Category: Healthcare

4DMedical Limited (ASX:4DX) released its FY26 full year results on 28 August 2026 for the year ended 30 June 2026. Operating Revenue was $7.1 million, up 21%, with gross margins above 90%. Underlying SaaS revenue rose 23%, the company delivered software at 540 sites globally (up 39%), and it produced 344,075 scans, up 77%, including a record 105,970 in the fourth quarter.

The company reported an adjusted net loss of $32.9 million, an improvement of 7% on $35.3 million in FY25. The statutory result includes a non-cash expense of $164.6 million from Fair Value measurement of the Equity component of the Pro Medicus facility, which the company said involves no cash outflow. Other income was $7.5 million against $10.6 million, and the cash balance was $278.0 million.

4DMedical is a respiratory imaging technology company that delivers XV Technology, CT:VQ and related software through a software-as-a-service model, and it has added AI capabilities through its 2023 Acquisition of Imbio and 2026 acquisition of contextflow.

Recent Development

In its 28 August 2026 announcement, 4DMedical described FY26 as the year CT:VQ moved from regulatory milestone to commercial product. The FDA cleared CT:VQ in September 2025, described as the first non-contrast, CT-based ventilation-perfusion imaging technology, and US reimbursement was confirmed at US$650.50 per scan. Five US academic medical centres, Stanford, University of Miami, Cleveland Clinic, UC San Diego Health and University of Chicago Medicine, were operating under full commercial terms at 30 June 2026, and Cleveland Clinic has since renewed under a three-year agreement with committed minimum utilisation.

Commercial arrangements widened. SimonMed Imaging, a network of more than 170 sites across 10 states, signed a three-year agreement in May 2026 with no evaluation phase, although its sites are not included in reported site numbers. Philips will distribute CT:VQ across the United States and Canada with a minimum order commitment for calendar 2026 and 2027.

Regulatory approvals reached six markets, including the EU (CE Mark in March 2026), the UK (UKCA in April 2026), Canada, New Zealand and Australia, where TGA listing in June 2026 was followed by paid contracts with several imaging providers. The company launched the CLEAR pulmonary embolism evidence program in June 2026 with Mass General Brigham, backed by about US$2 million of funding, and cited a publication showing CT:VQ-guided selection lifted response rates to lung Volume reduction surgery from 46% to 76%.

In Europe, contextflow was selected for a lung cancer screening deployment led by Curagita covering about 25,000 procedures across 25 German sites over three years. 4DMedical also invested about US$3.4 million (A$4.9 million) for a 10% interest in RevealDx and agreed a commercial arrangement with Azra AI, and completed placements of $150 million at $3.80 per share in January 2026 and $83 million at $5.90 per share in March 2026.

Sector Context

4DMedical operates in respiratory diagnostics, where the company estimates over one million nuclear VQ scans are performed annually in the United States at an average reimbursement of about US$1,150, implying an initial addressable market above US$1.1 billion in the US and over US$2.6 billion globally. Through CLEAR, it estimates the obtainable US market rises to US$3 billion from about US$500 million by adding acute pulmonary embolism, which it says involves around 5 million scans per year.

Health systems adopt new imaging with caution, and the company noted academic medical centres apply demanding evidence and procurement standards. Lung cancer screening programs, including Australia's National Lung Cancer Screening Program and emerging German screening, are also creating Demand for AI-assisted analysis, while pharmaceutical companies such as AstraZeneca and GSK are using the company's imaging analytics.

Risks and Uncertainties

Scale remains small relative to costs. Revenue of $7.1 million compares with an adjusted net loss of $32.9 million, other income fell 29% from $10.6 million to $7.5 million, and the company said savings from its FY25 cost reduction program were reinvested in commercialisation. Scan volume growth was primarily driven by the established product portfolio rather than CT:VQ, which is expected to contribute increasingly as adoption scales.

Market estimates are management's own, and several agreements are early stage: one US academic centre has completed a 90-day evaluation and is working toward a commercial agreement, a European key opinion leader site for CLEAR is still in discussion, and an application to the Medical Services Advisory Committee for Australian Medicare reimbursement is only in preparation. The Pro Medicus fair value charge is remeasured each balance date by reference to the share price, so it can vary.

What to Watch Ahead

4DMedical said its focus for FY27 is conversion, turning regulatory access, evidence and reimbursement pathways into routine scan volume. Catalysts include first patient scanning across the SimonMed network, Philips distribution activity, the conversion of the US academic centre evaluation into a commercial agreement, results from CLEAR and the Australian reimbursement application.

Other items include integration of contextflow, delivery of the Curagita screening contract, the rollout of RevealDx and Azra AI, further Australian public hospital pilots and quarterly updates on sites and scans.

The Bottom Line

4DMedical's FY26 update showed higher revenue, sites, scans and cash and a smaller adjusted loss, alongside lower other income and a large non-cash statutory charge. Conversion of CT:VQ agreements into scan volume is the next reference point.