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 am very pleased to welcome Andreas Fouras. He is the 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 back, Andreas.
Hey, great to be here, and thanks, everyone, for joining me today. I am really excited to share the story. Let's get into it. 4DMedical is here to solve a problem that has been building in healthcare for some time, which is that other parts of medicine have seen significant advantages from transitioning their imaging from structural to functional. I think many of you may be familiar with that. For example, if you have seen an ultrasound image that has the color over the top, the doppler over the top showing blood flow. MRI has seen the advance of functional MRI that shows not only just a picture of the brain, but a map of how that brain is functioning.
The lungs have been left behind in this race, and 4DMedical brings both structural and functional imaging to the lungs through nine FDA cleared devices, 120 something patents, and a presence now across three continents with 175 team members. Here is that portfolio of products. Now added, you can see in the bottom center with lung cancer screening through our acquisition of contextflow just recently. But those key products I am talking about that are really the core differentiator are our pulmonary function products down the left-hand side. You can see there our Gen 1, our Gen 2, and our blockbuster Gen 3 product, CT:VQ, sitting there. CT:VQ is the only technology that is FDA approved or improved in any major market, to measure both airflow and blood flow without the use of an injected contrast agent.
As I was saying, this problem that we are here that we are solving is that radiologist doctors have been forced to look at the lungs and to say, "Okay, by looking at these, by looking at the structure, by looking at the shape, we are going to guess about how the function may be impaired by what we are seeing in that shape." Now, there are some tools that do allow us to do that. We are not truly unique in that space in that other companies or other technologies have been trying to solve this problem before us. However, these technologies have not lived up to the promise of the opportunity of functional medicine. In particular, the ones that are used most regularly are all the way on the left there, nuclear medicine, VQ, and dual energy CT.
Importantly, one of the main reasons that those technologies haven't really seen the uptake that doctors would like, so that on every scan, ideally, they would see blood flow is because those. One of the key reasons is because those technologies require an injection to facilitate that. Nuclear VQ has been making tremendous inroads into the market, typically starting with replacing nuclear medicine VQ. Here we have example images of nuclear medicine VQ. In particular, I think these are relevant in the U.S., which is, of course, our most important market. There's 1 million nuclear VQ scans a year done in the U.S. I'll talk about the economics later, but at $500 per scan to us, that's an $500 million market for us, just replacing this test.
The way this test works, a patient comes in. In fact, I'll just take a quick moment to just to sort of to back that up a second. A patient, typically, a patient that we're seeing that is coming in because they're looking to get some kind of procedure, some kind of surgery or minimally invasive procedure on their lungs. They'll see the surgeon, let's call them that, the doctor. They'll see that surgeon, get a workup, which includes a CT scan, a bunch of other tests. The surgeon will have in mind how that patient will be treated, how the procedure will operate. They'll then send them to go and to get this nuclear VQ test.
That usually requires up to two weeks of booking time because the nuclear medicine department finds that nuclear VQs only bill about 40% of the median billing that they get for other tests. On the downside, it requires two lots of contrast, which I'm about to explain. A nuclear VQ scan is actually two scans. The V, which is where you first breathe in radioactive powder, sticks to the inside of your lungs to give a view of where the air flows the most. Then secondarily, an injection of contrast agent to get the blood flow, which is that Q scan there on the right. The surgeon now having had to wait for a couple of weeks to get these images, which are flat, so two-dimensional flat images, and as you can see, not the very highest in resolution.
4DMedical is making tremendous inroads into this space because the solution we offer to everyone involved is instead of having that flat two-dimensional image, and today I can't show you the three-dimensionality, but those images there on the right are not only sharp, high-resolution images, and color, they're also three-dimensional in nature. The surgeon gets the data weeks earlier. The patient doesn't have to inhale a radioactive powder, have radioactive dye injected, and clean, crisp, sharp images are delivered here. We're already seeing. We see that when we have conversation after conversation with doctors, they see this as an absolute no-brainer, and they're excited to transition to this technology.
But for those who are interested in having more evidence, there are some really great publications coming out right now, just showing that it is not just common sense that this is a better solution, but there is really significant practical outcomes, statistical outcomes, for the patient and the hospital delivering using our technology. Firstly, University of Michigan has published a paper in the top-tier journal in lung health in the United States, the "American Journal of Respiratory and Critical Care Medicine," showing that they can have an improvement of from 46% to 76% when using CT:VQ to plan for surgeries. That is an enormous improvement. While 30% is not in itself a huge way to look at it, you can also look at it from the perspective of the insurer, who often likes to think of failure rates.
If we flip those numbers around, we go from a 54% failure rate to a 24% failure rate, so more than halving the failure rate of these procedures. Additionally, Cleveland Clinic has recently presented showing their data that they reduce the workup time for their patients from seven weeks down to three weeks. We are now moving from not just clearly better, but also the hard numbers are there backing up exactly in which ways that you get superior outcomes from this. To be clear, there are a number of ways that nuclear VQ is used today, and we have designed and built and positioned CT:VQ in the market as an exact one-for-one replication, an exact swap for folks to be able to do that one-for-one swap.
All of these uses, bronchoscopic lung volume reduction, surgical LVRS, resection, all the way through to pulmonary embolism and to chronic disease management, CTEPH, and even transplant rejection monitoring. When folks ask us, "Oh, we need training to use the technology." What patients do we use it on? Exactly the same patients. In what ways do we read it? We read it in exactly the same way. That is the entire training course for CT:VQ right there in four seconds. That allows us to have this incredibly rare value proposition to take to the market, which gives us the supreme confidence that we will get 100% market share in this space, and that we will do so rapidly.
And that is that every character in this story, the patient who has better surgical outcomes, the patient who does not have to wait weeks for that surgery, or does not have to inhale or inject radioactive contrast agents. If you are a patient or a loved one of yours is a patient and you have a choice between two surgeons, one which has a 46% success rate or the other that has a 76% success rate, I think we all know where we want to go.
The referring doctor gets great value. This is the surgeon. They get to bring their procedure forward by four weeks. They get paid four weeks earlier, and who does not want to do that in their business? They also get to be, as I have been saying, that 76% surgeon, that surgeon with the higher success rates. The imaging provider, so that is the radiology department.
Right now, a CT scan, this is radiology now. We move the scan to the CT department to radiology. They get paid $105 CMS for doing a CT scan. The way the reimbursement money flows, they get an extra $150 as a result of doing this test. So it's the same CT scan, it's the same technician, the same time, the same million-dollar instrument and room, but now they get paid $150 more on top, so 2.5x the payment without having to do an extra scan. The current incumbent, that is the nuclear medicine department, are also often our strongest supporters. They want to stop doing this test.
They have a test in nuclear VQ right now, which bills at 40% of the median reimbursement that they get to bill and is twice as complex in that they have two sets of agents inhaled and injected, whereas typically there's really just one agent, and that's injected. We had a strong burst of uptake from the leading systems across the U.S. with four of the top 20 interventional hospitals and four of the top 20, so five of these top 20 hospitals taking it up, and we have an incredibly tight, in fact, really bursting-at-the-seams pipeline, and we expect to see these numbers substantially surge between now and the end of this calendar year.
Not only do we already have the thought leaders in this space, that's having an impact on their peers and the rest of that thought leadership layer are really starting to see that they might be in danger of being behind the eight ball and missing out on being seen as the leaders in this space. That gives us the center here of this bullseye, those 1 million scans per year we're incredibly confident about replacing. We're well on the way now with our CLEAR study being led at Harvard at Mass General Brigham, where we are targeting an additional 5 million scans per year. That study is underway, which is incredibly exciting. Oh, my apologies. There's a typo here.
We will read out in 2027, and that will deliver for us that $2.5 billion TAM, really growing us then to being a $3 billion a year opportunity at 99% margin. An incredibly exciting space. Also, we're getting really very excited as we continue to do our R&D. We see even more blue sky behind CTPA for the fourth generation opportunity for our platform. Also we have really significant opportunity here, in addition, are serving our veterans. I, myself, have spent eight years in uniform as an Army Reserve infantry officer. With the PACT Act having appropriated $280 billion specifically to assist veterans with their healthcare as a result of inhaled toxins, which, of course, typically focus on lung diseases.
Now with Congress having in front of it the AIR CARE for Vets Act, which specifically stipulates that a $20 million pilot going to 4DMedical to help deliver in this space. We are partnered with Philips to get ourselves there, and we feel confident that a $20 million pilot could quite easily turn into a $200 million a year contract with the military. We have had an incredible year. So we have these significant growth in terms of our markets. We have had geographic growth, and also we have had such a strong start out of the blocks with those five leading academic medical centers plus SimonMed, so six incredible opportunities.
Our generation two products are at 540 sites, up 39%, demonstrating that when folks start using our technology, you can consider growth built-in, locked in, and we expect very much to see even stronger continued growth with VQ after it reaches deeper penetration into the market. Strong scan growth, strong revenue growth, and an incredible cash position facilitating a war chest for us to both de-risk and accelerate the business. We have the regulatory and reimbursement positions in place. We are authorized in the United States and globally. CMS is there. Strong clinical adoption.
As the technology gets wider use, we get to go from a no-brainer, a common sense case for adoption to one that is also backed by peer-reviewed published evidence, 46 to 76, seven weeks down to three weeks. Harvard running the point on growing our market by 6X , and AstraZeneca and contracts in Brazil and elsewhere.
We have established our global footprint by expanding into Europe, through the acquisition of contextflow at incredibly sharp purchasing prices, with RevealAI-Lung and Azra AI in terms of our partnership. We now have a much broader, wider reach, allowing us to really fully claim our full service offering for our customers, which we know they really appreciate having. New providers for them are a point of friction, so being a full service offering really gives them exactly what the customers want, which is to not have to onboard too many providers to provide top tier healthcare for their patients. We are in an incredibly exciting position here at 4DMedical. I am incredibly excited with where we are at after having worked on this for over a decade.
We really now are in the position that we have wanted to be, which is that we have an incredibly strong foundation, and we are just getting started with the growth up above that foundation line. I think from there, I will open it up for questions. Okay. I will start here. We have the first question. Now that CT:VQ has CMS reimbursement at $650 per scan, how does that change the adoption conversation with imaging providers? It is incredibly helpful. There is no way around that. First of all, it means that we are not asking the hospital to reach into their pocket, and we are saying, in fact, with $650 of reimbursement, the hospital can keep $150 for their imaging department, for radiology, and $500 can come to us.
But I think one of the things which is an incredible position, but actually the position that we are in is significantly stronger than that. As we have these papers coming forward showing the healthcare outcomes, those healthcare outcomes are also economics outcomes. So if we talk about that $50,000 LVRS surgery, a 30% increase in outcome can very roughly been seen to be a $5,000 benefit to the healthcare system.
So in fact, asking for $500 out of that $15,000 makes it incredible value for the hospital. And for a surgeon, to not only have that increase in success rate, but to be able to bring forward, as Cleveland Clinic have said, by four weeks for their practice, bring forward that treatment, you avoid losing some leakage of patients, and additionally, frankly, you get paid four weeks sooner. So all of that demonstrates that the $650 adds clear, tangible value.
It allows us to put a hard number against something. But those other intangibles, we think hospitals are seeing them as actually significantly greater than that $650 amount. So the next question. With cash of roughly AUD 278 million, how aggressively can 4DMedical invest in sales, evidence generation, and global expansion without needing to revisit the capital markets soon? The answer is very aggressively. Our modeling, even our most conservative modeling, has 4DMedical bottoming out with a significant buffer of cash. Us using less than half of that cash. I think if you can just do the rough maths, we had a net burn last year of about $30 million. So with about $ 270 million there in the bank, you can see that that is really a significant buffer. And we can and we will use that.
I think CLEAR is an example of a project where for just a few million dollars, we are able to multiply our opportunity by six times. There are other opportunities like that out there. Opportunities to further expand that evidence generation, bring more clinical trials to light, and potentially expand both geographically and the product portfolio as well. Next question. How does the acquisition of contextflow broaden your European lung health strategy and create cross-selling opportunities? Well, that is, of course, the things that it does. And I will just take a moment, say how proud, how pleased we are with that contextflow acquisition. We made that acquisition for pennies on the dollar. Also, there is some great tax breaks built into that acquisition, and it has given us immediate boots on the ground in Europe.
Boots on the ground, a commercial operation that has relationships with the insurers in Europe, and of course, has a product that was just ready to be launched. That product, now launched, is really doing very well. We are excited, and every single one of those customers puts us in a position for cross-selling. And we should be in a position to commence that cross-selling, I think, very early in calendar 2027. So we have that boots on the ground operation, a native product there, and I think that really makes our penetration of VQ into Europe something that can happen much, much faster, and in fact, also less expensively than would have been possible without that acquisition. Next question. SimonMed operates more than 170 U.S. imaging centers. What would a successful first 12 months of deployment look like?
Well, we are getting very close to being able to announce that we have the full integration into the SimonMed system, which will give us access to those sites across 10 states. Also, that SimonMed partnership gives us complete transparency, data sharing, and partnership in terms of maximizing the insurance claims there for SimonMed. By us helping SimonMed, we get to learn that playbook, we get to see exactly what works, what doesn't work with the insurers. With the transparency that we've been granted as part of this agreement there, it allows us to pick up that playbook and transplant that across all of our other customers. Every extra dollar of reimbursement going to the customers effectively is going to end up being something like $ 0.80- $ 1 that comes back to us.
I think a successful 12 months is going to be really rapid integration, which we're very close to finishing wrapping up. It's going to see us gaining usage and coverage across a 10-state area, and it's going to allow us to be able to pick up and transplant that reimbursement playbook to all of the rest of our customers across the nation. Next question. CTPA is 5x the nuclear VQ market with a readout due next year. If that study reads out well, what changes in how a suspected PE patient gets worked up? I think it is great to see just how big an opportunity we have to make a positive impact to patients who deal with pulmonary embolism every year.
I think, for me, as we got into this space, I found that pulmonary embolism actually has some really shocking statistics that go with it. About 7% of in-hospital deaths in the United States are the result of a pulmonary embolism. About 30% of autopsies, which of course happen when there's some uncertainty about what's happened to a patient as they've passed, have a pulmonary embolism included in that autopsy.
So right now, for a significant majority of those patients, what happens is you come into the hospital, often the emergency department has a key indicator in mind. You've got tightness in the chest. They're immediately working you up, say, for example, for a heart attack. You progress through, maybe after an hour or so, they think, "You know what? We don't think it's heart attack at all anymore. Let's check for a pulmonary embolism." That requires now, because that scan, a CTPA, requires the injection of a contrast agent, that means sending you back to radiology, having you get the injection because of risk of allergic reaction, because of risk of kidney impact, a physician, a doctor, has to follow you there and observe you as you get that injection. That scan then has to go to radiology to get read out.
We can save an hour and a bunch of time and money out of that by saying, "Okay, you know what? That CAT scan you got at the start, let's run our software on it right now. Let's get you an answer really quickly." We can save an hour for that patient. Time saves lives, and time is money in an emergency department.
Once again, we'll get to have superior outcomes for the 100,000+ people who die a year in the U.S. from a pulmonary embolism, as well as saving time and money in an emergency department. Next question: Could CT:VQ become a standard add-on to routine chest CT workflows rather than a specialized test over time? I love this question, so thank you for asking that. Every doctor wants to see the airflow and the blood flow every time they look at a picture of your lungs. The only reason that they're taking a picture of those lungs is they want to have an understanding of how the air is flowing, how the blood is flowing. Right now, they're looking at that and they're guessing.
CT:VQ allows you to take that guess away, gives hard measurement to the doctors so they can be making their decisions based on much harder data. I absolutely believe that over time, that doctors are going to want to see this on every single CAT scan at every single time. Next question. I'm just looking at the clock. I think we've got time for one or two more. Next question: With contextflow, you've added structural lung AI alongside the functional side. What can you now offer a radiology department that neither piece could on its own? Well, I think that is the trick, is by being that full service offering, we give the complete picture so that a radiologist doesn't need to go and mix and match to get a combination of what they want. Radiology is under huge time pressures right now.
When a radiologist is given a scan or given a patient to deal with, they want to have it all on the one screen in front of them, have all of the data they need so they can give the report to give that advice to the treating physician. 4DMedical is now uniquely placed. We have the largest portfolio of technologies all in one place of any company, big or small. So it's right there on that one screen, saving vital seconds for the radiologist as they do that job. Nobody else can do that. It puts us in an incredible position. I think I'm going to call this one the last one. So final question: What is driving the strongest interest from customers today? Clinical differentiation, workflow efficiency, reimbursement, or the ability to avoid nuclear imaging?
Well, the great thing is, to the person who asked this question, is that actually, the doctors don't have to choose. They get all of it with us. That's incredibly rare that there isn't a compromise that a doctor is having to make. Do I go for workflow efficiency? Do I go for better patient outcomes? Do I go with the technology that's safely reimbursed? Do I allow nuclear medicine to get off my back because they don't want to do these scans anymore? We have positioned this product. CT:VQ is our third generation in that it's not just the technological evolution, it's not just the top-tier technology in this space, it's the top-tier product. Because we have that ideal product market fit precisely because the doctors don't have to choose. With CT:VQ, they can have it all. I think that puts us at time.
Really appreciate everyone's interest today. I will look forward to giving you an update soon.