Hello, and welcome to the Life Sciences Investor Forum. On behalf of OTC Markets and our co-host, Zacks Small Cap Research, we are very pleased you have joined us. The next presentation of the day is from 4DMedical. Please note, you may submit questions for the presenter at any time. You can also view a company's availability for a one-on-one meeting by clicking Book a Meeting. At this point, I'm very pleased to welcome Andreas Fouras, Founder and Chief Executive Officer of 4DMedical, which trades on the OTC markets under the symbol FDMDF, and on the ASX under the symbol 4DX. Thanks for joining us again, Andreas. Over to you.
Hey, thank you so much, and thank you everybody for your interest today. Let's get into it. 4DMedical are an Australian-based company that specialize in cardiothoracic imaging. We are the leading pulmonary and cardiothoracic imaging analysis company in the market. We were founded in Melbourne in 2013, and since then we have grown. We're now on the S&P/ASX 200 index. We're on three continents. Just excitingly, through a recent acquisition in Europe just a few weeks ago, we're putting boots on the ground in Europe to go alongside our boots on the ground in both the Australia-New Zealand region and in North America, where I've been living for the last 10 years. We have this entire portfolio of products. As you would've seen on that last screen, we have nine FDA approvals, and approvals across all three continents, as we've mentioned before.
I think the key thing to note from this is that that entire portfolio is something that our customers are looking for. While they typically come to us, and most recently are very excited by our third generation flagship product, CT:VQ, that you can see there. You can see on the left under Pulmonary Function, our gen 1, gen 2, and then gen 3 product, CT:VQ. That's really the game changer for us and what will be the core driver of our growth over the years to come. However, our customers do like to see a full service offering or a full stack, I guess, depending on your vocabulary there on that. We see that because there's a significant amount of friction for them to bring in a new provider of software capability in healthcare.
By us having that full stack there, they know they can get everything else they need alongside getting CT:VQ. However, having said that, now I'm going to focus the bulk of this presentation today talking to you about, as I said, our third generation product, CT:VQ. The core offering that 4DMedical brings to healthcare is we allow them to use their existing CT infrastructure. We have nearly 15,000 CT scanners across the United States, and CT:VQ brings the capability that you would typically expect to have a whole new scanner in order to bring, but we do that through a software layer. All of those billions of AUD worth of infrastructure get to remain in place. We're not asking hospitals to go buy themselves a new scanner in order to see what we bring them. They get to do that from that existing space.
Today, typically what CT brings is an image of the lungs. It gives doctors a picture of how the lungs look. The other parts of healthcare, so for example, neuro, cardiac, those spaces have incredible new functional imaging capabilities that show how those parts of the body work, not just what they look like, leaving the doctor to have to infer or use an educated guess as to what's happening from a functional perspective. Right now, today, in the lungs, if you want to see how the lungs work, the lungs' function, we need to go back actually to some data technology. We may need to, for example, inject a contrast agent into the lungs, or often what folks do for a sort of a functional map of the lungs is something called a nuclear VQ test.
There's a bunch of issues with that, and really those issues are the key area of exploitation for CTVQ to bring. That is, we can bring you the capability of that scan, but without any of the downsides. If we start by taking a look at what a CTVQ is and does. Here you see a CTVQ scan. I've had these scans myself, and so am quite familiar. Sorry, a nuclear VQ scan. These nuclear VQ scans have a V and a Q component. The V stands for ventilation, and the Q stands for blood flow or for flow. You can see here, they're actually not the highest resolution images out there in healthcare, but that's what we have to deal with.
The way that they work is the patient is asked to inhale radioactive powder. You're given a container of radioactive powder, you huff and puff into that container, it kicks that powder up, and it sticks to the inside of your lungs. You then go lay down inside a nuclear imaging system. You lay down on a bed, and a flat nuclear imaging panel is put up to your chest, and you get a picture of where the radioactivity is, which is meant to give you an image of the airflow in your lungs. You stay still, you're injected with nuclear contrast into your blood, and then you get a picture of where the injection went, and that's to give the doctor a vision of where the blood flow is.
Some of the use cases for this technology, commonly now it's used for doctors, as I said, to get that view of how your lungs are working. For example, for chronic disease management such as COPD, emphysema, or perhaps you've had a surgery like a lung transplant, and they're looking to see how your lungs are going. Perhaps, they're concerned you might have a blood clot in your lungs and they can't use some of the other standard tests that use a CT scan to detect that. In almost all of those cases, you'll have had a CT scan first to give you a picture of how your lungs look, because of course, you don't get to see how the lungs look in this image, and then you'll come and get this nuclear VQ scan.
What 4DMedical brings through CT:VQ is the capability to take that CT scan you already had and deliver images, ventilation and perfusion images or V and Q images like you see here on the screen right now. Here, you can see that V image there and the Q image here. Additionally, these images, like the CT scan, are fully in three dimensions. The doctor and the patient get to skip sending someone off to get a whole new test. The patient is spared inhaling radioactive powder and having radioactive dye injected directly into their blood, and you get these crisp, clean images, much less noise, in full color, and in three dimensions. Really, it's a game changer in this space. CT:VQ replaces nuclear VQ wherever it's used, and answers in minutes from the CT that they already ordered.
You don't have to go off and get that new test. This is used across a number of spaces, as I said, a whole bunch of basically procedures or surgeries, and also for the management and assessment of disease and disease progression. Now, if we talk just briefly, let's pick surgical lung volume reduction surgery, surgical LVRS here as an example. Patient is selected for that procedure, or they become selected as a candidate for that procedure, come in, see their physician, they get their CAT scan. They're then asked to go off, almost always as an outpatient, sent home to call in and to call into the hospital to book themselves that VQ scan. Often takes quite some time. Healthcare is very busy, takes quite some time to get themselves booked in.
Unbeknownst to the patient who's trying to book themselves that procedure, and we'll talk about pricing in a minute, but every time a nuclear department does a nuclear VQ, they effectively are losing money. The patients quite regularly will get messed around in terms of finding that appointment. They go, finally get that appointment booked in, come back to the surgeon, that delay is material, right? If you're being queued up to have what you hope is life-changing surgery, you don't want that to be delayed by weeks. You don't want your doctor making decisions based on images that look like this, when the doctor could be making decisions based on images look like that.
The surgeons, frankly, don't want to wait two weeks before they have you booked in, which is the key thing that surgeons like to do and of course, the thing that they get paid to do. When doctors see the capability of the technology, we get those appointments really quickly. Frankly, the thing that closes the appointments more often than not is when we can show them that they make more money by booking the imaging through us than by using their standard method. Not only is it better for the patient, but it's better economics, as well as the better workflows that I just talked about. Those workflows are material. If we're talking about a AUD 50,000 surgery, anything that impacts on the workflow of that is worth a portion of that AUD 50,000.
If you have a look down here is a range of tests. The most common tests here up the top, about AUD 1,300 in a nuclear department. You can see down here, the nuclear VQ down at AUD 588. You can see if we just work through the maths and we show that there is AUD 1,500 of upside per commercial customer, AUD 885 of upside per Medicare or CMS patient that comes through the system on top of those advantages on workflow for the surgery.
Additionally, there was recently at the American Thoracic Society, just a few weeks back in Orlando. There was a paper that came out led by the good folks at Michigan, where they showed that by using nuclear VQ, by using our test here to do the LVRS planning instead of these images, that you had an increase in performance. Successful LVRS outcomes increased from 46% to 76%. A really significant advantage, which is, as I said, all of that stacks on top of these advantages, which has been driving really significant uptake of the tech. I think really the summary here on that is that we have a really unique opportunity in a really big market here to have all of the key drivers of change pointing in the same direction, pointing towards 100% market share of these million scans a year.
That is, it's better for the patient. The patient doesn't get messed around booking an appointment. They don't inhale and inject radioactive material. For the referring doctor, for the surgeon in our example before, they get certainty. They don't have someone off for an unknown period of time waiting for an appointment for their answers to come back, and when those answers come back, they come back clear and sharp. For the radiology provider, as part of the economics that we offer a hospital, we share the AUD 650 reimbursement that comes in. We share AUD 150 of that with the radiology provider. If we're talking about a Medicare patient, the CMS on a CT scan is AUD 105. We effectively add AUD 150 to that, so they have two and a half times the value without having, for example, to do another CT scan or buy another CT scanner.
It's better for the nuclear imaging department. As we said, they get to go from doing a AUD 500 procedure to a AUD 1,300 procedure. They don't enjoy providing images that are of the quality in an old technology. They like to deliver new high-tech imaging that saves lives, such as whole body PET or theranostic procedures. The hospital value really lies in increasing the efficiency of an operating room and of a surgeon, which is a key value driver for the hospital system. Unsurprisingly, we have had really significant take-up in a very short period of time. Leading hospitals across the U.S. have taken up the opportunity, sorry, to deliver best in care at a rate that's quite unprecedented. We have examples, Stanford, Mayo, Cleveland Clinic, Chicago, using the technology.
Recently, the innovative imaging chain, SimonMed, 170 centers across 10 states in the U.S. using the technology. We have the thought leadership layer and that innovation layer are really getting in behind the technology with incredibly rapid adoption of this. We have this million-dollar, the center of a bullseye here on this graphic, nuclear VQ replacing those million scans per year. We have clear data that shows that there are supply side limitations that on a conservative basis can grow that market to one and a half million scans. With every single decision driver behind it, we anticipate 100% market capture. We're very confident that there's no reason for any scans to be left behind on the old tech. If you just work that through, that's an AUD 750 million TAM at 99% margins.
A very exciting business just for VQ out of our portfolio and just replacing nuclear VQ. However, those of you who follow us closely will have seen that we now have a multi-center prospective study underway to reach out to replace a procedure called a CTPA. That's one of the other tests in the body that requires imaging of blood flow, but uses an injection. This really just demonstrates the power of CT:VQ as a platform technology. We're the only FDA-approved technology to image blood flow without injected contrast. We're starting with the center of the bullseye, replacing nuclear VQ.
The next ring, the next part of that target will be replacing CTPA, 5 million scans there at AUD 2.5 billion TAM, taking us just with these two, the current place where we're literally winning daily, rapidly growing our market share for that AUD 750 million TAM, then expanding out to add an additional AUD 2.5 for an AUD 3.25 billion total TAM on these two capabilities. All of this data here is in the U.S. With our recent expansion into Europe, there's a 50% growth factor there, with the European market on our numbers being worth about 50% of what the U.S. market is. Then another opportunity that's really worth talking about, we have this exciting partnership with Philips Healthcare to address serving our veterans.
I'm proud to say I spent eight years in uniform, I'm very keen and excited about the opportunity to help brothers and sisters who deployed overseas, as a result, had exposure to airborne hazards. As the PACT Act recognizes that there are at least 4 million veterans who are eligible for screening as a result of their exposure to burn pits. The Biden administration allocated $280 billion of funding for this, the Trump administration has grown the size of that pie. We published a paper jointly with the National VA and folks at Vanderbilt University Medical Center showing that our technology can detect the presence of this disease that's otherwise not visible on a CAT scan. Through our partnership with Philips, we are ready to provide a technological solution.
Because right now, the current standard of care here is a surgical biopsy, so that is putting someone under, cutting down through between the ribs in three different places to take three pieces of tissue, sending that off to pathology. That results in a three-day hospital stay and is an AUD 30,000 procedure. You can do the math just as well. AUD 30,000 times 4 million veterans is AUD 120 billion worth of cost. Obviously, doing that off a CAT scan without injecting any contrast or a really nice, clear, simple procedure. We can have superior outcomes for only AUD 4 billion. 97% saving there available to the government, while also delivering a better outcome, as I said, for our veterans. I think really exciting prospects for 4DMedical. We are really only just getting started. And I really cannot wait to see what the rest of 2026 brings.
I think from there, I will hand over to Julian, who will help take us through your questions.
Thanks, Andreas. The first question is, "CT:VQ is the only FDA-approved way to image blood flow without contrast. How defensible is that position from a regulatory and IP standpoint over the next 5-10 years?
Thank you. It is a great question. We spend a lot of time thinking about this. We have been thinking about this question for quite some time. For a company of less than 200 people, we have had a full-time qualified patent attorney on staff for the last seven years. We have been building our patent position. We have over 120 patents and growing, or 20 patent families. And we have been digging that moat. You are also right to point out that if someone showed up tomorrow, and we do not see anybody even close to where we are, because with our generation two product, we have been in market for three years, and no one has caught up to that generation two product, let alone the gen 3 that we are now in market with. We are planting a forest of patents around it, but we are also moving quickly.
We're putting in place not just the patents, we're putting in place clinical trials, which are really important, powerful marketing tools. We're moving quickly on to the next product and the next opportunity. I think the combination of the really rapid pace at which we move and leaving that thicket of patents behind us is very powerful and to date has been working well in that not only do we not have someone in market with us, there isn't even anybody conducting clinical trials right now to compete with us.
Thanks. The second question is, "What milestones on the CLEAR pulmonary embolism program would you view as the key inflection points for unlocking the U.S. $2.5 billion-$3 billion CTPA TAM?
Yeah. Thanks. That's also a great question here today. One of the things that it's important to understand is that we're already FDA approved in this space. The CLEAR study is a marketing study, right? There are doctors are going to be, in our opinion, making their choice, not being driven by us, but making their choice to use CT:VQ to help them with the significant problem in pulmonary embolism. I think as we progress through preliminary readouts, I think that's going to empower more and more folks to start looking and thinking about how they can solve their PE problem.
If I just dip into that for a minute, I was looking at the clock, but if I just dip into that for a minute, 5 million times a year across the U.S. are folks that are injected with contrast, and in many sites around the country, only for about one in 50 of those people to have a pulmonary embolism. Yet at the same time, as many as one in two autopsies performed at hospitals show a pulmonary embolism that was not known to have been there in place. This really kind of wicked problem of too much imaging happening, not enough imaging happening, CT:VQ can really solve that. I think as we get through the preliminary readouts, that's going to be showing that. Also, the only thing that we need to show, in my opinion, is that we match performance with CTPA.
I expect that we'll show that we have superior performance, but if we show that we match the performance but we don't have the hazards and costs of injecting iodine, then I think that will be sufficient, and the earlier readouts with less statistical power will, in my opinion, be able to help us get there.
Thanks. Given the CE mark and the contextflow acquisition, how quickly can CT:VQ start contributing meaningful SaaS revenue from Europe? How big is the TAM there?
Look, I think there's a few more folks in Europe than there are in the U.S., with differences in insurance there, that gap is amplified. The payments are typically less. I think our math shows that if you roll those things in together, that the opportunity is about half of what it is in the U.S. Fortunately, with our margins at 99% with the cost of delivery of the tech being effectively nearly zero, the payment per scan doesn't really bite in from a margin perspective. We get to look just really simply at the revenue side. As I said, I think 50% is a really good marker point. We'll have more clarity on that as we get deeper into that market over the rest of this year.
Thanks. The share price has had an exceptional run, yet some analysts still see meaningful undervaluation. What do you think the market is missing about the size and speed of the opportunity for 4DMedical?
Look, I think that we are poised right over the top of, without even considering underserving of the market, a AUD 500 million opportunity at 99% margin. That's a very unusual business. We have an operating cost in USD of well under a 10th of that. In the ballpark of about $30 million-$ 35 million per year to get there. We could be in a position where we have operating margins on the other side of that in the 90% range. That's a very rare business. We can expect to have really attractive multiples on that. I think we're not very well-known. Not everybody really, I think, sees us and sees the opportunity. As more and more folks get in to see that opportunity, and they learn really just how significant the opportunity is, I think that really reflects the run that we've had.
We add on opportunities in the VA and as CLEAR, now up and running, and with the support of really top-tier hospitals behind the CLEAR study with a 6x on top of all of that. I think it's just that simple. As folks are getting to see us, getting to know us, they're buying into the stock and creating that share price growth.
We've seen top-ranked hospitals like Cleveland Clinic, Stanford, and University of Miami adopt CT:VQ. How are these marquee reference sites translating into shorter sales cycles with community hospitals and outpatient centers like SimonMed?
Yeah, I think SimonMed is the great example. Not surprisingly, I think in a very common sense perspective, these marquee sites or our early adopting sites at Stanford, so on, have put in evaluation processes into the front end of the contract. They're wanting to sign up, wanting to get started, but they're putting discounted periods at the front of those contracts, or evaluation periods at the front of those contracts. If we take a look at SimonMed, really big operator with scale, know the business, know the marketplace extremely well, very savvy about their margins, have been comfortable to sign up to us with no evaluation period at the front end. I think that really trims months off going from contracting to revenue binding. Additionally, folks really do know that places like Stanford, Cleveland, Mayo, do significant DD at the front end.
As they roll out, and they're rolling out really great progress, rolling all of them out through those discount and evaluation periods. I think as these other centers see that we are in full clinical use at these sites, that gives them the confidence to know that they don't have to push as hard on the DD. They don't have to invest on that DD because they know that these large sites with the resources to do that DD have done it for them effectively.
Thanks, Andreas. I think we're out of time. If anyone's got any other questions or want to follow up further one-on-one, please go to investor.relations@4dmedical.com and we'll come back to you. Thanks so much.
Thanks, everyone.