How PainChek’s FDA Clearance Unlocks a $175M US Market and Infant App Boom

FDA Clearance – A US Market Breakthrough

PainChek Limited has achieved a pivotal milestone with the US Food and Drug Administration granting De Novo clearance for its Adult pain assessment app. This regulatory approval positions PainChek as the first and only regulated medical device to assess pain in people living with moderate to severe dementia within the US long-term care sector. The clearance opens immediate access to an estimated AUD $175 million annual market, with potential expansion to AUD $582 million by including home care and hospital sectors through additional regulatory pathways.

Within days of clearance, PainChek secured its first US commercial agreement with a New Jersey-based long-term care facility, signaling strong market validation. The company has also built a robust US sales pipeline, bolstered by recent industry conferences and strategic hires, including a dedicated Head of Business Development and operational staff to support North American growth.

Global Growth and Market Penetration

Beyond the US, PainChek’s footprint continues to expand steadily. Globally, the company now holds 115,770 contracted licences across more than 1,900 aged care facilities, representing a 15.4% increase over the prior year and a 4.4% rise over the last quarter. Implemented licences stand at 71,751, with an annual recurring revenue (ARR) of AUD $3.5 million, reflecting a 16% year-on-year growth. Customer retention remains robust at over 85%, underscoring the value and stickiness of PainChek’s technology in aged care settings.

Key markets such as Australia, the UK, Canada, and ANZ show positive momentum, with notable contracts like Catholic Healthcare in Australia expanding PainChek’s presence into home care services. Integration partnerships with leading healthcare software providers further streamline adoption and embed PainChek into clinical workflows, enhancing user experience and operational efficiency.

Infant App – Targeting a $15 Billion Opportunity

Complementing its adult-focused solutions, PainChek has commenced sales of its Infant App in Australia, targeting a vast global market estimated at AUD $15 billion annually. The Infant App is the world’s first automated pain assessment tool for infants aged one to twelve months, using AI-driven facial analysis to provide rapid and reliable pain evaluations.

Marketing efforts are ramping up, with the appointment of Sasha Grant as Head of Growth, bringing extensive experience in consumer app commercialization. Early traction includes over 200,000 impressions and 383 app downloads in the quarter, alongside strategic partnerships such as with CPR Kids to enhance clinical credibility and user engagement. Planned rollouts in the UK, Canada, Germany, France, and the US are set to commence through 2026, positioning PainChek for significant expansion in pediatric pain management.

Financial Health and Outlook

Financially, PainChek reported unaudited customer revenue of AUD $849,000 for the quarter, a 12% increase year-on-year, supported by $1 million in customer receipts. The company’s cash reserves stand at a healthy AUD $6.3 million, bolstered by a recent $7.5 million capital raise. Increased expenditure on marketing and staffing reflects strategic investments to accelerate US and Infant App growth, while research and development activities continue to advance multiple hospital and international market projects.

CEO Philip Daffas highlighted the transformative nature of the FDA clearance and the company’s readiness to capitalize on global opportunities. With a growing sales pipeline, expanding integration partnerships, and a unique technology offering, PainChek is well-positioned to scale its impact across diverse healthcare markets.