4DMedical wins Australian CT:VQ approval as ASX:4DX faces Medicare reimbursement test

4DMedical Limited (ASX:4DX) has received Therapeutic Goods Administration approval for CT:VQ and secured inclusion on the Australian Register of Therapeutic Goods, allowing commercial deployment across Australia. The software converts paired non-contrast chest CT scans into quantitative ventilation and perfusion maps without injected contrast, radiotracers or dedicated nuclear medicine equipment. The approval gives 4DMedical access to a home market with one of the world’s highest CT scanner densities, although meaningful recurring revenue will depend on hospital adoption and future Medicare reimbursement. ASX:4DX opened at A$4.93 and reached A$4.96 before reversing to around A$4.23 during the June 26 session, down approximately 7.4%, showing that regulatory success has not removed valuation and execution concerns.

Why does TGA approval change what 4DMedical can commercially do across Australia now?

Inclusion on the Australian Register of Therapeutic Goods gives 4DMedical the regulatory foundation needed to supply CT:VQ commercially across Australia. Software classified as a medical device generally must be included on the register before it can be legally supplied, unless a specific exemption or exclusion applies. The June 26 decision therefore moves CT:VQ beyond Australian evaluation and pre-commercial engagement into a position where hospitals and imaging providers can proceed toward implementation.

4DMedical has indicated that several Australian sites had engaged with the company while awaiting approval. Those discussions can now progress into technical integration, clinical validation, workflow planning and commercial negotiations. This gives the company an opportunity to build an initial domestic reference network rather than beginning its Australian launch without interested customers.

The regulatory decision does not guarantee that these discussions will become paid contracts. Hospitals must evaluate budgets, clinical utility, information-technology requirements, staff training and how CT:VQ fits within existing diagnostic pathways. Radiologists and referring physicians will also need confidence that the additional functional information changes clinical decisions sufficiently to justify the cost.

The immediate achievement is therefore market access rather than market penetration. Regulatory approval permits 4DMedical to sell the product, but customer implementation and scan utilisation will determine whether the approval produces material revenue.

How could CT:VQ use Australia’s existing CT scanner network to widen lung imaging access?

CT:VQ analyses two reconstructed non-contrast thoracic CT scans, one captured during inspiration and another during expiration. The software quantifies regional ventilation and perfusion across the lungs, producing functional information that would traditionally require nuclear medicine equipment and radiotracers.

Australia has more than 74 CT scanners per million people, which 4DMedical identifies as the second-highest reported CT scanner density worldwide. This creates a potentially attractive deployment environment because many metropolitan, regional and smaller healthcare facilities already possess the underlying imaging equipment required to capture scans for analysis.

The software-only model could be particularly relevant in communities that lack nuclear medicine cameras, radiotracer supply chains or specialist nuclear medicine staff. A regional imaging centre equipped with a suitable CT scanner may be able to provide functional lung assessment without building an entirely new imaging department.

Existing infrastructure does not make deployment effortless. Sites must implement the required inspiratory and expiratory scanning protocol, connect data securely with 4DMedical’s software, integrate reports into radiology workflows and train clinicians to interpret the resulting maps. Differences between scanner configurations and hospital systems may also require technical validation.

The commercial advantage is therefore reduced infrastructure friction rather than zero friction. CT:VQ may be easier to introduce than a new hardware-based imaging modality, but each site still needs a clinical and operational reason to change established practices.

Why is Medicare reimbursement now more important than the regulatory approval itself?

4DMedical is preparing an application to the Medical Services Advisory Committee seeking Medicare Benefits Schedule reimbursement for CT:VQ. The submission is expected to incorporate clinical evidence, health-economic modelling and real-world utilisation data generated through Australian deployment.

The distinction between regulatory approval and reimbursement is crucial. The Therapeutic Goods Administration determines whether a device can be supplied, while the Medical Services Advisory Committee assesses whether a medical service should receive public funding. The reimbursement assessment considers clinical effectiveness, safety, costs and whether the technology represents value for money.

Without an applicable Medicare item, hospitals and imaging providers may need to absorb the cost, charge patients directly, seek private-insurance support or use research and innovation budgets. Those routes can support initial adoption, but they are less likely to generate broad and consistent national volumes.

Medicare reimbursement could change the commercial equation by establishing a recognised payment pathway for scans. It would make CT:VQ easier to incorporate into routine clinical decision-making and reduce the financial barrier for patients and providers.

The reimbursement process may still be lengthy and uncertain. 4DMedical must demonstrate not only that CT:VQ produces useful images, but that its information improves patient management or delivers comparable outcomes more efficiently than existing care. The committee may request further evidence, economic modelling or clarification before recommending public funding.

Australian commercial activity before reimbursement will therefore serve two purposes. It can produce early revenue, and it can generate real-world data to support the larger Medicare case.

Can CT:VQ replace nuclear ventilation-perfusion imaging without creating new workflow barriers?

Traditional ventilation-perfusion imaging commonly uses radiotracers and specialised nuclear medicine equipment to evaluate airflow and blood flow within the lungs. CT:VQ is designed to provide comparable categories of functional information through non-contrast computed tomography and software analysis.

A reader study involving 77 subjects and six experienced radiologists compared CT:VQ perfusion assessments with single-photon emission computed tomography imaging. The reported analysis found good-to-excellent agreement across lung zones, supporting the product’s ability to reproduce clinically relevant perfusion patterns.

That evidence supports regulatory and clinical discussions, but it does not prove that CT:VQ will immediately replace established nuclear imaging. Hospitals have existing protocols, trained employees and reimbursement arrangements built around conventional procedures. Referring clinicians may also continue preferring established tests in certain patient groups or complex cases.

CT:VQ may initially function as an alternative or complementary modality rather than a complete substitute. It could widen access where nuclear medicine services are unavailable, reduce logistical complexity for selected patients or preserve nuclear imaging capacity for procedures that cannot be performed through CT-based software.

The absence of injected contrast and radiotracers may be attractive for patients for whom conventional imaging presents practical or clinical challenges. However, CT:VQ still involves computed tomography and the associated use of X-rays, meaning patient selection and radiation exposure remain relevant considerations.

Commercial adoption will ultimately depend on whether CT:VQ helps clinicians answer important diagnostic questions more quickly, safely or economically. Technical novelty can open a hospital door, but repeat scan volumes usually require demonstrated clinical usefulness.

How does Australian approval strengthen 4DMedical’s wider international commercial strategy?

Australia becomes the sixth major approved geography for CT:VQ after the United States, European Union, United Kingdom, Canada and New Zealand. The expanding regulatory footprint allows 4DMedical to approach multinational imaging groups and hospital systems with a product that can be deployed across several jurisdictions.

United States deployment includes Stanford, Cleveland Clinic, UC San Diego Health, University of Chicago Medicine and University of Miami. Mayo Clinic is evaluating the technology, although an evaluation should not be interpreted as a commercial purchasing commitment.

The commercial agreement with SimonMed Imaging provides another important reference model. SimonMed operates high-volume community imaging centres, which may more closely resemble the environment through which CT:VQ could achieve widespread scan volume than a small number of prestigious academic hospitals.

Australian adoption could strengthen the international case by producing data from a healthcare system with extensive CT infrastructure and a mixed metropolitan, regional and rural population. Evidence of efficient community deployment may be useful when discussing reimbursement and adoption with overseas payers.

The home market also carries reputational importance. International customers may reasonably ask whether an Australian-developed medical technology has been approved and adopted in Australia. The TGA decision removes the regulatory part of that question, although 4DMedical must still demonstrate domestic utilisation.

The global footprint is becoming broader, but deployment announcements must eventually translate into recognised software revenue. Investors should distinguish between regulatory clearances, evaluation sites, implementation contracts and recurring paid scan activity because each represents a different level of commercial maturity.

Does 4DMedical’s A$282.7 million cash position reduce risk or raise the investment hurdle?

4DMedical reported a pro forma cash position of approximately A$282.7 million following institutional capital raisings completed during early 2026. The company raised A$150 million in January and a further A$83 million in March, giving it substantial funding for commercial expansion, clinical programs, product development and acquisitions.

Operational momentum has accelerated. The company reported 477 deployed sites at the end of the March quarter, up 32% from a year earlier, while quarterly scan volumes increased 79% to 86,200. Around 240,000 scans were processed during the first nine months of fiscal 2026.

Financial monetisation remains at a much earlier stage than the operating footprint. Fiscal 2026 year-to-date operating revenue was approximately A$5 million, despite growing deployment and scan volumes, while March-quarter operating cash outflow reached A$10.2 million. Gross margins were reported above 90%, and underlying software-as-a-service revenue increased 24%, but the absolute revenue base remains small relative to the company’s cash balance and market valuation.

The strengthened balance sheet materially reduces near-term financing risk. 4DMedical can invest in reimbursement evidence, hospital integrations and global commercial teams without immediately returning to shareholders for capital.

However, abundant cash also raises the standard against which management will be judged. Investors will expect the company to convert spending into recurring revenue rather than merely expanding the number of trials, sites and product announcements.

Acquisitions and international expansion can accelerate growth, but they can also increase organisational complexity and cash consumption. Capital discipline will matter because the company has already received substantial funding at a valuation that assumes significant future success.

In my assessment, the balance sheet gives 4DMedical enough time to prove the model. It does not reduce the need to prove that each additional scan and hospital deployment produces attractive recurring economics.

Why did ASX:4DX reverse sharply after opening higher on the June 26 TGA announcement?

ASX:4DX opened at A$4.93 after the approval announcement and briefly traded at A$4.96 before falling to around A$4.23 during the session. The intraday movement represented a decline of approximately 7.4% from the previous A$4.57 close, despite the positive regulatory news.

The reversal suggests that some investors had anticipated Australian approval or used the initial price strength to realise gains. The shares had already risen sharply during June, including a 17.6% gain on June 19 and further appreciation during the following sessions.

At approximately A$4.23, the shares were about 6.8% lower than their June 19 close, but roughly 27% above the May 26 close of A$3.32. The stock remained within an exceptionally wide 52-week range of A$0.23 to A$7.55, trading approximately 44% below the high while remaining more than 17 times above the low.

This performance illustrates the tension in the investment case. Regulatory approvals, hospital deployments and a large cash position have materially improved 4DMedical’s commercial probability. At the same time, the share price already reflects expectations that CT:VQ will achieve substantial global adoption.

The limited analyst sample reinforces that uncertainty. Public consensus data covering three analysts indicates an average recommendation around Hold and an average target of approximately A$4.97, with estimates ranging from A$3.00 to A$6.00. The wide range indicates disagreement over how quickly commercial revenue can justify the valuation.

The June 26 decline does not invalidate the regulatory achievement. It indicates that investors are moving beyond asking whether CT:VQ can obtain approvals and are increasingly asking how rapidly those approvals will generate revenue.

What should investors watch before Australian approval becomes material recurring revenue?

The first indicator will be the number and quality of Australian implementations. Investors should look for named hospital systems, radiology groups and regional imaging providers moving from discussions into operational deployment.

The second indicator will be scan utilisation after installation. A site announcement has limited financial value if clinicians order only a small number of scans. Growth in recurring scan volumes and revenue per site will provide better evidence of product adoption.

Progress toward a Medical Services Advisory Committee application will be the most important policy milestone. Investors should monitor submission timing, the proposed Medicare service model, the clinical comparator and any requests for additional evidence.

Australian clinical data will also matter. Evidence that CT:VQ changes patient management, reduces delays, improves access or lowers total diagnostic costs would strengthen both reimbursement and hospital purchasing arguments.

Financial disclosures should show whether operating revenue is beginning to grow faster than the cost base. The existing cash position provides substantial runway, but recurring revenue and improving cash efficiency will ultimately determine the quality of the business model.

The June 26 approval removes a genuine regulatory obstacle. The next stage will be more commercially demanding because 4DMedical must turn permission to sell into routine use, public reimbursement and repeatable software revenue.

What are the key takeaways from 4DMedical’s CT:VQ approval and ASX:4DX outlook?

• Therapeutic Goods Administration approval and Australian Register of Therapeutic Goods inclusion allow CT:VQ to be supplied commercially in Australia.
• The software produces ventilation and perfusion information from paired non-contrast CT scans without radiotracers or nuclear medicine infrastructure.
• Australia’s high CT scanner density creates a potentially scalable market, particularly outside major nuclear medicine centres.
• Regulatory approval does not provide Medicare reimbursement, making the planned Medical Services Advisory Committee application the next major commercial hurdle.
• Early Australian deployments can generate revenue while producing real-world evidence for the reimbursement submission.
• CT:VQ may complement or replace conventional ventilation-perfusion imaging in selected settings, but clinician adoption and comparative evidence remain essential.
• Approval across six major geographies strengthens 4DMedical’s international positioning and negotiations with multinational imaging providers.
• The A$282.7 million pro forma cash position reduces near-term funding risk but increases expectations for disciplined commercial execution.
• ASX:4DX reversed from an opening gain to trade around 7.4% lower on June 26, indicating that approval was partly anticipated and valuation concerns remain.
• The next valuation catalysts are Australian contracts, scan utilisation, Medicare progress, recurring revenue growth and improved cash efficiency.