4DMedical targets US$2.5B pulmonary embolism market

4DMedical (ASX:4DX) announced the launch of CLEAR, a clinical evidence programme designed to fast-track its proprietary CT:VQ technology into the acute United States pulmonary embolism market.

The breakthrough targets a US$2.5 billion market entry, effectively expanding the medical tech company's total obtainable US market value to an estimated US$3 billion by capitalising on both the traditional nuclear VQ sector and the substantially larger CTPA-dominated imaging market.

The CLEAR programme—standing for Contrast-free Lung Evaluation for Acute Risk—centres on a comprehensive, multi-centre, multinational, prospective observational study that will pit CT:VQ head-to-head against standard computed tomography pulmonary angiography in patients with suspected PE.

4DMedical secured a milestone clinical research agreement with the prestigious Mass General Brigham-affiliated teaching hospitals to serve as the lead site for the validation initiative.

Currently, pulmonary embolism represents a critical healthcare challenge in America, accounting for roughly 600,000 to 650,000 diagnosed clinical episodes annually.

Due to high mortality risks, current emergency workflows are heavily biassed towards over-imaging, resulting in an estimated 5 million CTPA scans performed each year.

However, CTPA demonstrates a remarkably low diagnostic positive yield of just 3% to 10%.

This means up to 97% of patients are routinely subjected to high-cost imaging and invasive iodinated contrast exposure without confirmation of PE.

At the time of reporting, 4DMedical’s share price was $3.98.