Australian medtech innovator PainChek Limited (ASX: PCK) has taken a significant step towards cracking the world’s largest aged care market. The company has submitted an FDA De Novo application for its Adult App, a groundbreaking pain assessment and monitoring tool designed for those who can’t reliably self-report pain, such as dementia patients in aged care facilities.
PainChek’s submission to the FDA is a culmination of years of innovation, clinical validation, and strategic planning. The company’s CEO, Philip Daffas, sees this as a transformative milestone. “The PainChek Adult App could become the first FDA-cleared pain assessment tool specifically designed for aged care residents with moderate to severe dementia,” he said. This potential clearance would pave the way for the app’s entry into the US market, where 1.7 million people reside in long-term care facilities—a stark contrast to Australia’s much smaller aged care sector.
The FDA De Novo pathway, which PainChek is pursuing, is used for novel medical devices that lack a pre-existing classification. The company’s application is buoyed by positive results from a US-based validation study that aligned with findings from previous observational pain tool studies. These outcomes bolster PainChek’s case for regulatory approval, with the FDA process expected to take up to 150 days.
Daffas is confident the company is well-positioned to succeed, thanks in part to two prior FDA pre-submissions that clarified the required clinical endpoints. The potential FDA clearance is more than just a regulatory win; it’s a strategic linchpin for PainChek’s broader market ambitions.
The US aged care sector represents a colossal opportunity, with PainChek estimating potential gross annual recurring revenue of around USD 85 million based on its current pricing model. However, the company isn’t just targeting aged care facilities. FDA clearance would also open doors to other sectors, including home care and hospitals, where demand for reliable pain assessment tools is substantial.
The company’s existing partnerships, such as with PointClickCare, further bolster its US market entry strategy. This integration could grant access to over one million aged care beds across North America, providing a ready-made channel for PainChek’s technology.
While the immediate focus is on the Adult App, PainChek has its sights set on additional applications. The company plans to leverage an FDA approval to facilitate entry for its Infant App, which assesses pain in babies aged one to 12 months, and potentially other market segments. The company’s granted US patent, valid until 2038, will further reinforce its first-mover advantage in the market.
PainChek’s innovative technology is already well-recognised, with regulatory clearances in Australia, Canada, the EU, and other jurisdictions. Globally, the app has facilitated over 7 million digital pain assessments, proving its efficacy and reliability in real-world settings.
PainChek is also looking to amplify its clinical credibility. It plans to submit the validation data for peer-reviewed journal publication and present at US medical conferences in 2025. These efforts aim to build awareness and acceptance of its technology among healthcare professionals, an essential step in driving adoption.
Daffas emphasises the importance of the US market for PainChek’s growth trajectory. “Having commercially proven the Adult App in Australia and the UK, we believe we can rapidly replicate our market penetration in the USA, where the clinical need and desire for this solution are paramount,” he said.
PainChek’s journey is emblematic of Australia’s growing prowess in medtech innovation. With its FDA De Novo application now under review, the company is one step closer to transforming pain assessment standards in the US aged care market. Success in this endeavour would not only validate PainChek’s innovative approach but also establish it as a global leader in pain management technology.
Investors and healthcare professionals alike will be watching closely as PainChek navigates the FDA process, with the potential for a significant re-rating of its prospects should clearance be granted. For now, the company is pressing forward, blending clinical validation with strategic execution to unlock a massive new market.