FDA APPROVAL!!!,, page-20

PainChek’s potential FDA approval marks a significant opportunity for U.S. hospitals and aged care facilities to align with the Trump administration’s healthcare policies, particularly those prioritizing regulatory efficiency, cost reduction, and patient-centered outcomes. Painchek assess pain in patients with dementia or communication challenges, producing standardized, encrypted, and auditable records. These records ensure compliance with federal regulations, such as those enforced by the Centers for Medicare & Medicaid Services (CMS), which emphasize accurate documentation for care quality and safety. By streamlining the pain assessment process, PainChek reduces the administrative burden on facilities, directly supporting the administration’s goal of cutting bureaucratic red tape in healthcare while enhancing patient care standards.

The Trump administration’s focus on value-based care models, which tie reimbursement to patient outcomes, makes PainChek’s ability to reduce preventable adverse events like falls, hospital readmissions, and overmedication particularly valuable. By enabling precise pain identification and tailored treatment plans, the app minimizes the risk of complications that could lead to costly penalties under CMS guidelines. For example, falls in aged care facilities, often linked to unmanaged pain, contribute to over $50 billion in annual healthcare costs. PainChek’s data-driven approach helps facilities mitigate these risks, aligning with policies that reward cost-effective, high-quality care. Its integration with PointClickCare, covering over one million aged-care beds, ensures scalability across the 1.7 million U.S. long-term care beds, amplifying its impact on compliance and operational efficiency.

PainChek’s established success in markets like Australia, Canada, and the EU, where it holds regulatory approvals, underscores its reliability and readiness for U.S. adoption. The app’s cloud-based platform securely stores pain assessment data, enabling facilities to track long-term care trends and demonstrate compliance during audits. This capability is critical under the Trump administration’s push for transparency and accountability in healthcare. By providing a standardized tool that ensures consistent pain management practices, PainChek helps facilities avoid legal and financial risks associated with non-compliance, such as fines or litigation stemming from inadequate care documentation. This reliability strengthens its appeal as a solution that supports the administration’s market-driven healthcare vision.

The app’s versatility extends beyond traditional aged care, enhancing compliance in home care and pediatric settings, which aligns with the administration’s goal of expanding healthcare access across diverse populations. In home care, PainChek empowers caregivers to deliver consistent, regulator-approved pain assessments, ensuring compliance with standards like those set by state Medicaid programs. In pediatric care, where non-verbal patients pose assessment challenges, the app provides a breakthrough solution that meets regulatory requirements while improving outcomes. This broad applicability positions PainChek to address compliance needs across multiple healthcare sectors, reinforcing its alignment with policies aimed at inclusive, efficient care delivery.

For shareholders, PainChek’s potential to generate $85 million in annual recurring revenue from the U.S. market highlights its financial promise, but its compliance benefits are equally compelling. By reducing regulatory risks, lowering costs, and supporting scalable, high-quality care, PainChek is well-positioned to thrive under the Trump administration’s healthcare framework. Its ability to meet stringent standards while addressing critical issues like falls and overmedication makes it a transformative tool for facilities and a valuable asset for our investment portfolio. As PainChek moves toward FDA approval, its alignment with policy priorities ensures both clinical and financial success