4DMedical Accelerates CT:VQ™ Market Rollout with $3B US Opportunity and European Expansion

CT:VQ™ Breaks Through Regulatory and Commercial Barriers

4DMedical (ASX:4DX) turned a pivotal corner in FY26, transforming its CT:VQ™ technology from a regulatory milestone to a commercial reality. The US Food and Drug Administration cleared the world’s first non-contrast, CT-based ventilation-perfusion imaging technology in September 2025, swiftly followed by a Medicare reimbursement rate of US$650.50 per scan. This dual breakthrough removes two of the most significant hurdles to adoption, enabling hospitals and imaging centres to confidently integrate CT:VQ™ into routine workflows without additional infrastructure.

CT:VQ™ leverages the existing installed base of roughly 14,500 CT scanners across the US, democratizing access to advanced lung imaging beyond nuclear medicine centres. The potential market is substantial, with over one million nuclear VQ scans annually in the US alone, reimbursed at around US$1,150 each, and a global market estimated at US$2.6 billion. The technology’s promise lies in its ability to deliver comprehensive functional lung assessment without radioactive tracers or contrast agents.

Academic Medical Centres Drive Adoption and Validation

4DMedical’s commercial strategy hinges on securing adoption among leading US Academic Medical Centres (AMCs), which set clinical standards and influence broader healthcare practice. By 30 June 2026, five top-tier institutions, Stanford, Cleveland Clinic, University of Miami, UC San Diego Health, and University of Chicago Medicine, had adopted CT:VQ™ under full commercial terms. Notably, Cleveland Clinic renewed its contract with a three-year subscription featuring committed minimum utilisation, signalling growing confidence in the technology’s value.

This AMC-led approach has paved the way for downstream deals, exemplified by a three-year commercial agreement with SimonMed Imaging, a major outpatient network spanning 170 centres across 10 US states. SimonMed’s immediate commercial deployment of CT:VQ™ without an evaluation phase underscores the technology’s maturing market acceptance and clinical validation. Technical onboarding is complete, with patient scanning imminent, marking a significant expansion into the outpatient setting.

European Expansion and Strategic Acquisitions

Beyond the US, 4DMedical has broadened its regulatory footprint with approvals in the European Union, United Kingdom, Canada, New Zealand, and Australia, totaling six major markets. The acquisition of Austrian AI imaging firm contextflow established a European commercial and regulatory platform, immediately delivering a significant lung cancer screening contract in Germany. This deal covers approximately 25,000 screening procedures across 25 sites over three years and includes prestigious institutions such as Heidelberg University’s Thoraxklinik.

Complementing this, 4DMedical invested in RevealDx and partnered with Azra AI to integrate AI-powered malignancy risk assessment and patient navigation tools into its cardiopulmonary pathway. These moves aim to enhance clinical workflows from disease detection to treatment planning, strengthening the ecosystem around CT:VQ™ and related imaging technologies.

Clinical Evidence Bolsters Market Potential

Clinical validation has been a cornerstone of 4DMedical’s market advancement. A landmark study published in the American Journal of Respiratory and Critical Care Medicine demonstrated that CT:VQ™-guided patient selection improved lung volume reduction surgery response rates from 46% to 76%, potentially increasing procedural success and hospital margins.

Further, the CLEAR clinical evidence program, launched in mid-2026 and anchored at Massachusetts General Hospital, targets the acute pulmonary embolism market. This program pits CT:VQ™ against the current standard CT pulmonary angiography in a prospective, multinational study. Given that five million US patients annually undergo contrast-enhanced scans for suspected pulmonary embolism, with most testing negative, CT:VQ™’s non-contrast approach could disrupt this $3 billion market segment.

Financial Performance and Operational Momentum

4DMedical reported FY26 operating revenue of $7.1 million, a 21% increase over FY25, driven by SaaS product growth and expanding global site penetration. The company delivered 344,075 scans in FY26, up 77%, including a quarterly record of 105,970 scans in Q4, reflecting strong adoption beyond CT:VQ™ to its broader portfolio.

Despite an adjusted net loss of $32.9 million, the company improved its position by 7% year-on-year while reinvesting cost savings into commercialisation efforts. With a robust cash balance of $278 million, 4DMedical is well-capitalised to pursue its aggressive growth strategy.

CEO Andreas Fouras highlighted the strategic progression from early AMC adoption to large outpatient networks and the evolving nature of contracts, including minimum utilisation commitments and Philips’ revenue-backed distribution agreement. This trajectory underscores 4DMedical’s ambition to establish CT:VQ™ as the global standard for functional lung imaging.