4DMedical targets US$2.5B PE market entry

4DMedical is expanding its CT:VQ lung imaging technology through new studies, partnerships, and international growth across the US and Europe.

4DMedical Limited (ASX: 4DX)

on 2 June 2026, announced the launch of CLEAR (Contrast-free Lung Evaluation for Acute Risk in Pulmonary Embolism), a clinical program designed to support the use of CT:VQ in patients with suspected pulmonary embolism (PE). The program aims to help CT:VQ move beyond its current nuclear VQ market and into the much larger PE imaging market in the United States. As a result, the company believes its obtainable U.S. market opportunity could increase to around US$3 billion per year. A major part of the program is a multinational clinical study that will compare CT:VQ directly with CTPA in patients being assessed for PE. The study will be led by hospitals affiliated with Mass General Brigham. The study will help doctors understand whether CT:VQ can replace current scanning methods in emergency settings and improve speed, safety, and accuracy of diagnosis in hospital departments over time use

CT:VQ Offers a Contrast-Free Alternative

The company also explained that CT:VQ can create detailed ventilation and perfusion images from standard CT scans without using contrast agents. Because the underlying ventilation-perfusion indication is already FDA-cleared, the pathway for further adoption is supported by an existing regulatory foundation. 4DMedical stated that diagnosing pulmonary embolism remains a major challenge, with many patients receiving contrast-based imaging while some dangerous clots are still missed. Through a planned US$2 million investment in CLEAR, the company is seeking to enter the estimated US$2.5 billion pulmonary embolism market while continuing to grow its presence in its existing respiratory imaging segment.

Acquisition Creates European Growth Platform

4DMedical, on 1 June 2026, announced an agreement to acquire Austrian medical technology company contextflow. The acquisition gives the company an immediate commercial, clinical and regulatory presence in Europe, adding a third major operating region alongside North America and ANZ. The transaction includes approximately A$18.56 million in upfront consideration, with additional performance-based incentives over the next two years. The deal also includes around €19 million in accumulated tax losses. Through this acquisition, 4DMedical gains an experienced local team, established healthcare relationships, and access to a European respiratory and thoracic imaging market estimated at US$1.5–2 billion.

SimonMed Agreement Expands U.S. Presence

4DX announced a commercial agreement with SimonMed Imaging, one of the largest outpatient imaging providers in the United States on 29 May 2026. The agreement allows immediate deployment of CT:VQ and LDAf across SimonMed’s network of more than 170 imaging centres located in 10 states. The partnership begins on commercial terms from day one and will also support the collection of evidence needed for reimbursement discussions with both government and private healthcare payors. This agreement gives 4DMedical access to a large outpatient imaging network and broadens the reach of its technology across the U.S. market.

(Source: Company Report)