4DMEDICAL LTD (4DX) - Reinventing Lung Imaging

A lung scan can do more than show a shadow on an image. We sit down with Dr Andreas Fouras, MD, CEO and founder of 4DMedical, to talk about the shift from “how the lung looks” to “how the lung works” and why functional lung imaging is becoming a commercial reality across Australia, Europe and the United States.

We dig into the binding agreement to acquire Austria’s contextflow and why an established Vienna-based team with existing insurance reimbursement contracts in Germany can beat a slow greenfield build. Andreas explains the uncomfortable truth in medtech: FDA clearance and CE marking open doors, but reimbursement is what builds a durable business. We also explore how adding AI lung cancer screening and workflow tools complements CT:VQ™  and CT:VQ™ , creating a fuller clinical pathway from screening through to functional assessment and procedure planning.

Closer to home, we cover the TGA approval and ARTG inclusion for CT:VQ™   and why Australia’s high CT scanner density makes a software-only, non-contrast solution so compelling. From there we head to the US, looking at adoption at leading sites and the commercial meaning of the SimonMed Imaging agreement across 170 outpatient centres, including the value of health economics data for payer conversations. If you want a clear view of what to watch through 2026, we outline the practical metrics that matter: site wins, network progress and the scan volumes that drive SaaS revenue. Subscribe, share the episode with a mate, and leave a review to help more listeners find ASX Briefs.

Transcript

Andrew Musgrave

Welcome back to ASX Briefs, and joining me today is Dr. Andreas Fouras, the MD, CEO and founder of 4DMedical, a global leader in respiratory imaging technology. It's been an extraordinary run of announcements for the company. From a binding agreement to acquire Austrian medical technology company contextflow, establishing an immediate commercial platform in Europe through to a commercial agreement with SimonMed Imaging's 170-site Outpatient Network in the US, and most recently TGA approval for CT:VQ™ here at home in Australia. Andreas, thanks for joining me today and welcome to the ASX Briefs Podcast.

Andreas Fouras

Thank you. It's great to be here.

Andrew Musgrave

Now, Andreas, it's been a busy few months for the company. So, before we touch on recent announcements, can you just provide a brief overview of the company to our listeners?

Andreas Fouras

We are bringing a revolution to lung imaging that has, you know, that arrived decades earlier to heart imaging and brain imaging. You know, those the lung we felt as somewhere that's been left behind. And it's been left behind in that imaging in the lung has typically been limited to or has only been easy to do to give a picture of just how the lung looks. We also show you a picture of how the lung works.

Andrew Musgrave

Okay, and let's start with the contextflow binding agreement. Can you explain what this business does and why it was the right fit for 4DMedical's European ambitions?

Andreas Fouras

Great young start up over in Europe, and they've been making really great success, you know, good success in winning reimbursement contracts with insurers in Europe. And I think that, you know, folks certainly who follow us or who follow healthcare know that FDA is the first hurdle, but really getting reimbursement contracts, getting paid by the insurers is really the, you know, is really the real win. And seeing them able to deliver that really just demonstrates that they have a great team, and they understand, you know, how the business of healthcare works.

Andrew Musgrave

And the deal gives 4DMedical and immediate boots on the ground presence in Europe via an experienced Vienna-based team. So why was buying an established platform preferable to building a green field presence?

Andreas Fouras

We've only just really, you know, we've only just completed a capital raise fairly recently. And so, you know, last year as we were heading into getting European clearances, we didn't have the cash position back then to start, you know, what would probably be a 12-month process to, you know, to go build a team from scratch. And now that we did have the capital and this really exciting opportunity to acquire contextflow came up, it really opened the door for us. You know, normally there's a you know, different folks have different ways of expressing this rule, but you know, there's a there's a basic law of the universe, right, that says that, you know, you can do something well, you can do it fast, or you can do it cheap, right? You've got to pick two maybe at best. And this opportunity really allowed us to get that very rare three out of three for you know establishing ourselves in Europe.

Andrew Musgrave

And contextflow brings a CE marked lung cancer screening solution and existing insurance reimbursement contracts in Germany. So how significant is that existing commercial traction to the company's near-term plans in Europe?

Andreas Fouras

It's a great starting point. And I think those conversations they've been having, those relationships, those boots on the ground, you know, really are a great machine to be able to take our VQ product, our CT:VQ™ product, and sell that into, you know, sell that into Europe. But additionally, we're going to be able to take that lung cancer screening technology they've built, get it, you know, TGA approved for Australia, FDA approved for the US, and allow that to sort of fill out our portfolio. And we know, you know, from a hard-earned experience that in particular in the US, customers want a full stack or a full-service offering. And being able to offer lung cancer screening side by side with our other products, in particular CT:VQ™, is going to be something our US customers want.

Andrew Musgrave

And you've said 4DMedical has grown its addressable market opportunity by 50% for only 6.5% of the company's existing cash balance with less than half percent of shareholder dilution. Can you put that into context for investors?

Andreas Fouras

We've been talking very clearly about the initial opportunity, the centre of the bullseye, if you like, in the US of being a you know, $500 million per year opportunity for CT:VQ™ in the US. And, frankly what we see as another 250 million US per year opportunity for a CT:VQ™ market in Europe. We've been able to do that for a total cost of acquisition of $30 million and a cash position of you know less than 10 million in cash to do that. So, and then the icing on the cake is that there's you know that there's $20 million of tax credits, tax debts attached to that business as well. So, over the long term, in fact, it gets even more attractive.

Andrew Musgrave

And contextflow's technology, which is AI-based lung cancer detection and workflow tools, is described as complementary to 4DMedical's existing portfolio. How does this deepen the company's offering across the full clinical pathway from screening through to functional assessment?

Andreas Fouras

Yeah, so there's two key pieces to that. One, I already briefly mentioned, which is that we know our customers want a full-service offering. If they're having a partner like 4DMedical to provide lung technology, they don't want to have another two or three lung technology partners there. There's real friction to them of having those additional suppliers, especially in parts of healthcare like ours that have risks of you know that they have to manage patient data across. But additionally, and in some ways, you know, more exciting than that, is that you know, when folks get lung cancer screening, there's two things that happen. Number one is of course you may find some lung cancer in there. And, you know, downstream of that, there's going to be, for example, either typically you know, either just goes from observation, or if it's more serious, you know, it'll go for biopsy or for surgery. And in both of those biopsy and surgery pathways, our CT:VQ™ technology is a key part of delivering that procedure. So, we sit really nicely downstream of that testing. Or alternatively, in fact, for every time you find a cancer, five times as often you find something else, you find emphysema or pulmonary fibrosis. And once again, our technology sits ready and waiting downstream of that as well. So, it really creates a position where we can follow the patient along their journey, and that really multiplies the value for both the patient and the doctor.

Andrew Musgrave

Now, what are the key conditions and milestones still ahead before this transaction completes? And when do you expect that to occur?

Andreas Fouras

We believe that the final the final steps are a formality. Both Austrian law and European law require there to be an oversight of foreign acquisitions of assets. So, it's really you know equivalent of an Australian foreign investment review. And given the size of the company and the fact that it was low on cash, we firmly believe that both the Austrian and European authorities will give this the tick of approval. And you know, within something that's probably closer to weeks and months, we should have that all signed up.

Andrew Musgrave

Turning now to Australia, CT:VQ™ has now received a TGA approval and been included on the ARTG. What does this approval unlock for the company here at home?

Andreas Fouras

Well, for me, first and foremost, it's always exciting when the technology we've worked so hard to build and to take and export to the rest of the world can be available to Australian patients. It's really, you know, we are very proudly a very heavily Aussie company. The overwhelming majority of our workforce is here in Australia, and you know, very heavy Australian investment base. So, when we can deliver better healthcare to Australians that we get really excited about. And you know, this technology really allows us to do to do just that.

Andrew Musgrave

CT:VQ™ now holds regulatory clearance across the US, Europe, UK, Canada, and New Zealand, and now Australia. How does each additional approval compound the value of the ones before it in terms of clinical evidence, reimbursement precedent, and physician familiarity?

Andreas Fouras

If we give the example of Australian doctors looking at CT:VQ™, you know, I think we can see how they will get confidence by the fact that it's been approved in Europe and we're rolling out in Europe, that it's been approved in the US, and in fact that leading sites like you know, like Mayo, Cleveland Clinic, Stanford are adopting, adopting the technology. But it does in in both directions. And you know, certainly I think you know insurers in the United States do like to see that there's insurance happening in Europe and do like to see that in the home country of the of the product, you know, that it's being rolled out and delivered. So, I think no one really likes to be left out on a limb and feel like they're taking a risk. And by just having it happening across the globe, or at least on three keys, you know, three important continents across the globe, just gives everyone that confidence that, you know, it seems to them like a no-brainer. And you know, and that evidence across the ocean seems to support that and back it up.

Andrew Musgrave

And Australia has one of the highest CT scanner densities in the world. Why does that make this market such a compelling opportunity for a software-only non-contrast solution like CT:VQ™?

Andreas Fouras

Kind of like the two edges to that cut. And you know, one of them is that if somebody wants to get a VQ scan in Australia, the infrastructure is here right now as a result of our technology, you know, on every CT scanner across the country. And you know, so it really means that right now, today, that a vast number of places someone can go and get that test today, you know, using our software. Because the alternative would be, either to use nuclear imaging equipment, which of which there is far less and you know, for which there are far better uses, you know, really high-tech life-saving use cases for nuclear imaging equipment. Or alternatively, if we wanted to develop and build a new generation of scanner, you know, to roll out with that same density would literally cost you know tens of billions of dollars to put that infrastructure out across the country. So, whether it's because we're saving you know the development of you know a whole new tier of infrastructure, or because right now, today, folks can just go out and get the test at a place that's convenient to them.

Andrew Musgrave

And what's driving that pace of adoption since FDA clearance last September at medical centres such as Stanford, Cleveland Clinic, and UC San Diego Health?

Andreas Fouras

The kind of 10-second version of this is that we show folks what CT:VQ™ can do. They're surprised, you know, they're amazed by the capability, and they immediately see opportunities for their patients. And so that gets us meetings with doctors where, you know, which are which are often really hard to get that first meeting. But then when we sit down with the doctor and show them that not only is it good technology and good for the patient, but it's great for their practice as well. That the hospital makes more money through the deployment of VQ, that their practice will operate more efficiently, you know, so they'll have not only have better patient outcomes, but also, they'll be able to see more patients, which is, you know, which is more money for them. That's really what shifts it from, you know, we get we get the meetings because of the wow factor of the tech. And then when we show them that it's not only better for the patients, it's better for the doctors and the hospitals, you know, folks, folks sign up and they've been doing that at a rate that's you know far quicker than you know, usually new technology is adopted.

Andrew Musgrave

Looking now at SimonMed, the commercial agreement with Simon Med Imaging gives CT:VQ™ and LDAF access to a network of over 170 outpatient imaging centres across 10 U.S. states. What does this partnership mean for 4DMedical's commercial trajectory?

Andreas Fouras

Firstly, it's you know 170 sites, exciting, a real opportunity to drive volume. Secondly, SimonMed are very influential. People follow them, they know they pick up trends early and so I think the rest of medical imaging, you know, the rest of healthcare in the US watches SimonMed to see what they're doing. And then thirdly, we have an agreement with SimonMed where they will be sharing health economics data with us. And that's going to be something that you know we can take that data and we can use that to continue to drive positive relationships with insurance companies. And that that's also you know, that's you know a third angle to the value add with them.

Andrew Musgrave

And this deal moves straight to commercial deployment with no evaluation phase. Why is that structure such a strong signal of confidence in the technology?

Andreas Fouras

The arrangements before that have, you know, our technology is brand new. And you know, we've been less than a year in the market. And I think it's quite traditional for folks for technology in those very early stages, you know, to want to have a try of it, to want to evaluate it, to want to test it. But because we've been so successful with key leaders like Mayo and Cleveland and others, I think it's really putting out confidence into that, into that marketplace that doctors think, you know what, they don't need to go to the effort of running their own evaluation. That if it's you know good enough for the great docs at Mayo and UCSD, then at Simon Med, it's good enough for them and their patients. So, I think if this is where we're going and we can cut those three months out of at the front end of every contract, it's a significant acceleration of the take up that we're going to get.

Andrew Musgrave

Now, finally, Andreas, what should investors in the market be watching for over the remainder of 2026 as these initiatives progress towards completion and commercial scale?

Andreas Fouras

We have been winning top-tier sites like the ones we've been discussing at a prodigious rate. And we expect that to continue. And I think that, we're very happy for our shareholders to hold us to account on that. So, let's use the balance of calendar 26 to look at how many new sites does 4DMedical sign up, how many of them are these top-tier academic medical centres, like the top 20 hospital list. And you know, how do we make progress with networks like SimonMed or hospital chains or, for example, the VA, which we're getting more excited about. And then you know, we can I think that will allow us to be in a position for folks then you know in 27 to see that all of that success for signing up customers inevitably leads to you know strong growth in scan volume, which of course is you know, as a software as a service company equals revenue in the door.

Andrew Musgrave

Okay, Andreas. Well, thanks so much for taking the time to speak with us today on the podcast. It's been a significant time for the company, and we look forward to tracking the company's progress across Europe, Australia, and US in the upcoming months.

Andreas Fouras

Awesome, thank you so much.

Andrew Musgrave

That concludes this episode of ASX Briefs. Don't forget to subscribe, and we look forward to catching you on our next episode.