PainChek Secures First US Customer Following FDA Clearance

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Stock Painchek Ltd (PCK.ASX)
Release Time 13 Oct 2025, 8:38 a.m.
Price Sensitive Yes
 PainChek Secures First US Customer Following FDA Clearance
Key Points
  • Initial agreement completed within days of receiving FDA De Novo clearance
  • Agreement is for an initial three-year period with upfront payment
  • Establishes PainChek in the US market with a leading reference center
Full Summary

PainChek Ltd (ASX: PCK) has announced its first US customer, Jewish Home Family, a leading senior care organisation in New Jersey. This milestone follows PainChek's recent FDA De Novo clearance, officially recognising its Adult App as the first and only regulated medical device for pain assessment in the United States and solidifying a first-to-market competitive advantage. Jewish Home Family will deploy PainChek at its flagship location to enhance pain detection and management for residents living with moderate to severe dementia. The agreement term is for three years for the single facility in New Jersey, with the total $26,200 USD fees being paid upfront to PainChek. Training and implementation will commence on Monday 13 October 2025. As part of the plan for rapid US market penetration, PainChek is attending, exhibiting and also presenting outcomes data from the US FDA clinical study at the AHCA/NCAL convention and expo (Las Vegas, 19-22 October) and the 2025 LeadingAge Annual Meeting & Global Ageing Network Conference (Boston, 2-5 November). PainChek has recently recruited Heads of Business Development in both the US and Canadian markets, and a US Operations Manager. The Company is also in the final stage of negotiations with additional Business Development Managers to fast-track direct sales and implementations across the US and Canada. PainChek is supported by strategic integration partnerships with PointClickCare and Eldermark, who combined service approximately 60% of the US and Canadian long-term care market.

Outlook

PainChek is scaling its US commercial team and preparing for broader market penetration, including home care and hospital sectors. The Company is unable to provide an estimate for the additional revenue to be derived from these direct sales and partnership initiatives.