Hello, and welcome to Virtual Investor Conferences. On behalf of OTC Markets, we are very pleased you have joined us for our AI and Technology Conference. The next presentation of the day is from 4DMedical. Please note you may submit questions for the presenter in the box to the left of the slides. 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. Welcome, Andreas.
Hey, thank you so much for having me here today. I really appreciate those who are tuning in to hear about the 4DMedical story. Let me just give a 1,000-foot view of who 4DMedical are. We are a software company that takes images CAT scans of the human body and adds value to them, adds significant or dramatic value to them through software as a service processes. No doubt you're hearing my Australian accent, although the company is 13 years old, and for 10 of those years I've been living Stateside with my family. We have a structural and functional imaging portfolio, 130 team members trading on the ASX, in fact in the ASX 200 index, and now have a global presence in three continents.
Here is our portfolio, and you can see here that we have nine FDA-approved products, and we've collected them into three categories. Now, I think that really it's important to us, we've developed over time the understanding that having a full-service offering is important to our customers and therefore to our commercial success. Although really I think the key thing that differentiates 4DMedical from a lot of other players in the medical software space is this core focus on function. What is that and why is that really a differentiator? Medical imaging typically shows you, of course, an image, a picture of how the lungs work or how the human body works. For us, in our case, we focus on the heart and lungs.
I think really the key challenge that are given to radiologists or to doctors looking at a CT scan or an image of the lungs is to look at the picture, to look at the structure or how the appearance of the lungs, and to work out how do the lungs likely working. If they can see something that looks not quite right, what's their inference about how that leads to a loss of function? That is actually pretty hard, and so the technology has been trying for some time to get into that space and to provide assistance. For example, there are some scans like a dual-energy CT scan or a nuclear VQ scan, and those technologies have some drawbacks. Among them or the core of those is that they require contrast to be injected into the human body.
You need to have a dye injected into your body, for example, to see how the blood is flowing. Really the center of the bullseye for us as a company and for our investors right now is the 1 million nuclear VQ scans a year that are performed in the United States. Let's talk a little bit more about that, and the way that 4DMedical is approaching that opportunity is by adding a software layer that allows us to take a CT scan of the human body and emulate this nuclear VQ scan with a software process. Here are some images of a modern nuclear VQ scan. Yeah, this really is exactly what they look like.
I've had one of these scans, and the process as a patient is you're asked to go into a separate room, you're given a container of radioactive material, and you're asked to pant or to inhale, to breathe that powder into your lungs. You then go lay down in the scanner, and you get an image of where you're radioactive, where you're hot, and that gives you the V image, the ventilation image, giving information to the doctor about where more air is flowing, or less for that matter. It takes about 20 minutes to take that V, that ventilation image. You then stay laying and try as hard as you can not to move in the scanner. You're injected with a radioactive dye, and then the scan is run again.
Now where you're hot should be showing where the most blood is flowing. I think if I just take a moment here to also talk about what is the kind of, I guess, a patient story of the most likely scenario as to why somebody is getting one of these scans. That would be that you have healthcare issues, you have lung problems, and you find yourself talking to a surgeon or an interventional pulmonologist to try some kind of procedure to help you with your breathing. The way that that would work, you would come in, obviously you get worked up, you meet with your surgeon, and they do that workup. In amongst the workup is certainly-
Andreas, if you can hear me, can you please try refreshing your browser? Thank you for your patience, audience. He will be right back.
Hey, can you hear me now?
Perfect. Keep going. Thank you.
Great. They absolutely want a CAT scan to really show the structure, the anatomy of your lungs in fine detail. They also do need these images showing the ventilation and perfusion. They need to know where there's blood flow, where there's airflow, before they deliver that procedure. They'll send you away to go home and to call up and to book an appointment with the nuclear department to get this test done. Now, for reasons that we'll talk about in a minute, it can often take two or three weeks at a major U.S. hospital to get yourself booked in to get this scan. That's something that's typically frustrating for everybody involved. The surgeon is keen to have you come in and do the procedure. They want to book that slot in the operating room as soon as possible.
You have a life-threatening or debilitating lung condition, you want to have your procedure as soon as possible. In fact, that is the 4DMedical alternative, which is to say that from the CT scan, from the CAT scan you got, right at the beginning, in that appointment with the surgeon, we can deliver our software V and Q, or ventilation and perfusion imaging, that looks exactly like it does just right here.
We have this really exciting scenario for everybody involved in that the patient gets to skip the inhaling radioactive material, injections of radioactive material, and the surgeon gets to have not only a cleaner, crisper image showing your ventilation and perfusion, but they get to bring forward all of that information, and therefore, the procedure, and if you think of that surgery as a business, both for the hospital and for the surgeon involved, they get to bring forward that moment where they get paid. We have this exciting alignment of benefits. No contrast, as we just said, clarity, much nicer, cleaner, color-coded images as opposed to dotty, blurry images. Greater accessibility. For example, across the United States, we have about 15,000 CT scanners compared to about 1/10 of the number of nuclear imaging systems.
Without getting too technical, the scan time is only about five minutes on a CT, versus about an hour on the nuclear imager. Even if you say call that a 4-to-1, 4-to-1 throughput times 10-to-1 the number of instruments, they're 40 x more accessible. Patient-friendly, so I said five-second, or a five-minute scan time, but just five seconds to breathe in and out for the patient versus an hour of inhaling radioactive materials and so on. We're a software-as-a-service business. We deliver that value sitting on top of the CAT scan that the patient already got, without having to buy any extra equipment. Just simply our software layer sits on top. CPT eligible, so there's a $650 reimbursement for doing our procedure.
Here, in that value, cost, and impact nuclear revenue improvement, this is one of the things that people are most surprised about, which is that the nuclear team don't really want to be doing the VQ scan of the total, and we'll get to this in a second, but of the procedures that they can do, a nuclear VQ is right at the lower end, and there are a bunch of other procedures they can do that have significantly better billable. Other savings in terms of radiation, the contrast media involved, scalable access, widely accessible equipment, broad deployment, and we offer our technology through the cloud. One of the things that is often difficult in bringing new technology to medicine is driving through change. Our CT:VQ offering is really just tuned to maximize that or streamline that as much as possible.
Really what we mean by that is that if a doctor says, "Hey, what patients do I use CT:VQ on versus nuclear VQ?" It's just exactly the same patients. They'll say, "Well, how do I use it? How do I read the scan?" Once again, the answer is just exactly in the same way. CT:VQ is just a really exact one-for-one substitution, although it does come with those benefits. Here is just a bit more detail on the economic upside. There's a very compelling $2,500 upside without even including some factors that are harder to quantify, like dropout rates of surgery over the three-week waiting time. On the left there, you can see CT:VQ in green, as the billable, the two primary billables that that technology offers and with the median billable being $1,300.
There's an AUD 800 upside, just right there. Then, of course, you can add the reimbursement that we bring to the table. It's a AUD 650 reimbursement and we ask for basically AUD 500 of that per patient. We have here this really incredibly rare circumstance. Typically, healthcare is really all about finding the right level of compromise, finding something that net-net is better for patients. For example, the new drug that comes through that delivers long-term, better outcomes to more patients, but, for example, has a range of side effects. The new technology that looks overwhelmingly better, but costs quite a bit more as a result. We have all five decision drivers pointing in the same direction. We have better for the patient. It's better for the referring doctor, so for example, the surgeon.
As we were saying before, better for the imaging provider, so the radiology team, b etter for the incumbents, or in this case, the nuclear imaging department, and better value for the hospital. It's incredibly rare that you have something that drives all of those. That really leads us to the view that we are looking to take 100% of this market. We are looking to displace every single one of the nuclear VQ scans in the United States, which really represents a really significant opportunity. As we just said, $500 per scan times 1 million scans right now across the United States, and with the opportunity for that to grow, because as I've been saying to you, the economics right now make it unfavorable for nuclear teams to deliver nuclear VQ scans. We know that there's demand higher than that supply that's been coming through.
At a minimum of 1 million scans, $500 per scan, that's a $500 million opportunity for 4DMedical and our shareholders, and at software margins. We're delivering VQ scans at a gross margin of better than 99% right now. Over the very short period of time, just the few months since we've been FDA approved, there has been a phenomenally rapid uptake of the technology across leading institutions across the United States. Started with Stanford, UCSD, Cleveland Clinic, Mayo Clinic. We have four of the top 20 interventional pulmonology sites in the U.S. and four of the top 20 overall hospitals in the U.S. taking up this technology. That's six of them in all, and that's a really incredible rate of uptake. Having those key opinion leaders, those top-tier sites taking on the technology has been a strategy of ours.
We firmly believe that dedicating 2026 to winning those top-tier logos, those opinion leading sites, to get behind the technology, which will allow us to really capitalize on that in 2027 and have a network-driven 2027 across the other 6,500 hospitals in the U.S. The momentum has been phenomenal. It's been something that really just doesn't happen, that rate of uptake across the top sites. Just finally, we have an additional and compelling opportunity that we have shared with Philips Healthcare, and that's with respect to the PACT Act here in the U.S., where initially this number here, $280 billion, was the initial funding provided by the Biden administration. The Trump administration has in fact increased PACT Act funding.
There are 4 million veterans who are eligible for this screening that they need as a result of their exposure to burn pits. We've partnered with Philips to deliver this. We have the technological capability, and Philips has really significant footprint across the VA and other government sectors. In fact, their software coverage has more than 50% take-up. They are really the dominant provider of healthcare software in this space. The solution or the take-up is that we can offer a screening exam using our technology for about $1,000 per veteran, compared to the only other viable option right now, which is a surgical biopsy. That would be a three-day stay, $30,000 cost per procedure. It doesn't take long to see $30,000 per veteran to be screened, times 4 million veterans is $120 billion.
We can save the government $116 billion by delivering this, not to mention saving 4 million veterans from a three-day stay in hospital. Yeah, I really appreciate everyone sitting through that presentation today. I'll just move over to the other terminal. I can see that we do have a bunch of questions here, so I am going to bring up the questions and start rolling through those. I'll read out the question first and then get to my answer. Actually, I can see quite a few questions, so I'll have to start moving. The first question is, Philips has committed to at least $10 million of VQ orders in 2026 and 2027. How should we think about that floor evolving into a much larger, longer-term pipeline as they ramp their dedicated VQ sales effort? Look, thanks for that.
Absolutely, we can think of that as the bare minimum. A corporation like Philips doesn't make a commitment like that lightly. In fact, I'm told quite clearly from Philips that they've actually never done something like that before. You can be assured that their view is that they can do significantly more than that. Philips is a very big and very heavy machine. I think you can think of them as a battleship or as a cruise liner. Right now, we're sitting there. We can see the ropes have come off at the dock, the propellers are churning, and the Philips boat is about to pull away. The pipeline there is really incredible. They have folks on the team who are only selling VQ. It's phenomenal that a company like Philips would hire salespeople dedicated to someone else's product, but that's the depth of the relationship.
I'm incredibly excited about what they can do, especially as our more agile sales team can continue to bring the cream of the crop there. That, for example, when Philips' salespeople are out on the ground and they get that inevitable top question of who else is using it, and they can answer with right now, six of the best hospitals in the country, and we expect by the end of the year, we'll be able to say 10 or 12 of those. Moving on, the next question. With CT:VQ now cleared in both the U.S. and Europe, how quickly do you think you can move from a handful of flagship sites to meaningful revenue across major U.S. and E.U. networks? Look, what we're asking for is to give us just a little bit more patience. We want to spend 2026 adding to that network.
As I was just saying, we want to spend 2026 getting to the majority of the top-tier sites, or in fact, a super majority of the top-ranked sites in the United States. We want to add some sites in Europe to that flagship coverage. One of the things we say is that doctors don't buy from us. They buy from each other. Doctors want to have either that person that they see at the conferences who gives the podium talk or the senior doctor that they really like and respect, and they do tend to follow that. In the software world, we call that the network effect, right? We really want to be able to invest in that network effect. The other advantage we get from that is hospitals like Cleveland Clinic are incredibly big customers. They are dozens of times bigger than the average site.
Investing in those, having that thought leadership with us will also allow us to really quickly turn this around. Not just because we can add lots of sites because they're all impressed by following the leaders, but also because those sites themselves are very large. They do a lot of procedures and as we grow inside of those, we have sort of land and expand as we have our expand team in there. That will be a rich source of revenue as we rapidly grow scan numbers in 2027. Next question. You talk about CT:VQ displacing 100% of nuclear VQ scans. Are there other opportunities outside of this market? Yes, absolutely there are. 4DMedical with CT:VQ has the only FDA-approved imaging technology to see blood flow in the human body without an injection. There are dozens of imaging-
Andreas, you froze for us again. If you could refresh your browser.
I think I'm back. Is that right?
Welcome back. Go ahead.
Yeah, I'm so sorry about that. The question was: you talk about VQ displacing 100% of nuclear VQ scans. Are there any opportunities outside of that market? I was saying that we have that only platform that can image blood flow without the use of contrast injections. That's a really very exciting platform. Not only can we grow the million scans, as I said, as we provide something that's scalable and easy, we see that million scan number growing. Additionally, there are a range of other tests, and I think if we stay just really very close to nuclear VQ, there's something called a CTPA, a CT pulmonary angiogram. That's a test in the lungs to see blood flow, once again, in the lungs.
In this case, that test is used almost exclusively, pretty much exclusively, for detecting a blood clot in the lungs, something called a pulmonary embolism. There are 5 million of those tests a year done in the United States. We'll be talking more to the market, we'll be coming out with announcement within the next few months to talk about how we're going to address that opportunity. We are feeling more and more confident that within two years, we're going to be able to talk about having grown our TAM from 1 million scans to 6 million scans. At $500, 6 million scans is $3 billion a year. We are heading towards a $3 billion obtainable market for ourselves at 99% margin. Next question: can you give us a sense of timing on the VA opportunity?
Where are you in the procurement process, and what does the Philips reseller agreement mean in practical terms for deal flow beyond the VA? We are really chasing this burn pit opportunity in the VA. We think that that's something that 4DMedical can uniquely provide, and it's something that I feel very personal about. I'm a veteran of the Australian Army myself, spent eight years in uniform there. We know that the government team at Philips are incredibly dedicated to our veterans. Not only is there this burn pit opportunity, that $4 billion opportunity that we had in the last slide, of course, veterans have all of the same regular health issues in the lungs, and in fact, they have them at about three times the rate of the civilian population.
Veterans need that day-to-day healthcare in the lungs as well, and that's really one of the ways that we see ourselves to be able to bring that timing forward. Driving through a $4 billion contract or multiple contracts to get to serving those veterans up to the $4 billion level is going to take some time. We don't see that as being something that's going to happen overnight or imminently. Now that we can see we've got great visibility on day-to-day regular doctors in the VA saying, "Hey, we can use this VQ scan in the same way that the civilian population can use it." That's building our connectivity to the VA. It's very exciting, great customers for us from this bottom-up or organic level. We also believe that that brings forward the opportunity to win a whole of VA contract to provide that screening capability.
Sorry, just looking at the time, I think, we've got maybe time for a couple of more. What is the competitive landscape like for your products? We have 120 patents surrounding VQ and the associated technologies at 4DMedical. I'm the lead inventor on 80 of those, and that's a significant moat around this really remarkable opportunity. I think that really it allows us to be effectively in that monopoly position or that leadership position. Additionally, we're moving quickly. I was just talking to you about how we're already started planning to move towards the next level of the technology that will allow us to multiply our TAM by six times. Really, we don't have other competitors there in the space offering the same things that we do. We're globally unique in that space. We do see things that slow down our entry into the marketplace.
How do we drive change? How do we make our products as seamless as possible to just drop into today's workflow so that doctors can change as little as possible to use what we use? Also, we're finding ways to do the installation or the onboarding process with our software faster and faster so that we can climb up that sector first. We don't have traditional competitors. We've been first, we've been innovative, and we've put a moat around those products. We're treating the friction in the market as our competitor and constantly working to beat that, to get out ahead of that. Yeah, I'm not being called out to, so I'll go on to the next question. We have the next question here.
With a much stronger balance sheet and two major regulated markets open, do you see scope to accelerate into additional regions like the U.K., Middle East, or Asia sooner than originally planned? Yeah. Obviously as an Australian company, we report AUD 280 million, so about $200 million on the balance sheet. Dramatically more than we need to bring the company to break even. Really that means we have a war chest there. That war chest will be used to de-risk our position, to accelerate our position, and also to grow our TAM. I think that there's really two key ways to grow the TAM. That is to attack into new opportunities, to provide new healthcare opportunities. There's, for example, what can we do?
We're just talking about replacing the CTPA, but where else of the scans today that use contrast agent, can we build a product that serves that? Some of those opportunities are really big. The question here was about geography and we've already committed, as per our announcement a few weeks ago, to enter into Europe. We'll be making an announcement there in the next six or eight weeks about exactly what our plan is. It's looking very good. I'm excited. I can't wait to be able to share that. I can drop a hint that those plans certainly will include the U.K. With the Australian DNA in the company, we always have a really strong global interest, also a strong connectivity to Asia, we are thinking and planning about that.
If we have Australia, New Zealand, North America, and Europe, including the U.K., it's really great coverage, picking out the sectors where typically the highest profitability are for a company like ours. The next question, as you deploy more sites, you are getting to growing real- world data set, how important could that dataset become for future models? That is so exciting opportunity for us, and this is part of the secret sauce for the speed at which we're able to develop new products faster than anyone else. Our rate of delivering scans is growing something like doubling year-over-year. We did 150,000 scans just in the last half alone. That is big data at scale coming in really rapidly for us. Yeah. I think that's a call on time.
Really appreciate everyone's interest, appreciate the questions, and I think we're gonna have an incredibly exciting 2026 at 4DMedical. Thanks a lot.