Thank you for standing by, and welcome to the 4DMedical Limited Market Update on Recent Developments conference call. All participants are in listen-only mode. There will be a presentation followed by a question-and-answer session. If you wish to ask a question, you will need to type your question into the Ask a Question box and click Submit. I would now like to hand the conference over to Dr. Andreas Fouras, CEO. Please go ahead.
Thank you so much, and thank you to everyone for your interest in hearing an update on our recent developments. It's been an incredible rate of progress for us over the last few months, and I'm really excited to have the opportunity to share all of this with you. Of course, we have to pay attention to the usual legals. I'll begin for those of you on the call who aren't necessarily completely up to date with 4DMedical and who we are, with a brief introduction to 4DMedical. We are a software company with an incredible software platform that allows doctors to see inside the lungs for the function of the lungs for the first time. We're also expanding that to the development of a dedicated scanner that leverages that XV Technology platform.
This technology puts us in place to target an incredible opportunity. Respiratory diseases represent one in six of all global deaths, resulting in an economic burden of over $173 billion. And in the United States alone, almost $14 billion is spent on respiratory diagnostics every year across 73 million procedures. In addition to that, the U.S. PACT Act, signed in last year, just a little over a year ago, represents an additional $280 billion of funding specifically for veterans who have been exposed to airborne hazards. We have a software-as-a-service business model that layers us on top of existing infrastructure. That's both important to us as a company, but also to our customers. They have their existing infrastructure.
Every hospital across and every major medical center across Australia, the United States, and in fact, almost every other country around the world, has the existing infrastructure to deliver our cloud-based service. And that cloud-based service delivers for us 90% margins on our technology. And we have. We've been starting with a pre-approved pricing model that sees us in the United States at about $170 per scan, and in Australia, about AUD 160. Although we've had a real breakthrough with CMS having assigned us payment of about $299 per scan. And, you know, we see a fluoroscopy imaging cost inside of that of about $35-$45. So we think that there's, there is significant upside on that $171 per scan.
So from that, you know, introduction there. We have a, you know, a really brief elevator pitch of what the technology offers us, you know, which is that there's new insights, so it's better information for the doctor, and we know that better information leads to better decisions, and better decisions lead to better outcomes for patients. It's also safer for patients, which can drive patient decision-making and can be beneficial, therefore, for both the patient and the supplier, and really high, you know, really superior results. You know, we have the resolution of a CT scan, the functional outputs of a pulmonary function test, and the availability and cost base of X-rays. All of that in combination leads to a fast scan that's low cost, and once again, is good for patients.
From there, you know, really excited to get into the core reason for today's presentation, which is to talk to you about the incredible rate of progress we've made over the last quarter. The team at 4DMedical have been, as I like to say, they've been busy planting seeds for several years now, and the last quarter has shown, you know, what's been happening under the surface, you know, like you've never been able to see before. And so, you know, we have these five incredible announcements that we've shared with you, that we've been able to expand our Australian, New Zealand offering from I-MED to also include Integral Diagnostics.
We have that network agreement with them with an initial pilot in regional Victoria, with really strong feedback already coming back from the doctors involved. You know, that extends our network to multiple providers and creates a longer term opportunity for us in New Zealand. And then the monumental outcome of having achieved CMS payment on our Category III. This provides us access to 65 million people across the United States, but it's also really worth mentioning that that population group, those folks who are over 65, really represent the largest users of lung diagnostics in the United States and indeed around the world. This will accelerate our adoption and you know lead to income generation for us.
This is a larger payment than we were expecting, frankly, and is well ahead of schedule. Once again, putting us into a cycle where this will drive more usage, and the more usage will allow us to expand from that 65 million Medicare patients in across to private insurers in the United States. From there, we'll move to FDA approval of CT LVAS. Many of you will know that we've had CT LVAS available in Australia for some time, and we've been getting incredible feedback on the use of that technology, and we're really excited about unleashing this product in the US market.
It expands access to folks who are, for example, may already be having a CT scan anyway, and so therefore it makes sense, or perhaps are at a location where fluoroscopy is not available. We're also particularly excited about now being in a position to, in our 510(k) for CT:VQ, being able to use this CTV approval as a predicate device, de-risking and perhaps accelerating our CT:VQ approval. You know, if we cycle back around to our CMS Medicare reimbursement, having payment opens the door, removes barriers to customers getting on board, and we've already seen evidence of that with SaaS contracts in Detroit and Memphis. So we have outpatient practices in those locations, already signed agreements, ready to go on the first of January when that CMS payment kicks in.
And I've just recently come back from RSNA, the world's largest radiology conference. It's been in Chicago, and it has been an incredible conference. And, you know, we've just had such, you know, such strong interest from so many places. But, you know, of course, the highlight for that conference for us is the Philips Memorandum of Understanding that we signed. Philips is, of course, an iconic brand name and one of the leaders in radiology across the world. So their partnership with us will expand our reach, our ability to rapidly scale and to get to customers and bring forward the utilization of our technology. It's also really exciting that they have really prominent operations within the VA.
The US CEO of Philips is a West Point graduate, so a military man with strong commitment to the VA. And the VA team inside Philips are the most committed corporate VA team I've seen anywhere outside of 4DMedical. And that includes that they have already won 50% penetration into the VA, you know, really putting us in a very strong position, as said, to leverage that scale, to leverage that size. And our initial focus will begin by looking at taking our C- our XV LVAS to screening solutions for veterans exposed to burn pits. But there are a whole range of opportunities for us, including with our CT LVAS product line inside the VA, but also expanding outside of the VA within North America, and perhaps over time, taking the deal global.
Sorry, I've covered all of these details here on that previous slide. And, you know, as you know, we have a very strong board. Having recently elevated Lil Bianchi to chair of our board, having recently brought on Dr. Geraldine McGinty, a world-renowned radiologist, a previous chair of the American College of Radiology, one of the most important organizations in radiology in the United States, and who have also a very large voice in the delivery of reimbursement to radiological products. Also, many of you will k now that, we've had long-standing support from Dr. Sam Hupert, Professor Bruce Thompson, eminent in their field in Australia, and recently appointed Dr. David Shulkin, the ninth Secretary of the VA, to our advisory team.
In addition, we have an incredibly strong, committed, passionate management team, including Matt Tucker, a recent CEO of GE Healthcare in our region, to our management team, and he's now running our commercial operations. So that includes sales and marketing for the company globally. So we have incredible progress from the work that we've been doing over these years. We have a great team to deliver on that, and now we have additional levers. Barriers have been taken down now that we have reimbursement, barriers taken down now that our CT LVAS product is approved in the United States, and additional muscle in our corner in the form of our Philips partnership.
So we have the people, we have the resources, and we've never been in a stronger position. So thank you, everyone, for listening to that presentation, and happy now to proceed to questions.
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 Paul Evans, who asks: What are the details of the MOU with Philips?
Hi, thanks for the question. So the details are that we have a really very firm commitment with Philips to proceed to an ultimate arrangement, which is labeled as a reseller agreement. So that will mean that Philips will be able to sell our technology with us to customers. So that will mean that, you know, those sales become a sale to Philips, and then we'll have an arrangement where Philips reimburses us for those payments. The MOU also talks about the opportunity to expand, you know, from North America across to a global arrangement.
And if I, I should be able to just move slides here, and, and I can leave this up for a while, while I'm answering other questions, 'cause, you know, in those lower dot points, you can see some of those, some of those there. But I think it's also, you know, really, as I said, to me, the... I've really been very, very, very pleased by the obvious level of commitment that Philips has to, to this, to this partnership. And, you know, that's been evidenced by the, you know, by the, the level of attention we've received from them, you know, including at RSNA, where we've had, really long conversations with both the, the North American CEO and the, the global CEO of this, this very, very large business.
Thank you. Your next question comes from [audio distortion] , who asks: Given the recent MOU with Philips to improve the sales opportunity, is there any update on the revenue outlook for FY 2024 and FY 2025?
Look, I feel very confident that this partnership with Philips will accelerate and bring forward our revenues. I feel very confident about that. As I say, the scale and reach of the organization is really very, very significant. They have great ties to the VA, which has been, you know, and to the DoD, which are key targets for us for our revenue over the next 12-24 months. So yes, you know, our outlook is substantially improved now that we have this Philips MOU achieved.
Thank you. Your next question comes from Kazuya Wright, who asks: When can we expect progression and signing of the VA deal?
We're expecting, in terms of a timing down that direction, we're expecting to see you know, further conversations, further updates from us, you know, within this calendar year. I think that should put us in a position, you know, this calendar year, where we will have a much clearer view of how our pilot process will proceed with the VA. And then we're expecting that pilot process to take about six months, you know, which puts us to about the middle of the year. And then, we expect to be, you know, to be looking to roll out on a much wider scale, across the VA in the second half of calendar 2024.
Thank you. Your next question comes from Tina Wilson, who asks: How are the conversations with private insurers in the U.S. now that Medicare has agreed reimbursement?
Thank you. It's, it's a really exciting area for us. You know, having been able to bring forward the Medicare reimbursement to sooner than we expected, it absolutely opens the door, and we have already been having those conversations as, you know, as you would expect us to. We've grown the size of our reimbursement team, and, you know, this really sets the scene, sets the framework to bring those private reimbursements forward to operate under our Cat Three code instead of having to wait for the Category I.
And, you know, the general process will be whereby we have our, you know, our hospital partners, our healthcare delivery partners putting in claims to those, to those providers, to, you know, as a side by side with us, reaching out to talk to those insurers, to, to bring about them adding us to their, to their claims list.
Thank you. Your next question comes from Vincent Nigro, who asks: how's the AU rollout going with I-MED, et cetera, along with scanning take-up?
So we've had some really great progress here. As you know, as I've already mentioned, as you know, as you've heard, that we've now brought on Integral into the process. And there are some regions that I-MED doesn't cover across Australia that Integral does, and so that's gonna be very helpful in those regards. But we've also had some really great progress with I-MED. We've recently successfully run a number of GP campaigns, expanding out the level of interest from lung specialist doctors to include the GP portion of the market as well. And we're increasingly seeing really significant opportunities for us there in that GP market.
We've also added on more training folks to our team, and that allows us to have, you know, to have more conversations with doctors after they've delivered their scans and, you know, for them to be able to have conversations with someone from 4D about, you know, the scan, what it means. And that's really had a positive effect with those doctors who have been using the technology. So, and all of that is already showing positive impact on increasing scan volumes.
Thank you. Your next question comes from Sean Rapley, who asks: What is the anticipated timing of converting the Philips MOU to a reseller agreement?
Thank you. So we are, you know, a standard timeline to that is a several month timeline, especially with the end of year in place. But we will have an intermediate opportunity to sign a teaming agreement with Philips, and I think that should really put us in a position to have a much clearer view of the timeframe, of the timeframe and, you know, the final details of the reseller agreement. So look, I think, several, you know, we'll be looking at weeks, and so we're certainly hoping to have the teaming agreement completed this calendar year, and then early in next year to convert that across to the reseller agreement, but with an update in that in-between period when we complete the teaming agreement.
Thank you. Your next question comes from, Syed Ap—apologies, Syed Apak, who asks: How is the Department of Defense pilot processing? You mentioned that you were very eager and expected to sign agreement, possibly in three to four month time period back in May. How close are you to finalizing that deal?
Look, we feel very close on that, and, you know, the... We've had multiple discussions with the team. I think we absolutely can call that pilot a success. Our Department of Defense have been very interested and very pleased with the outcomes of that pilot, and, you know, we're well into discussions to see what we can do for the, for an additional step there.
Thank you. Your next question comes from Dan Stewart, who asks: Does 4DMedical view companies such as Optellum, who apply AI to CT scans to identify lung problems, as competitors?
The short answer is, in general, we don't. I mean, we do keep a close eye on all of these companies, especially when they operate on or have a focus on the lungs. But the 4DMedical technology focuses principally on function. And so we measure how the lungs work, and that's information right now that's not available from any of these other technologies. You know, in general, AI companies offer a technology that allows a radiologist to do what they already do, perhaps quicker, perhaps with less risk of error or omission.
You know, but our technology offers radiologists and doctors, you know, new information, new things that are not available anywhere else. And, you know, in addition to that, we have a fantastic patent moat around our technology, about 75 patents now and counting. And, so, you know, at where we sit with our technology offering, there's really isn't an opportunity for anyone else to offer that.
Thank you. Your next question comes from Tom Godfrey, who asks: Have recent developments improved the timeframe for CPT ? Any updates?
Yeah. So, yeah, I'm really excited about this because, you know, two things have happened, and one of them is that we think the opportunity to accelerate CPT 1, you know, has materialized here with this, but also at the same time, that we need CPT 1 much less than we did before. You know, the previous driver to get to CPT 1 is because that's the only place that you can be assured of gaining the payment code. But now that we do have a payment code in our CPT 3, you know, we're certainly interested in looking at, perhaps even dwelling here a little longer. The...
You know, there's plenty of examples of folks who have been very successful in CPT 3 and perhaps even withdraw their CPT 1 applications because, you know, if they're able to gain first, CMS reimbursement as we have, and then bring on private payers as well, then that's really an excellent outcome and, you know, one that we ought not to delay. So I think, as I said, we've both put ourselves in a position to get there easier, but actually we need that - we don't really need that anymore. We're in a really great place where we are right now.
Thank you. Your next question comes from Sriram Viswanathan, who asks, "Are you exploring, are you exploring including the 4DMedical lung scan procedure in the Australian Medicare cover?
Yes, absolutely. It's absolutely our goal to get our technologies reimbursed in Australia as well. And, you know, we're doing, you know, we're doing everything that we can to bring that to fruition.
Thank you. Your next question comes from Nicholas Boston, who asks, "What are the challenges in education, GPs, and promoting adoption of new technology?
I think that, you know, there's a really a multi-stage conversation for us to have with the community. And I think, you know, we've done a really great job in, you know, getting the technology out there. And, you know, many, many more folks, you know, many more GPs, many more lung specialists know about the technology than did, you know, even just six months ago, and certainly many, many more than a year ago. But then, you know, we're also, you know, doing specific campaigns, email campaigns, advertising campaigns in the appropriate literature, and also attending conferences and meeting these folks, you know, face-to-face. Giving them the opportunity to see the technology and meet our team and discussing it.
And then, you know, really there's a slightly different value proposition for the technology for GPs versus specialists. And so we've been working hard to re-articulate what that value proposition is and how this can help GPs in ways that are subtly different to the way that the technology helps specialists. So we've been articulating that, putting that together, and, you know, getting that out there in the messaging.
Thank you. Your next question comes from Kevin Liang, who asks, "What is the timeframe for getting a second Authority to Operate at VA? And from there, what is the likely timing and process for national ATO?
We, you know, we have multiple applications pending with the VA, and, the, you know, we feel, we feel very comfortable that, those applications are in a good place. But the VA doesn't give transparency on progress for those applications when they're pending. And so, you know, it's, it's really very hard to give specificity on, you know, specificity on when those, when those applications will come out. But we've got multiple applications in place. We, we really only need one of those to come through to be able to then convert to a national ATO.
And so, you know, while we don't have, you know, we don't have details, we've got, you know, with multiple applications in, our previous success under our belt, our growing strong relationships with the VA, we do feel very comfortable that, you know, a second ATO will be imminent, and that then we'll be in a good position to convert that to a national ATO. And at that point, I note that it's now half past, and the scheduled time on this has elapsed. So I think we might call that as the last question.
Thank you. That's all the time we have for-
So-
Our question and answer session. I'll now hand the conference back to Mr. Fouras for closing remarks.
Thank you. So, you know, we, we've been, you know, really working hard, doing all of the work to, to, to build 4DMedical into a very significant, you know, global business that can deliver healthcare to, to millions of people. The progress we've been able to make over the last few months really has been, I feel, quite dramatic. We're really in a very strong position here. Barriers have been knocked down, you know, muscle has been added to our corner, and, you know, I really feel incredibly excited about, about where we can get to over the next few months and that, you know, feel very excited about being able to keep up the pace of, of news flow that we've had so that you can all follow along that, that journey with us.
Thank you very much for your interest. Thank you for listening today.
That does conclude our conference for today. Thank you for participating. You may now disconnect.