4DMedical Limited (ASX:4DX) closed at AUD 4.07 on 6 October and in a year, it has recorded 80% rise in share price. The respiratory imaging company released its FY26 full year results and Appendix 4E for the year ended 30 June 2026 on 28 August 2026, with figures in Australian dollars unless stated.

Across the broader market, the S&P/ASX 200 Health Care index [XHJ] (INDEXASX: XHJ) stood at 31,982.20, up 0.63% (+200.50 points) as of 6 October, and is down 16% over the past year. Meanwhile, the S&P/ASX 200 stood at 8,735.70, up 0.57% (+49.30 points) at the same time, and is down 2.74% over the year.

Business Model and Operational Footprint

4DMedical is a global medical technology company in respiratory care, using its XV Technology and artificial intelligence to turn standard scans into functional lung information. It is headquartered in Melbourne with a Los Angeles presence, and it delivers Software-as-a-Service (SaaS) products at 540 sites globally, up 39% from 30 June 2025.

Its lead product, CT:VQ, was cleared by the FDA in September 2025 as the first and only non-contrast, CT-based ventilation-perfusion imaging technology. It uses routine CT scans without radioactive tracers or contrast agents and can use the installed base of about 14,500 CT scanners across the US. Commercial partners include SimonMed Imaging, a 170-site network in 10 states, and Philips, with a North American commercial contract carrying contractual minimum Revenue targets. The company acquired contextflow, adding a European footprint, and invested about US$3.4 million (A$4.9 million) for a 10% interest in RevealDx.

Sector Dynamics

Functional lung imaging currently relies largely on nuclear ventilation-perfusion scans. The company states that more than one million nuclear VQ scans are performed in the US each year at an average reimbursement of about US$1,150, an initial US addressable market above US$1.1 billion and over US$2.6 billion globally.

CT:VQ received CMS reimbursement of US$650.50 per scan, payable in addition to routine chest CT fees, and regulatory authorisation in six markets: the United States, European Union, United Kingdom, Canada, New Zealand and Australia. The company is adding clinical evidence, including a publication in the American Journal of Respiratory and Critical Care Medicine reporting that CT:VQ-guided patient selection lifted response rates to lung Volume reduction surgery from 46% to 76%.

FY26 Results Update

Operating revenue was $7.1 million, up 21%, with gross margins above 90%, and underlying SaaS revenue was up 23%. The company produced 344,075 scans, up 77%, including a record 105,970 scans in the fourth quarter. Other income was $7.5 million, comprising government grants and the Research and Development tax incentive, down from $10.6 million in FY25.

The adjusted net loss was $32.9 million, an improvement of 7% on $35.3 million in FY25, as savings from the FY25 cost reduction program were reinvested into commercialisation. The statutory result includes a non-cash expense of $164.6 million for the Fair Value measurement of the Equity component of the Pro Medicus facility, which is remeasured at each balance date by reference to 4DMedical's share price. The company states that this charge is unrealised, involves no cash outflow and does not reflect operating performance. Cash at 30 June 2026 was $278.0 million.

Commercial milestones included adoption of CT:VQ by Stanford University, Cleveland Clinic, UC San Diego Health, University of Miami and University of Chicago Medicine under full commercial terms, a three-year agreement with SimonMed, and TGA approval in Australia in June 2026 followed by paid contracts. The CLEAR clinical evidence program, anchored at Massachusetts General Hospital, targets acute pulmonary embolism and lifts the obtainable US market to US$3 billion by the company's estimate. Partnerships include AstraZeneca in Brazil's lung health screening program, a GSK imaging analytics contract, and a lung cancer screening deployment led by Curagita covering about 25,000 procedures across 25 German sites over three years.

Growth Catalysts and Critical Operating Risks

The company states that its focus for FY27 is conversion, turning regulatory access, evidence, reimbursement pathways and commercial footprint into routine, at-scale scan volume. Catalysts named include the Philips distribution contract, the SimonMed rollout following technical onboarding, expansion of the CLEAR program with a European key opinion leader site, and cross-selling of the contextflow, RevealDx and Azra AI products.

The release also contains figures that frame operating risk. Operating Revenue of $7.1 million is small relative to an adjusted net loss of $32.9 million and the statutory charge of $164.6 million. Other income from grants and the R&D incentive fell by $3.1 million. The company noted that academic medical centres are slow to win, and the pace of conversion from adoption to scan volume, reimbursement conditions, regulatory timing in new markets, and integration of acquired businesses remain uncertain. The statutory result will also move with the company's share price because of the Pro Medicus Facility remeasurement.

The company further reported a significant runway of cash to execute on its short and long-term objectives, and noted that it is delivering SaaS products at 540 sites with scan volumes of 344,075 in the year while reducing cash burn. Founder and CEO Andreas Fouras described FY26 as the year the lead product reached the market.

The Bottom Line

4DMedical's FY26 shows operating revenue of $7.1 million, up 21%, 344,075 scans, up 77%, an adjusted net loss of $32.9 million and cash of $278.0 million. The statutory result includes a $164.6 million non-cash charge linked to the Pro Medicus facility. The company has described FY27 as a year of conversion, with CT:VQ authorised in six markets and commercial agreements in place in the US.