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Highlights
- PainChek has applied for FDA De Novo approval for its Adult App.
- US-based validation study completion supports the application.
- Partnerships in North America to accelerate market entry.
PainChek (ASX:PCK) has made a significant move in its US expansion strategy by submitting an application for FDA De Novo approval for its PainChek Adult App. This innovative tool is designed to provide advanced pain assessment for adults who cannot effectively communicate their pain levels. The application follows the successful completion of a validation study conducted in the United States.
A positive outcome from the FDA would mark a milestone in PainChek's journey, potentially making it the first FDA-cleared pain assessment tool of its kind in the US. The company has forecasted an annual recurring revenue of approximately USD 85 million (AUD 130.2 million) from the aged care sector in the country, which accommodates around 1.7 million residents.
PainChek’s approach to the US market includes not only the Adult App but also its Infant App, expanding its reach into diverse segments such as home and hospital care. These developments align with its broader mission of providing effective solutions for individuals unable to communicate their pain.
To further bolster its presence in North America, PainChek has partnered with PointClickCare and other healthcare providers. These collaborations are expected to accelerate the company’s integration into the US and Canadian aged care markets. With access to approximately 1 million aged care beds through these partnerships, PainChek is well-positioned for rapid market penetration.
The company plans to disseminate its validation data through peer-reviewed journals and will present findings at major US medical conferences scheduled for 2025. This move aims to solidify the credibility and scientific backing of its innovative pain assessment technology.
PainChek’s CEO, Philip Daffas, emphasized that obtaining FDA clearance through the De Novo pathway could position the PainChek Adult App as a groundbreaking solution in pain assessment across the United States. The De Novo classification is specifically designed for novel medical devices, further highlighting the unique nature of PainChek's technology.
As a leader in pain assessment technologies, PainChek continues to focus on the development and commercialization of its mobile medical device applications. These tools play a vital role in improving the quality of care for individuals who are unable to communicate their pain, offering a significant step forward in global healthcare solutions.
