From Echo IQ Chief Executive Officer Dustin Haines and U.S. President and General Manager Nick Lubbers. The webinar will provide an overview of the company's latest milestones, which include the expansion of Echo IQ's commercial agreement with the Mayo Clinic for EchoSolv HF, providing a potential distribution pathway across the Mayo Clinic platform network and more than 80 external partner hospitals following anticipated FDA clearance. And also the recent deployment of EchoSolv AS within the Mount Sinai Health System, one of the leading cardiovascular healthcare networks in the U.S. After the presentation, we'll commence a Q&A session which will include written submissions from the audience. Please feel free to send in your questions via the question pane in the webinar control panel. A copy of the webinar will also be available on Echo IQ's website and social media platforms later today.
For now, I'd like to throw it over to Dustin to kick things off for us. Dustin, the floor is yours.
Fantastic. Thanks, Alex. Man, I feel like you did the presentation for us, maybe we'll just call it good and go right to the questions. Appreciate that. No, it's great to have everybody on the call. This is always such an honor for us to be able to have a chance to communicate with, you know, those that are most important to the business, which is the shareholders and investors who are supporting us in our journey. Thank you guys for taking your time. It looks like the numbers are fantastic here. We'll just kind of go through the process. I really encourage everybody, if you have questions, you know, type them in.
You know, long gone are the days where we can actually have people jump on a call and ask the questions. Just type them in if you have questions. We'll do our best to get every answer we can. Like we've done in the past, if we don't get to all the questions, then we're happy to do our best to try to circle back around and get as many of the questions answered as possible. Look, I'm really excited today. You're gonna see both Nick and I and those that haven't met Nick is one of the most fantastic additions we've had to the team in the last several months, Nick started on early last year. I'll tell you, it's pretty fun, Nick and I working together.
Between he and I think we've got some crazy thing like 50 years of commercial experience. It's pretty fun to be able to bounce ideas and start to build a strategic commercial pathway with Nick and be able to see how his team is really accelerating. We'll spend some time today sharing that with everybody about where we've been. I will argue, I think we've had one of the best quarters that, you know, I could have anticipated, you know, for the company as we started to really commercialize strong with aortic stenosis and obviously the opportunity for us with heart failure coming. We're gonna spend a few minutes going through some slides. I promise I'll try to really just hit the slides that are new for everybody.
Our goal is to have the slide deck up and available for you guys in the next two days, post the post this webinar so that you can have access to the slides and see the entire slide deck in full. We're just gonna do a condensed version of it today. Look, I wanna start first by just thanking everybody. I think many of you probably had gotten wind or had heard that I was in Hong Kong and Australia the last two weeks. I have to say it was an incredible trip. You know, really that trip was designed to get out and start to see a number of new folks who have come across the story, some new folks who have taken positions in the company.
And then obviously to, you know, to see some of the folks that have been around for the story for a long time. I will have to tell you, we had some crazy thing over 20 days, I think 70 different groups that we met while we were there, and probably during that invitation process. Turned away just as many, which told me that the webinar was going to be important thing to make sure I share the story with everybody as we continue to progress the business. I will tell you, we had a really great time meeting with a number of folks. Unfortunately, I had to get back to the U.S., and hopefully, you guys appreciate this as part of what we're doing with the business.
Nick and I were invited to a Think Tank at the American Society of Echocardiography. This was a small room where they brought a few select industry members together with the society. The discussion was around how AI is going to impact healthcare in the future. I think for us, it's really nice to have a seat at the table and really to start to build ourselves as a thought leader in this space when it comes to AI and healthcare. Very excited to get back and have that. I flew right from Sydney to Boston for Nick and I to have that meeting. Then, of course, we had other commitments where we had a presentation you may have seen on social media.
I was presenting at a Med Tech conference here in Miami, and I just flew back to Arizona yesterday to be able to get back for this call. Nick and I are leaving right after this call for Washington, D.C., where we're meeting with the Department of Health and Human Services and Centers for Medicare & Medicaid Services to start having conversations about how we partner with the government on a number of initiatives, primarily around heart failure, of course, progressing the conversation around how the reimbursement landscape will change over time for AI solutions in healthcare. Again, hopefully, you're starting to get a sense that we're really starting to build ourselves as a thought leader in this space as well, and we're having a seat at some of the most important tables when it comes to how we are developing and leading the business.
I think that should give a lot of confidence to where we are as a company and where we're starting to go. I'm going to get into the slides, but it'd be silly for me not to jump into the probably number one question that everybody dialed in to hear, which is where we're at with the FDA, and obviously, it's a pivotal milestone for the company. I figure I'll just address that one right up front just so everybody can get a bit of confidence and comfortableness about where we're at, and then we'll get into the slides. The main goal here is what I will tell you is you're not going to get every answer you want from the FDA on this one because, to be honest, I just can't give you every answer.
I can tell you where we are as a company. I really wanted everybody to see not only my face, but Nick's face on this one when we talk about confidence. Right now we're in the middle of the discussion with the FDA. The way I characterize this, I think Nick would say the same, we are as confident today as we were the day we submitted this, the application with the FDA. Most of you who have met me probably appreciate I'm an impatient individual, you know, on best of days, and it would be great to have this done sooner.
Obviously, we go through the process, and we're in the middle of what would be considered a standard process for review under a 510(k). I can tell you the conversation's going very well from our view. Whether you talk to the regulatory clinical, or Nick or myself, we will all say the same, that we feel incredibly confident about where we're at. You might have seen the most recent news, the head of the FDA, Marty Makary, had just resigned. So we've been given the assurance and confidence from the FDA that anything that's currently in process should not be impacted by the leadership changes. Obviously, you know, the FDA is gonna be going through some change management with leadership there.
I think it's probably a good change, and probably the FDA needs a bit of relooking in terms of resource management and things like that. At this point, we are very confident with where we're at. We are right in the normal timeline and process of where the FDA would be for a 510(k). There's plenty of, you know, information out there on the FDA website about, you know, timelines, but we're right in that timeline where we expect to be, having some robust decisions from the FDA shortly. I know I'd love to have you guys say, you know, here's exactly the date that we have. I can't give you that. I'm sure you guys would love to hear every single question the FDA has asked us.
What I will say, as we prepared for this submission, obviously, you guys have seen the heart failure data. You know, the data looks incredible. We had a pre-sub with the FDA. We knew exactly what the protocol and the design of the study was. We knew the questions the FDA were looking for. All of those things got us to the highest level of confidence, and I think this is a really strong application. I'm giving you as much of the information as I possibly can here, so hopefully that will give people the confidence and the comfort level of where we're at with the company with the FDA, because that is obviously a big milestone for us as we come forward here in the next several weeks. All right.
You know, where do I want to jump into first. I think, I'm just going to bring this slide up just because I think it's an important thing. It's always a good thing to, from a hygiene perspective, talk about where we are as a company. Most of you that have gotten to know me over the last, you know, year or so being, you know, being in the driver's seat. You know, we talk a lot about fiscal responsibility. You know, we've managed our money really well. I think in our quarterly, as we put out the quarterly, you saw that we still had about AUD 11.5 million in the bank, burning right around, you know, a million a month.
We still have a really nice runway there. We've been very judicious about how we invest our money. We do that to make sure that we're getting the best return on investment every single time we put that investment out there. I think from a balance perspective, balance sheet perspective, we look really good. We're very strong in that area of the business. Of course, the little chart there at the bottom, it's always fun for a CEO to be able to show the, you know, the movement up to the upper right corner on your share price. We've had a nice run from December, and I wanna thank everybody who's participated in that run. I think the share price is reflecting the story and the opportunity we have in front of us.
I will tell everybody on this call that I still think we are undervalued, even where we're at AUD 1.20, AUD 1.30. I think we're undervalued for what the opportunity for the business is and what the technology has to benefit the overall healthcare industry. Right now, if you feel like you missed the run, I can tell you haven't. I think we're right at the real beginning of that. Obviously, since December, we've made a really nice run there. I think from a balance sheet perspective, we've got a good, you know, good 12 months of runway ahead of us. We've got another, let's call it million or so that's coming back from the Australian government on a research and development rebate.
Love the government for that benefit. We should be seeing that come in, you know, in the early part of Q2. All right. I think it's important for everybody to just come back to the story around the investment highlights. This is what I think is the most important piece of our technology here, that we've built a business that really is defined by, you know, exceptionalism. We really looked at, you know, how we define AI in cardiology models. If you really looked at our aortic stenosis and heart failure models, you're starting to see a very clear pattern here that, you know, we develop models that are really effective at diagnosing cardiovascular disease. Their clinical accuracy is really high.
It's a testament to the heart failure solution at the 99.5% on the sensitivity analysis. It's continuing to show the strength of our technology. The fact that we've created these integrated workflows to make sure that we have the light lift to come into the hospital, I think a lot of companies forget that. This is something that we've excelled at in terms of creating a solution that sits directly within the hospital's workflow, creates efficiency gains and really ultimately has the ability to work directly with the physician in real time. All of this, I think, is why this story is resonating for us, why you're seeing such a market penetration from us at a high level.
Nick will talk a little bit about the customers and where we're starting to build the pipeline and obviously some of the big announcements we've just recently made with the Mayo Clinic and Mount Sinai, which, you know, when you think about how big these institutions are and how quickly we've been able to get contracts in place. I think it's a testament to not only what we can do as a commercial organization, but really what the model can do to help the overall healthcare systems. I'm not gonna go into the entire model, but I think for most of you guys understand now, and you're starting to see a picture of how important echocardiograms are when it comes to cardiovascular disease, and we've talked a lot about this being the nexus of care.
You've got this upstream, kind of challenge with EKGs, and if any of you guys are really into the, what's happening in the longevity space or you're looking at wearables, you're seeing a lot of this kind of, you know, matriculate in this space where it's, you're seeing, you know, AFib starting to get developed, diagnosed. You're starting to see the wearables giving you some information about your heart health. Ultimately, it's performing like an EKG. That's all kind of noise at the top end of the funnel. Really where we see the biggest hurdle and challenge is around the echocardiogram. It really becomes a gateway into every other kind of cardiovascular intervention that will happen, and it's usually the initial diagnosis happens at a, at an echocardiogram.
Unfortunately, these modalities for aortic stenosis and heart failure will demonstrate missed and underdiagnosed patients on a pretty routine basis. In fact, we just had a recent study I'll walk you guys through that demonstrates that, you know, even with, you know, the most skilled and highly trained cardiologists. They still miss things like aortic stenosis at 20% of the time and heart failure up to 50% of the time. Of course, all of this is getting exciting because everything from an echo feeds downstream to things like CT and MR. When you really look at that from a U.S. perspective, you know, we don't really think of us as a step or even at the top of the funnel. We really are the funnel when it comes to cardiovascular disease.
We know that around 20 million-25 million echocardiograms are being done in the U.S. alone per year, which really talks about the fact that there is a huge opportunity here for us. When you compare that, and it's not necessarily the same comparison, but when you compare that to things like the CT scan world, obviously we got companies in Australia that are focusing on this space from an AI diagnosis as well as HeartFlow and Cleerly and those in the U.S. You know, you're talking around 4 million CTs being done every year, and that's a critical phase for a lot of patients.
When you get to kind of put that in perspective and connection to the fact that there's about 20 million-25 million echoes in the U.S., you can see that the size of our opportunity becomes incredibly large. This graph is probably one of the best, I think, that gives you that in a pictorial presentation. This is just a scatter plot of the U.S. of where the number of echocardiograms are done versus the number of cardiac CTs, et cetera. You can just see how full that U.S. map is, but really how densely connected it is around echocardiograms. This is where Nick and the team are really focusing their efforts on making sure that we take and maximize that opportunity for a number of echoes. You guys have heard us talk about this before.
Just with two solutions alone from heart failure and aortic stenosis, the addressable market for us is right under AUD 4 billion. This is really probably the serviceable market, to be honest. This is actually number of echocardiograms being done for heart failure and aortic stenosis just timesing it by the actual reimbursement price. This is a large market with huge opportunity. We won't talk a lot about the competitor on the space today, you guys have heard us talk a little bit about our competition or the lack of competition in this space today with really one other competitor who. At this point, I think we have demonstrated to have significant clinical benefits over, which I think shows us to be the market leader in this space. You guys have seen the technology. You see what we do.
The beauty of what we do about using the measurements allows us to do this in real time, have incredibly high level of sensitivity and specificity for the model, allowing us to be able to give that real-time feedback to the cardiologist to make an accurate diagnosis. Doing this all agnostically to whatever software and hardware is currently being run in the system. I think that's an important component and why I think our story is really starting to resonate with our commercial customers when you think about the institutions. What they're looking to us and saying, listen, we wanna do integrations, but we can't.
We can't have these really challenging integrations where you're taking all the data out of the system, where you're taking a long time to process information, and ultimately you're changing workflows. We simply come in and say, great news is we don't do any of those things. In fact, we actually keep the data, you know, to just measurements, which means there's no patient-identified information. We're able to do it in real time to be able to help your workflow, and we integrate directly in with whatever systems you're having. We become that real true integration partner. I think Nick will probably talk about that in terms of how they've been able to build that pipeline so quickly.
When we look at all that, I think it's important here, and sorry this slide builds, but I think it really starts to tell our story really nicely. If you're comparing us to other folks and you're looking at what's happening with the other AI models and you say, why does Echo IQ have such a different approach to this? It really is because we've taken all of the aspects of what it means to bring an AI solution to the market, integrating in the market, and ultimately working directly within workflows. We've layered all of that together to create a true platform which allows us to be able to work directly where the physician needs the solution to be sitting and do it at a very high level of sensitivity and specificity to give them the accurate diagnosis every time.
Those patients, whether it's, you know, one of your friends, family member, or loved ones or mine, we're making sure that every single person gets accurately diagnosed every single time. If you saw the quarterly, hopefully you've had a chance to look at that. We decided to take a different approach with the quarterly and really add a bit of business update to it. You might have picked up in that section there our most recent clinical paper that was published. One of the things that you guys have heard from me over and over again is that we in the company and I strongly believe that as an AI company, we have the obligation to continue to deliver good clinical evidence-based science so that we can actually demonstrate how these models will work, not just simply in does the model work, but how does it actually impact healthcare overall.
This most recent one was published in Science, and it comes back again to that same kind of repeated process for us. We had 100% accuracy in the diagnosis of severe aortic stenosis with the model. The physicians were about 80%, which holds true to pretty much national average. About 20% of patients are missed or underdiagnosed, unfortunately, for severe aortic stenosis. For us, finding those patients, especially with the low flow, low gradient, is an important component. What's most important here wasn't necessarily that the model worked. In fact, it was 100% accurate. What's most important is really in that middle section there where you actually see the model for the first time was able to demonstrate in clinical practice a 24% increase in speed to reading an echo.
Think about that, right? If you're a cardiologist, right, 24% faster time for you to reading echoes allows you to have more time to focus on those patients that need it or to focus on some of the other things that are happening within the clinical practice. For the first time, this AI model in real world practice has been able to show efficiency gains. We've had fewer patients that were missed, and ultimately these were statistically significant. This was just recently published, and I think you're gonna continue to see from us as a company, not only do we build new models. We talk about disease states, we talk about multimodal approaches, but we're also delivering the clinical evidence to support why these technologies are so important. I'd be remiss if I don't continue to remind you guys about how strong the heart failure model was.
Again, with the Mayo Clinic, you know, on the back of this data, the Mayo Clinic putting a commercial agreement in place. The heart failure model showing 99.5% and 91.1%, again, demonstrating significant clinical value when it comes to diagnosing patients. With all that said, you know, you can kind of see where we're going from an overall perspective of how we, how we think about the models, how we think about we're putting into clinical utilization and where we're going to go. I'm going to come back on the call here after Nick speaks with you guys a little bit and talk to you a little bit about where our pipeline is and where we're going.
I think it's a great opportunity to have you guys get to know Nick a little bit better, and really kind of hear from Nick what the commercial pathway looks like going forward, because I think what you see from us in Q1 is just a testament to, I think, how we're starting to build the business and where we're gonna go forward. Nick, I'll kick it over to you, and then we'll jump into questions after that.
Yeah. First of all, I sincerely appreciate it, and I do wanna make it clear that we do not have an Echo IQ uniform. I've been working all day, came off of a plane straight into this conference, I already had the blue blazer and the white shirt on. Last time I saw Dustin, he had the white shirt on and thought this looked good, obviously. Dustin, if you wanna go to the next slide, we can talk about what we're doing from a go-to-market perspective. For those of you that it's the first time hearing this, it's a very strategic approach. One of the things that we can look at is the total number of claims for echocardiography across the United States. Very much concentrated. The top 250 do a majority of that volume.
We have an opportunity to democratize that and expand out in these hub-and-spoke models, but our initial focus is. How can we put people in place to serve those markets where that density is the greatest? We've got the Midwest covered. That's just where I came back from. We've got the Northeast covered. We've got the Southeast covered. We're actually treating Florida as its, as its own geography. It kind of lights up like a candlestick if you look at the heat density map relative to the total number of claims for that state itself. Just recently, we've got two final candidates for Florida that are in queue this week for their final interviews, and we just had another superstar start out in the California market. We've got the entire U.S. covered. It's that two-prong approach.
Right now we're leading with EchoSolv AS. A big opportunity, one of the accounts that we engaged with in the Midwest here today is actually one of the AHA Target: Aortic Stenosis pilot sites, and that is really looking at identifying aortic stenosis sooner rather than later in the disease progression to make a difference in those patients' lives. An intervention sooner, medical intervention sooner, it changes the outcome for these patients, and there's a lot of interest in how we work at the point of clinical decision in terms of making sure that that patient is flagged. Whether it be their first echo or a serial echo, we can flag it. The clinician makes the call, puts them into the appropriate care pathway. We're having a lot of success with that messaging and that story, but the focus is pretty specific.
We're not taking a shotgun approach. We're working with large institutions, targeting large institutions, large private practices, then the intent is to remove the subjectivity across their network from an echo perspective and make it more objective and make the output clean and the clinical decision happen sooner. As Dustin alluded to with that study, any place that we can drive efficiency is going to be of gain and of benefit to these institutions that are facing sonographer shortages. The cognitive load that a physician faces at the end of the day when they have to do that read, any assistance that they get elevates Echo as a platform and that's what we're here to make as our primary objective. If you wanna go to the next slide. Thanks.
Like I said, we're taking a very specific approach, and that does not only apply to the country, it applies as to how we engage with these high-volume centers. There are multiple stakeholders across a technical sell like this. You know, I've been in this space, particularly AI in the cardiac imaging space, for over a decade, and it's never just one decision-maker. We're targeting the Director of Echocardiography. We're targeting the Director of the Structural Heart programs, the Interventional Cardiologists, the Cardiothoracic Surgeons. We rally the troops from a clinical perspective, identify our champions, what pain points do they have, and then we engage the executive leadership. Every institution in the U.S. right now has an AI governance committee, and that's because there is an executive there that has a vision on how they wanna execute on AI within their system.
Dustin mentioned that we were at the ASE Think Tank the past weekend in Boston, and there were a lot of issues that were being raised that we are a natural solution to, and that is because we exist in the workflow. Whether that's a sonographer, a clinician, or technical. We're a light technical lift. As Dustin mentioned, we don't data scrape. We don't need to train. We are very blessed that we have a data set that has over 200 million echo measurements in it and is linked to mortality, right? Some of these challenges that other companies face relative to large data files, DICOM images that have to be uploaded, data scraping when they get into the headers in the PHI, we eliminate that.
Oftentimes we can skip about 200 questions in a security and tech assessment because we try to be intentionally a light lift, provide the results that they need into the clinical workflow. In doing that, we hit a PACS. We can scale efficiently across that program from a hub-and-spoke model. Typically they reside, you know, at the main institution, and all the satellite facilities all feed into the same PACS. It's an easy install for us. We get to kind of run that train-the-trainer approach. Go in, make sure that we've identified the clinical champions that we're going to be working with, make sure that they understand the process. As we'll get into in a couple of slides, you'll see how that process tends to grow the volume over time, and that's exactly what we want.
We want users to, one, experience it firsthand, and then if they're not part of that core group, to word of mouth and effort on our part understand that, okay, something different is happening here. You know, it's not necessarily that we're getting the answers before the test as we like to say when we provide these results, but it is, hey, these guys are serious. They are in our clinical workflow. It's not we don't have the swivel fatigue. We don't have to do these extra clicks. It is producing results where we actively read and engage the echoes themselves. The high volume centers engage the appropriate personnel, then just demonstrate that once we're in there, we can scale efficiently, and that starts as soon as we have that contract signed.
Relative to that, this is a little bit of a change. I think that, you know, we're pressure testing our fair market value. It's being received very well. One of the things that we've done is we've developed a first-in-kind pricing program because there is a lot of noise out there, not just in the healthcare space, but in general on AI. Everything from large language models, computational fluid dynamics, mixture density networks like we run on ECG AI, a lot of confusion, a lot of trial and error. Because, again, our dataset is so large and we're not DICOM dependent, we have a couple of unique opportunities where we can go into an institution, and we've branded these programs, the EchoSolv Shadow and the EchoSolv View, in addition to our subscription model.
As a precursor to our subscription model, we can say, hey, lot of noise out there. AI behaves differently on different datasets. That's their experience. That's what they're trying to weigh and balance. With our programs, we can actually go in and say, in quick fashion, we can demonstrate that we work on your specific patient population. Again, the diversity of the dataset that we've trained on, as we've seen in our validation with Mayo, is second to none. The fact that we're using measurements mean that we can do this quickly and at scale, so they can look at the clinical ROI on their programs before they even get started with a full integration.
This is resonating with customers because it's a low barrier for them and allows us to kind of demonstrate that we are the most effective solution because we can prove that with that specific patient population, no matter where it is in the U.S. That we perform and the clinical output and the upstream identification and downstream clinical utility will be specific to that institution and that program on a case-by-case basis. This has resonated really well. We've been rolling this out for the past month. If you want to look at time to paper, I'll get into what the funnel looks like, I can tell you that the coming back from the Midwest as of today, when we progress through the funnel, it is opportunities and programs like this that don't give them a ton of choices.
But give them an opportunity that makes sense to them, and they can demonstrate that, hey, this is going to prove that it does work on our patient population. A lot of success with that. As you can see, as I mentioned a little bit earlier, part of that strategy is when we engage the right stakeholders, and you look at the clinical champions who are crucial to the success and the expansion, just as much as any Echo IQ teammate that goes into the building relative to generating adoption, it is that word of mouth. You can see that our quarter-on-quarter growth from Q4- Q1 was 130%. This is even with EchoSolv AS, as we continue to bring on accounts, these numbers are going to continue to scale in a significant fashion.
Coming out of the Midwest, one of the things that we always do when we engage with these institutions is we work with them to look at the CPT codes that they're running for echocardiography and, you know, first meeting, we figure out what their total echo volumes are. These particular engagements for institutions across the network that we wanna target, the academic medical centers, the large private practices, and then the regional hospitals that sometimes are part of a national health system. We had that full opportunity in the Midwest. That volume ranged from 10,000 to just over 100,000 echoes within a given system in a single market. This is a huge opportunity for us. As we bring on these counts, we expect these numbers to scale pretty quickly.
This is where it gets exciting because I could tell you, again, having been in this space for 10 years and launched markets with absolutely no coverage. You always want to be conservative in your approach and go after the white whales, so to speak, later in the process. We've had this unique opportunity. It starts with Mayo. This is actually a commercial agreement. This is really exciting for us. It's because of the validation work of that we did with them on heart failure, and they see that opportunity and that utility. This is a 3-year commercial agreement. It speaks volume as to how the product performs in the real world across a diverse dataset.
They come to us in that partnership, and let's figure out a way to expand it. This is gonna be a huge opportunity for us as we get heart failure clearance to expand within the Mayo Clinic platform to actually partner with them on selling this product. It's not necessarily an easy button, but it gives us a defined target base that is a firm believer in the product, because they help validate it. Most recently, as everybody has seen, the agreement with Mount Sinai is a huge opportunity for us. This is a program that we entered with EchoSolv AS, one of the best structural heart programs in the country, one of the best readers relative to low flow, low gradient, and echocardiography.
This is an opportunity for us to go in and demonstrate the utility at that main Mount Sinai location. With our clinical champion and the fellows that support him and the attendings that support him. Ultimately, what this does is it creates an opportunity for us to train the trainer, develop the expertise at that core center, and then roll out across that network in that bub-and-spoke model and go to the next institution that is within the Mount Sinai network. The agreement that we have in place covers all the Mount Sinai facilities. This creates an opportunity for us to go from 40,000 to 60,000 echoes over the course of two facilities, right?
As that utility grows within those, we expand to some of the smaller facilities, then all of a sudden you've got an objective output across the Mount Sinai Health System from an echocardiography perspective. That's the tip of the iceberg. It is also one of the largest heart failure programs in the country. Upon clearance, this is both a technical lift that's rather light and a contractual lift as we expand our commercial agreement upon clearance into heart failure. It creates another big opportunity. I think what I really wanna point out about that is these opportunities that the EchoSolv AS platform is creating for us allow us to quickly pivot and expand our market in two ways.
We expand it with additional disease states from an FDA clearance perspective, and then we expand it to additional facilities within that given health system. Ultimately, what that does is a huge favor to us is it creates FOMO, fear of missing out in these markets as to, hey, we're the most advanced program in the market. We're using AI. We're using it to detect AS. We're using it to provide better care for our patient where that patient resides, so they don't have to make the 2-to-3-hour trip into the main facility if they can be served and have that same kind of output produced at maybe a more rural facility. There are really two core opportunities that are gonna allow us to expand rather quickly in the back half of the year, relative to the roadmap.
As I indicated on the map that we have, four area sales directors in place now, this is starting in Q1. This actually changes daily. As I said, we were in the Midwest market and met with nothing but decision-makers today. The team did an excellent job of setting up these meetings. The conversation is no longer, are you interested? It's like, we got to figure out a way to make this move. You're going to see these opportunities. We've got over 65, as of today, active opportunities in the funnel. That doesn't mean that it's just 65 accounts that we've engaged with. It means it's 65 accounts that we have qualified that meet the criteria for us in order to commercialize them from an EchoSolv AS perspective.
As we progress down, the team does a fantastic job of, you know, calling Dustin and myself in as a resource to help advance these opportunities, use us as a force multiplier, use us to create leverage, to bring additional clinicians, champions to the table, expand the conversation as to what does this look like for each reader. Every health system is different. Our Director of marketing says, if you've talked to one physician, you've talked to one physician. Same thing, if you've been in one hospital, you've been in one hospital. The level of engagement that we're getting to the decision-maker, and then figuring out a way to, hey, we're ready to make the financial commitment here. Let's start the technical process. Let's start the security review.
Let's go through AI governance. We are seeing a quick cascade down that funnel, and I think the opportunity that we have is, as we grow, we continue to actually simplify that process, and we make these moves a little bit faster. As a result, when we bring on the new area sales director in Florida, and we'll probably add another one in Texas, that'll give us a fantastic runway to close out the second half of 2026 and simplify the process, but accelerate the speed. Right now we're putting everything in place to be able to do that. I will turn the floor back over to best CEO that I've ever worked with.
Oh my gosh. Look at that. I didn't even pay you for that yet. I appreciate that.
Yeah.
Well, thanks, Nick, and hopefully as everybody gets to hear Nick, I'm always, you know, pleasantly, you know, kind of smiling to myself like, man, he works for me. This is awesome. Thanks Nick for what you're doing. The guys out there are just doing a bang-up job for sure. Hopefully that's building a bit of confidence for you guys in terms of what you think the company is and where you think the company's going. I can tell you we're exceeding every one of our expectations internally, and hopefully that will start to translate very clearly into how you start to see the second half of the year when we've always projected out that we expect to see a ramp-up and significant revenue.
Look, I think the short term and the midterm, because I do wanna just get to questions, you know, we've got a tremendous amount of opportunities in front of us. In the short term, obviously the FDA clearance is a big milestone for the company. We've talked a lot about the heart failure reimbursement. We're very confident still, as we've signaled in the past about using the 0932T as a CPT code. We've also signaled to you probably in this call that we're gonna be progressing a number of different pathways for reimbursement with the CMS and the Department of Health and Human Services because I truly believe as a, now I think in this space, a true thought leader and probably really a market leader here, we should be setting the future pathway for reimbursement.
You'll see some stuff from Nick and I in the future around what we think is gonna happen with reimbursement. That's only gonna be more positive for us as we continue to go forward. I think as we start to steer that conversation with the government, I think we're gonna start to see some really positive outcomes from that. Stay tuned on that space. Right now for us, we remain incredibly confident for the heart failure solution. Also having launching into a CPT code directly in the market, which is why we see that revenue ramp happen very quickly in the second half of the year. I wanna get to the questions. I think this is important for everybody, because I've really given some clear signals about what I think the pipeline's gonna look like.
Again, a company our size normally wouldn't even talk to you guys about pipeline. As you start to see what we see as a company, you know, we can't we're not gonna stop at heart failure. You know, we could argue heart failure makes a company, and it is probably just a single solution for a company would be great. Given the fact that we've got this dataset and that we're working through the dataset and we're training the models, you're gonna see cardio-oncology. You're gonna hear from us very shortly on probably the first kickoff of a clinical trial in cardio-oncology here. You know, think about that chemotherapy-induced heart failure. I mean, such a devastating thing to happen for a patient anyway, right?
You got, you know, you're dealing with your cancer, and then you got this potential that your chemotherapy could drive you into, you know, another significant thing like heart failure. We believe a solution's in place with our heart failure model for that. Hypertrophic cardiomyopathy, again, we've done some sprints here. The team is working diligently here on this. We don't spend a lot of money in this space right now. We're really looking at just proof of concepts. We're working on gaining on the technologies, and you're gonna see some pretty significant ramp-up from us over the next 12 months-18 months. Then of course, pulmonary hypertension sitting out there, mitral valve regurgitation. All of these are very thoughtfully being looked at now in terms of structural heart disease and the challenges that are there.
Every one of these, when we look at them, has an unmet need, and we believe that our goal is to bring in this technology that helps with these unmet needs. Continue to stay tuned to this space. We're investing here. We're excited about what's coming. As we start to, you know, move further into this process, you might see a little bit more ramp-up of investment for us going forward. I'm going to stop there because you guys can hear us ramble all day long, and you can probably tell from Nick and I that we get pretty excited when you get us ramped up on what we're doing. I think he and I could go for two hours, and we probably wouldn't have enough time to cover everything.
Why don't we stop there, Alex, and see if there's some questions from the audience. I'm sure there's plenty. We've kept, you know, a couple 100 people on the line for 45 minutes almost. Let's see if there's questions, and then we're happy to address as best we can.
Thanks, Dustin. Yes, look, I just wanna say thank you to everyone for joining the webinar. As Dustin mentioned, we have nearly 200 people on the call as of now, which is an excellent turnout. We have been inundated with questions. Obviously we have finite time, so we just wanna make sure that we get through as many questions as we can. Dustin, thanks for the presentation. To start, you've done a rundown on the status of your EchoSolv HF, FDA submission earlier. For investors that may have missed it, can you just provide an overview of where this currently sits? Has the FDA made any requests for additional information?
Yeah, great question. Of course. I mean, that's exactly in the process that we're in. You know, I mean, I won't bore everybody with the process of an FDA 510(k) clearance. You know, there's a moment in time when you submit, there's a moment in time when the FDA does their thinking and reviewing, and then there's a moment in time where they kick it back to us with questions, and then we go back and forth for a period of time. That's where we're at right now. We've had obviously questions from the FDA. We've answered, you know, most of them. We're going back and forth.
I will tell you, this is where my confidence is the strongest right now, is when you start to get a feel for the interactions with the FDA, it really is based off the questions they're asking you. As you start to go through this process, the questions that they ask you start to become more and more comfortable in the fact that we believe we've got a really clear path for a clearance. That's where we're at now. Of course, we're in the middle of questions back and forth. You know, we're gonna have another meeting with the FDA. Oftentimes you can do a call which covers, you know, 10 emails or 15 emails. That's where we're at now.
You know, to give you guys the long answer to a simple question, yes, you know, we're in the middle of that conversation with them now. I can tell you that's where my confidence comes from because as we see these questions and the tone of the questions and the kind of the trajectory of the questions, it leads us to that high confidence that, you know, we should see a clearance here happening pretty soon.
Thanks, Dustin. Now, Nick, I'll just turn to you. Now, based on your last quarterly report, there is a good pipeline of opportunities being built in the U.S. What's the likelihood of other major U.S. hospitals signing up to integrate EchoSolv AS and HF?
I'll do everything but guarantee it. I will tell you that every institution that I just engaged with on this trip to the Midwest is a brand name institution, whether that's from a national healthcare perspective. A large academic medical center, or a private practice that's recognized across the U.S. for the way they operate and the efficiencies that they drive within their practice. These are going to start happening in the second half with, I think, pretty consistent frequency due to the ones that we're engaged with. I will say this. The team that we've built has the experience and the not only from a health system perspective but from a new technology perspective.
These are the kind of guys and ladies that can walk into the carpeted rooms within the healthcare system and get the audience that they need to help move these things pretty quickly. Also to see not only how can we plug into their clinical vision, but as I mentioned a little bit earlier, how do we plug into that vision around AI? The reality is, can you make it efficient, and can you do it within our workflow, right? We hit those two in the dead center of the target. I'm highly confident that we will continue to bring on large key brand name health institutions over the course of the year.
Yeah. I think what's important, Alex, and sorry, and Nick, you know, reminds me of this on a daily basis, is that it is so fun to present to you guys Mayo Clinic, Mount Sinai, and whatever big institution comes. The reality is, you know, when we talk to our sales reps, and Nick and I are out there doing the sales as well when we have the time to do it. We can't drive by 10 hospitals to go to the one big one because every one of those hospitals needs our solution, and they need our help, and we wanna make sure that we're doing that at scale.
You know, you guys may not think it's sexy when we go and sign up five hospitals that do five or 10,000 echocardiograms. At the end of the day, these are the guys that need it, and these guys actually create a bit of revenue ramp that we have. We will continue to give you guys not only those big logos, those are coming, and, you know, Nick's modest and he won't guarantee it, but, you know, I'm seeing the contracts, so we know that they're coming. It's really a lot of these smaller hospitals and institutions that need the technology, right? We talk a lot about democratizing echoes, and Nick says it really well. You know, it shouldn't matter if you're in a rural part of the U.S. or a small community hospital.
You should get the same level of care when it comes to an echo as you do when you go into Mount Sinai or Stanford, and that's what we're trying to achieve here. Everybody should have access to technology.
Thanks, Dustin. Does the Mayo Clinic agreement reflect them using the software as a customer in their major hospitals similar to Mount Sinai, or is it a different style of agreement?
You wanna take that one, Nick?
Yeah. This is a true commercial agreement. If you look at their flagship facilities, it's Rochester, Scottsdale, and Jacksonville. This is an opportunity that goes well beyond that. Yes, this is a commercial agreement, and we have the opportunity to partner with them to not only expand within that network, but to sell this to the Mayo Clinic platform.
We joke, this is not a 90-day free trial with one doctor at one hospital. This is a full 3-year commercial agreement with the Mayo Clinic. Yeah, this is a big one for us. I think both Nick and I, it's unprecedented to get a contract like this before you even have an FDA clearance, which is pretty fun to see how good the technology is being received.
Thanks, Dustin. Nick, can you just tell us about the adoption pattern that you're seeing in the practices in which EchoSolv is being used? Is it gradual over the course of many weeks, or do clinicians start using it almost straight away? How quickly does the AI become a permanent part of the work process?
Yeah. Our goal is to get it a permanent part of the work process as quickly as possible. I think that you can look at the numbers that we presented and show that expansion continues to happen over time. Ultimately, we wanna run on 100% of the echo. That's our goal. It's from an institutional perspective. Right now it really helps us from an efficiency perspective if we go in and we work with that core group, make sure that they're fully trained clinically, that if they identify or have clinical questions relative to how the software performs, that we've answered those, and then we continue to expand. That looks like a 30 day-45 day process.
Just depending on the size of the institution, we have touch points where we do these business reviews, 30, 60, 90 to start with, and then we'll do quarterly business reviews. That's an opportunity for, one, us to demonstrate that it is effective. We are identifying things that would've traditionally been missed. Two, who else can we target within your institution that may be an echo reader that's been on the fence about the use of AI because we, like I said earlier, we build the case within that institution for its own performance. It's a very unique opportunity with the data set that we have and how we can go in and show specifically, prospectively how this works within your institution and increase adoption.
Thanks, Nick. Can you just talk about opportunities for strategic partners? How could this accelerate the runway or go to market? Is there any engagement with downstream CT MedT ech companies, PACS providers, et cetera?
Yeah. Strategic partners are a huge opportunity, right? It's one that we have to balance with the customer engagement that we have from the health systems. You can look at it, anybody that we engage with, particularly from a brand name health system. If they have a platform and there's interest in us partnering with that platform, we are doing this at Mount Sinai right now, and it creates a huge opportunity. Not only does it create an opportunity for us within the existing health system on the partnership platform, but collectively we can go out from there, and this is the broader strategy, and look at other opportunities that we would share with that partner. I'll let Dustin add, if you wanna add anything relative to CT and what the customer base is looking for from a multimodal perspective.
Yeah, no, thanks. Thanks, Nick. Yeah, and Alex, it's a great question, and for those on the call, if you, if you've started to kind of see my tone change over the last few months, it's because I think we're now starting to really look at what a bigger opportunity this actually is starting to evolve into. If you look at strategic partners, you know, I showed you the nexus kind of slide of echo. Right below us is CT. We become a natural referral down to CT. If you're, you know, if you're a CT company, you're kind of looking up and going, man, Echo IQ kind of actually just sends patients down to us, and they do it at scale. We become a great partner for them.
Then of course, as we start looking upstream, we look at things like EKG and things like that that screen patients coming in. We're really looking at creating an ecosystem with a number of strategic partners. I think you're gonna see something from us over the next several quarters. We're talking about platform and how we build a platform and how we actually expand this out to multi-disease state and multimodal approach to this, which is ultimately where the hospitals want us to evolve to. We are, I think, poised as the company that can do this. Of course we're talking to HeartFlow and Cleerly and Aidoc from Australia. We're talking to the CT companies, of course. It makes sense. You know how those partnerships evolve.
You know, we'll obviously be giving you guys updates in the future on that. We're talking to PACS providers, of course, the software providers, so if you're a Pro Medicus or ScImage or any of these guys that are creating a PACS system, it makes sense that we're working really close together. Of course, you're just a hardware or device company. If you're Medtronic or Edwards, and we're doing a number of projects with those guys now and you want more valves put in, we find those patients, it makes sense. If you're a pharma company, Novo Nordisk, AstraZeneca, BMS, and you wanna have more patients on your drug for heart failure, we help them find those.
I think Nick and I spend a lot of time balancing between the commercial piece of the business and then also what the strategic partner, you know, abilities are for us as a company. The great thing about what we do is we help a lot of people, and we actually drive a lot of business for a lot of other companies as well. We're a great partner, and we're looking to continue to expand that, so stay tuned. You'll probably hear something from us, you know, as the next several quarters come on about strategic partnerships.
Thanks, Dustin. I'll address this one to you as well. Do you think there is a natural acquirer of the business if equity markets are not willing to realize Echo IQ's full value? There are comps trading at multiples of your valuation in the U.S. that are less advanced. What are your thoughts on that?
Yeah, I mean, obviously, you know, my job as the CEO is to drive the, you know, drive the most value for the organization as possible for the shareholders. Of course, we have to look at all things. I mean, is there somebody out there? There's somebody out there for everybody. That's, you know, of course we have to be mindful of that. You know, my job is to make sure that, you know, we don't run into situations where we're devalued when it comes to having discussions with strategic partners. The answer is sure. I think there's probably lots of folks, and you guys all could probably draw, you know, a list of 10 or 12 names on a piece of paper that all would be natural fits for Echo IQ.
You know, I look at this and say, listen, I think we're pretty damn valuable, and I think we also should be thinking about are we a natural acquire for some of these guys as we start to build the business out as well. When you start thinking about platforms, you know, sure, it's great for me to go and say who might buy us, but it's also great for me to say who might I go and start to bring into the platforms over time as well as we start to expand the business, because we truly are unique in this space.
I think the markets are going to appreciate the value of the organization as we continue to give you guys the news and the information you need to show what we're doing as a company. Listen, you know, my job is to create the value. I'll do that. And I'll drive the valuation as high as possible for the company, both on the commercial side of it from an equities perspective, but also from a strategic partnership perspective when it makes sense.
Thanks, Dustin. Will there be any issues concerning reimbursement codes for EchoSolv HF?
Leave that to Nick.
Yeah, no. Again, having been through this before, I think we're in a stream extremely fortunate position. We're confident that we will launch into this code. We will be able to use that. As Dustin said, we'll be in D.C. on Friday working on a broad strategy. We've got our bases covered, but the confidence of launching EchoSolv HF into a code is very high, and that is part of our strategy.
Thanks, Nick. Now, Dustin, when does the company expect to deliver first revenues?
I mean, we've been, you know, pretty clear that we think the second half of the year is going to be, you know, where we see the biggest revenue ramp for us and, you know, as you showed, kind of saw the pipeline of what Nick and the team are putting together from a sales side, you can start to see that that's gonna materialize pretty quickly. You know, look at, you know give us some time here, but I think you're gonna see it, you know, materializing pretty significantly into the second half of the year and, you know, maybe even preempting that, I'm sure somebody's gonna say, well, what do you think your revenues are gonna be? I'm sure everybody would love to hear that from us.
We haven't given guidance to the street, I will appreciate that we've got at minimum, we've got three analysts right now that are covering us. I think if nothing else, I'd encourage everybody to go out there and see what the analysts are saying. You got Tom Godfrey over at Ord's and Iain Wilkie over at Morgans, Dirk has covered us over at Candor. I think all of them have given a pretty nice kind of picture of what they see the revenue ramp building up from 2026 to 2027, 2028. What I typically say to them or when I saw what they put out there is, I think directionally, you guys have done a good job. I think you see this really steep ramp into 2027 and 2028. I think that's right. My job is to beat their you know, beat the analyst forecast.
I think that we're poised to do that.
Thanks, Dustin. Now just, Nick, would you be able to provide an update on the reimbursement status of EchoSolv AS? Is the company's goal still to pursue a code for EchoSolv AS?
Yeah. This is part of our broader strategy. We're pressure testing the code that we've talked about for EchoSolv AS with a certain customer base and certain MACs within the U.S. The Medicare administrators have local MACs. We have a specific strategy that we're executing on. I'm confident in that. I will also say that the pricing program that we've put together has given us an opportunity to talk about the downstream clinical value of the patients that we can identify. We've got a pretty good story that we've got customers that are willing to push the envelope with us from a reimbursement perspective, and then also they realize the clinical benefit of that specific platform as an individual platform by itself. We're in a good space with that, and AS is also part of our broader strategy and the conversations we have with HHS.
Thanks, Nick. We have a couple more questions to go before we finish up today. Nick, I'll stick with you while I can. You've mentioned product development for additional indications. Can you talk us through the development pathway and timelines for new solutions?
Yeah, I think that's a question both of us can answer. If you look at heart failure is so broad and just the tip of the iceberg that the dataset that we have, you can continue to model on that. We've got a very dedicated team looking at those pathways. As Dustin showed on the roadmap, hypertrophic cardiomyopathy is of interest. That's a form of heart failure. We've got pulmonary hypertension and then cardio onc. Really, again, the unique opportunity that we have is that we are a measurement-based solution. When there is the opportunity to investigate these additional disease states, it can happen rather quickly.
You know, what we have to do is validate, determine market demand, and then work with Dustin to say, this is the strategy that we're going to pursue. Do we need to leapfrog? Do we have the right clinical pathway going? Is something easier than another? What is the clinical demand for these? again, the dataset that we have and the ability to train on that is a competitive advantage and a moat from a even a product perspective.
Thanks, Nick. I'll address this one to both of you to finish. In regards to new solutions, has the decision to pursue specific indications been influenced by cardiologists or potential partners, or are they based on total addressable market opportunities?
Yeah, I'll take that one, Nick, maybe.
Sure. I'll say this, you got to have a little bit of both, because the data science and engineering team here is incredible, right? They can build it. I have complete confidence in that. Does it increase the total addressable market? It's in almost all scenarios it's going to, even with rare disease. Now, can we position it in a way that the clinicians want that? We do get that feedback specifically, right? We have key opinion leaders. We've actually got a process to develop thought leaders in the space, both from a AI perspective and a clinical perspective. If there is a need that they see, we can, like I said, investigate that pretty quickly. It is a little bit of both. It is the total opportunity. We wanna make sure the bang is worth the buck, but we can't do that without clinical guidance and expertise.
Yeah, I think the question we ask always when we sit down with the R&D team is, can we do it, should we do it? Those are obviously two different questions that you get answers for. You know, we look at these and make sure that there's an addressable market there, make sure there's a market need, make sure there's no other solutions in the space. We also, we work with our partners to say, what is being missed out there? You know, when somebody like, you know, Edwards or Medtronic comes to us and say, listen, the mitral valve space is really interesting and there's no real good solutions, obviously we can do joint partnerships and look at what kind of solutions can we create for that. I think Nick's right.
This is an and answer to the question, because we do both, I think that's important for us. We will, you know, always evaluate not only can we do it, but should we do it if there's a real market there. If there's not, what's the point? That's always gonna be the main focus for any kind of commercially, you know, focused organization.
Fantastic. That ties up the webinar quite succinctly. Thanks Dustin. That concludes today's webinar. Thanks to Dustin and Nick for the presentation and for taking the time to answer some questions. Thanks also to our attendees and those who submitted questions for the Q&A. As I mentioned, we've had nearly 200 people on the call, which is an incredible effort. Thank you for your participation. We were inundated with questions today. Apologies if we didn't get to your question. As mentioned today, as mentioned earlier, a recording of the webinar will be on Echo IQ's website and social media platforms later today. Dustin, before I go, any final comments from you?
I think the final comment is just, thanks everybody. You know, always know that we can have this many people join a call and then actually stay on the call and with people who have busy schedules, we really appreciate it. I think what you're seeing from Nick and I is that, you know, we're really building something special here. Hopefully you see the energy between Nick and I that every day we're out there making sure that every decision we make is to return value back to the organization, and hopefully you guys are seeing that progress as we go forward. Stay tuned on this space. More news to come. I appreciate everybody for taking the time.
Great. That wraps up things here. Thanks everyone for joining us today. All the best and have a great day.
Thank you.