2025 was a defining year for 4DMedical (ASX: 4DX), marked by major advances across its clinical, regulatory, and commercial programs.
The company strengthened every part of its respiratory imaging business – from technology development and clinical trials to commercial partnerships and scalable operational systems.
The transformation was driven by landmark US FDA clearances, rapid growth in its subscription-as-a-service (SaaS) offering, expanding distribution channels, and increasing global adoption of its technology.
Above all, 4DMedical’s standout achievement was securing FDA clearance for its breakthrough CT:VQ platform – a milestone that could see the company reshape respiratory diagnostics.
A step change in lung health
In August, the company nailed down FDA clearance for a commercial rollout of its third generation respiratory imaging product, CT:VQ.
Unlike historical advancements in medical imaging, such as the introduction of MRI, this technology is instantly compatible with an install base of 14,500 CT scanners already deployed across the US.
In essence, it unlocks the ability for any CT scanner to perform high-resolution, non-contrast ventilation-perfusion imaging.
This shift removes major barriers that limit traditional nuclear ventilation-perfusion (VQ) scans.
Technological advancement
CT:VQ is the world’s first non-contrast CT-based ventilation-perfusion (VQ) imaging technology.
In other words, it is the first technology to deliver perfusion imaging without injected contrast, enabling clinicians to assess lung function without radioactive agents or specialised equipment.
Compared to traditional nuclear VQ scans – which take about an hour and expose patients to radioactive tracers – CT:VQ is free of injections, faster, and more widely accessible given the abundance of CT scanners across the US.
Multibillion-dollar opportunity
More than one million nuclear VQ scans are performed in the US each year.
And 4DMedical believes CT:VQ has the potential to capture much of this US$1.1 billion domestic market, as well as a significant portion of the US$2.6 billion global opportunity.
Beyond replacing existing scans, CT:VQ may also expand into new applications such as chronic respiratory disease monitoring, surgical planning, and lung cancer screening, where safer and more efficient imaging is urgently needed.
Regulatory tailwinds
Following FDA approval, 4DMedical also secured US Medicare reimbursement for CT:VQ.
More specifically, the US Centers for Medicare & Medicaid Services confirmed reimbursement for the CT:VQ technology at US$650.50 per scan, on top of the healthcare provider’s standard chest CT payments.
Reimbursement certainty removes a major barrier to adoption and positions the platform for rapid uptake across hospitals, outpatient clinics, and imaging networks nationwide.
US growth accelerates
Within two months of FDA clearance, US adoption was underway.
Stanford University became the first American academic medical centre to implement CT:VQ under a commercial contract, soon followed by the University of Miami.
4DMedical also secured at least US$10 million in early CT:VQ orders through its North American distribution agreement with Philips signed late last year.
Most products are now live in the catalogue, IT integration is complete, and more than 200 Philips sales professionals have been trained to sell 4DMedical’s solutions.
Under the agreement, Philips will add CT:VQ to its North American product portfolio, distributing the technology through its established channels in the US and Canada.
Notably, Philips’ long-standing presence within the Department of Veterans Affairs and Department of Defense provides a direct pathway to high-value respiratory care markets.
Strong operational performance and customer growth
4DMedical delivered robust operational results even prior to FDA clearance.
FY25 operating revenue rose by 56 per cent year-on-year, with underlying SaaS revenue nearly doubling.
Global utilisation also increased, with nearly 200,000 scans completed across 388 sites – 74,000 of which occurred in the June quarter alone.
Total income in FY25 reached $16.5 million, including $5.9 million in operating revenue, reflecting growing customer demand and the early impact of US commercial expansion.
Advancing clinical leadership
During the year, 4DMedical also strengthened its position as a scientific leader in respiratory diagnostics, with peer-reviewed publications growing across multiple clinical applications.
For instance, a study conducted with Vanderbilt, Miami, and the Alfred hospitals demonstrated that the company’s XV Technology could replicate surgical biopsy results in detecting deployment-related constrictive bronchiolitis among US veterans, with up to 98 per cent agreement.
These findings highlight the platform’s clinical precision and its potential to improve outcomes for patients exposed to toxic environments.
Positioned for scale
2025 marked a decisive shift in 4DMedical’s trajectory.
The company enters the new year with a leaner operating model, an expanding customer base, and a breakthrough technology positioned to redefine lung diagnostics.
CT:VQ represents a major inflection point – opening significant US market opportunities and positioning 4DMedical for growth on a global scale.