PainChek’s FDA Win Poses New Challenges for US Pain Management Landscape

A Regulatory First for Pain Assessment

PainChek Limited, an Australian medical technology company, has reached a significant milestone by securing a De Novo classification from the US Food and Drug Administration (FDA) for its PainChek Adult App. This clearance not only establishes PainChek as the first and only FDA-regulated medical device specifically designed to assess pain in individuals who cannot reliably verbalize it, but also creates a new FDA product code, 'SGB', recognizing the app’s unique position in the market.

This regulatory breakthrough is particularly important given the critical unmet need for accurate pain assessment in the US aged care sector, which encompasses over 3 million long-term care beds. The FDA’s recognition validates PainChek’s innovative AI-driven technology and sets the stage for commercial rollout in the world’s largest aged care market.

Unlocking a $100 Million Market Opportunity

With this FDA clearance, PainChek gains access to an initial addressable market estimated at over USD 100 million annually within US long-term care facilities. The company’s clinical trials conducted over the past two years in the US provide strong local evidence supporting market acceptance. Moreover, the regulatory approval streamlines pathways for rapid clearance in adjacent segments such as home care and hospitals, potentially expanding the total US aged care market opportunity to $582 million.

Strategic partnerships with leading healthcare software providers PointClickCare and Eldermark, which collectively cover around 60% of the US and Canadian long-term care markets, further bolster PainChek’s commercial prospects. These collaborations, combined with reseller agreements, are designed to accelerate market entry and sales growth, with business development activities already underway.

Global Expansion and Patent Protection

The FDA De Novo classification also enhances PainChek’s prospects for expedited regulatory approvals in other key markets, notably Japan, which has the world’s second-largest long-term care sector. Additionally, markets such as Brazil and the UAE, which often accept FDA approvals for faster market entry, represent further growth avenues.

PainChek’s technology is protected by patents in major international markets including the US, European Union, UK, Japan, and China, providing a strong intellectual property moat. The company is actively expanding its US and Canadian commercial teams, with recent appointments aimed at fast-tracking sales and implementation efforts.

Looking Ahead

As PainChek prepares to showcase its technology at major US aged care conferences later this year, the company is well-positioned to capitalize on a regulatory environment increasingly focused on improving pain management. Medicare and Medicaid reimbursement policies, alongside minimum data set requirements emphasizing pain assessment, create a fertile landscape for PainChek’s adoption.

CEO Philip Daffas highlighted the transformative nature of the FDA clearance, emphasizing its role in validating PainChek’s technology and accelerating growth in the US market, building on successes in Australia and the UK.