PainChek's US Ambition: The Adult App Nears FDA Submission
PainChek Limited (ASX: PCK), the innovator behind the world's first smartphone-based pain assessment tool, is inching closer to a pivotal milestone. In a significant update to the market, the company has announced it is in the final stages of its FDA De Novo submission process for the PainChek Adult App, with the final Clinical Evaluation Report nearing completion.
Having wrapped up data collection across five US aged care homes in Iowa and New York in July 2024, PainChek has analysed the performance data from 105 participants. With these results locked in, the company’s Clinical Research Organization (CRO) is finalising the necessary statistical analyses. As PainChek prepares to submit the data to the US FDA, it marks a crucial moment for the company’s expansion into the world's largest aged care market, which services 1.7 million residents.
Cracking the US Market
PainChek’s FDA journey comes at a time when the US healthcare system is hungry for innovations in aged care. Should the PainChek Adult App gain FDA clearance, it would be a ground-breaking first: an FDA-approved pain assessment tool designed for aged care residents with moderate to severe dementia, a population often unable to communicate their pain.
CEO Philip Daffas noted that the potential annual recurring revenue in the US market could reach around USD 85 million, assuming successful penetration into the 1.7 million-strong long-term aged care sector. This alone speaks volumes about the business opportunity for PainChek in the US, but the potential ripple effects are even more tantalising.
“FDA clearance would also provide an important predicate for the PainChek Infant App and support the expansion of the Adult App into larger US markets, including home care and hospitals,” Daffas explained. He also emphasised that the company’s granted US patent, valid until 2038, provides a sturdy legal backbone for the technology as it moves into the US.
The FDA De Novo Pathway
For those unfamiliar, the FDA De Novo submission process is a regulatory pathway designed for novel medical devices. This classification is reserved for products that are low- to moderate-risk but without an existing predicate device in the market. Given the unique nature of PainChek’s technology, the De Novo pathway is an apt fit.
It’s not just about clearing regulatory hurdles, though. PainChek’s timing and execution seem carefully considered. The company has already satisfied the majority of the submission requirements, including those related to cybersecurity, software documentation, and device labelling. With these formalities nearly complete, the submission’s last piece—the Clinical Evaluation Report—is set to be finalised by the end of October.
In fact, investors won’t have to wait long for more news. PainChek has committed to a further update, likely in line with its quarterly Appendix 4C report, scheduled for later this month.
A Foundation for Growth
Securing FDA approval for the Adult App is just one step in PainChek’s broader US strategy. The company is strategically positioned to hit the ground running once clearance is obtained. Existing partnerships, such as that with PointClickCare, give PainChek access to over 1 million aged care beds across the US and Canada. This existing infrastructure could offer a rapid path to market, ensuring swift deployment of its technology.
The potential is clear: PainChek’s patented AI-driven app uses facial recognition technology to assess pain levels in those who cannot communicate effectively, offering carers and clinicians a powerful tool to ensure patients receive appropriate pain management. With its app already cleared in Australia, Canada, the EU, and other jurisdictions, the US remains the largest market on the horizon.
Broader Implications for PainChek’s Technology
While the immediate focus is on the Adult App and the US aged care market, the long-term ramifications of FDA approval extend far beyond this. As Daffas highlighted, clearance for the Adult App would pave the way for its Infant App in the US as well, which assesses pain in infants aged one to 12 months. This diversification could open doors to paediatric hospitals, home care providers, and even consumer markets.
Additionally, gaining a foothold in the US could spur the technology’s adoption in other care settings, such as hospitals and home care services. PainChek’s ability to integrate with electronic medical record systems, thanks to partners like PointClickCare, makes it an attractive option for healthcare providers looking to streamline pain management across diverse patient populations.
Looking Ahead
While PainChek can’t offer specific details on the final contents of its FDA submission just yet, the update indicates that the finish line is within sight. The next few months will be critical as the company submits the final data and awaits the FDA’s response.
If successful, PainChek stands to transform pain management in the US aged care sector, addressing a long-standing gap in the market. Investors will be watching closely, especially with the FDA submission update due by the end of October. Should everything fall into place, PainChek could soon be a name synonymous with innovation in pain assessment on both sides of the Pacific.
