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Melbourne-based respiratory imaging company 4DMedical (ASX: 4DX) has made three major announcements in the past five days, securing a commercial contract with one of the largest outpatient radiology networks in the United States, signing a binding agreement to acquire a Vienna-based AI imaging startup and launching a clinical evidence program targeting the US$2.5 billion pulmonary embolism market.
The rapid-fire moves mark a significant escalation in ambition for the company, which raised $150 million from institutional investors in January to fund its US rollout.
Together, the announcements extend 4DMedical from a US-focused nuclear ventilation-perfusion replacement play into a three-continent operation targeting what the company frames as a combined obtainable market opportunity of more than US$4.5 billion.
Last week, 4DMedical announced a three-year commercial contract with SimonMed Imaging, a US outpatient radiology provider operating more than 170 sites across multiple states.
Under the deal, 4DMedical's CT:VQ technology will be deployed across SimonMed's network on a per-scan software-as-a-service pricing model.
The company notes the contract is "not immediately financially material" but describes it as a validation of its commercial model in the world's largest radiology market.
CT:VQ is 4DMedical's software platform that analyses standard CT scans to produce ventilation and perfusion maps of the lungs, effectively replacing nuclear medicine VQ scans that require radioactive tracers and dedicated gamma cameras.
SimonMed is the first large-scale outpatient network to adopt the technology commercially.
Yesterday, the company announced a binding agreement to acquire Contextflow, a Vienna-based AI radiology decision-support startup, in a deal that establishes 4DMedical's European platform.
The acquisition comprises $18.56 million in cash upfront plus 56,235 4DMedical shares, with an earnout of up to 2.59 million zero-exercise-price options tied to performance milestones including a €5.8 million ($9.4 million) European revenue target for FY28.
The Contextflow deal also brings €19.0 million ($30.8 million) in accumulated tax losses, which 4DMedical expects to use to offset future European earnings. The acquisition is subject to Austrian regulatory approval and is expected to complete in late July.
Andreas Fouras, the founder and CEO of 4D Medical, says the European expansion grows the company's addressable market by 50 per cent with the continent representing an estimated US$1.5 billion to US$2 billion opportunity.
Today, 4DMedical announced the launch of CLEAR, a clinical evidence program with Mass General Brigham - the healthcare system affiliated with Massachusetts General Hospital and Harvard Medical School - designed to fast-track CT:VQ into the acute pulmonary embolism diagnostic pathway.
The program is funded at US$2 million, with Massachusetts General Hospital as the lead site.
Pulmonary embolism diagnosis currently relies heavily on CT pulmonary angiography, or CTPA, scans and 4DMedical estimates five million of these scans are performed annually in the US. This represents a US$2.5 billion market opportunity that the company has not previously targeted.
If CT:VQ can demonstrate clinical value as a companion diagnostic layer on existing CTPA scans, it will effectively multiply the company's obtainable US market from US$500 million in nuclear VQ replacement to about US$3 billion.
"The detection of pulmonary embolism remains a significant problem in emergency medicine," says Fouras.
"Today, we image too many patients for PE, exposing them to costly and potentially risky contrast, while still missing dangerous clots, contributing to unnecessary death and disease burden.
"This problem represents an enormous opportunity for 4DMedical to drive meaningful clinical impact at scale, improving outcomes for hundreds of thousands of patients, by reshaping one of the largest acute CT imaging workflows globally."
Fouras says CT:VQ enables contrast-free functional lung assessment within routine CT workflows, unlocking expansion beyond the company's current market.
"Our US$2 million investment in CLEAR accelerates entry into the US$2.5 billion pulmonary embolism segment," he says.
"We continue to gain share in our core segment as CT:VQ displaces nuclear VQ in the United States at an incredible pace.
"Leveraging our war chest, we are also expanding into new segments: adding 50 per cent through our entry into Europe, and now, through this investment, multiplying our opportunity sixfold. 4DMedical continues to accelerate."
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