PainChek Lands $26K US Contract, Eyes $100M Aged Care Market Opportunity

FDA Clearance Opens US Door

PainChek Limited, an Australian medical technology company, has taken a decisive step into the US aged care sector by securing its first American customer, Jewish Home Family in New Jersey. This milestone follows the company’s recent FDA De Novo clearance, a regulatory first that officially recognises PainChek’s AI-powered pain assessment app as a medical device in the United States.

The FDA’s De Novo classification not only validates PainChek’s technology but also establishes it as a category-defining product, creating a new product code and giving the company a significant first-mover advantage in the world’s largest aged care market.

Strategic Entry with a Leading Partner

The initial agreement with Jewish Home Family is for three years and includes an upfront payment of USD 26,200. The deployment at their flagship facility will focus on improving pain detection and management for residents with moderate to severe dementia, a group notoriously difficult to assess due to communication challenges.

Jewish Home Family’s leadership has praised PainChek’s technology for aligning with their mission of elder-directed care, highlighting the app’s ability to empower clinical teams with objective, real-time data to enhance treatment responsiveness and dignity.

Accelerating US Market Penetration

PainChek is not resting on this initial success. The company has established business development and operations teams in North America and is actively recruiting to expand its sales footprint. Strategic partnerships with PointClickCare and Eldermark, which together cover approximately 60% of the US and Canadian long-term care market, are set to accelerate deployment across thousands of facilities.

In addition, PainChek is leveraging major industry events such as the AHCA/NCAL convention in Las Vegas and the LeadingAge Annual Meeting in Boston to showcase clinical data and engage with key stakeholders, including top long-term care providers.

A Large and Growing Opportunity

The US aged care market represents an initial addressable opportunity of over USD 100 million annually, based on the 3 million long-term care beds nationwide. Regulatory pressures from Medicare and Medicaid around pain management are expected to drive demand for innovative solutions like PainChek’s, which combines AI-driven facial recognition and behavioural analysis to provide objective pain assessments for those unable to self-report.

Globally, PainChek’s technology is already in use across more than 1,900 aged care facilities with over 12 million pain assessments conducted. The US launch marks a critical phase in scaling the company’s footprint, with future expansion planned into home care and hospital sectors.

Looking Ahead

While the initial contract provides a clear revenue stream, PainChek has yet to disclose forecasts for broader US sales. The company’s ability to convert its regulatory advantage and strategic partnerships into sustained growth will be closely watched by investors and industry observers alike.