Okay, hi everyone. Welcome to today's webinar. My name is Sam Jacobs from 6 Degrees Investor Relations. I'll be hosting this presentation from Echo IQ Chief Executive Officer, Mr. Dustin Haines, alongside the Group's Head of US Commercial Operations, Mr. Nick Lubbers. In today's presentation, Dustin and Nick will provide an update on recent clinical progress for EchoSolve HF, EIQ's heart failure clinical decision software support tool, following the successful completion of its clinical validation study for EchoSolve HF with the Mayo Clinic's Validate program. After the presentation, we'll commence a Q&A, which will comprise both written and live questions, and will be moderated by Echo IQ's Chief Commercial Officer, Mr. Deon Strydom. A recording of the webinar will then be made available on the company's media channels later today. For now, we'll commence this presentation. Over to you, Dustin and Nick.
Wow, fantastic. Thank you, Sam, and I appreciate everybody for dialing in. I always feel like I'd love to have these webinars where I could see all your faces and kind of get some facial recognition of whether we're hitting the right spots or not. I'll just have to imagine in my mind seeing all your faces out there. Thank you guys for taking the time. We're obviously really excited about being able to share the most recent news. Obviously, it was a pivotal study for us around EchoSolve heart failure. We'll get into a little bit of that. More importantly, I'm excited to introduce our new Head of Commercial, Nick Lobbers, who is coming to us with an incredible pedigree.
Nick will spend a bit of time introducing himself and showing you guys kind of the talent that we want to continue to bring in our organization. We'll spend about 25-30 minutes or so, maybe a little less. Then we're going to open up for questions. I think for everybody, you know, you can do the typing questions in the chat feature there. Please send those questions in. For those that sent questions in ahead of time, thank you for that. It makes our job really easy to start preparing. We're really excited about the level of engagement that we have with all of you. I know many of you have been early investors, and many of you have been very interested in and connected with Echo IQ for a period of time. Thank you for that.
For those that are new and wanting to learn more, we've got an exciting probably 20, 25 minutes here of being able to share what we're doing as a company and obviously what the new data is. We'll jump ahead now, and then I'll let Nick introduce himself here as we get into his section. Nick, if you can go forward through the next couple of slides there, obviously disclaimer there, but we can get that out. I want to spend just a second here. Nick, actually, if you click the button, I think it'll just finish the—there you go. I think for many of you, you've had experience with us and what we do as a company. Our platform sits on is called EchoSolve. It's a cloud-based system that sits on a SaaS platform.
I think what's really important here is just continuing to highlight what makes us unique as an organization and a company and how our offering is having an impact on the clinical decisions. You guys have seen this slide in various different forms, and we're continuing to refine that in terms of what we do. Quite simply, we simply help cardiologists to diagnose cardiovascular disease, especially structural heart disease, more accurately and faster than they're currently doing today. It's an unfortunate reality that we know a number of patients get missed and underdiagnosed for things like aortic stenosis and now potentially for heart failure in a new solution. It's not because cardiologists are doing a bad job. They're incredibly well trained. These are great clinicians. It's just a hard thing to do.
If you look at what we're doing here, and I think you're going to see us separating ourselves from any of the kind of competitive landscape going forward, is the simple fact that there are really intricate data that comes out of an echocardiogram. What you're seeing on the left there are those images, and you guys have seen me and heard me talk about this. What you see on those images really doesn't tell the whole story. I think that's the key thing that we're really trying to instill in our customers. In fact, many of them are calling us now because they've heard about what we're doing from our clinical data as well as our presentations that we simply see what they can't. That's what the trick with—and not a trick, but really what the uniqueness is of our technology.
These companies out there that are looking at images and trying to train their AI models to read an image is a fantastic use of the AI tool. It's just imprecise, and unfortunately, it's unreliable because, as you can see here, these images are not easy to read. They're grainy at best. Oftentimes, the resolution is poor. Maybe the angle or the resolution doesn't come in the way the cardiologist needs to. They simply can't train these models well enough to work through some of the human error that comes from not getting a perfect echo. Simply by us being able to take what sits behind those images, and we've talked about this before, there are a series of measurements that are done with these images, and there's a series of metrics that are taken. All of that gets compiled into a simple report.
That is where the special sauce comes from our technology. By being able to take those images and strip them away and simply have the data behind it, and again, it's about the measurements themselves, we can actually have a phenotypic analysis taken of that patient's heart. I think of it now as a fingerprint of that patient's heart. It really is. It's the unique fingerprint that that patient has. Because we can deliver that information directly off of the echocardiograms with those measurements, we can do a couple of things. I think Nick will talk about this in terms of why he even considered coming to our company, is we can do things in real time. We can do things that integrate directly in the current workflow, and we can actually do this when there is missing information.
Because of that, we have that 3D version of that patient's heart or a phenotype of that heart, and we can deliver meaningful outcomes to the physician. In fact, if you look at the data that we're able to produce, the validation studies, the real-world analysis of the technology, we can do this at scale, and we can do it incredibly accurately. What you're seeing here is our ability to train the model to look at things like aortic stenosis and heart failure and be able to have a really meaningful impact for those patients. At the end of the day, reduce the ability for those patients to get missed and underdiagnosed. In fact, you guys have seen the data for us on aortic stenosis in over four large studies.
We've pretty much hit 100% on diagnosing severe aortic stenosis because the model has a sensitivity and specificity that can really see oftentimes what the cardiologist can't see. That's what makes us unique. We're pretty excited if you can go forward, Nick, to really kind of highlight from your guys' side what the market opportunity is. Again, you guys have seen these slides. This is a different version of the slide. We're going into two markets that are incredibly large and very much underserved. If you look at aortic stenosis today, 2025 is expected to be a $10 billion market when you look at overall healthcare expenditures for stenosis. That's growing at 8%. You can see those numbers rapidly increasing out to 2035. The question is, why? Really two parts to that. One, we have an aging population.
We see that in a number of countries around the world. We see it in Australia. We see it in the US. We see it in many of the European countries. We're seeing it in most of those Asian countries. As the aging population continues, obviously, they're going to see an increase in overall risks of cardiovascular disease and aortic stenosis being one of them. Now, if you look at the heart failure kind of opportunity there, you can see that, again, it starts at a much higher base, $55 billion this year. It's probably actually higher than that, given some of the recent data that we've been seeing. That's growing anywhere around 4%-5%. You can see how big those numbers come over time.
Again, as an aging population starts to develop and also the quality of the diagnostic tools start to improve, we're going to see a very significant growth of heart failure over time. This is a market where you're seeing about half of patients on average get missed and underdiagnosed. It is a very challenging disease. There's a number of classifications of this disease. For physicians, it becomes quite challenging. We believe we're going to have a solution that's going to represent this market very well and take a very large percentage of that market share in the space. Nick, if you can go forward, please. What does that really equate to? I think you guys have seen these to varying degrees. When we talk about aortic stenosis, this is pretty significant.
You're talking one in two people with a heart valve disease don't even know they have it. When you talk about a valve disease, we know that the mortality rate for a patient who is diagnosed with severe aortic stenosis is about 50% in two years. When you think about that kind of scale of the mortality rates of this type of disease, we all can understand how important it is to find these patients early, get them diagnosed accurately, and then get them into the right medical intervention. In this case, it's a valve implant. If you look at the five-year survival rate for somebody who's had a TAVR put in, which is a valve implant, it's upwards of 85%.
What we know from that is that if we can diagnose them accurately, get them into the right heart care team, get the right medical intervention done with the TAVR, these patients can have a long, happy life. More importantly, they'll reduce the overall healthcare cost to the system. These patients show up anywhere from 11-12 days annually in the hospital, and they have significant overall cost. You can see this market is large. This market is underserved. It is really in need of having a solution that can be done in real time and sit directly in the workflow to help these cardiologists be better at what they do. You can go forward, Nick. That same thing holds true for heart failure. In fact, the numbers just get bigger and more robust because of the way the patients present.
We believe that we're going to affect not only the outcomes of patients, but the overall healthcare expenditure that's associated with them. I shared a story just the other day when I was at one of the investment conferences, and I was asked to give a 5-10 minute presentation about our technology. It just so happened before I went on stage the week before, I actually had an aunt of mine show up at a family reunion. She asked me what I was doing. I said, "I work for a company that works on cardiovascular disease." She proceeded to tell me the story that's often way too many times told around the world. Here's somebody in her late 60s, early 70s. She was a yoga instructor. She's a very fit woman.
She said, "For two or three years, I've been kicking around the healthcare system. I had a cardiologist. I was seeing my general practice physician. I had an echocardiogram. I knew something was wrong with me. I had lower back pain at times. I was having these phantom chest pains here and there. I attributed it to getting older. Maybe we needed to get physical therapy done. Some of it was even that they thought I had anxiety." Unfortunately, she fell off her bike about six or seven months ago while she was out riding and broke her leg. She got taken to the emergency room. The internist heard some of her symptoms. They did another echocardiogram. They diagnosed her with severe aortic stenosis as well as mitral valve regurgitation.
Here's somebody who kicked around the system for a couple of years, knew something was wrong, and yet got missed in their diagnosis. It just goes to show that this can happen to any one of our family members, friends, or loved ones. It's something that's important to me as well as our company that we can help diagnose these patients. If you can go forward, Nick. What are we ultimately looking at here? Obviously, we've got a commercial pathway we think is going to be important for the business. I know I'm teasing you guys a bit because we haven't even gotten to the heart failure stuff. It's coming, I promise. The commercial pathway that we've shown in the past is still holding true.
As Nick has come on, he's done a phenomenal job of actually challenging some of the things we're doing to say, "Look, I think we can do it even better and faster," which is fantastic for me to have a partner like Nick knocking on doors in the United States. We have been very clear. We've got three commercial pathways that have to be delivered in order for us to be successful in growing the business in 2026. That is hospital integrations. We have been very clear about when we bring on new customers. You will see something coming from us towards the end of the year where we talk about our ultimate integrations that we've had, the customers we're looking at.
Nick is even going to share a little bit about what he's looking at in terms of ramping up that integrations now that we have more clinical data on heart failure. Obviously, for us, revenue is going to be the most important thing coming forward in 2026. I've always said this that we have a catalyst that is the heart failure model. That is going to be the accelerant for us in 2026. We're working through our reimbursement strategy, how we're delivering our subscription model, and obviously shortening our sales cycle. Nick will share a little bit about that because he's pretty excited about what we can do here with the model. Finally, the platform that we sit on in the pipeline.
I think it's fair to say when we get through the heart failure data that you're going to see that our platform is real now. We're seeing our first near-term pipeline product coming that will be with the FDA. We've got a number of products in development that really heighten the sense for us as a company that we're not just a single solution, but we are a platform solution that can look at multiple different challenges in the cardiovascular space. Stay tuned on this. I think we're going to be excited about sharing what we have coming next. Obviously, that near-term solution for us was heart failure.
The data that we have just seen gives us the incredible amount of confidence that we now have a suite of potential solutions that sit on one single platform that physicians can use to help them be better at diagnosing the patients. If you can go forward again, Nick. We have shared this before. Nick will speak a little bit around how we think we can actually accelerate this in terms of reducing the overall pilot program and things like that. I have been so excited about how he has kind of come to the table thinking more strategically about how we can do this. I think you guys will be impressed with his thoughts. Obviously, the subscription model for us has not changed. We are very comfortable knowing that the overall US market has been pretty clear around subscription models.
We have a number of companies that do this without reimbursement. We have a number of companies that do it and are working on or have reimbursement. I think the model itself is very similar across many of the different companies where you look at number of echoes times whatever kind of coverage you get. Obviously, you guys have heard me talk about the CPT codes and how that works. In fact, we are very comfortable that not even having a CPT code can still drive a valuable part of our business. Obviously, for us, having that code just simply accelerates and exacerbates our ability to grow revenue. We will talk a little bit about that. Of course, getting the ultimate reimbursement value. We see those numbers anywhere from $150-$300.
We are very excited about what the opportunities are lying in front of us. You will see us continuing to talk about this model. We tweak this model slightly depending on the size of a customer, depending on how early the customer comes in, and really kind of some of the parameters that the customer is trying to achieve. Right now, we are very confident that this is the right path forward. We are very confident that with reimbursement and/or even without reimbursement, in many cases, we are going to be successful in this space. If you can go forward, Nick. The real question comes, and why you all dialed in, because we just recently announced the data. I want to just kind of level set us on what we saw with our heart failure solution and early validation.
This is stuff that's new or not new. You guys have seen this. This is the validation study that we did with the metadatabase early on. This has now been presented a number of times and working through publication. Obviously, we saw early on with the model that as we put it into a very large cohort of patients, we saw the model in the middle there working at about 86% of the time to accurately diagnose heart failure. In fact, when you gave the clinicians expertise, you got that to 97%. We were incredibly thrilled with this. This was the early parts of validating the technology. We were looking at large cohorts to understand what the test set could look like. Obviously, we saw some really good results here in the study.
If you go forward to the next slide, Nick, this is what we've seen now on the most recent data set. Even for the uneducated in this space, and I'm mindful that not everybody lives and breathes cardiovascular and understands the health tech space. Just looking at these numbers gets us incredibly excited about what the future has for us. If you look at our sensitivity analysis, we finalized that at 99.5%. When you think about that, that's really about identifying accurately those patients with heart failure. If you look at the specificity, you see 91%. I will tell you, we met our primary endpoint on this validation study. It was done over 17,000 individual echoes. This was done over a diverse data set. These were patients that were equally distributed between males and females.
There was a representative sample of ethnicity. You know, we saw between white, black, Hispanic, and Asian. You can see that we have an ethnic diversity. We had a geographical diversity where we had patients from a number of different sites around the United States. That was the value of partnering with the Mayo Clinic because they have robust data sets. It's diverse, and it's geographically spread across the United States. The most important part about this partnership with the Mayo Clinic is it was the partnership that the FDA highly recommended as doing our validation because it is trained on a very significant data set. If you look at this, we've got a ton of data coming.
We promise we'll get you guys that data probably post the FDA clearance because we believe now, looking at the model and the outputs that this model has, that this will warrant being submitted to a major top-tier publication. We are going to be looking at a number of these publication sites. We'll be talking to editors to see which one of them will accept it. We want to make sure that we can maximize the benefit of this data to get it into a publication form, which allows us to share it widely across the globe. In this case, you can look at the top-line numbers, and we'll continue to have these numbers present. 99.5% and 91% are exceptional numbers. We are incredibly excited about what the opportunity has for those patients in the real-world setting. If you can go forward, Nick.
The question now is, what do we do next? Obviously, regulatory pathway is the final step for us. We are currently working on our submission. We expect to have that in shortly. If you look at the 510(k) standard review process, it is about 90 days. Of course, a number of things can happen in that review process. You can have what is called a stop clock. It does not typically happen, but you can have that from the FDA if they are asking you additional questions and you have to get the answers for them. We are very confident in this process. We have gotten EchoSolve AS through the FDA process. We had our pre-sub meeting where we got very clear direction from the FDA. In fact, they signed off on the protocol. They signed off on the partnership with the Mayo Clinic.
Obviously, given the significant data that we've seen, we feel very confident that we'll be able to move through the 510(k) process. This is a regulatory process, and it obviously takes a lot of focus on our side. The team is working diligently to get that submission in. We've had our first initial conversation with the FDA, and we don't anticipate any delays with the FDA given the U.S. government was shut down. We think they're back on track and ready to receive submissions. We'll notify you guys all when we do the submission to the FDA. Of course, we're expecting clearance from that in some time in 2026 as we work through the process. The data has now given us that ability now to submit for the FDA, and we're quite excited about that.
If you can go forward, Nick. What do we see in the future? We've shared this slide before. We're quite confident now that we've gotten our second solution with the clinical data that we see here. Obviously, we're waiting for the FDA submission, and we're pretty excited about that. That gives us the confidence to know that we can continue to look at our pipeline. You're going to see things like hypertrophic cardiomyopathy potentially coming out with some clinical data. You're going to see things like pulmonary hypertension, which we think is going to be a very large market that is unmet need right now, very complex to diagnose. In fact, there's a number of companies out there that will be incredibly interested for this solution, whether it's pharmaceuticals or it's the cardiac societies themselves.
Of course, a little bit further out as we start to develop the model for this mitral valve regurgitation, it's going to require a slightly different skill set for us. Oftentimes, this is going to require both images as well as the measurements. We are phenomenal at the measurement piece, but there are some diseases that you just need to have an image to see, especially things like mitral valve. There is nothing in this space today. We think that we have a great opportunity to develop something that could be significantly impacting the market overall. The first solution, aortic stenosis, is in the market. Second, with heart failure, it's been de-risked now to see the clinical data. All it takes is for us to get the FDA submission in, and we're very confident there.
That opens up the opportunity for us to invest wisely in our pipeline. Obviously, that could not have happened if we could not have seen the heart failure data itself and what we know to be some really exciting opportunities for us. We are going to leave it there. If you can go forward, Nick. I just want to close on this last slide. We are really excited as a company our size to get invited to a couple of major health investment conferences. We are going to be at Piper Sandler Conference here next week. This is a group that actually worked on the underwriting for the HeartFlow IPO that just recently came out in the US that has done, I think, damn near a 10X at this point now, but if not, it is multiples of what they came out at the IPO.
Of course, we got invited to the JPMorgan conference in January. Again, another major milestone for us as a company our size to be able to be invited and present at these conferences just shows the robustness of the ability for the business as well as the technology to capture the attention. What you guys have all seen early on with the company, the US investors now are just getting to see it now for the first time. We're pretty excited about what that has to offer. I'm going to stop there. We're going to go ahead and kick it over to Nick to have him introduce himself. I got to be careful here because Nick is a phenomenal and very experienced commercial person in this space.
If we give him too much, like he gets his head a little too big, then it's going to be impossible for me to work with him too much over the next several months. Nick is a phenomenal guy. I'm joking, obviously. When I sent the recruiters out and said, "Go find me the unicorn," the guy that has experience in software sales, experience in selling an AI software solution to hospitals who also has it in cardiovascular disease and, by the way, has done it both with reimbursed and non-reimbursed products, the recruiter said, "I don't know if I can find that unicorn, but I can tell you what, we got one of the best in the industry with Nick." I'm going to turn it over to Nick, let him introduce himself and kind of what he sees with the company.
We will open it up to questions after that. Nick, over to you.
I appreciate the introduction, Dustin. I will tell you that if my head does get any larger, then it will not fit in the circle of this picture. I will quickly find ways to deflate it, as you mentioned. I have been living and breathing cardiology for over 20 years now, as Dustin mentioned, both from an invasive perspective and then software as a medical device before software as a medical device actually existed. What I wanted to bring attention to relative to my background were some of the highlights that I think are significant and really pointed me in the direction of once Dustin and team reached out and I investigated the opportunity, what in my background can help really drive things, which with what I feel is pretty special technology.
I'll get into that in a little bit. For about 15 years, I spent time with Guidant and Boston Scientific and helped commercialize the Watchman left atrial appendage closure device. That was the first foray into launching a therapy, albeit invasive, that had no DRG or no CPT. The physicians were not reimbursed, and the hospitals were not reimbursed when we first brought that technology to market. I will tell you the differentiator there and what we were able to create, similar to what Dustin is doing here, is you had a leadership team that knew how to build and scale and brought the right people in from the beginning to do that. Now left atrial appendage closure is greater than a billion-dollar market, established a national coverage decision. CPT codes were late to follow.
Part of that in that mission was the belief that we're doing something right for patients and that the physicians delivered on that belief in unison with the Boston Scientific team. That naturally led into an opportunity with HeartFlow. Everybody, as Dustin mentioned, HeartFlow has gone public. It was, again, I don't think we were referred to as software as a medical device. That guidance came out from the FDA during the early course of the HeartFlow days. Again, it was a scenario where you had a technology that was actually going head-to-head with diagnostic casts, which were very profitable for health systems at the time. This was a better solution for patients. You rallied the physicians, the clinicians, and the societies behind that, and you're able to drive through that and establish reimbursement over the course of time.
There was just a publication that kind of laid the new technologies on the horizon and how long it took them to establish coverage. As I'll get into, I think we have an advantage on that front. Again, HeartFlow IPO'd and has been a rocket ship since. More recently, and this was another foray into software as a medical device, Tempus AI, which has gone public. That is, again, a case of best-in-class technology, MD, PhDs that trained on massive data sets, ECG AI. We looked to establish a cardiology platform within Tempus AI, having success of doing that. We had a partner, a competitive partner that really was the spearhead in terms of getting the initial codes out there. Again, created a business unit within a successful company. That was before the reimbursement had been established.
There were not clear pathways, but you build the clinical utility, you demonstrate the clinical value, you elevate patient care. That is part of the recipe for success that I say is a commonality between these three companies. When Dustin reached out and you start to do your due diligence, there were some things that really set this opportunity apart versus any other opportunity that I have been fortunate enough to work with. The network that has been created throughout the startup environment is probably second to none in terms of people that see a vision and begin to execute on it and then deliver and change the standard of patient care. One of the things that was so appealing right off the bat is the metadata set.
If you're trained on greater than 2 million echoes and counting, and then you have hundreds of millions of measurements, as Dustin mentioned earlier, that we perform on that are linked to mortality, that's a differentiator, particularly in any real-world data set or real-world evidence we get into in the United States because that kind of data is often fragmented. This is a unique opportunity to do what I like to call point-of-care clinical decision for the physician. We show up where they are. We seamlessly integrate into the workflow. We've got a best-in-class team relative to implementation, DICOM via API. It's not disruptive to a healthcare system. It's not disruptive to the clinical team that initiates contact with the patient. The echo is completed. We can exist within that workflow without having to impact anything. That is a huge advantage.
We're not having to go in and train an entire clinical team on a new workflow in order to maximize use of the technology. We exist where they already are. The other big thing, and this is probably what I would rank the fourth pillar, is the reimbursement pathway. Everybody is aware that in the US, there are T codes that exist that have been recognized by CMS. It's outpatient, inpatient, and professional codes. It kind of covers the gamut. That pathway is important. I will say that this is often, if we look at this as a four-legged stool as opposed to a three-legged stool, you want to have a team that from the onset can fill the gaps in terms of execution and operation along the way.
That allows you to scale rather quickly while you're working through things like reimbursement, while you're working through integrations with partnerships. You have the team that's able to deliver for the clinicians and ultimately pass that along to the patients. You've created a winning formula. As you work through the necessary steps, everybody asks about reimbursement. It's a natural question in the implementation of a software. Health systems are getting much smarter in the way that they ask questions around AI. The ease of use, the training data set, and then meeting the physicians where they are gives us a leg up in terms of the opportunity as we diligently work through the pathway to coverage. I would say that the Echo AI landscape is even getting more mature. I think we plug in nicely from an EchoSolv standpoint.
If you look at opportunities and both competitors and potential partners, you have your point-of-care ultrasound solutions. You have your ECG AI solutions, which both would be fantastic screening tools that we'd be agnostic to the way that measurement and metric data is captured. You have the companies in the space that actually focus on measurements. Some of the big OEMs develop their own platforms. We are, again, agnostic to how that data is captured. We exist within that workflow wherever it's captured from. We're able to push it back into a clinician. Point-of-care clinical decisions is what we're able to aid. Relative to the competitive landscape, there will be platforms out there that we're able to differentiate ourselves from both from an implementation perspective and ease of security and technical assessment because they are all image-based and derivatives of that.
There are more challenges relative to implementation in the U.S. healthcare system. The more touchpoints you have within a healthcare system, we need measurements. I can't echo that enough, no pun intended. It is a unique opportunity because our data sets are numbers-based and our results are near real-time. They happen in seconds. In the workflow, measurement-based, results in seconds. I think that if you look at what we would consider players in the space, we, as Dustin just reviewed, have pretty significant data milestones that we achieve from a heart failure perspective. What I really want to focus on is we have a unique opportunity to go in with our EchoSolve AS platform that provides a very sound and structured approach to identifying a subset of patients that everybody's focused on that has a structural heart program.
Dustin and I just got back from the AHA in New Orleans. The AHA actually has a Target AS program that I'll get into that's part of our focus that really looks for patients that we can help identify by the metrics that are produced within Echo Acquisition. That's looking for those and surfacing those low-flow, low-gradient patients that are frequently missed or, as Jeff Strange always says, the watchful waiting. This is an opportunity for us to differentiate ourselves in that space, establish relationships with key health systems in the United States, and then behind the scenes plan for what we believe is going to be a very successful launch of our next platform upon FDA clearance. Dustin's giving me kudos. I've been here approximately four weeks. I think there are always opportunities to do things better.
That only is not just from a team perspective, but from an individual perspective. One of the things that is unique about being in an early-stage startup, particularly here in the US, is that it's just as much grunt work as it is anything else. You have to have a repeatable, scalable process. You have to have targeting. We've already engaged with the top 250 facilities from an Echo standpoint with adjudicated claims in the United States. We are doing that step by step. You reach out to systems daily. We have a team, a dedicated sales team that we're working with that is targeting these facilities. As Dustin mentioned, one of the unique things that we were at the AHA, I was just recently at the Georgia ACC meeting. Health systems and physicians are starting to come to us now. They're coming inbound.
They've heard about what the technology is doing. This press release that we just recently did with the validation that we released is creating more interest. It's allowing us to pivot into that EchoSolve AS platform and look for institutions. We segment these academic medical centers. Those are the institutions that we know we need to partner with that are going to create huge opportunity for us, huge volume, more complex cases, pretty standard and tightened clinical workflows that we know we can embed right into. We'll have the opportunity to transition into national and regional health systems. We're actively doing that.
We had a lot of engagement from some of the more rural facilities here in Georgia because we fill a need that they have both from an upskilling and identifying and shoring up that Echo program and the measurements that are created and surfacing it to the physicians so those patients are identified in the right time no matter where they are. I think I've heard Dustin say this, but we have a unique opportunity to democratize Echo wherever it is done and make sure that those patients are triaged appropriately. When we look at that specific subset, I do want to get into the American Heart Association Target AS program that I had mentioned is a very specific program that the AHA is doing in partnership with Edwards Lifesciences and where they are working with 75 pilot institutions to target patients earlier in disease progression.
What this does is it creates an opportunity for more dynamic testing for those patients that are moderate to severe. It creates an opportunity for the heart care teams to interact and educate these patients sooner in the process. The goal, as we've seen and we've got data to support, is ultimately to change that curve within the five-year mortality by identifying these patients sooner. We have a phenotypic solution that does exactly that. We're going to use that to our advantage with these accounts. I'd say the last thing that is a huge opportunity for us is just the pathway. EchoSolve AS is our beachhead. As Dustin shared with the roadmap, we'll have a platform that really allows us to act as the operating system across echocardiography.
That is to the tune of 20-25 million of these done in the United States. It gives us an opportunity to have a massive impact on clinical workflow and, at the same time, elevate, triage patient care appropriately. Ultimately, if we do those two things, we are going to save health systems a lot of money because we are identifying the patients that need these physicians the most. We are doing it sooner in the process. I think the icing on the top of the cake, and again, that fourth pillar that we work to is 0932T exists. It is a code. We believe, and we have the team in place from a health economics and reimbursement standpoint, that that is one that all of us can benefit from.
It is kind of that pathway or the appeal that I had alluded to joining this is that we have got a fantastic team in place. We have got a pathway to reimbursement. We have got an outstanding clinical solution. In the new environment of AI, where data is the new oil, we have a data set that is unique to our product and unique to echocardiography that produces a fantastic opportunity for us to capitalize on here in the United States. With that, I think it is time for us to open it up into Q&A. I will say that the same that Dustin said of me, he has probably got a maybe not as big a head, but this has been a pretty unique opportunity. I think we are learning from each other every day, me probably more so than him.
We will see how this shakes out over the coming months as we work in lockstep to execute on this opportunity.
Awesome. Thank you, Nick. I will kick it over to you, Deon. Thank you guys for sticking in there with us. You have got a lot to share every time. Hopefully, you are seeing the passion and energy from the both of us because there are many days where you look around and say, "Did I make the right decision?" I think both Nick and I go, "Yes, we have every single day because this is an incredible technology." What better than to help millions of patients around the world with our technology eventually? Thank you guys for sticking with us. Deon, if you have some questions, we would love to hear from the group. We probably will not get to all of them. What we can do, we can obviously get back out and address those to the individual folks.
Sure. Thanks, Dustin. Thanks, Nick. Thanks, everyone. We've seen through some questions. What I've done is I've grouped them into five broad buckets. A little bit about the study, the FDA submission, some commercialization questions, reimbursement, and then competition. We will go through those. There will be a lot of repetition of questions that I've just bundled together. Let's start with the first one. The first question is around the clinical study. The question is, the Mayo Clinical Validation Study announcement refers broadly to heart failure and does not specify any subtype such as HFpEF and HFref. Can you confirm whether EchoSolve is able to detect the HFpEF subtype specifically?
Yeah, I'll take that one, Nick. Yeah, great question. Whoever sent that in, thank you for doing even some more research on this. The answer is yes. I'll probably not elaborate much more. We did take into consideration as part of the protocol that all subgroups of classifications of heart failure were included. The answer is yes, HFpEF is part of those classifications. What you'll see from us as we work out the subgroup analyses and we get that as part of the publication, that'll come out probably right around or post the FDA clearance.
The simplest answer to that is yes, HFpEF is one of the classifications of heart failure that we're looking at as well as all the other classifications, which again, I think makes us quite unique in the ability for us to look across the heart failure spectrum.
Thanks, Dustin. The second question is, how confident are you and Nick that the FDA will accept and approve the 510(k) application for EchoSolve heart failure?
All right. All right. I'll take that one, Nick. Then I'm going to make sure you get the rest of them. Yeah, the FDA, you can never say guarantee because that's silly in this line of work. I think we've done just about everything we possibly could to de-risk the FDA submission and the overall outcome of a clearance. I mentioned before the fact that we worked with them directly on developing the protocol that they signed off on, the fact that we went with the partner of choice for them, which was the Mayo Clinic. It makes sense. Mayo has got one of the strongest kind of diversified data sets there are in the United States. The fact that we met those primary endpoints and in many cases exceeded them from our original protocol design.
We feel confident that the submission packet we're sending in will be successful. Obviously, the FDA has learned from us now about the aortic stenosis solution. They understand how our algorithm works. They understand what we do in terms of providing a phenotype and a risk score. We feel very confident. I could never say guarantee, but I feel very confident walking in the door on this one that we've got a submission that will be very compelling for the FDA.
Thanks, Dustin. Nick, maybe one for you. On the back of the success of the Mayo study, has the Mayo Clinic decided to integrate the EchoSolve platform into their hospital group? If so, can you give us a bit of a timeline update for the integration?
Yeah, so another great question. I think to effectively answer that is we have to have FDA clearance before we integrate with anybody commercially. Part of the ability to integrate with Mayo is in the contract that we use relative to this validation. I would forecast that upon FDA clearance, we are getting our implementation timelines tighter and tighter. We will continue to have a smooth process and look forward to them as a partner. That is all contingent upon FDA clearance.
Okay. A follow-up question to that. It sounds like there's quite a few partnership discussions happening. Does Echo IQ have the team necessary to staff the implementation integrations across multiple hospitals simultaneously?
I'll take that one. Dustin, if you want to add anything, please feel free to do so. I will tell you one of the things that I mentioned earlier is do you have a team that can hit the ground running and wear multiple hats? From the four or so weeks that I've been here, we've demonstrated that we can continue to scale and handle more volume. We understand where those breaking points are and will resource them appropriately. I don't anticipate anything relative to commercial activities impacting our ability to integrate with a customer. These guys are all very seasoned, have already demonstrated that in the conversations we've had. We have a pretty big opportunity to capitalize as customers and clients need us.
Yep. The only thing I'll add is Nick has been part of that build-out too. I think hopefully you guys are seeing the caliber of kind of commercial experience he brings to the table. One of the things we're also doing is making sure that we can do this at scale. The back-end processing, we're looking right now, we can do somewhere in the neighborhood of 10,000-15,000 echoes a minute right now on our system. We're very comfortable with that. I pressure-tested the team to say, "Go and be able to do multiples of that to get ready for scale." We're doing that in the background now because I'm confident that Nick and the team are going to start to drive that utilization to an extensive level. I think the commercial team is there for sure.
We will get even more high-quality people coming in. The most important thing is, can we also sustain the growth that we are going to have in terms of scaling the number of echoes? Right now, the technology looks like we can do that very easily.
Thanks, Dustin. We've got quite a few questions around reimbursement. We may spend a bit of time on this one. Can you please provide clarity on why the reimbursement code for EchoSolve AS was knocked back twice and why you have confidence you will attain a code next time you submit?
Yep. I'll take this one, Nick, because we obviously had a bit of toing and froing on that over the last several months. I will tell you, in all honesty, I was quite shocked at the kind of change that we saw from the American Medical Association on giving out CPT codes. Nonetheless, these are bureaucratic systems, so I understand that. I feel like when we went into the first one, probably a little bit more surprised at the level of scrutiny we had on there. I hadn't seen that before. I can tell you going in on the second one, there were headwinds that were probably out of our control. Many of you, if you've done a little bit of Google searching, you'll see that the American Medical Association is actually setting up an algorithmic aided diagnostic forum.
We'll be invited to that in December just to learn what they're trying to do to change this process. We'll probably be the recipients of that kind of future process. We got caught up a little bit in the new administration with the U.S. government pushing really hard for AI technology and the bureaucratic system not quite catching up. That's fair. That's fine. We're going to become even better at that. Why do I think we're going to be comfortable in the future? I think Nick articulated that beautifully is that we have an existing code that we know we're going to be able to utilize. In the meantime, we believe we also have a solution that can work and build within those hospitals as we build that reimbursement.
To me, I've always said this to you guys, as you heard me, it was a speed bump, not a roadblock by any stretch. While we're frustrated with that, we're very confident that we have plenty of paths forward. Stay in this space with us. With heart failure, we had always said that we were going to utilize existing codes in the market that will allow us to be able to get that done within a very short time after clearance. On the aortic stenosis, we've got a number of pathways set for us. We're going to keep working with us. Nick and I are beating every different pathway available to us. You will see something very material come out of that in the future. The first two, yeah, a little bit frustrated and upset about the way the process rolled out.
I think the government and the bureaucratic system are starting to catch up and will be part of those conversations.
Thanks, Dustin. The next one's a two-part question. You mentioned previously that you can utilize Ultramix CPT code. Part one is, how confident are you that we can do that? Part two to the question is, what if any other risks are associated with this? Do Ultramix have any recourse ability to lobby against Echo IQ's utilization of their code?
Yeah, I'll take that one. I think that, again, this is the course of doing business in this healthcare market. I still think we have a unique opportunity. We think that we can meet the requirements of the code as it's written. We'll continue to work with, again, a best-in-class health economics and reimbursement team to make sure that we have fully assessed all the risks and understand all the opportunity and what we need to ensure and do to have success with that code. I will also say that from an 0932T perspective, that specific code, a rising tide lifts all boats. We want clinicians and systems who are using that code to submit it because ultimately, that demonstrates that the therapy is being adopted and that a formal code is necessary. It's a unique opportunity for us. They are a competitor.
Again, we'll position ourselves so that we can maximize our opportunity with that code. Then we'll hope that as many physicians that are using technologies that are supported by that code continue to submit it.
Thanks, Nick. I've got a question here around competition. There's increasing buzz around companies like MyCardium, Aster AI, and Ultramix. How do you view the broader AI Echo landscape? Where does EchoSolve sit in the terms of a platform potential?
Yeah, I'll take Dustin. I'm not hogging them. I'll take first pass at this if you want to add anything. I think that, again, health systems are getting better at asking questions around AI. The hype cycle is over. The hype of the utility is just beginning. That includes adoption. I think some of these opportunities or some of these competitors are on different modalities, even though they dabble in what I would consider the Echo space. Some of them are complementary to what we're trying to do. I think, again, if you look at the landscape, we differentiate ourselves by the speed with which we're able to produce a result. We are embedded in the clinical workflow at the point of clinical decision. We're a diagnostic aid for those physicians.
I think there are what some are considering competition now that are very complementary to what we're doing. There are some that are going to be straight-up competition where we look to take share from each other. Nobody can process as quickly as we can. Nobody is at the point of clinical decision as we'll be able to demonstrate across our platform.
Thanks, Nick. A little bit about expansion. Dustin, is Echo IQ looking at getting clearance from any other countries outside of the US? If so, any timeline updates?
Sure. Yeah, great question. Obviously, you guys are starting to learn me and understand me. I'm a very pragmatic leader in this space. I don't want to distract our team from the mission. I wanted to get the heart failure solution one on one of the validation data. The other, I needed to get the FDA submission in. Both of those are now meeting our timeline. We are definitely looking at other geographical areas. I think finishing up what's called an MDSAP, which kind of opens up the company to then demonstrate that we can operate in other countries, then opens up an ability for us to do a CE mark for the EMEA. We will look at the European market, sorry. Of course, we're looking at Australia.
I think it's critical that while Australia is still a fairly small market, we have developed this technology here. This technology was thought up here. This technology was using the data from the Australia market. We definitely want to have the TGA clearance. We'll be looking at that in the early part of 2026. I think you guys all can appreciate that we didn't want to lose our eye on the ball and drop the heart failure aided stenosis until we had that across the line. We're doing that now. Now I've opened up the team for timelines of when we'll look at finishing up for the European and for the TGA. It is a country-by-country decision for us after that. Obviously, there are some parts of the world that would make sense and other parts of the world that wouldn't.
We will be looking at those very thoughtfully. Of course, as part of that is looking at partnerships. I do not feel like I need to build a global team that sits in every one of these markets. We can obviously use really good partnerships and distribution agreements with some of the local commercial businesses to help us with that. More news to come. The whole goal first was get that heart failure solution submitted in and across the line and then open up our regulatory team to then start looking at European and Australian regulatory approvals.
Thanks, Dustin. It looks like we've covered most of the broad questions that have been asked. As we're coming up to the hour mark, there's just one more general question that I'll ask. One of the shareholders has asked, do you anticipate any obstacles that may be presented by the Trump administration's attitude to healthcare? You had another one coming.
Perfect question. I'm hoping that's an Australian that asked that question. We got to air our dirty laundry with the Trump administration. No, look at it. I mean, for as controversial as he may seem, he is very pro-business. We've actually seen a white paper come out of the administration around wanting to see more AI in the healthcare space to create efficiencies and ultimately save on costs. I'll take that win all day long. Obviously, that translates into the bureaucracy below him, like CMS, the Centers for Medicare and Medicaid Services, as well as the American Medical Association, getting some pressure from the administration above to say, how do we get these things across the line quickly? Obviously, can I say that there's no obstacles? I mean, I don't know. Obviously, governments make decisions quickly sometimes, whether they're logical or not.
Right now, when you look at the head of HHS and FDA, which is Robert Califf, he's been very forward-leaning on this. He's made very clear public statements. If you look at Donald Trump and the most recent agreement they had with the U.K., sitting down with the Prime Minister there to look at how you can invest in AI technology for healthcare, you can see an administration that's leaning in on this. What that translates to now, obviously, we're going to work through that. We're keeping an eye on there. Right now, anytime a government administration is leaning into the area you're focused on, you take that tailwind all day long and you take the benefit. Could something change? Of course. Right now, I feel very confident that the U.S. government is definitely leaning into AI.
We're definitely going to be in that space for healthcare.
Dustin, Nick, I think you're off the hook. We've exhausted all the questions.
Yeah, that's awesome. I'll do a little last closing here then, Deon. Look, for those that stayed on through the full hour, thank you very much. We've had some pretty good success on these webinars of keeping people's interest. Hopefully, we've done the same on this call. Hopefully, you guys are seeing the level of talent that we're bringing and surrounding us with. You guys have known Deon for quite a long time. You're getting to know Nick. What our goal is, is to not just build a best-in-class platform, but to also do it with best-in-class employees and teammates. We're going to continue to do that.
Obviously, the news that we just delivered today with the Mayo Clinic validation study is just another example and reminder of just the strength of what we believe we have with this technology and a platform we're building. We are going to continue to maximize that to our best ability with aortic stenosis now and hopefully heart failure when and if it gets FDA clearance in 2026. For those that are new to the business, thank you. I hope you continue to see the value of what the company has. I strongly believe that we've got a chance to grow. For those of you that have been with us for a long time, thank you for sticking with us. I think you're going to continue to see the benefits of what we're doing as we grow out from here. Thank you guys for your time.
Obviously, we'll take any of the questions and follow-ups after this call. Thank you guys for spending the time. Nick, Deon, thank you guys for joining me on the call.
Brilliant. Thanks to the Echo IQ team there, to Dustin. Yeah, Nick, is there any final comments that you wanted to add as well?
Just to reiterate what Dustin said, we have a unique opportunity here. We're building the team to capitalize on it. We look forward to continued updates to talk about the momentum we're creating.
Yeah, well noted. Look, thanks again to Dustin and Nick for that comprehensive presentation and to Deon for moderating the Q&A. Obviously, there's a lot of investor interest in Echo IQ and the company's technology. As Dustin says, they'll continue to use initiatives like this to communicate directly to investors. Look, thanks again to the Echo IQ team. As we mentioned before, a recording of this webinar will be made available on the company's website and media channels later today. We'll wrap things up there. Thank you to the presenters and their attendees. Yeah, we'll see you next time.
Thanks, everybody.
Thank you all.