearance and international expansion.

Research and development remain a priority, with ongoing projects including the HealthChek reporting tool, PainChek for Kids for children with disabilities, and validation studies in hospital and international aged care settings. The company’s leadership underscores its commitment to becoming a global leader in AI-powered pain assessment technology.

Governance and Remuneration

PainChek’s board and key management personnel remuneration includes performance rights linked to share price targets, aligning executive incentives with shareholder value creation. The auditor issued an unqualified opinion on the financial statements but highlighted material uncertainty regarding the company’s ability to continue as a going concern due to ongoing losses and net current liabilities. The board remains confident in the company’s strategic plans and recent capital raises to support future growth.