4DMedical Launches CLEAR Program to Target $3B US Pulmonary Embolism Market

CLEAR Program Aims to Disrupt $3B US PE Imaging Market

4DMedical (ASX:4DX) is setting its sights on a significant expansion of its CT:VQ™ lung imaging technology into the US acute pulmonary embolism (PE) market, which it estimates to be worth around US$3 billion annually. The company has launched CLEAR (Contrast-free Lung Evaluation for Acute Risk in pulmonary embolism), a clinical evidence program designed to accelerate CT:VQ™ adoption beyond its existing nuclear ventilation-perfusion (VQ) market into the much larger computed tomography pulmonary angiography (CTPA) segment.

Addressing Over-Imaging and Under-Diagnosis in PE

PE remains a challenging condition to diagnose accurately due to its non-specific symptoms and potentially fatal consequences if missed. In the US, approximately 600,000 to 650,000 PE cases are diagnosed annually, though the true incidence is likely higher due to under-diagnosis. Despite this, imaging volumes far exceed the actual disease incidence, with CTPA scans for suspected PE estimated at around 5 million per year. Yet, the diagnostic yield of CTPA is low, with only 3–10% of scans confirming PE, exposing a vast majority of patients to iodinated contrast injections without benefit.

CT:VQ™ Offers Contrast-Free Functional Lung Assessment

CT:VQ™ leverages routine non-contrast CT scans to produce detailed three-dimensional ventilation and perfusion maps, enabling functional lung assessment without the risks associated with contrast agents. This technology is FDA-cleared for the underlying VQ indication, providing a regulatory foundation for its expanded use. The CLEAR program will generate the clinical evidence necessary to challenge CTPA as the standard of care in acute PE imaging, positioning CT:VQ™ as a safer, potentially more efficient alternative.

Mass General Brigham Leads Clinical Research Effort

4DMedical has secured a clinical research agreement with Mass General Brigham (MGB), anchored at Massachusetts General Hospital, Harvard Medical School’s largest teaching hospital and a globally respected academic medical centre. MGB will serve as the principal enrolling site for CLEAR, a prospective, multinational observational study directly comparing CT:VQ™ with CTPA in patients suspected of acute PE. The company has committed approximately US$2 million to support patient recruitment, imaging analysis, and data generation.

Scaling Market Opportunity Amid Rapid Adoption

Already making inroads by displacing nuclear VQ scans in the US, 4DMedical expects CLEAR to unlock a sixfold increase in its addressable market by penetrating the acute PE segment dominated by CTPA. This expansion aligns with the company’s recent strategic moves, including a leap into the European market through its acquisition of contextflow, enhancing its global footprint in respiratory imaging. With CLEAR, 4DMedical is leveraging its existing SaaS delivery model to scale without the need for new hardware or contrast agents, promising a more cost-effective and patient-friendly approach to lung health diagnostics.