Hi everyone, thank you so much for joining us today and for your interest in 4DMedical and today's investor presentation. Of course, the key focus of today's presentation is going to be CTV-Q post our announcement that we now have FDA approval for that product. This is a transformational milestone for 4DMedical. CTV-Q is the world's first and only non-contrast ventilation and perfusion imaging technology. We have an incredible addressable market. In the United States alone, there's over a million nuclear VQ scans a year performed with a $1.1 billion US market opportunity. Globally, we see that as being at least double that at a $2.6 billion US opportunity. Furthermore, we really strongly feel that the introduction of CTV-Q into the market will drive long-term growth in demand through both increased accessibility.
There are far more CT scanners across the United States than there are nuclear scanners, and through improved workflow and health economics for the providers. Additionally, and aligned with that, unlike rollouts of transformational technologies in the past, VQ is instantly scalable. There are already 14,500 CT scanners across the United States. Nobody needs to invest in new infrastructure to be able to deliver this game-changing technology. CTV-Q is set to displace nuclear VQ scans and expand functional imaging. As part of our pathway to deliver that as rapidly as possible, I want to talk to you today about the clinical validation that we've performed and also the commercial traction already underway. CTV-Q, all the contrast, none of the injections. We have a technology where there is no need for contrast agents. You have a clearer and faster diagnostic capability, enhanced access through a broad range of CT scanners.
As I've said, in the United States, 14,500 scanners there are ready to go and dramatically improved patient experience, dramatically lower cost of care, improved economics for the providers. Over and over again, we hear from doctors, hospitals, when we talk to them about VQ, that shifting to CTV-Q is a no-brainer. Every decision metric points in the same direction to say yes. Part of that is that we're evaluating to standard of care to routine CTs with non-contrast functional imaging. You see there on the left a routine CT that is already part of standard of care. Folks coming in to receive, for surgery already have a CT. Folks coming into the ED already get a CT. Folks who are part of chronic lung disease workshops already get a CT.
These CTs are routine, and then we can value add to those with our game-changing technology, you know, first of its kind to allow doctors to see ventilation, the ventilation image you can see on the right, which of course is based fundamentally on our CT LVAS that's been in market for some time, and brand new, first of its kind perfusion in that bottom image. We've been doing this for some time, and in particular over the last few years, we've really been gaining traction with the products that we have, the products that we have in market. Not only is that because we have the biggest portfolio we've ever had, not only is that because we've got the best team that we've ever had, but we also really understand what's needed to be successful in the market now today.
That is for CTV-Q, dual-facing outputs coming out of the technology. What do I mean by that? We have our patient-facing workflows. We're talking about what do we give to the GP, to the lung specialist, or the interventional pulmonologist who are, you know, who is seeing that patient. What we give them is this report on the right. One, lung volumes. Two, those graphs that show low-bar distribution summary, that just in a split second, the doctor can look at that and can see, is the ventilation and perfusion matched but low, or is it mismatched high? All of those things can be seen in a split second on the graph, and then in the numbers to the right. Underneath that, representative images, pictures tell a thousand words, once again in a split second, a doctor can look at these and see what's happening inside their patient's lungs.
For the radiologist, we deliver reports that are delivered in line with existing radiology workflows within their current viewing platforms on their PACs. They already get their non-contrast CT, and then we add these as additional layers on top of that. The data is streamed in under SRDICOM, under FIRE, these standard protocols, because we know radiologists are incredibly busy. They don't want to spend just even one second that is not adding value to their patients and to their practice. We offer that to them in how we provide this technology. Not only is it a game-changing technology, but it's delivered in a way that's completely streamlined for the workflow for the physicians who are in charge of delivering that. Frankly, a key part of the driver for us and for this shift is that there are logistical and technical challenges for existing technology.
Nuclear medicine is a high-cost procedure, relatively poor resolution, time-consuming, high patient compliance, expensive infrastructure, complex procedure. For those of you who have heard me give this presentation before, I apologize. I'm going to repeat something that I say always at this point. We are a very patient-centric organization at 4DMedical, and I've had a nuclear VQ scan. You have to go sit down, inhale a radioactive powder into your lungs. That's not great for the patient, but also the hospital needs to either manufacture that material, that powder, that dust on site, or have it delivered on very short timelines because it has an incredibly short shelf life. You then have to, having inhaled that, get the ventilation part of the scan. You then have radioactive materials injected into your blood, and you get the perfusion, the Q part of your scan.
4DMedical CTV-Q technology replaces all of that with a click of a button and running of software. The patient almost always will have already had the CT scan run. On top of that, now the VQ technology can be provided. Reduces the cost, increases productivity, far better patient experience, and then also through greater accessibility, it's much better equity. Folks in country towns have access to CT just like they do in the big cities. In particular in the United States, the nuclear imaging infrastructure is actually somewhat more aged than it is here in Australia. Two-thirds of the nuclear imaging infrastructure in the United States is planar. It's just a single view. It's like a chest X-ray type scan, not a three-dimensional image.
Through our technology, not only do we give that better accessibility, but we get to leapfrog over at 10 years of out-of-date technology to come to our solution. Part of the reason, one of the many reasons why I'm so excited today, why we're excited, is that this FDA clearance has come ahead of schedule. I'll talk to you about what that means for us and for the success of the technology. In order to thoroughly assess the performance of CTV-Q, we delivered a package to the FDA that had three core components of clinical evidence. Number one, standalone device performance, quantitative. We put numbers head-to-head between CTV-Q and SPECT VQ. Reader performance assessment, a qualitative assessment where expert radiologists and nuclear medicine physicians, once again, head-to-head looked at our scan, looked at the nuclear scan, and came back with their thoughts of similarities and differences.
Finally, a case-based review where a selection of cases were reviewed in depth to highlight areas of agreement and discrepancy. As I said before, one of the things that we're so proud of and the key driver of our FDA approval coming through early is when we delivered this package to FDA, there were no questions on our clinical evidence. That is something that we're incredibly proud of. It's the most obvious place for FDA to stop and pause and say, what about this? Prove that. Do you have more statistics? Do you need more patients? We don't like your methodology. The evidence was so clear, so overwhelming that we had no questions from FDA on this component.
That mimics what we see when we put this material in front of potential customers, mimics what we see when we talk to doctors out there looking to adopt this technology into their practice. I'll just quickly come back to our FDA submission. We said there was quantitative assessment. Here you can see where on the left, perfusion, on the right, ventilation, that there's very strong agreement. The more perfect the agreement is between the technologies, the more that data lies just perfectly along that line. You can see, especially for the perfusion, there's really great agreement. On the ventilation, there is also very good agreement, but it's well known that there is greater noise, greater variability in ventilation imaging in the United States in particular.
From there, our reader study, we had six radiologists and nuclear medicine physicians between them with well over 150 years of experience examining case after case after case, looking region by region. You can see, for example, these blue arrows, the blue arrows here on the image on your screen showing where they see something that's noteworthy that appears both in the SPECT images and in the CTV-Q images. You can see really excellent agreement. They're identifying the same structures with the blue arrows. With the red arrows, they're showing what they call, you know, contrast artifacts, which are caused either by clumping or by leakage of contrast in the scans. Of course, they only occur in the SPECT imaging because we don't use contrast in the CTV-Q technology. Here's another example. I really like this example.
If you look at where these blue arrows are pointing, you can see a shadow sitting on the lungs. This is what's called a wedge defect that's typically seen as the key signature of a clot or a pulmonary embolism in folks. That is, of course, one of the use cases for VQ-type technology. You can see very clearly identified in the CTV-Q. Really just a really key example demonstrating the technology. In the SPECT, you can see there's significant clumping and leakage in that SPECT ventilation image. Once again, as I said, in the United States, the infrastructure is typically, you know, 10 years out of date compared to what it is here in Australia, which leads to those clumping. We also did a statistical analysis of that qualitative assessment. We used something called Kendall's Tau.
The standard here for this is if you look on the right of that table, there's the strength. You see strong would be the typical standard that we would be required to meet. That's a score of 0.49 or greater. You can see all through this graph, you know, greater than 0.7 or greater than 0.71, which is greater than the very strong. It's the very highest standard, well in excess of what FDA was expecting from us and just one part of why they had no questions to ask when examining our data pack. What does that mean? We believe very strongly from the get-go that in order for 4DMedical to be successful, we only need to be clinically equivalent to the technologies that we're replacing, right? In order to win the billion-dollar market.
That's because if we're clinically equivalent, if we give doctors the same output, but we have technology that has economic drivers, it's cheaper, convenience drivers for the patient, much better patient experience, workflow advantages for the hospital. These are all things that we've seen that have been mixed for us, you know, at 4D in the past. Now all of these factors align as tailwinds for taking VQ to market. We were very clear. We just need to meet clinical equivalence to win this market. We absolutely have demonstrated that clinical equivalence. In the standalone comparison, in the clinical reader study, we've shown that it's clinically the same. However, we do believe that we've demonstrated significant aspects of superiority, for example, through absence of contrast-related artifacts and, for example, through lower noise and higher correlation with physiology.
Not only do we have better economics, better workflow, higher convenience, we are at the very minimum clinically equivalent, but we believe we have also demonstrated superiority. To wrap up my presentation today, we are the world's first and only non-contrast perfusion scan, ventilation perfusion scan. We have a large addressable market, $1 billion in the United States, instant scalability with 14,500 CT scanners in the U.S. We don't have to fight through building infrastructure, for example, as with the deployment of MRI. We've confirmed our diagnostic accuracy. We have superior workflow, improved experience, increased accessibility. We have commercial traction ready to go from before we had FDA approval. Of course, we're going to be driving that harder. We already have Stanford University, Brooke Army Medical Center lined up, a whole bunch of other potentials behind that, results presented, and we've strategically positioned ourselves to displace nuclear VQ.
We couldn't be more excited. I think this is great news for patients. This is great news for doctors and great news for our shareholders. Thank you. That's my presentation today. I'm very happy to proceed to questions.
Thank you. First up, we have some questions from Jack Smith at the Investor Center. Does CTV-Q require further validation or trials from practitioners before contracts can be signed, or is it ready for rollout?
Thanks for your question. We've worked very hard. We are ready for rollout. The FDA approval was the last thing we needed to roll out across the United States. We have record amounts of evidence to support clinical adoption, and we have the big tick of approval from the regulator. We are absolutely ready to go.
Jack also asks, will 4DMedical be commercializing CTV-Q directly, or will this be done through partnerships with companies like Philips?
Thank you for the question again. Both of those things, we have partnerships out there in the field, and we'll be using every lever, every channel that we have to take this product to market.
Jack asks, does 4DMedical have a commercialization plan in place, and specifically, do you know which hospitals currently perform the highest volume of nuclear VQ?
We've absolutely been out there. We've been talking to the market in the lead-up to this. We know who are the leaders in this space. For example, in the world of pulmonary embolism, UC San Diego Health is an example of a hospital that has really large volumes of post-acute, subacute PE clinics. In the world of COPD, for example, Cleveland Clinic has one of the largest clinics. Yes, we know sector by sector, use by use, where these scans are being deployed, and we've already been initiating and engaging in conversations with those folks ahead of the good news that we've gotten over the weekend.
Matthew White with Shawn Partners asks, what is the timeline for Medicaid for the VQ rollout? Will that be a prohibitive factor for the rollout of VQ across clinics in the U.S.? Cheers.
Yeah, look, we've been, we'll stand by our guidance that we've provided earlier, that we're saying that I've been personally very confident that this year that we will have reimbursement for this product. If you take a look at the time it took between FDA approval for XV and reimbursement for XV, and then the time between FDA approval for CT LVAS and reimbursement there, you can see that we've been building those relationships. We have a clearer understanding of how to drive and operate these systems. I feel that this is absolutely on track to be our record shortest time between FDA approval and reimbursement of any product. We're confident that this will be, as we get that, this will be another tailwind for us to help drive to market faster.
Anthony Ives with Ordminet asks, what will be the cost of the scan? What will the hospital receive, and what will 4DMedical receive? When do you expect your first commercial contract?
All great questions, and I think the truth is you all know that I can't really answer those questions here on this call today. We will be working, we'll be working morning and night. We have been already before FDA approval, but now post-FDA approval, working around the clock to deliver contracts on this technology in record time. There are significant opportunities in the near term. Once again, this calendar year, the RSNA conference is in late November. There's a chest conference in late October. We have some really great conferences, some great opportunities to take the technology out, as well as, of course, our sales team this week are going to be beating the doors down to the hospitals that we've been working on lining up ahead of this. I think that in terms of pricing, that's something that is going to have some variability.
Of course, especially when you go out to market, it's pretty common to have variability as you grow market share. I'm sure you'll agree that the key thing for us to do in the early days is to grow market share. I think, but our expectation is where we'll land is that this will be in the ballpark of $600 per procedure and around the same pricing as CT LVAS, so $650 US per procedure. There'll be, there's with a cost of delivery for us of about $4 on that, there's plenty of room to share some of that revenue with the hospital who are working to get the CT and do the reporting and any channel partners we have along the way.
Leon Oxford asks, what pushback are you expecting in the rollout? What are the challenges in moving providers from the current nuclear medicine scan to CTV-Q?
We've received really incredibly strong feedback. I think that especially for the two-thirds of the U.S. market that today are using the planar imaging, there's just really no reason for them not to leapfrog over 3D nuclear imaging and come straight to CTV-Q. That's validated in interactions we have in the marketplace. I think for other folks, there's, you know, we have the usual points of friction of contracting and IT connectivity, but we've also never had more options and more different ways of completing both of those pathways, whether it's through partners such as Philips and other players in the space to assist us with those steps. We're not saying that immediately overnight all of these customers are going to show up on our accounts, but this is the first time that our sales team has had the ability to be selling a replacement product.
Historically, they've been out there looking to take to customers, "Hey, look, there's this incredible new technology. It can help your patients. You just need to do this little thing differently, or you just need to do this differently." That can really be a benefit to your practice and your patients. That's been incredibly successful. We've worked out how to do that. You've seen, give or take, ballpark 100% year-on-year growth. You've seen that quarter after quarter for quite a few quarters in a row now for us as a business. Now, not only do we have, for example, the Philips partnership where our sales team can be multiplied with a much larger sales force, but it's the first time we can say, "Look, if you're doing VQ, you can still be doing VQ.
You just have to switch it over." In fact, the economics are better and the workflow is more convenient. This is easier. We really do see this as a no-brainer.
John Piper with Shawn Partners, as we understand that some users of the technology are getting it for free, like a trial period, what's the typical timeline for the fee-free service? Is it three months for free, then pay for it for six months? I think everyone wants to know when the cash is coming from all these scans. Terrific growth in last quarter, but limited income, it seems. Annualized run rate of 300,000 scans per annum, which should equate to $30 million revenue at $100 per scan, maybe.
Look, we have been growing the price that we bill per average on our scans as we go. We have been offering for other products and other technologies trial periods and pilot periods. One of the things that I'm incredibly, incredibly proud of at 4DMedical, and I'm absolutely sure this won't change under VQ, is we've never done a pilot that hasn't converted into a paying customer. If you just really think about what that means, that means that no single doctor that once they get their hands on this technology and use it with their patients doesn't come back around and say, "Oh, I really need to have this and I'm willing to pay for it." That's an incredible backing that we have. It allows us to really believe in our technology.
It allows us to say all we need to do to win here in the marketplace is to get the product in the hands of doctors, and they will demand it and they will use it with their patients. We have been doing that with other products. There's also going to be, I think, a number of different models that we can deploy here too. We can deploy subscription models, we can deploy pay-per-use models, and we can see really what wins out there in the marketplace and what gives us the biggest market share. With $1 billion for the initial market on hand, I think you can see where this can go. $300 million is really just the beginning.
Jules Paris with George Clinical says, will CTV-Q be included in the Philips portfolio too for VA?
Our partnership with Philips is very strong. We will need a little bit of time to work out the nuances. I have no doubt that Philips will indeed be selling it to the VA. Exactly what those arrangements are is something that we will be working out. It is not stopping us from having the Philips team out there talking about this technology already.
Luke Bryan from Movement by Design says, hi there and congratulations on clearing the FDA for CTV-Q. My question is about progress with the VA and Department of Defense. These have been ongoing goals for the company. How close are we to a material contract here? Would it be immediately VA or Department of Defense-wide initially, or more likely to be a pilot?
Look, I think it is, you know, we continue to invest in this space. We have, we've had our team on the ground in DC, and now that we're joined by Philips, there's a lot more muscle there to, you know, to get our technology into the hands of VA doctors and veterans. The truth is we are working, continuing to work, as we always have, with both top-down and bottom-up approaches. Just to be clear, what I mean by that, we are working to, for example, go to, you know, regional hospital networks such as statewide VA hospital networks, where they are called VISNs, and, you know, work with them to do pilots or to do contracts at that level.
We are also talking at senior leadership level in DC and around the VA to see about deploying our technology, especially, you know, you might have seen recently that we had our work published talking about the efficacy of our technology to screen for veterans with burn pits and avoid biopsy. That data's come out showing 98% agreement with biopsy. A biopsy is $30,000. You know, a test here with this is going to be something like $1,000 when you include the CT. It really is, I think, a significant opportunity for the VA to save some money. While, of course, there has been some turbulence in Washington over recent months since the change of administration, this administration is proving to be committed to delivering healthcare, and the recent VA budget was, in fact, significantly up from years past. We're attacking that from every angle.
You know, smaller contracts, nationwide contracts, every possibility.
Private investor Dean Egan says, would it be much of a barrier for a doctor to learn how to read a CTV-Q, also LVAS, etc., compared to their current long-term methods?
Thank you for that question. It's a great question. As I shared in that slide before, we create, for example, for the radiologist, we create image layers that layer directly on top of the CT that radiologist is already reading. We provide those images to look and to be customizable to look exactly the same as the nuclear VQ images appear on their screen. There's literally no difference in their ability to read them. In fact, that's been validated through our FDA approval process as well, FDA clearance process as well, that there's no gap in readability from the first scan read between our technology and the existing technology. That's something we've worked very hard to do, and I believe we've been incredibly successful in removing that hurdle to get to market.
Investor Ujwal Arial asks, are we thinking of including this as a package with PME's product, or have we had any discussion?
Look, I'm not going to give any public comment on that. I think that there are plenty of opportunities there. There's technological compatibility between our technologies, and obviously, we're very excited about the support from Pro Medicus to get to where we are today. We'll have to wait a little while before we can talk more about that.
Investor Craig Hutchinson says, when can the non-U.S. market move into question, is CME approval being sought?
I think that we have a really significant opportunity right now for this technology in the United States. It's ballpark of 40, 45% of the global opportunity for total sales, well over 50% for the total global opportunity for profitability. I think given the size and that where 4DMedical is at, I think the best bang for our buck, the best return on investment for our shareholders right now is to focus on the U.S. market. We do have global ambitions, and when the time is right, we'll be ready to take this technology around the world.
Thank you. That is all the time we have for questions and answers today. I'll now hand back to Andreas.
Thank you very much. I hope you can hear just how excited I am. We've been working towards this for a long time, and now that we're here, we're putting everything we've got on the line to execute and to deliver. Thank you very much for your interest, and I'm looking forward to a really exciting closeout to the rest of the year. Thank you.