4DMedical (ASX: 4DX) has closed FY26 with strong growth in scan volumes and customer sites, as its CT:VQ lung imaging technology moved from regulatory approval into commercial deployment across multiple markets.

The respiratory imaging company reported FY26 operating revenue of $7.1 million, up 21% on FY25, with gross margins above 90%. It finished the year with $278 million in cash at 30 June — a balance sheet that far exceeds annual revenue, giving the company substantial funding to continue expanding its technology platform and commercial footprint without near-term reliance on external capital.

A major focus of the year was the rollout of CT:VQ, which received US FDA clearance in September 2025 and subsequently secured a CMS reimbursement rate of US$650.50 per scan. That reimbursement coding is a key commercial enabler in the US healthcare system, as it determines what hospitals and imaging providers can be paid for performing the scan. During FY26, CT:VQ received regulatory authorisation across the EU, UK, Canada, New Zealand and Australia, bringing its total number of approved markets to six including the US.

The technology uses standard CT scans to generate ventilation-perfusion information without requiring radioactive tracers or contrast agents. This differentiates it from conventional nuclear medicine ventilation-perfusion imaging, which involves radioactive materials and specialised imaging equipment, and CT pulmonary angiography, which requires iodinated contrast — limiting their use in patients with kidney impairment or allergies.

By the end of FY26, five major US academic medical centres had adopted CT:VQ commercially: Stanford University, Cleveland Clinic, UC San Diego Health, University of Miami and University of Chicago Medicine. 4DMedical also signed a three-year agreement with SimonMed Imaging, giving CT:VQ access to an outpatient network spanning more than 170 imaging centres across 10 states.

Clinical data also provided a boost during the year. Research published in the American Journal of Respiratory and Critical Care Medicine found that using CT:VQ to select patients for lung volume reduction surgery increased the proportion responding to the procedure from 46% to 76%.

The company also launched CLEAR, a multinational clinical program led by Massachusetts General Hospital targeting the acute pulmonary embolism market. According to 4DMedical, this expands the potential US market for CT:VQ to around US$3 billion.

Operational metrics continued to climb, with the company's SaaS products now deployed across 540 sites globally, a 39% increase from June 2025. 4DMedical generated 344,075 scans during FY26, up 77% year-on-year, including a record 105,970 scans in the June quarter.

4DMedical said its existing product portfolio remains the main contributor to scan growth, while CT:VQ is expected to make an increasing contribution as commercial adoption expands. The rate at which newly authorised international markets convert into paid scan volumes, and the progress of the CLEAR program, will shape how quickly that shift occurs.

Source: The Market Online Australia