Good morning, everybody. We welcome our many investors to the 4DMedical boardroom here at Melbourne Connect. We are very excited to present, to our stakeholders today on our capital raising that's recently been completed. I'd like to hand over to the Managing Director and Chief Executive Officer of 4DMedical, Dr. Andreas Fouras. Andreas?
Thanks, Clint. Thank you everyone for your interest in 4DMedical. As Clint said, we're excited to have completed the placement on Friday of last week and equally as excited to be opening tomorrow with an SPP that will facilitate our, you know, our fantastic base of really loyal shareholders to participate on the same terms as the placement was conducted. We have to, of course, go through the usual disclaimers, which I'm sure all of you or many of you will have seen before. We can take these as read, and of course, that'll be included in the documentation that needs to be completed.
I'll just start with a brief introduction of 4DMedical, talk about who we are, our opportunity, our product pipeline, from there really start focusing on, you know, more recent and more timely events. 4DMedical is a software technology company with our flagship product, XV Technology. This technology is proven, patented, and allows doctors and patients to more easily see things that are happening within the lungs. This important mission comes side by side with really important opportunity. Lung disease represents about one-sixth of all deaths, really there's a trillion-dollar opportunity in lung health, out of that, we believe that there's about a AUD 40 billion opportunity or an addressable target market specifically for 4DMedical and our products.
We've been establishing our strategy of building evidence, a dual strategies of clinical trials side by side with commercial pilots to demonstrate the usefulness of the technology. You know, our Software as a Service business model allows a rapid rollout of our product line and using existing diagnostic equipment. We have a full service offering across lung diagnostics, where we have our XV LVAS and CT LVAS products, leveraging existing X-ray and existing CT equipment already in every major hospital on the planet. Coming soon, you know, we're very excited about continuing status of CT:VQ, which will allow us to use CT scanners to measure both ventilation and perfusion, which we believe will really open up a premium end of the market for us for our Software as a Service product.
As you can see, in addition to leveraging existing image acquisition technology, existing X-ray and CT Scanners already everywhere on the planet, we're excited to have been funded to the tune of $28.9 million by the federal government to build the XV Scanner. We think sites that have the XV Scanner will be much stickier customers for our software, and really that's what the XV Scanner is all about, is driving software sales. As promised, we'll start with talking, briefly talking about commercialization in Australia as we continue to gain momentum with our successful rollout of I-MED. The official documentation here is as per previous announcements of 27 sites, although we do have some late changes with a small number of sites coming online right now.
I think we can take that as read as about 30 sites for the product. CT LVAS was successfully launched, and you know, we are getting faster and faster and more seamless with our implementation and integration with I-MED infrastructure. We're also working with I-MED to refine the workflow for their radiologists. You know, the efficiency of that radiologist's workflow is incredibly important for them. As a good partner, we've been able to streamline that over recent months. Our objectives over 2023 and 2024, you know, continuing rollout of CT LVAS to I-MED, you know, leveraging their high penetration of CT scanners, and we have an expectation of getting up into about 100 sites there across that site.
To build the referral base amongst clinicians, you know, so specialists and GPs, to explore adjacent markets. We are incredibly excited with where I-MED is going, this really serves as a template for 4DMedical, for other corporate radiology providers, in other locations around the world. You know, certainly worth noting that there are some significant corporate radiology providers in the United States, and our success with I-MED really can serve as a template for how we can progress in that market. Progress quickly to the United States, where, if you'll allow me just to give a brief explanation around the size of that market. The United States is about $13.7 billion US opportunity year on year for 4DMedical products and services.
Briefly, we see ourselves as segmenting that market or separating that market into portions of the market that can be accessed without reimbursement, such as the VA, and parts of that market that will require reimbursement to gain really significant penetration into, such as the academic medical centers and the, and the market more broadly. We have really two significant advantages for as being our original, our initial target, in terms of the those sectors of the market that don't require reimbursement, particularly the VA. That is, of course, that as I said, the core being that, you know, we can receive payment immediately at those sites. They don't require us to finish that reimbursement process or to seek additional funding.
PACT funding, for example, adds $280 billion to burn pit exposures over 10 years. The size of the opportunity with 3.5 million troops being exposed to toxic burn pits, and needing to be scanned. Legislation actually gives a guarantee that under PACT, that all of those folks who have been exposed will receive screening. You know, you can easily see the size of that opportunity when you look at our NAS price of a $171 per scan, and those numbers, 3.5 million troops.
Of course, in that space, we also have significant advantages created by both appropriations language, so legislation that specifically gives, makes mention of 4DMedical and our XV Technology, and the fact that our clinical trial results have shown that our technology really is the only imaging or the only non-invasive technology that can detect the presence of damage from burn pits. Chest X-rays do not, CTs do not, pulmonary function tests do not. The only reliable method of detecting this damage from burn pit exposure to veterans is an highly invasive biopsy. You know, that procedure is highly invasive, uncomfortable, inconvenient, takes 3 days in hospital to recover, at least, and costs somewhere between $15,000 and $30,000 U.S.
dollars, versus, a total cost of delivery of just $200 for a 4DMedical scan. Significant advantages there. This is why we're targeting that really very, very big opportunity, and we're incredibly excited about our opportunity to help in that space. We're also very excited to announce. This was announced last Thursday, last Friday, that as we've been working with the VA, we have been rubbing shoulders with and interacting with folks from the Department of Defense. You may be surprised, as I was, to hear that for the 1.3 million active service personnel in the U.S. Department of Defense, they are looked after by something called the Military Health System that has an annual spend of $55.8 billion.
A really significant, very, very significant organization. We're incredibly excited that we've been able to become partners with, you know, to effectively establish a pilot for them to examine and to see the utility of 4DMedical technology. This represents a really significant milestone in our commercialization strategy. It demonstrates that our sales team is effective at being able to capture really significant clients. It shows that our technology can pass through a due diligence of one of the most sophisticated and well-funded organizations on the planet. While the size of this arrangement is not material from a revenue perspective, we really do think those things are indeed quite significant.
On top of that, of course, we won't be resting until we can, you know, we're gonna be doing everything possible to completely grow this contract out into something that is indeed quite significant. The payment is on, is fixed on full terms, and allows us to use the technology across a broad range of respiratory illnesses, not just burn pits. There we go. Sorry, just a small technological glitch there. As we, you know, we expect to have significant value, significant opportunity working within the Department of Defense and the VA. That, as we said, we can get paid from them, and in fact, we have been paid from them already. You know, making great progress to expand that out over the next two years.
Side by side with that, we're also, as we said, targeting the other $13 billion component of that really of the U.S. market. While we are excited, and we'll talk about Miami in a moment, that we are making progress there already without reimbursement, having reimbursement is gonna be a significant boost to that. We've been making great progress there. Reimbursement, which has been identified by the fact that we now have Category III, a CPT Category III code, which really is the halfway mark towards a complete reimbursement of a Category I code. What's required to get to that next stage is additional presentation and publication of clinical trial results. Demonstrated usage of the technology.
I think over 2023, 2024, we will continue to make presentations and publication of clinical trial results. We will continue with execution of commercial agreement with U.S.-based hospital network, you know, we'll leverage opportunities associated with the scanner. As we said, a big part of winning the Category I code is that continued publication of clinical trial results. These clinical trial results also help us across every conversation that we have with a doctor is based on evidence, and the more evidence we put in that, in that clinical literature, just helps build that story and makes it more and more likely, easier and easier to close doctors to be converts to using our technology. We have significant progress across all of those clinical trials, and we're...
You know, we currently have 12 pieces of clinical trial data passing through various stages of dissemination and publication, you know, significantly up from 4 at this time last year. You know, we're also very excited, just in recent weeks to announce our first SaaS contract with a US hospital, with the University of Miami, our first academic medical center and our first US-based hospital. These deals are difficult in this space without gaining reimbursement, we're excited that, A, we have University of Miami closed, and B, that we have a pipeline of additional academic medical centers in behind University of Miami that we'll hope to continue to close over the next months and quarters.
you know, I think the quote from Professor Naresh Punjabi really, in some ways, says it all, that XV LVAS has the potential to revolutionize the way we diagnose and manage respiratory conditions. It's incredibly exciting. It's great support and a great reference from a key customer. Given that we are making progress here, it's a great sign. We are winning revenue from these sites. We'll continue to add more. This really sets the stage that when we add that network of sites to, in 18 months or so, when we add reimbursement to that really means the U.S. market will really be able to explode for us to really take off from that position. In the, you know, short to medium term, VA and DOD, we're working on reimbursement behind the scenes.
At the front of the game, we're bringing academic medical centers in slowly, when we mix all of that together at the end of a network of academic medical centers plus reimbursement, we really will be able to load up into that very significant, you know, $13.6 billion opportunity. In order to help get this done, we're really excited to have a great board that has the right mix of medical and commercial experience. You know, I think given the time we have here, given the strength of the directors, I don't think we have time for me to go through what they add, we also have a really strong set of advisors to the company.
You know, very pleased to have Sam Hupert as both an investor in the company and an advisory board member. Raelene Cherrie , Bruce Thompson, you know, really well-known in lung in this part of the world. Also recently that we've added Dr. David Shulkin onto the team. Some of you may know that the company will be presenting some of our clinical trial results and having a trade show at the ATS conference starting in a few weeks from now. We're really pleased and excited that Dr. Shulkin will be attending that conference with us. A little ahead of schedule on that. I think we'd suggested 20-minute presentation. I don't think anyone's gonna complain that we loaded that in 18 minutes.
From here, really very pleased to finish up with the executive summary. We are really building significant momentum. Receipts of $1.2 million in the last quarter, up 67% quarter on quarter. That includes a five-year contract with Miami, successful completion of our first scans with the VA and with the DOD, strong pipeline of further commercial agreements to be announced this year. You know, really significant market opportunity in the US alone of 74 million scans or $13 billion. The VA alone is really very significant with PACT delivering $280 billion of worth of funding, Dr. David Shulkin joining us on board to support the effort. This is laid on top of the year-on-year budget of the VA of $300 billion.
We've got agreed pricing, we've got support from Congress, legislative support there, our first scan delivered through Harry S. Truman. DOD opportunity is new and exciting, we'll work to expand that, making ongoing progress towards reimbursement, which doesn't deliver anything to the company immediately, but over about 18 months when we get that reimbursement, it really will help set that U.S. market on fire. Looking to raise approximately AUD 35 million. You know, pleased to have closed the placement at AUD 20 million. I think AUD 15 million side by side with that makes this one of the largest relative SPPs versus the total size of raise that certainly that I've ever seen. This is really because we're looking to support and provide the same opportunity to our loyal shareholders who have been supporting us over weeks, months, and in many cases, years.
The rest of the offer details, I think I can take as read. I'm sure you're all familiar with those. As I said, thank you very much for listening in, and I'm excited to progress from here over to the question time.
Thank you. If you wish to ask a question via the webcast, please type your question into the Ask a Question box and click Submit. Your first question comes from Alexander Lemsger, which reads, "What in particular will the capital funds be used for? The statement referenced assisting in commercialization. Does this involve sales crews, et cetera, or something else? Thanks.
Thank you, Alexander. Absolutely. You know, we will be using these funds to progress the commerciality of the technology. Principally, that will be to grow our customer base, and once again, principally, that will be in the United States. Associated with that, of course, that will mean an increase in sales, and we're already advertising for more salespeople right now. In fact, I interviewed someone this morning for a new sales position in the company. It's not just sales teams. Side by side with that's the software implementation. There's the trainers who go out on site from time to time, and that's needed. Medical affairs people also from time to time to talk to doctors about the technology.
Across the board of all of those areas.
Your next question comes from Philip Chisholm. How difficult/easy is it for a U.S. company to copy the 4D technology and therefore to get the advantage in the U.S. VA market?
Thank you for that question. That's a great question and something that we've spent quite a lot of time working on, you know, in terms of building that moat. I think we have an incredible moat here at 4DMedical. You know, I think that we've built elements of that moat across every dimension of the business. I think, you know, where you started with the question in terms of is copying the 4D technology. At 4DMedical, we have 75 patents and counting. In fact, at 4D, one of our senior engineers is a fully qualified patent attorney and helps us build that internal patent strategy from the inside in the most cost-effective and timely manner. Those 75 patents are really a significant moat.
The clinical trials are not easy and not fast to deliver. The relationships we have with all of the key hospitals in terms of those clinical trials, the Cleveland Clinic, Johns Hopkins, Temple, Duke, also contribute significantly to that moat. Finally, you know, particularly with the VA, we've taken the time, we've worked with Congress, and there's legislation that specifically talks about, you know, our form of technology, which is really the hardest part and the hardest thing to copy. We feel really very secure in terms of the fact that it's very difficult or impossible to copy our position.
Your next question comes from Sam Baker. Do you envision a scenario where all 1.3 million members in DOD MHS require a lung scan as part of their annual health assessment?
Yeah, I love this question. The short answer is yes, there is a scenario where we get to there. I think that, you know, I wanna be cautious and not say that I think that that scenario is likely to occur tomorrow. We are, in fact, working on that space. Population health is a very strong angle for our technology. We are looking and working to identify ways to align our technology with population health. For example, are we able to provide lung cancer screening with our technology or no-nodule screening? Are they things that we can do? That would bring that day forward.
Certainly, with the technology and the relationships we have now, I think scans every time a member of the DoD deploys overseas, a pre-deployment and post-deployment scan, I think is absolutely something that we could achieve. That might in fact be a not too dissimilar number to annual scans for every member.
Your next question comes from Naveed Fazelbauer. This reads, "The company has seen success in the Australian market through its commercial arrangements with I-MED. Can you please update us on the status of the Medicare reimbursement? Is Medicare reimbursement critical to gaining a greater share of the Australian market in the same way CPT category codes are for the U.S. healthcare market?
Thank you, Naveed. It's a really good question. Our view is that it is not as important to get Medicare for our growth in Australia as it is to get CPT three in the United States. A big part of that is, you know, the cultural and traditional differences between those two healthcare systems. Now, that doesn't mean that, A, we are not working towards gaining Medicare reimbursement in Australia, and B, that wouldn't help. It certainly would help widen out our share, but it's not as urgent or not as important in Australia as it is in the U.S.
Your next question comes from Jeff Shenfield. How important is the actual new scanning hardware to the overall market penetration strategy? What volume of scanners are predicted within the next 3-5 years?
We see the scanners as a value add or as a value multiplier for our software business. There are a number of parts of the market that will be important in. I think we, for example, we think that the dedicated scanners will be important in terms of allowing us to make greater progress in assisting the pediatric, the child population. Radiation dose is very important in that population, and we think that our scanners can assist there. We also think that the scanners may assist if we do have opportunities such as the one that you mentioned, you know, scanning, that was mentioned by a question just before. You know, for example, annual health checkups for members of the Department of Defense or scanning large volumes of veterans before a deployment.
Because of the very high throughput nature of the scanner, because you can do, at least theoretically, you can do a scan in 4 seconds on that instrument, that really will allow very high volumes of patients. We think there'll be particular sectors where adding the scanner can really help increase both the stickiness and importantly, to both us and our healthcare provider partners, increase the volume or the throughput on those, on those scans. In terms of predicting volumes, I think that's something that is, you know, it is difficult. It's tricky for listed companies like ours to get too deeply into that.
You can certainly take a look and see, you know, how many military centers, how many military health centers there are in the United States and how many pediatric hospitals there are in the United States and Australia. I think those are really, I think those, the best and most likely targets.
Your next question comes from Matthew White. Can you explain the competitive landscape? Who has market share? Are there any other technologies coming online in the next 5 years?
Yeah, yes. Thank you. Thank you, Matthew. There are a few different ways of looking at this, and I think our preferred way of looking at the market share right now is what technologies are being used, what are the imaging modalities that are being used right now to investigate or diagnostic modalities being used to investigate people who have concerns about their lung health. You know, right now, there's 98% of the market is covered by CT scans, X-ray scans and pulmonary function tests. They cover about 98% of the market. If we add to that list, the scan called the nuclear CT:VQ scan, then we get to about 99% or 99% plus of that market share.
There are, of course, you can look at that and identify that there are a number of technologies looking to layer on top of CT, AI technologies, for example, looking to layer on top of CT scans. We broadly speaking, consider ourselves different to that. We see ourselves as a new modality, a new way of investigating the lungs. When we go to large conferences like the RSNA, the world's largest radiology conference, the participants there and the radiology community tends to agree with us on that. That's where we're at. I think that we demonstrate significant advantages against all four of those modalities. Significant advantages against CT, X-ray, pulmonary function tests.
When we release our CT:VQ technology or submit to the FDA later this year, we'll be one step much closer to having very significant advantages over the nuclear CT:VQ test as well.
Your next question comes from Satish Nagarajan. What's the timeframe for the US DoD trial?
Thank you, Satish. This is quite exciting. The trial with the DoD is a fixed number of scans. Something that's really quite exciting is just how quickly and promptly those scans have headed our way. In fact, we've never seen anything before in our experience of scans showing up so quickly after having an arrangement in place. I suspect that it won't be very long at all on that trajectory that we'll have completed doing the imaging and the analysis. We'll have sent all those scans back to the DoD within weeks or perhaps, you know, at the longest timeframe, a few months. That really then opens the door for us to have that next conversation with them.
You know, "Do you agree how much, how great this technology is and what's next?" In fact, informally, those what next conversations have already begun.
Your next question comes from Sayica Pack and reads: With VA, do you expect all 9 million veterans to be scanned under the PACT Act or the only affected population of 3.5 million veterans?
Yes. We expect that the number of how many veterans have been exposed to be refined. You know, perhaps that might lead to that number increasing. Veterans are being sent questionnaires, they are being asked when they attend VA medical centers to confirm their exposure. There are still veterans adding themselves onto those lists of exposed veterans. I think that 3.5 million is around about the ballpark of the number, and that really will be those folks that we're screening. However, under PACT Act. Veterans, you know, by definition, typically older than the average person, they certainly have significantly higher rates of smoking. We can, with the...
Our capacity to demonstrate the presence of constrictive bronchiolitis is very important under PACT, but the VA also has an annual healthcare budget of $300 billion per year, and our capacity to assist with asthma, with COPD, emphysema, all conditions of the lung, and our efforts to get more broadly engaged into other areas of population health, you know, such as nodule or other screening, really does open the door through those capabilities to the entire 9 million population.
Your next question comes from Agilan Ratnakumar. How will scans be used to continually improve the technology? How do you see 4DMedical's technology improving over the long term?
One of the great parts of being a software-as-a-service offering is that we have and we collect every scan that's delivered to us. You know, for example, if we were a bricks and mortar, you know, radiology company, say for example, providing CT scanners or X-ray machines to a site, then there's no real reason or way that we would have access to all of those, all of those scans and all of those images. We have the exciting capability to be able to have access to all of that and to be able to continually improve the software with access with that access. As an example, we're getting very close to implementing a new upgrade to the software this year that will see a 30% reduction in the time it takes us to return a scan.
Incidentally, while we only have operating costs, you know, that are less, somewhere between 1% and 10% of the scan, that will take 10% that will take 30% off those operating costs as well. You know, which moves those operating costs to about somewhere between 0.7% and 7%. We are able to continually upgrade our products. We also listen very carefully to our customers. We're listening to I-MED, to the VA, to all of our customers. What do they like? What do they not like? We're working to improve and add value to the things that they like and to get rid of and ameliorate the things that they don't. Continuous improvement of the software on really rapid timescales that generally in medical technology aren't possible.
Your next question comes from Tao Lu. Any update on the development of CT:VQ?
We're very close. I was hoping to be able to have an update for you in this meeting on the development of CT:VQ. What I can tell you is it won't be long before you do get one. I think you can expect an update, a formal update from us on CT:VQ very, very shortly. Informally, I'm happy to tell you that it is really looking great. We're incredibly excited by how it's looking. We have clinical trial data in our hands and, you know, I'm very happy with how that's going, and it won't be long before we can give you a formal update to really read you into what the business opportunities are, how it's looking, and when we think it'll be out in the market.
Your next question comes from Agilan Ratnakumar. Can you give me your vision for where you see 4DMedical in the next 5-10 years?
Yeah. I'll start with a very brief, you know, short in view of that. You know, over the rest of this year, we expect to make continued progress with the VA and DOD and academic medical centers. Over a two-year period, we really expect that to be very significant and to have really be able to be generating really significant revenues out of the United States, principally from the VA, but with also support there from DOD and those academic medical centers. That will continue to grow over the foreseeable future. Side by side with that, at around about the 18 to two-year mark, we'll have reimbursement, which will really allow us to make a big splash out of that $13.7 billion US opportunity.
You know, we are adding new products to the list, you know, such as the CT:VQ particularly that I've been talking about. From that base of success, you know, we absolutely see ourselves getting to being a profitable company. As a profitable company, we will be reinvesting, you know, those resources that we have to allow us to expand out from being just a lung imaging company to, for example, to all of the chest. That's the next obvious step. We will have the heart and the lungs. We have really significant opportunities. We're concentrating, I think, for very good reason right now in Asia-Pacific, so ANZ and North America, concentrating in those areas for good reason right now.
As we progress into profitability, that'll also release the funds for us to expand 4DMedical globally. If we talk about the ten-year mark, we have really high ambitions at 4DMedical. We wish to be the key source, the key provider for functional data inside the human body within that timeframe.
Your next question comes from Satish Nagarajan. What is the main competitive disruptive technology which is a potential threat for 4DX?
4D is a very agile company, and we are extremely well-placed to make decisions and to tack, subtly tack around threats as they may or may not appear. Through our great partnerships with the leading hospitals in the world, you know, both in Australia, The Alfred, The Royal Adelaide, you know, UNSW. In the United States, Johns Hopkins, Cedars-Sinai, Temple, Duke, Miami. We see and know new technologies as they are moving along. We see and have really great eyes on AI and how AI is looking to change the world of CT and other parts of medical imaging. We see how new CT scanners, such as photon-counting CT scanners, are coming out. We are really very well placed in all of those, in all of those cases.
In fact, not to see this as disruption, but to see this as opportunity. That's really how we're getting into that. We think that AI can be something that can be layered on top of 4DMedical technology instead of competing with it. You know, and similarly with new CT and new other imaging hardware that comes out, we layer ourselves on top of existing medical technology, therefore we don't see ourselves as competing with it or being threatened by it.
Your next question comes from Rod McLennan. Will I be able to access a recording of this presentation?
You know, I'm gonna have to pass that question. That's not something that I'm aware of. I'll just pass to the team to give an answer on that.
The answer is yes. When we wrap up today's presentation, I'll let you know where that is. In fact, it's going to be at 4dmedical.com. If you go to our investment center, what I will arrange is for a link to today's session to be put there for you.
Thank you. There are no further questions at this time. I'll now hand the conference back over to Mr. Fouras.
Look, thank you so much. You know, really very pleased to have your interest, to have the opportunity to tell more about the 4DMedical story. You know, just to reinforce just how, just, you know, just how pleased we are with the loyalty and support we've had from our fantastic investor base. You know, I'm pleased therefore to be offering, as I said, by percentage terms, I think the biggest SPP that I certainly can recall and, you know, on the same terms as has been offered to the rest of the market.
As I said, thank you so much for your support and your interest, and I'm sure, you certainly can expect to hear continuing news from us, you know, updates on our pipeline and on the progress with products such as CT:VQ in the near term. Thank you.