4DMedical Limited - Special Call

2025-09-02 01:23:43 ET

4DMedical Limited - Special Call

Company Participants

Andreas Fouras - Founder, MD, CEO & Director

Presentation

Andreas Fouras
Founder, MD, CEO & Director

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 CT:VQ post our announcement that we now have FDA approval for that product.

This is a transformational milestone for 4DMedical. CT:VQ 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 1 million nuclear VQ scans a year performed with a $1.1 billion U.S. market opportunity. And globally, we see that as being at least double that at USD 2.6 billion opportunity.

Furthermore, we really strongly feel that introduction of CT:VQ 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.

So CT:VQ is set to displace nuclear VQ scans and expand functional imaging. And 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. CT:VQ, all the contrast, none of the injections. So 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 CT:VQ is a no-brainer. Every decision metric points in the same direction to say yes. And of course, part of that is that we are value adding to standard of care to routine CTs with non-contrast functional imaging.

So 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. So these CTs are routine, and then we can value add to those with our game-changing technology, 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 in market. And 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. And that is for CT:VQ dual-facing outputs coming out of the technology. And what do I mean by that?

So 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 -- who is seeing that patient. And what we give them is this report on the right: one, lung volumes; two, those graphs that show low by distribution summary, that just, in a split second, the doctor can look at that and can see, is the ventilation of 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. And then 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.

And then for the radiologist, we deliver reports that are delivered in line with existing radiology workflows within their current viewing platforms on their packs. So 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 SR DICOM, under FHIR, these standard protocols because we know radiologists are incredibly busy. They don't want to spend just even 1 second that is not adding value to their patients and to their practice. And we offer that to them in how we provide this technology. So not only it's 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.

And 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, it's a high-cost procedure, relatively poor resolution, time-consuming, high patient compliance, expensive infrastructure, complex procedure. And 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 4D, and I've had a nuclear VQ scan. You have to go sit down, inhale a radioactive powder into your lung.

So 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 time lines because it has an incredibly short shelf life. You then, after 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 VQ -- CT:VQ 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. And then 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.

And in particular, in the United States, the nuclear imaging infrastructure is actually somewhat more aged than it is here in Australia. 2/3 of the nuclear imaging infrastructure in the United States is planar. So it's just a single view. It's like a chest x-ray type scan, not a 3-dimensional image. Through our technology, not only do we give that better accessibility, but we get to leapfrog over 10 years of out-of-date technology to come to our solution.

Part of the reason where -- 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. And I'll talk to you about what that means for us and for the success of the technology. But to -- in order to thoroughly assess the performance of CT:VQ, we delivered a package to the FDA that had 3 core components of clinical evidence: number one, stand-alone device performance, quantitative. We put numbers head to head between CT:VQ and SPECT VQ.

Reader performance assessment, so 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; and finally, a case-based review where a selection of cases were reviewed in depth to highlight areas of agreement and discrepancy. And as I said before, one of the things that we're so proud of and the key driver of our FDA approval being -- 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.

And 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. But I'll just quickly come back to our FDA submission. So 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. And you can see, especially for the perfusion, there's really great agreement. On the ventilation, there is always a 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. So we had 6 radiologists and nuclear medicine physicians between them with well over 150 years of experience, examining case after case after case looking region by region and you can see, for example, these blue arrows, the blue arrows here are on the image on your screen, showing where they see something that's noteworthy that appears both in the SPECT images and in the CT:VQ images. And 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 contrast artifacts, which are caused either by clumping or by leakage of contrast in the scans. And of course, they only occur in the SPECT imaging because we don't use contrast in the CT:VQ 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. And that is, of course, one of the use cases for VQ-type technology. You can see very clearly identified in the CT:VQ and so really just a really key example demonstrating the technology. And then 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 10 years out of date compared to what it is here in Australia, which leads to those clumping.

And then we also did what's a statistical analysis of that qualitative assessment. We use 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. And you can see all through this graph greater than 0.7 or greater than 0.71, which is greater than the very strong. So 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.

So 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, and in order to win the $1 billion market. And 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 at 4D in the past. But now all of these factors align as tailwinds for taking VQ to market.

And so we were very clear. We just need to meet clinical equivalents to win this market, and we absolutely have demonstrated that clinical equivalence. In the stand-alone 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. So 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.

So 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. And of course, we're going to be driving that harder.

We already have Stanford, Brooke Army Medical Center lined up, a whole bunch of other potentials behind that, results presented. And we 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.

So thank you. That's my presentation today, and I'm very happy to proceed to questions.

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