4DMedical Eyes $2.5B PE Market as CLEAR Program Targets 5M Annual US Scans
4DMedical launches CLEAR program to capture US$2.5 billion pulmonary embolism market
4DMedical (ASX: 4DX) has launched CLEAR, a clinical evidence program designed to fast-track its CT:VQ™ technology into the acute pulmonary embolism market. The strategic expansion grows the company’s obtainable U.S. market from the existing nuclear VQ segment (approximately 1 million scans per annum) to a combined opportunity of US$3 billion by targeting the CTPA-dominated PE segment (approximately 5 million scans per annum). Massachusetts General Hospital, a Mass General Brigham affiliated teaching hospital and the original and largest teaching hospital of Harvard Medical School, will serve as the principal enrolling site under a clinical research agreement. The company has committed approximately US$2 million in total funding to support patient recruitment, imaging analysis, and data generation.
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The pulmonary embolism problem: Why this market exists
Pulmonary embolism is a major acute cardiovascular condition resulting in approximately 600,000–650,000 diagnosed clinical episodes per annum in the U.S., with the true burden likely higher due to under-diagnosis. In a meaningful proportion of cases, sudden death is the first presentation.
The condition presents with non-specific symptoms such as chest pain and shortness of breath. Because PE carries significant morbidity and mortality if untreated, clinical pathways are intentionally biased toward exclusion rather than confirmation, driving imaging volumes significantly above disease incidence.
CTPA (computed tomography pulmonary angiography) has become the de facto imaging modality for suspected PE. Since 2004, CTPA utilisation has increased dramatically, with multiple large health systems reporting 4x growth in scan volumes. This expansion has occurred despite the introduction of validated clinical decision rules designed to limit unnecessary imaging.
Diagnostic efficiency has declined alongside this overuse. Across large cohorts, the positive diagnostic yield of CTPA has been reported in the range of approximately 3–10%, meaning 90–97% of patients undergo iodinated contrast exposure without confirmation of PE. Consequently, large volumes of patients are subjected to higher-cost imaging using contrast injections to rule out PE as part of standard emergency and acute care workflows.
Based on aggregated health system utilisation trends, total U.S. CTPA imaging for suspected PE is widely estimated at approximately 4–6.5 million studies per annum, with approximately 5 million scans per year representing a conservative midpoint estimate. This inefficiency creates the commercial opportunity — millions of patients currently receive costly, contrast-requiring scans that often find nothing, representing a workflow ripe for disruption.
| Metric | Current CTPA Standard | CT:VQ™ Advantage |
|---|---|---|
| Annual U.S. PE imaging volume | ~5 million scans | Same workflow access |
| Positive diagnostic yield | 3–10% | Contrast-free assessment |
| Contrast requirement | Iodinated contrast injection | No contrast required |
| Nuclear infrastructure needed | N/A | Not required |
How CT:VQ™ works and why it changes the diagnostic pathway
CT:VQ™ generates quantitative, three-dimensional ventilation and perfusion maps from routine, non-contrast inspiratory and expiratory CT scans. This enables contrast-free functional lung assessment within standard CT workflows, allowing physicians to evaluate lung function without requiring iodinated contrast agents or specialised nuclear medicine infrastructure.
The underlying VQ indication is already FDA-cleared, which reduces regulatory risk. CLEAR is designed to generate the clinical evidence needed to drive adoption in acute PE settings rather than seeking new regulatory clearance. The technology does not rely on new scanner hardware, iodinated contrast agents, or nuclear infrastructure, positioning it for integration into existing hospital imaging workflows.
The CT:VQ technology’s clinical evidence base has been building across multiple indications: peer-reviewed lung surgery validation published in AJRCCM demonstrated a 76% surgical response rate versus 46% under current methods, establishing the kind of outcomes data that underpins physician adoption in high-stakes settings.
The FDA-cleared status de-risks the regulatory pathway while CLEAR builds the clinical evidence base required to drive adoption in high-volume emergency and acute imaging settings.
CLEAR program structure and the Mass General Brigham partnership
CLEAR is a prospective, observational comparison of CT:VQ™ head-to-head with CTPA in patients with suspected acute PE. The study follows a multi-centre, multinational design.
Massachusetts General Hospital serves as the principal enrolling site, with the ability to extend to additional Mass General Brigham hospitals. Mass General Brigham is a leading integrated academic healthcare system and a principal teaching affiliate of Harvard Medical School, known for generating high-quality clinical research and translating it into routine care.
The company has committed approximately US$2 million in total funding to support patient recruitment, imaging analysis, and data generation.
MD/CEO and Founder Andreas Fouras
“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.”
Market expansion math: From US$500 million to US$3 billion
Current market position
4DMedical is already displacing nuclear VQ at pace in its core segment (approximately 1 million scans per annum).
The sixfold opportunity
CLEAR opens the pathway to the approximately 5 million CTPA scans per annum performed for acute PE in the U.S., lifting the company’s obtainable market to US$3 billion per annum. This represents a step-change in scale beyond the core nuclear VQ replacement opportunity.
Management has framed the expansion trajectory as follows: entry into Europe adds approximately 50% to the addressable opportunity, while the PE market entry multiplies the opportunity sixfold.
The European dimension of 4DMedical’s growth strategy took concrete form with the contextflow acquisition, a binding agreement to purchase Vienna-based contextflow GmbH for approximately A$18.56 million, which brings CE-marked products and German insurance reimbursement contracts and removes the need for additional regulatory approvals across European markets.
4DMedical’s market expansion strategy can be summarised as:
- Core nuclear VQ displacement (ongoing) — ~1 million scans
- European market entry — adds approximately 50% to addressable opportunity
- CLEAR program and PE market entry — targets ~5 million scans, US$2.5 billion segment
- Combined U.S. obtainable market post-CLEAR — US$3 billion
Investment thesis: Why CLEAR matters for 4DMedical shareholders
The US$2 million investment to access a US$2.5 billion market segment represents a disciplined capital allocation strategy with compelling risk-adjusted potential. CT:VQ™ is delivered through a Software-as-a-Service model, enabling integration into existing hospital infrastructure without the friction of hardware sales cycles.
The FDA-cleared underlying indication reduces approval risk, while CLEAR generates the clinical evidence required to drive adoption. Management has referenced “leveraging our war chest” to fund growth initiatives, positioning the CLEAR investment as part of a broader capital deployment strategy targeting high-conviction clinical evidence generation.
The announcement demonstrates a clear line-of-sight to commercial expansion in the world’s largest healthcare market, with the potential to extend CT:VQ™ beyond core nuclear VQ replacement into mainstream emergency and acute imaging workflows.
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What comes next
4DMedical will host an investor webinar at 11:00am AEST on Tuesday 9 June 2026, where CEO and Founder Dr Andreas Fouras will discuss recent company developments and host a live Q&A. Registration links are available via the ASX announcement.
CLEAR is designed to “fast-track” CT:VQ™ entry into acute PE, though specific enrolment or completion timelines have not been disclosed in this announcement. Success in CLEAR would position CT:VQ™ to extend beyond core nuclear VQ replacement into mainstream emergency and acute imaging workflows, materially increasing the company’s addressable market without reliance on new scanner hardware, iodinated contrast agents, or nuclear infrastructure.
Want to track 4DMedical’s expansion into the US$2.5 billion pulmonary embolism market?
The CLEAR program marks a strategic inflection point for 4DMedical, targeting a sixfold expansion of its addressable market through contrast-free CT:VQ™ technology. With Mass General Hospital leading clinical validation and approximately US$2 million committed to evidence generation, the company is positioning to disrupt the CTPA-dominated acute PE imaging workflow.
For detailed company updates, project milestones, and investor presentations, visit the 4DMedical investor centre. Stay informed as the CLEAR program progresses and the company executes its strategy to capture a US$3 billion combined U.S. market opportunity.