4DMedical’s DoD Pilot Deal Highlights Risks Ahead of FDA Approval for CT:VQ™

A Strategic Win for 4DMedical

4DMedical Limited (ASX:4DX) has taken a decisive step forward in commercialising its advanced lung imaging technology by securing a paid pilot contract with the United States Department of Defense (DoD). The agreement tasks 4DMedical with deploying its CT Ventilation-Perfusion (CT:VQ™) platform to assess lung health in a fixed cohort of 80 active-duty military personnel. This pilot precedes the company’s anticipated FDA submission, underscoring strong institutional confidence in the technology’s clinical utility.

The DoD’s interest builds on a prior successful pilot involving 4DMedical’s CT Lung Ventilation Analysis Software (CT LVAS™), signalling a growing recognition of the company’s imaging solutions within one of the world’s largest healthcare systems. With over 9.6 million beneficiaries and more than 200 military hospitals and clinics globally, the Military Health System (MHS) represents a substantial and influential testing ground for innovative medical technologies.

Disrupting a Billion-Dollar Diagnostic Market

CT:VQ™ is positioned to disrupt the established Nuclear VQ scan market, which performs approximately one million procedures annually in the US alone. Traditional Nuclear VQ scans rely on radioactive isotopes and costly infrastructure, whereas 4DMedical’s CT:VQ™ offers a non-invasive, radiation-free alternative that promises faster, safer, and more accessible lung imaging. This shift could not only improve diagnostic precision for conditions such as COPD and chronic thromboembolic hypertension but also reduce healthcare costs and expand patient access.

By providing detailed insights into ventilation and perfusion abnormalities, CT:VQ™ addresses a critical need for early detection and monitoring of pulmonary diseases, especially among military personnel exposed to hazardous environments. The DoD’s pilot contract, conducted on commercial terms, reflects a tangible commercial validation ahead of regulatory clearance, enhancing 4DMedical’s credibility and market positioning.

Looking Ahead: FDA Submission and Market Adoption

CEO Andreas Fouras emphasised the significance of this contract as a testament to the competitive advantages of 4DMedical’s technology and the company’s aggressive market adoption strategy. The pilot with the DoD not only provides critical data and operational experience but also lays the groundwork for potential expansion within the DoD and the Veterans Affairs (VA) healthcare systems.

While the pilot is limited in scope, it signals strong demand for innovative respiratory diagnostics and could accelerate the pathway to FDA approval. The company’s recent acquisition of Imbio, an AI-driven medical imaging solutions leader, further strengthens its product portfolio and capacity to transform lung health diagnostics globally.

As 4DMedical advances toward regulatory milestones, investors and industry watchers will be closely monitoring the outcomes of this pilot and the company’s ability to scale adoption across the US healthcare landscape.