Key Highlights

• 4DMedical is an Australian respiratory imaging company.

• The company says it received FDA clearance in September 2025, and that US reimbursement of US$650.50 per scan was confirmed shortly afterwards.

• It has since been authorised in six markets, including the EU, the UK, Canada, New Zealand and, in June 2026, Australia.

• Net operating cash outflow was A$15.2 million, including A$0.8 million of one-off costs linked to the contextflow acquisition.

How far has 4DMedical (ASX:4DX) turned regulatory approvals into recurring revenue? The September 2026 quarter offers the clearest evidence yet that scan volumes are rising quickly, although revenue remains small relative to the cash being spent. Unaudited Operating Revenue for the first quarter of FY27 was A$2.3 million, up 66% on the prior corresponding period, while scan analyses reached 119,672, up 61% of the company's Quarterly Report published around 27 to 28 October 2026.

What the company does

4DMedical is an Australian respiratory imaging company. Its software analyses X-ray and CT data to show how air moves through the lungs, offering a functional view of ventilation that conventional scans do not provide. Products are sold largely as software-as-a-service, so revenue depends on subscribing sites and scan volumes.

The newest product is CT:VQ, which derives ventilation and perfusion information from CT scans. The company says it received FDA clearance in September 2025, and that US reimbursement of US$650.50 per scan was confirmed shortly afterwards. It has since been authorised in six markets, including the EU, the UK, Canada, New Zealand and, in June 2026, Australia.

The September quarter in numbers

Gross Margin was above 90%, the SaaS install base reached 724 sites (up 77% year on year and 34% from the end of FY26), and cash stood at A$242.8 million at 30 September 2026, compared with about A$278.0 million at the end of June.

The cash decline reflects two things. Net operating cash outflow was A$15.2 million, including A$0.8 million of one-off costs linked to the contextflow acquisition. Investing outflows were A$22.5 million, which included an A$18.0 million completion payment for contextflow and A$4.9 million for an Investment in RevealDx.

FY26 results in context

The quarter follows full-year results released on 28 August 2026. For the year to 30 June 2026, operating revenue was reported at A$7.1 million, up 21%. Scans totalled 344,075, up 77%, including a record 105,970 in the fourth quarter.

The adjusted net loss was A$32.9 million, an improvement of 7% on A$35.3 million a year earlier. The statutory result is far larger because it includes a non-cash charge of A$164.6 million tied to the Fair Value of the Equity component of the Pro Medicus funding facility.

The Balance Sheet was strengthened by equity raisings: A$150 million at A$3.80 per share in January 2026 and A$83 million at A$5.90 per share in March 2026. Those proceeds explain why cash remains substantial despite the ongoing losses.

Why the revenue gap matters

The central tension is easy to state. Scan analyses are growing at a rate of 60% or more, yet quarterly revenue of A$2.3 million is modest beside an operating cash outflow of A$15.2 million for the same three months. Management's stated focus for FY27 is conversion, meaning turning approvals, distribution agreements and installed sites into paid scan volume.

Evidence of progress includes the SimonMed agreement, signed in May 2026, which covers more than 170 outpatient sites across ten US states over three years.

Other recent developments

The company completed its Acquisition of contextflow. A related Curagita arrangement in Germany is expected to cover about 25,000 lung cancer screening procedures across 25 sites over three years.

Separately, the AIRCARE for Vets Act, which would authorise US$20 million for a Department of Veterans Affairs pilot of functional lung imaging, has been introduced in the US House. It is a bill, not law, and its passage is uncertain. Neither item should be treated as assured revenue.

Sector conditions and competition

The company estimates more than one million US ventilation-perfusion scans a year at an average of about US$1,150, giving an initial addressable market above US$1.1 billion in the US and over US$2.6 billion globally. These are management estimates rather than independent figures.

The company's CLEAR programme, launched in June 2026 with about US$2 million of funding, aims to test CT:VQ in acute pulmonary embolism. If successful, management says the obtainable US market could rise from about US$500 million to about US$3 billion, adding roughly five million acute scans a year. A clinical readout is targeted for calendar 2027.

Competition comes from established nuclear medicine scans and CT angiography, which clinicians know well. Persuading hospitals to adopt a newer software layer requires clinical evidence, reimbursement certainty and workflow integration.

Risks and what to watch

Key risks include slower-than-expected conversion of installed sites into scan volume, continued cash consumption, reliance on a small number of distribution and customer relationships, and the possibility that reimbursement or regulatory conditions change. Integration of contextflow adds execution demands, and further acquisitions or investments would draw on cash. The CLEAR readout may not support the broader indication, and legislative proposals may not progress.

Upcoming points to monitor include the next quarterly report, further disclosure of Recurring Revenue per site, cash burn relative to revenue, and any update on the CLEAR study timetable. A single quarter should be read cautiously.

Overall, scans and sites are growing quickly from a small base. Whether that becomes sustainable revenue and narrower losses remains the open question.