Good morning, everyone. Welcome to iRhythm's 2022 Analyst and Investor Day. I am Dan Wilson, EVP of Corporate Strategy for iRhythm, and I am honored to kick things off today. On behalf of the entire iRhythm team, we'd like to thank you all for joining us today, and we are excited to share our vision for the future of iRhythm. Before we jump in, I want to remind everyone that this presentation will contain forward-looking statements, so the Safe Harbor here and risk factors apply. In addition, today's discussion will include references to adjusted EBITDA, which is a non-GAAP financial measure. Please refer to our latest SEC filings, including our 10-K and 10-Q for more information. We have an exciting agenda today, and you're going to hear from a number of leaders across our business.
We will be running the day in two sessions. In the first session, we will cover our overarching strategy for value creation, our focus on clinical-led innovation, our growth strategies for our core U.S. business, and finish with our international expansion efforts. At that point, we will have our first Q&A session. We will pass mics around the room for that, and then followed by a 15-minute break, which we expect to be around 10:30 A.M. Eastern. In the second half of the morning, we start with a focus on some of our innovation efforts, including an introduction of Know Your Rhythm, as well as a high-level look at the technologies we are building for the future. From there, we will provide an overview of our operational excellence initiatives and finish with our financial outlook, leading into our final Q&A session.
A couple of quick housekeeping items. Please note that the presentation materials have been posted to our investor website for your reference, so please download those slides if you'd like to follow along offline. I would like to ask those of you in the room to please silence your electronics for the benefit of those joining on the webcast. Here's a look at our presenters today, and you can find full bios of each on our investor website. Before I turn the call or turn it over to Quentin, I would like to take the opportunity to say a couple thank you's. First, I would like to thank all of you in this room and on the webcast for your support and the trust that you have in us.
As you will hear from Quentin, we aim to be good stewards of the business, and as part of that, we truly value your input and engagement with us. We incorporate your input into our thinking, and we hope that you see that reflected in our presentation today. And last but not least, a big thank you to my colleague, Stephanie Zhadkevich, our Director of Investor Relations, who has worked with many others across iRhythm to bring this all together. Stephanie, thank you for getting us here today. With that, I will turn it over to Quentin Blackford, iRhythm's President and CEO.
That's terrific. Well, thank you, Dan. Good morning, everybody. It's great to be here with you this morning. It's so nice to be in person. This is the first real, I would say, significant activity that we've done in person. It's so great to be here. I wanna thank each of you folks for making it a priority to be with us this morning. I think we have an outstanding morning planned for you. We're excited about what lies in store with the future, and I know our leadership team is excited to share with you what lies in store of the future here at iRhythm. Before I get into the future of the company, though, I wanna take a quick moment and just talk about who we are here at iRhythm today.
We truly are the gold standard when it comes to long-term cardiac monitoring in this space. You're gonna hear from Mintu and Mark a bit later today on exactly why we believe that is the case. As a result, we are disrupting and completely transforming the way that arrhythmias are detected in the marketplace today. We've now served more than 5 million patients in and around the globe, with yet significant runway that continues to exist in front of us, with only about 25% of the marketplace utilizing our technology. When I say that we're the gold standard, of course, you would expect to hear somebody from iRhythm, particularly the CEO of iRhythm, tell you that we are the gold standard in this space.
The reality is, we have more than 35 peer-reviewed independent publications that stand behind our technology, articulating how we're unique, how we're differentiated, why we're not like just any other player in this particular space. We have a strong track record of success, now having served more than 1.5 million patients on an annual basis at a clip that's growing very quickly. We're backed by a global employee base now that expands far beyond just the U.S. and to other countries as we really focus intently on globalizing iRhythm into the future. It's the passion and the commitment of those people who have led to a track record of success. When we take a differentiated product in a space that's ripe for disruption, it leads to incredible results, and that's what we're seeing here today.
While there's been a lot of reimbursement noise in the market over the last several years, the one thing that has not been noisy at all is the focus of our commercial teams working directly with the physicians in the community to have them realize and recognize the uniqueness of our product and the differentiated capabilities that we offer versus the traditional Holter monitor that continues to make up the preponderance of the market today. The reality is the traditional Holter monitor, it hasn't seen new innovation or disruption in years, in decades. This market is ripe for disruption, and it's exactly what we're doing. Our past track record demonstrates that we're having that success, where we've had a CAGR, both from a revenue dollar perspective and unit volume perspective of more than 30% over the last five years.
I think this demonstrates very clearly we know what we're doing, we have the confidence that we can continue to do this, and we're doing this in a market that is just scratching the surface in terms of the potential that it has to offer in the early adoption phases that it's in. When I think about the future of iRhythm, I can't help but get excited about what sits in front of us. I do believe that we're one of the most uniquely positioned companies in all of the med tech space to take advantage of some of the shifts that we see taking place in the healthcare universe and the fundamental focus that's beginning to transform this space. You think about the patient-centered aspect of care. We hear about it being talked about all the time.
We have a perfect product to address putting information into the hands of the patient on a near real-time basis. We check that box incredibly well. You can't go into a physician's office today without hearing about the difficulties around staffing challenges, and that's not something that's gonna get any better as we move into the future. You have more and more folks retiring who are part of these coming into this particular area of expertise, which is gonna continue to mature. Our home enrollment product is perfectly positioned together with computing through the cloud, capturing near real-time information continuously. It's perfectly positioned to move into the virtual setting, and that's what you're gonna continue to see become more and more of a focus in this particular area. We feel good about how we're positioned with the move into a virtual setting.
You hear about the power of artificial intelligence and data. There's not a company that has more significant data sets in the arrhythmia monitoring space than what iRhythm has today. With more than 1 billion hours of curated heartbeat data powering our algorithms and data science that makes us unique in this industry. You can't go into a payer discussion without having some sort of focus on value-based contracting any longer. The one component most important to delivering an effective value-based solution is the ability to diagnose early on exactly what is taking place with the patient or the customer. We have the perfect product to meet the need in the value-based segment, and we're incredibly excited this morning to share with you what we're doing around Know Your Rhythm, which is our first launch into a silent AF undiagnosed population to better manage and monitor those patients.
You're gonna hear from Sara later today, talk more about how we're launching that, but we're extremely pleased to have the term sheet in place with our first pilot effort that we'll launch later this year. Again, we're well-positioned as we think about the shift in the fundamental areas of focus in a market that is relatively untapped. We still see incredible runway ahead of us in this space. Being the gold standard in this particular area is gonna continue to position us to have incredible success for years to come. We have the potential to expand far, much farther into the existing markets that we serve. We're gonna talk about what we're seeing in the primary care channel. I've spent a lot of time talking about the opportunity to move into the primary care space. We're already seeing it in our data.
Chad will share with you exactly what we're seeing, but it's moving at a fast clip, and we're excited to see that. We have the opportunity to open up adjacent spaces, things like silent AF, undiagnosed arrhythmias, sleep disease, heart failure, hypertension. Those are all areas that have incredible overlap with arrhythmias that we firmly believe we're gonna have the opportunity to get into over time. When you look at those sort of opportunities, it's gonna lend itself to a situation where we're gonna be able to deliver outpaced revenue growth. As we introduce an operational discipline into the company, it's gonna result in some incredible financial leverage and improvements in the profitability profile of the company for years to come. We're excited by what that has to bring.
Looking ahead, there's really four areas of focus that we think about and that you're gonna hear the team speak to over the course of this morning. The first is with respect to market expansion and adoption opportunities. Today, we serve less than 25% of the core U.S. symptomatic market. We will become the standard of care. We're already becoming the standard of care in this space, and I expect you're gonna see that move north of 50% of the market over the planning horizon. Today, we serve roughly 30% of all cardiologists and EPs in the U.S. space, leaving incredible runway to continue to go further in that area. We have the opportunity to go a whole lot deeper in the accounts that we're already in.
In many cases, we may have two or three cardiologists in a 10-15 cardiologist practice or even more than that, maybe 20 cardiologists. We have the ability to go a whole lot deeper into the accounts that we're already in. Chad will talk more about that as well. I think there's a tremendous opportunity as we continue to refine the AT product in this MCT space to see it become more reflective of the same sort of market share statistics that we have with the XT business. That excites us. I mentioned the fact that we're moving into the primary care setting. We're seeing it in the results already. When you have discussions with IDNs, ACOs, payviders, as we like to call them, or payers in general who are taking on risk, they see the need to monitor and diagnose earlier in the care pathway.
There's no question at all that that's how they're focusing in their own practices in terms of how do we see these things earlier in the commercial patient pathway. It's gonna move into that space. We see it happening as we speak today. Our own market assessment and segmentation in these areas, we've done a lot of work around this, would identify that there's nearly 14 million patients in the U.S. alone who are showing up in the primary care space with cardiac-related palpitations identified in their medical records. To me, that becomes the opportunity in this space that we can begin to monitor and introduce a better way of caring for those patients.
Of course, there's post-procedure monitoring opportunities, whether it's post ablations or TAVR, we think there's clear evidence that's beginning to come together that demonstrates the value that post monitoring can bring to these patients. We see a clear opportunity to play there. There's the opportunity to move into the hospital, emergency departments. We're seeing studies coming together with respect to putting patches on in that space, hospital in general, hospital to home. Those are all very interesting and exciting spaces for us that I believe will open up new channels and find ways to contribute to the top line. Of course, there's the international opportunity as well. You're gonna hear from Sandrine later today talk about what that commercial runway and pathway looks like into some of these new markets that have us excited and that are on our roadmap.
From an innovation perspective, you're gonna hear Mark talk about how we've completely transformed the company out of thinking about ourselves as a unique product, but really into a platform. We are so much more than a product today. The differentiated AI capabilities that we have and the significant data sets that we've now built, in many ways give us an unfair advantage in a market that's being disrupted that I believe is gonna lead to years of success into our future. It also gives us the opportunity to think much more broadly around what we can do in terms of the power of that data and the data sets. How can we connect data sets and look into adjacent spaces? How can we find ways to disrupt some of these other markets?
The correlation between some of these spaces like sleep and arrhythmias or heart failure, hypertension, and the arrhythmias that we monitor today are incredible, and I believe we're gonna find ways to open up those opportunities. Of course, working off of a single platform brings with it a lot of cost efficiencies as well that are gonna play through from a financial perspective and an improving financial profile. You're gonna hear Doug and Bryce talk later today around our operational efficiencies and what we're doing to drive operational discipline into the organization. We're a company that has done all that we can to keep up with the growth profile of the company. What we haven't done is taken the opportunity to really understand where can we maximize these efficiencies? Where can we introduce automation and robotic processing, for example, or digital transformation?
Our organization is ripe for those sort of opportunities that are gonna bring with it the ability to drive meaningful financial leverage as we move into the future. At the same time, there's the opportunity to globalize the organization as we think about being more efficient. Truly being a global company starts to open up so many different opportunities that we haven't been afforded historically. The ability to put regional workforces in place to be closer to the patient is something that becomes very important to us. The ability to take advantage of working around the clock, 24 hours, lower cost geographies, for example, that will supplement the teams that we already have in place today, all provides an opportunity to drive meaningful improvement.
When you think about an outpaced top-line growth profile with the introduction of operational discipline and transformation, it will result in an improving financial profile, and Bryce will talk more today about exactly how we think about that evolving into the future. At the end of the day, what enables all of that for us is our platform. We are not simply a patch company. Mark and the team have built, they've established a technology platform here that allows us to do so much more than just monitoring arrhythmias. Yes, we're differentiated from a hardware perspective. We have a much smaller form factor in the marketplace today than most all of our competitors. Our new Zio monitor is significantly smaller yet than what Zio XT has been in the past. That will be the same platform we use for AT into the future, and that excites us.
What we're finding from the market evaluation with the Zio monitor that's in the market today is some remarkable results and improvements in terms of the patient experience. What really sets us apart, what makes us unique is the differentiated and the unfair advantage that we have with our data science, the artificial intelligence, the deep learning capabilities that have been established here, and the massive data sets that power who we are. Mark's gonna talk a whole lot more about this into the future, but these sort of things open up new opportunities for us to think differently and bigger as we move into the future. Which brings me to how we do think about our future. We are beginning to think a whole lot bigger in the organization.
It's one of the things that I've been intent on as I've come into the company is, with this platform, we can do so much more than how we thought about the company in the past. You know, our historic focus has been around the detection and diagnosing of arrhythmias, and we've made incredible progress with that focus, and we've built an incredible company. We are now thinking much further and much bigger than what that historic focus has been to where now with our vision of better data, better insights, better health for all, it begins to open up the realm of opportunity for us. Yes, arrhythmias, without any question, are gonna continue to be our focus in the near term, but we believe we can do so much more with this platform, and it's why we talk a lot, frankly, about getting into adjacent spaces.
We truly believe there's the opportunity to open up those sort of market opportunities. With our powerful data sets, we can go beyond just simply detecting and diagnosing, moving into things like predicting, managing, or better yet, can we prevent disease altogether? We believe there's a future where that can be possible. It leads into the bigger questions, though, of what are we doing with the data that we have? What are we learning from it? How are we transforming healthcare? Importantly, how do we get this technology to more and more people around the globe? We have that responsibility, and we're gonna find ways to do that. How we do that is captured with our mission. Boldly innovating to create trusted solutions that detect, predict, and prevent disease. A much broader focus for us than what we've been historically focused at. That excites us.
It starts to open up a new way of thinking when we think about the markets that we have the potential to address into the future. To the left of this slide are the current markets that we address today. We think about the U.S. core symptomatic market of being roughly 5.6 million ACM tests that are prescribed each and every year. We clearly play in that space today. We also have a presence in the U.K., where there's about 500,000 ACM tests being prescribed each and every year. Clearly, we're playing there, but we're just scratching the surface in terms of that market opportunity. There's roughly six million ACM tests being prescribed in the markets that we currently serve. As we think to the future, there's the potential to see significant expansion in these addressable markets for us.
As we discussed, I absolutely believe you're gonna see monitoring move further up the care pathway into that primary care space, and we're seeing it already in our data. Our early results, as we sharpen our pencils and really do our analysis of what that opportunity is, would indicate again, that there are 14 million people versus the historic 5.6 million symptomatic tests that are being prescribed. There's 14 million people in the primary care setting who already have identified cardiac palpitations in their medical records. We believe that's a population that we can get at and begin to monitor. The international expansion as we lay out the roadmap for you guys and you see where we're planning to move into that international space, would represent roughly five million ACM tests that are being prescribed today.
That's already in place in terms of the monitoring that's taking place. You have to believe there's probably some similarity in the primary care setting in that international market. That's not something that we've been able to really sharpen the pencils on just yet. We'll continue to dig into it and research it, but you got to believe that that opportunity probably exists as well, which means the 5 million probably has potential to get larger. If we just think about the 14 million and the 5 million that I've laid out for you today, that's 19-20 million folks that have symptomatic issues already present in terms of their care pathway that we believe we can get after and begin to monitor. That's a significant market opportunity for us.
Beyond that, we start to think about things like the undiagnosed asymptomatic space that we believe ought to be monitored as well. When we think about that market opportunity, if we just take the 65 million folks in the U.S. alone that sit in a Medicare fee-for-service plan or a Medicare Advantage plan, and if we assume roughly 20% of that population is at high risk of a dangerous arrhythmia, you get a 12-13 million patient opportunity in the undiagnosed space that we ought to be monitoring on a routine basis to understand whether arrhythmias are present or not. To put that into a bit of perspective, if you were to look at the mSToPS study, in their work that they did, they identified nearly 25% of that population was at high risk.
We believe using a 20% assumption is probably a pretty reasonable assumption for us. Of course, there's probably a similar opportunity in the international space as well. Those figures that I was throwing out there, that was just the U.S. market in and of itself. If we assume something similar, somewhere around potentially 10 million or so folks, there's roughly another 20 million undiagnosed asymptomatic patients out there that represent a population that we believe we can begin to get after. Our Know Your Rhythm program, that we'll talk about later, begins to open the door into this channel. In addition to all of this are the adjacent markets, right? If we can open up those adjacent markets like sleep, like heart failure, like hypertension, those all become additive to what I've identified as roughly 40 million folks between symptomatic and undiagnosed folks.
It could put the total opportunity into the hundreds of millions into the future if we can find a way to open up those spaces that have significant populations within them. While the significant opportunities exist out there, and that gets us super excited each and every day that we're here at iRhythm, and we have initiatives in place to open up those sort of opportunities, we wanted to put together a financial plan or pathway, goals, objectives that we had a high degree of confidence that we could deliver on over the next five years. The way we've thought about this is truly a base case scenario for us. Let me talk you through that. Bryce will get into much more of the details later this morning.
From a top-line perspective, we are not contemplating any contribution at all from silent AF, from sleep disease, from heart failure or hypertension. This really is serving the symptomatic market that we're addressing today, both U.S. and international, with the roadmap that we're gonna lay out for you. At the same time, though, from a financial spending perspective, we have worked into our financial plans the investment to open up those market opportunities. If we do open those up and we find ways to generate revenue from them, that becomes incremental or supplemental, additive, accretive to the top line over the planning horizon.
It's truly from our perspective, from a top-line perspective, is a base case scenario that we would look to find ways to elevate as we open up these new markets. At the same time, if we don't have success in opening up these markets, then we would pull back on those levers of investment that are in the P&L and in this profitability profile that we're showing, and we'd let that flow through, and there would be a higher profitability margin that we would ultimately deliver if we didn't find ways to deliver into these adjacent markets. Again, the $1 billion is focused entirely on that core business. Let me talk through each one of these for just a second. One, we are reiterating our 2022 guidance this morning. What you see in the charts are the midpoints of that guidance.
From a revenue perspective, $415-$420, we've put the midpoint onto the chart, call it 417.5. That's a 20% CAGR over the next five years in the core business alone as we move to $1 billion of revenue. From a gross margin perspective, the midpoint of our guidance, 68%-69%. So 68.5% here. A 450 basis point improvement as we move into the low- to mid-70s over the planning horizon. A couple key, I guess, assumptions that we're baking into here that I'll lay out. From a CMS pricing perspective, we're assuming a $250 average blended rate will continue to flow through our P&L over the planning horizon. Really no change in that $250 rate as we move into the future.
From a CMS perspective, I feel good about where we sit today with the proposed rule. We'll look forward to get to the final rule here in October and November. I will tell you, one of the things that has me most excited is the fact that we can get that put behind us, and there's no longer that noise in the organization, just lets us focus entirely on the business. I feel good about where that's at. I feel good with the assumption of roughly $250 into the planning horizon. From a commercial pricing perspective, we're assuming low single digits% in terms of pricing pressure over the course of the five years. Again, Bryce will get into further details here.
The other thing that we're gonna do this morning, and it's the first time that we've done this in the history of the company, and it may be the only time that we do this, we're not gonna commit to do this routinely into the future. We are gonna show you the mix of our volumes in our business, in the XT business in particular, which is 90% of our business. We'll demonstrate to you, we'll show you what our ASPs are between CMS and commercial pricing so that you understand what that premium is that sits out there in the commercial business versus CMS. Again, it's not something we're gonna continue to talk about each and every quarter or each and every year, for many different reasons, primarily competitive.
I do wanna make sure we get models level set as we move into the future, and you understand what we're looking at there. From an adjusted EBITDA perspective, we're looking to deliver nearly 1,850 basis points of improvement from the midpoint of our guidance this year. One of the things that I think is important as you look at this chart is we've made incredible progress already from 2021 to 2022. These improvements are simply from where we're at today on into the future. It's already demonstrating that we're focused in this area, we're making improvement. You ought to have the confidence we can continue to do it into the future. Within that EBITDA, there's about 250 points or $25 million of spend at $1 billion of investment that's going into opening up adjacent markets.
We're driving the core business something beyond 15%. Think about it . That affords us the ability to invest into these adjacent opportunities, open up those markets, and if so, accelerate the top line. As I mentioned, if we can't, we can pull that lever back and let it flow through to the bottom line. I don't wanna lose sight, though. Given the fact that we've presented a base case financial scenario, we absolutely are interested, intent in investing into opening up these adjacent spaces. To reiterate, we haven't included any contribution at all from these areas. As we think about into the future, the opportunities to open these up, they have the opportunity to be supplemental or incremental to what it is that we've put in front of you.
I'm not gonna get into a lot of the details around how we're thinking about this. You're gonna hear from an innovation perspective how we think about data science, our algorithms, the data sets, and what that has the power to open up. For competitive reasons, I'm not gonna share exactly how we think about opening up these adjacent spaces, but you can see they're meaningful markets that we're focused on. To validate that fact that we are, in fact, investing into these areas and spending time and effort learning how to open those up, I'm excited to announce that for the first time ever, we're launching our Know Your Rhythm program. We've got a signed term sheet in place.
We will begin to roll out pilots later this year and in the early part of next year, really taking the opportunity to learn in this undiagnosed asymptomatic space how we can begin to change and impact that entire market. Sara is gonna spend a bit of time later this morning getting into the details of our Know Your Rhythm program and how we've set that up and the business model that's involved there. Again, our intent is to open this space in as meaningful of a way as we possibly can and in these early stages with the pilots to really learn what levers to push and pull on to make this as attractive as possible to the at-risk entities that this appeals to, and in many ways, getting the product onto as many patients as possible who need access to this sort of technology.
There's incredible opportunities to address the concerns of equitable access to care through programs like Know Your Rhythm, and you're gonna hear us talk about that. I wanna touch on operational discipline for just a moment. I personally have a deep-rooted belief that we have a responsibility as we lead this organization to be good stewards of the company that you entrust us with. As a result of that, this will be a key pillar that you're gonna hear us talk about routinely into the future about who we are trying to become here at iRhythm. There's many ways for us to get after this, and we're already beginning to bend many of the cost curves in the organization. We're seeing our unit cost economics begin to move in a favorable direction after years of moving in the wrong direction.
The first quarter, second quarter of this year have seen nice, steady improvements. Doug will get into more of the details around what we're seeing there and where we think it can go into the future. We're focused on being good operators of the organization. One of the areas that we have an incredible opportunity to get after is our G&A profile. We spend north of 50% of every revenue dollar today on G&A. There's nothing structurally unique to our company that requires that to be the case. We've just simply done everything we can to keep up with the incredible growth that we've had. We're now beginning to think about how do we streamline our processes? How do we transform processes? How do we introduce automation where we can? How do we think differently around where the work that we do is being done?
Those are sort of things that are gonna bring with it significant benefits. I talked about the impact of globalization. I love what that introduces to the company as we begin to look outside the borders of just The U.S. here, both from a top-line perspective, but also from a workforce perspective in terms of what we can deliver. There's tremendous opportunity for automation and digitization in the organization. A lot of times when we think about those opportunities, we think about manufacturing and assembly and what can we do to automate the production of the product. We think about it more broadly than that. What can we do in the back office to transform the way we do the work that we do each and every day?
When we think about innovation at iRhythm, it's not just product innovation, it's as much process innovation as well, and we're ingraining that down into the organization at every opportunity that we have. Altogether, as we get after these areas of opportunity, there's about $250 million of cost avoidance that we will achieve over the planning horizon from the current run rate of spend as we approach that $1 billion in revenue. As I wrap up this morning, there's two additional areas that I wanna speak to. One comes with capital deployment and strategic opportunities that we see. I wanna be really clear that the financial goals and objectives that we've put out this morning, we can deliver from an organic perspective. We do not need inorganic activity necessarily to get to those goals and objectives.
However, where there's the opportunity to supplement what it is that we're doing or to accelerate what we're doing, we will look for those opportunities. Again, we'll be very disciplined in this area if we were to pull on this lever. It will have to meet sort of the criteria that we lay out internally, but from a strategic perspective, aligning to what I've laid out for you this morning in terms of where our areas of focus are at. How do we drive further penetration from a commercial perspective in a faster way? How do we drive faster adoption of our technologies? How do we expand into new channels more aggressively? How do we build upon and supplement the datasets that we already have in place today, the ability to connect different disease states to learn more and more out of the rich datasets that we already have?
That's of interest to us. How do we expand our OUS presence and our footprint more aggressively or faster than what we're after today organically? That would be of interest to us. Or how do we fill the product bag that we already have and take advantage of the call points that we already have in place with our customers today? Those would be the sort of things that could really accelerate our financial plans and would be of interest to us if we were to move into the future and see opportunities present themselves. The other area is ESG. This is something that's very important to the organization. It's something that we've been elevating our focus around for the last couple of years now.
We have a corporate and a product profile that I believe fits very nicely with the areas of focus within this realm of interest. We have dedicated teams in place that help us keep oversight and focus on ensuring that we continue to make improvements each and every month, each and every quarter, each and every year. We have a reusable, a recyclable product profile that checks so many of the boxes from an environmental perspective that we got to do a better job telling the story in and around. We have a product that very clearly serves a very important role in the patient and community itself. With our Know Your Rhythm program, we have ways to elevate equitable access to care, and we're excited by what that can bring for us. We've implemented clearly defined ethics and integrity programs into the organization.
We've got a privacy council that we've now established to ensure that we protect the data of our patients that they entrust us with, and we're improving our governance structure as we speak. We've hired a chief risk officer, she's actually here with us this morning, who sees to it that we continue to elevate the focus in and around our control environment, and that we have the right sort of governance programs in place, as well as looking after things like enterprise risk, looking after DEI, and of course, ESG. We will continue to focus in these areas. It'll continue to be a priority for us and something that we elevate and make progress in and around. In wrapping up, I wanna take the opportunity just to reiterate, we are not like any other competitor in this space. We are the gold standard in this market.
Everybody in long-term monitoring points to iRhythm as the company that they're like. They're not like us. We are clinically unique and differentiated, and that's not just our own point of view. That's independently backed up by the significant amount of peer-reviewed publications that stand behind our technology. We will be disciplined operators of the company. When you think about having a gold standard of a product like we have in an untapped market, massive markets that are out there, that top-line opportunity will deliver outpaced revenue growth relative to the rest of the marketplace and our competitors, coupled with an operational discipline, is gonna deliver a financial profile that is showing significant improvement from where we're at today. I think it's a truly unique story in this space that not many can deliver.
At the end of the day, it starts with leadership and we have a proven leadership team with us today at iRhythm. We've taken the absolute best of what has built iRhythm into what it is today, and we've complemented it with experiences, skill sets, capabilities of folks who have been to where we're going to and aspire to be in the future, and that's a terrific recipe for success. We've done this before, we'll do it again, and I hope to have all of you folks along with us for that journey. I couldn't be more excited about what lies in store for us here at iRhythm. With that, I'd like to take the opportunity to introduce to you our next speaker, which is Dr. Mintu Turakhia. I couldn't be more pleased to have Mintu joining us here at iRhythm.
He's relatively new, just a few months into the role, but he brings a whole different experience set into our organization. When we talk about thinking bigger and thinking differently, he has helped us push that envelope in ways that we had never experienced before. You're gonna hear from him this morning. You're gonna see how we think bigger and differently than what we have historically. He's gonna share with you as well some of his own personal perspective of having sat in the seat of the physician, which I think is very interesting. With that, Mintu, the stage is yours.
Quentin, thanks so much for that really kind introduction and it really is great to see all of you be here in person. My name is Mintu Turakhia. I am a cardiac electrophysiologist and was previously at Stanford for about 14 years, where I ran the EP program at the Palo Alto VA and founded our Center for Digital Health and had a large research program in AFib. I've worked with some of you prior to this job in other roles, and so it is again great to see you. Really I am excited to be here for many of the reasons you heard. What Quentin told you isn't just a thesis for the company, it's a thesis, of course, why I joined as well.
I do think there is so much opportunity ahead of us to create impact at scale in all the domains you heard, clinical, scientific, digital health, all the things that are important to me. Again, to work with this great team is a fabulous opportunity, so thank you. What I wanna come back to is our vision statement because this also defines our clinical and scientific spirit. Better data, better insights, better health for all. This is a historical framework of the company, and it also captures my perspective, having worked early with its founders when this was spinning out of Biodesign. At the beginning, iRhythm was addressing an unmet need, a better way to diagnose arrhythmias in non-hospitalized patients, which of course can lead to better diagnostic yield and outcomes.
That created the bones and the foundation of the company with hardware, IDTF services, and software. Today, we're scaling and leading the long-term continuous market. The capabilities have grown, as you see in the middle column, and there's greater emphasis on platform, algorithms, and data. If we look ahead, we can leverage all of these stacks and build more as we are and really redefine the market here. This goes beyond the core services to all the areas of AI, analytics, decision support, disease management, and everything here. Again, fundamentally, we are rooted in understanding the intersection of unmet clinical needs and opportunity, and that is the origin story, but you can see how we are progressing toward the future from the original bones. Our clinical priorities are aligned to proactively address the shifts in the market.
If you look at the market today, there's a lot of fast followers in this space. It's crowded and noisy. We also know that healthcare delivery, particularly of diagnostics and care, has changed, especially accelerated by the pandemic. The people you see are often not the clinicians that are your, quote, "main doctor" that are in the brick-and-mortar facility that you used to identify with. Zio is delivered by mail, as are other diagnostics. In our view, the consumer pre-diagnostics that have accelerated with the use of consumer wearables, we believe augment the market and create more opportunities for us. Finally, physician practices, and I felt this, have greater strain as revenue is declining. There are reimbursement cuts all around, especially in the procedural areas with ablation, for example.
There is more push for passive revenue and also ways to generate more procedures such as ablation and pacing. Our clinical innovation priorities reflect these shifts, and they're really here, these fourfold areas that I'll discuss. Enhance core products, augment clinical evidence, explore and enter adjacencies, and again, leverage our data, our EHR integration, and platformize Zio Suite. Here's a deeper look. If you think of the first pillar, we can continue to enhance our core products. We can iterate, provide new insights, and design not only for the initial diagnosis of arrhythmia or disease identification, but long-term care management. This is an opportunity to show greater value for repeat testing. Mark is gonna discuss these and where we are with our next-generation technologies. We can continue to strengthen the clinical story and generate high-value evidence that continues to differentiate us.
This is not just for AFib. This is in all the adjacent aspects of arrhythmia management that are relevant to the broader cardiovascular population. We can also explore and enter adjacencies, as you've heard Quentin talk about. This can be across many areas, but again, this is an intersection of what we call technology-adjacent areas with clinically adjacent areas, and we'll talk about this. Finally, we can leverage the data science and the AI and the stack and the assets we have to address the capabilities for where we believe the market needs to go, and again, we can lead there looking at disease classification, prediction, and augmented intelligence. If you look at our clinical products, again, speaking as a clinician and also as a representative of the company now, we believe we are compellingly differentiated.
If you look at the patient experience, and my experience here is also having read 15,000 of these in the course of my clinical career, our compliance is very high with our patients. The monitoring is continuous and uninterrupted. There's no battery changes, there's no change of the adhesive or the CPU. It's all one device, one shot. In fact, if we survey our patients, 81% prefer just having the Zio for 14 days than another solution that could be shorter for 24 hours. Our analyzable time is very high at 99%. Again, we have a patient app. This is, again, the bones for us to think about our broader strategies. It's here. On the physician side, we have proven time and time again that 14 days and our product specifically give greater diagnostic yield.
We have the deep learning AI that again makes this easier for physicians. 99% of our physicians agree with the Zio report first pass. They can sign off on it. This AI coupled with curation and the high-quality approach that our technicians use when they read this allows greater brand trust of the product. There's further efficiencies, and we also have a reading app. As a doctor, I would walk around with this app on my phone, and I could read and sign off on my reports at any point I had downtime. My nurses or I could see the alerts that come in from AT if there was real-time notification. If you got called, the fellow or I didn't even have to get out of bed. We can see everything on our phone, and of course, it's compliant.
Again, these are the new innovations we have for the clinician user experience that we believe is sticky and can make a big difference. Our clinical outcomes are strong, and we'll talk more about this as well. As we have demonstrated clinical outcomes, we've also shown value to multiple stakeholders looking at patient journeys, operational cost, healthcare utilization, and some of the workflow enhancements you get with automation and integration. I'm now gonna switch and talk more about clinical evidence generation, and I do wanna say we take this very, very seriously. Clinical evidence is the cornerstone of establishing our place in the market, leading the market, and continuing to gain traction.
This is our playbook for clinical science, and this is again, deeply rooted in the company, and now it's a chance to take this one step further as we think of all the new areas and the new products we're launching. The early clinical evidence is not just for regulatory approval. The studies are designed to align with use cases and workflow and have early clinical experience as we see this simultaneously with the necessary clearances that we need. From that point on, we continue to build the story and demonstrate value, not only post-market but pre-market. This is also the origin story of XT and effectively and this is relevant for us.
We then continue through the life cycle of our products to reinforce features, use cases, demonstrate superiority across the spectrum, then the themes that has made our brand so recognized, the diagnostic yield, quality, utility, and actionability. Finally, of course, we do leverage our data at scale, and this is not specifically around AI, but around large healthcare system studies where we can leverage and link the Zio data to entire healthcare systems or payers to understand the value and the outcomes within those environments. Again, very important for those stakeholders and for the general body of evidence we have. Finally, we take this evidence base and use it to align with professional societies and key opinion leaders, and we can influence from papers, podiums, programs, and guidelines.
We have a runway now to do even more at a global level, and we've worked very hard to maintain and now strengthen these alliances. This slide describes the geographic range and scope of our collaborations across North America, Europe and Europe as well. You'll hear about Europe, specifically the U.K. and Germany from Sandrine, but our collaborations have expanded in reach and scope, and they continue to. This list continues to grow with these very strong institutional, academic, and healthcare system partners. Our body of evidence is growing. Even during the pandemic years, where research took a hit in many areas, particularly on the commercial side, we generated a high volume of abstract presentations over the course of the company. Since inception, we've had almost 130 at 32 conferences.
The key premier societies in the U.S. for cardiovascular, American College, American Heart Association, and the Heart Rhythm Society account for more than half of our presentations. Again, that is strategic. If you look at publications, our manuscript impact is also strong. The abstracts allow us to disseminate quickly, but the manuscripts are enduring, and this is what gets into professional society guidelines and in the hands of clinicians. There are almost 200 publications since 2011 that have studied Zio Patch in 110 journals. Now with 92 original research manuscripts, that represents almost 300,000 patients, 1,200 citations, which is quite high. You can see the case mix and the distribution. This volume continued to rise during the pandemic and maybe in some ways because of it.
This year alone, the scientific organization has done an excellent job in showcasing our work, and you can see that in some of the conferences shown here. In-person conferences are back, and they are, in my opinion now, having gone to a few, more vibrant than ever. We've leveraged some recent meetings, notably HRX, which is a meeting that was a few weeks ago in San Diego on health tech. Then the American Heart Association Scientific Sessions is planned in November, where we have a lot of interesting and important analyses that I'll talk about. These on the right are those that have been accepted for presentation. This is just a sampling of recent peer-reviewed publications, and we don't need to go through the details, but what this highlights is the core product evidence expansion. I'll talk a little bit more about GUARD-AF later.
It's a 12,000-patient randomized trial using the Zio Patch, and again, hugely important in the undiagnosed AFib category, and it's anchored to our product. This slide shows the study breakdown by disease or content area. Again, this is strategic to augment value, not only in sort of atrial fibrillation, but the adjacencies that you can see here. We have studies looking at additional diagnostic yield across multiple arrhythmias, such as ventricular arrhythmias, disease conditions such as heart failure, hypertrophic cardiomyopathy, health economic analyses, and a lot of the other things we show here. The other important thing is our studies are well distributed across the pipeline. As studies come off, we are very strategic in having studies come on, and you can see how many in that, dark blue color are already in the enrolling phase.
This will continue, and this machinery is well-oiled to support all of our future products. We're also pursuing new indications, and our primary target, as you've heard, is undiagnosed AFib. You're gonna hear a lot more on this from Sara. My goal is to set the background and context for you. This is sort of an estimation of the AFib prevalence that we see projecting out quite a bit to 2050. These are ranges based on best available data and estimates, and they are estimates. What you can see is the trend. By 2030, it's estimated there will be 5-12 million persons with AFib, and that is significant, and this will continue to rise, and I'll talk about why. Here's analysis that my lab did before, and it's the most widely cited estimate now for undiagnosed AFib.
Actually, if you look at undiagnosed AFib, and you can back calculate this using a number of modeling strategies, a conservative estimate is about 600,000 persons in the U.S. have undiagnosed AFib, representing 11% of the total prevalence pool of five million patients with AFib. If you loosen the assumptions around modeling, you get to a much higher number, 1.5 million undiagnosed, representing 23% of the total AFib market. Again, these are academic estimates, and should be viewed as that from peer review. If you cost out the incremental cost of undiagnosed AFib, we did that in a Medicare population. You end up with an excess or incremental cost of $3.1 billion, and that's based on 2014 dollars from earlier claims data, so much more now.
What was very interesting about the analyses, that the cost accumulation, if you break it down by claims, is not just for AFib and it's not just for cardiovascular disease. It actually represents cost as well, $1.3 billion. Again, this augments the thesis that AFib is an inflection point in the disease trajectory of a patient, and that is what you wanna get after. Now we have trials to support that. We know from our own work, the company's own work in the mSToPS trial on the left, if you look for AFib, you are gonna find it. In 2,100 patients who got a patch, AFib was found in, at one year, 6.3% of the monitored compared to 2.3% of the controls, an absolute increase of 4%.
This was not designed to look at stroke outcomes, but again, it augmented the thesis that in a high-risk or an enriched population, you will find AFib. On the right is the Apple Heart Study that I led as a co-PI when I was at Stanford. The purpose of this is not to talk about wearables, but to really frame what's out there in terms of undiagnosed AFib. This study validated Apple's irregular pulse detection algorithm in 419,000 enrolled patients in the U.S. The overall notification rate was 0.5%. This was a fairly specific algorithm, so it's a reasonable estimate to assume that that is the undiagnosed AF population, not just the alert population. Overall, 0.5% of the population had an irregular pulse notification. What's more impressive is the pre-Medicare and the Medicare population.
Age 55 and 64 had a 1.3% of the population that were notified. The overall prevalence of notification over an eight-month period was 3.1% in the Medicare population. That is significant. By definition, you did not have AFib to get into this trial. Again, important numbers to give background and context for the undiagnosed market. The prevalence of AFib is only gonna increase for a variety of reasons. If you look on the left, the incidence of AFib is rapidly rising from roughly five or so cases per 1,000 person years, not persons, but person years, steadily increasing monotonically overall and also seen in the outpatient and inpatient setting. It's gone up to about probably seven or so now in 2022, if you extrapolate this out. There are 2 reasons for this.
The first is people are living longer with the exception of the last two years. We know AFib is a diagnosis of the elderly, and so you're gonna find more AFib at the tail end of life. But the other thing that's happening is, I'm sorry to say, generational shifts in comorbidities. So this is a Blue Cross Blue Shield analysis on the right that showed that matched for age, Millennials had a higher prevalence of hypertension, cholesterol, tobacco use, and type two diabetes compared to matched Generation X from the previous generation by age. If you think of these as risk factors for AFib, which they are, we expect AFib prevalence and incidence to not only rise at the tail of life, but earlier on.
We think there's going to be an extraordinary uptick in the amount of AFib that we see. The other major change now is the sense of the data. AF, a lot of the earlier screening studies looked at this. They were primarily anchored on anticoagulation therapy and stroke prevention and looking at stroke as sort of the only outcome of choice. In some ways, that was due to the fact that we had new direct oral anticoagulants on the market and other therapies really hadn't had as much maturity or growth, such as ablation, as we have now. There's also a greater acceptance of rhythm control for antiarrhythmic therapy. These three studies also affect the way clinicians, professional societies, and we as a company are thinking about early identification of undiagnosed AFib.
From the EARLY-AF trial, we found that early ablation compared to rhythm control medical therapy had a greater success of freedom from AFib. We sort of know ablation is better. This is the first time this was applied early on. This has started to move the professional society recommendations for being more open to offer ablation as a first-line therapy, which is effective and important as we think of what comes downstream of diagnosis. More importantly was the EAST-AFNET study that was published that looked at early rhythm control after recent diagnosis of AFib. Looking at a combined endpoint, you see that there was a reduction in the incidence of cardiovascular death, stroke, or hospitalization with early rhythm control. This did not have to be ablation. It could have been antiarrhythmic drug therapy.
The other important finding is that the curve starts separating, you know, at about one year, going on with further divergence. Again, the value and the outcome differences are gonna show relatively early, and this is important as we think about the payer lens. If you look at CASTLE, it was a study of heart failure and AFib, looking at ablation in patients with heart failure, and the combined endpoint of death or hospitalization for heart failure was reduced with ablation compared to medical therapy. The curves in this case started separating before the 12-month period. The point here is we are not anchored only on stroke prevention therapy. There is greater tailwind now to use rhythm control as supported by the evidence and emerging professional society guidelines.
We also believe that the silent AFib market can develop and move forward via risk sharing, and Sara is gonna discuss this. In tandem, the clinical evidence will continue to build support for payers and for clinical care. The mSToPS trial I've described, it's important to know that the cost-effectiveness analysis of the mSToPS study is going to be presented at the American Heart Association meeting in November. It's led by Matt Reynolds, Steven Steinhubl, and Dave Cohen, commissioned by us, and that will be an important finding to note. GUARD-AF continues. Again, 1:1 randomization, 12,000 patients randomized, so 6,000 receive Zio. Primary outcome is stroke. Secondary outcomes are a range of cardiovascular outcomes. The initial yield data has been shown. The outcomes data probably won't come until next year or the year after. We are already seeing clinical guidelines evolve.
European Society of Cardiology's guidelines, which are probably the most influential globally, including changing practice in the U.S., has recommended opportunistic screening in a 65+ population if they have risk factors and systematic screening 75 years and up. This is based on STROKESTOP, which was a European trial that showed a modest but significant decrease in the risk of ischemic stroke. USPSTF, the U.S. Preventive Services Task Force, has given a grade of inconclusive pending clinical trials, but again, we think this will continue to move. There are some other trials in place, such as the Heartline study, looking at disease management after wearable-identified AFib, and another VA study that intends to use Zio Patch and couple it to disease management in a randomized trial that is going to continue. It's in early development now. I'm gonna kind of step now and discuss the Zio Watch.
I'll briefly discuss the clinical framing, and Mark is gonna talk a lot more about the technology. The context here is to think about consumer watches, and the first thing I wanna say is we all know these. We see these. Many of us wear these. If you look at the labeling for the irregular rhythm and ECG, these are, as the FDA describes them, over-the-counter pre-diagnostics. They are not approved for AF diagnosis or management, so they cannot be embedded in clinical care in their intended use. These are pre-diagnostics seeking clinician review and, for the case of irregular pulse notification, requiring clinical confirmation. That being said, the wearables' popularity has driven up public awareness and, again, we believe this augments the market. I've worked with a lot of these companies in my prior roles. They're good devices, but they are pre-diagnostics.
We think this provides tailwind, driving more patients to seek diagnosis and care from the healthcare system. Here's how we're thinking about the landscape and where the watch may fit in. I talked about consumer wearables. They are pre-diagnostics. You need to couple them to clinical confirmation and clinical care. Our 14-day continuous monitor and XT and AT are going to stay a permanent part of the landscape. You need continuous signal for a lot of the care that you have to provide. That is going to be important, and that is not gonna go away in the foreseeable future. Again, these are medically cleared. Where we see the watch to start is a mid-range or long-term monitoring solution. The PPG irregular pulse notification algorithm will run in the background, but it's coupled to ECG confirmation right on the watch.
As Mark will tell you, our algorithms for AFib are approved for clinical use. They are not pre-diagnostic consumer-grade over-the-counter algorithms. That's a very important distinction. There's some other technical factors here shown, but we think that this is going to be an entry point for medical-grade diagnostic for care and disease management. Out of the gates, we think that this can be a medium-term solution between a 14-day patch and an implantable device. That being said, we also think there is pressure on implantable loop recorders or insertable cardiac monitors, whatever you wanna call them, to obviate them, especially as the monthly monitoring reimbursement for those devices is declining in many areas, including New York.
Again, with this type of technology, with these design features that can aid in disease management, not just new diagnosis, and also with the data that may be accessible with the patient, to the patient, we think there's tremendous opportunity. This is how we're thinking about positioning it. Again, thinking of a mid to long-term monitoring strategy and how we're thinking of the use cases. We think there's a broad market for newly diagnosed or established AFib, especially to anchor to a therapeutic strategy such as rate or rhythm control. Right now, as a clinician, you see somebody, they get a Zio Patch, they go out, you look at it, you may dictate care, a nurse or you may call them, and then you won't repeat that. There is no synchronous care.
Of how we segment that, there are specific use cases we can look at. Post ablation, cryptogenic stroke, or postoperative conditions where a recurrence of AFib is actionable, and then this more broadly across the new and established AFib-based therapeutic strategies. There are other areas we're looking at, including asymptomatic or undiagnosed AFib, as well as syncope or loss of consciousness. Again, primarily our use cases right now to build out are around AFib. What we're doing now is continuing to evaluate how we wanna think of this, the business models, the reimbursement pathways. We're starting on clinical evidence generation soon, and that should continue into 2024. We do not expect revenue contribution before 2025. I'm gonna now talk briefly about data science, AI, and our new technologies from a clinical perspective.
Mark will discuss a lot of this in more detail. We believe we have the entire stack of the data science hierarchy to leverage our core products and to create new ones. If you start at the bottom with the data and if you move upward, these are the pieces that you need to develop AI, train, test, validate, deploy, generate clinical evidence, and then deploy at scale. Again, as you've heard from Quentin, we believe this is one of our unfair advantages because of the data, the maturity of the clinical and scientific programs here, and our data science groups to be able to do all this. We have the entire stack. One of the reasons for this is EHR integration. Presently, one in four accounts is EHR-integrated, and you can see all the EHR systems that we support and this number about this.
It also allows us to create opportunities to develop deep learning AI and AI algorithms for prediction, prevention, and also disease classification. We've done this many times. I did this with iRhythm in my previous life at Stanford, where we took healthcare system-level data, linked it to Zio data, and looked at outcomes. You can now extend that to death data and now not only claims data but the structured data in the health record. Drugs, labs, vital signs, ECGs, other patient-generated data, the unstructured data that is now part of the EHR and part of these systems, as well as the imaging data. This again creates major opportunity for us. I believe a lot of this can augment our existing products and leverage new technologies. This is how I think about AI. This is sort of a clinical perspective.
It's a two-by-two of measurement and insight. There are known ways to measure things, and there are new ways to measure things. There are known insights and novel insights. If you start with a 12-lead ECG, it's a known measurement. It can do a bunch of things. It can diagnose AFib and detect arrhythmias for the 10 seconds that that patient is in front of you while you press record on the ECG. We now know that there is some deep learning that can be applied to a standard 12-lead to assess ejection fraction, risk of AFib, and some other things. When you take Zio or the dimension of time over 14 days and even start combining it with other sensors, you then can expand what you can do.
What we know we can do with Zio is we can look for paroxysmal AFib over 14 days, not just 10 seconds or 24 hours, and we can get into other insights for like regarding activity, sleep, and so forth. When we start augmenting this with clinical data in the way that I described, you can take this to a whole new level. We think these are opportunities for us to go after across disease areas, prediction and classification, to identify this, creating extraordinary value for our diagnostic capabilities. Here are some adjacent market opportunities, and Quentin has already discussed these in terms of what we can do, where we can go. What's important here is not the absolute prevalence but the shared prevalence in patients with atrial fibrillation, as you see on the right. Two things.
Patients with arrhythmias have sleep apnea, heart failure, and hypertension, but these patients also live in the clinics or the channels where we already are with the Zio Patch, cardiology, EP, and increasingly primary care. As cardiologists continue to take on these adjacencies, and we believe there's pressure on them to do so, we think this provides large opportunity. Even now, if you go to AFib clinics, you'll hear most of them complain about how hard it is, even in their own healthcare system, to get a sleep study. This is something they definitely wanna take on. There's a lot of opportunity for us here. Here, in summary, this is a very exciting time for iRhythm. It's an exciting time for me and for the company, and I've laid out where we view clinical innovation to be and what the path forward is.
This is fundamentally driven by unmet clinical needs and opportunity. We have a robust pipeline of evidence and ability to leverage our data science and AI that you've continued to hear us talk about, and the competitive advantages are in our favor. I'd like to thank you for your time and pass it over to my colleague, Chad Patterson, our Chief Commercial Officer.
Thanks, Mintu. Nice to meet you all. I am one of those fresh faces, and I couldn't be more honored to be a part of this team and lead the commercial efforts moving forward. Mintu's section was truly a perfect introduction. From a commercial perspective, success starts and ends with our ability to meet our customers' needs better than the competition, both today as well as anticipating those needs in the future. Nobody does it as well as we do. We're driving value at the patient level, at the prescriber and their staff level, and at the payer level. We pride ourselves on being a customer-centric organization. I wanna take a quick moment to highlight a story we just received recently. This is Scott, a 37-year-old male who was experiencing palpitations, fatigue, and headache.
He went to see his primary care physician, who prescribed him an XT. After it was read, it was discovered that he had arrhythmias, and he was referred to a cardiologist. Upon reviewing the Zio report, the cardiologist prescribed additional testing, which revealed heart failure. He then underwent a procedure that revealed two blocked arteries, and he received multiple stents. In Scott's words, "Had my provider not mentioned Zio to me, I may not be here." This is a success story for both Scott and his care team, and this is our why. Frankly, it's why I'm here, to be able to touch in positive way, many more people's lives. We literally have the opportunity to touch millions more as we look at the addressable market in the US. In particular, the PCP market, which will absolutely be an entry point for millions, just like Scott.
Quentin mentioned the 14 million number earlier, but I just wanted to walk quickly through how we arrived there. 213 million adults, 20 years or older with insurance. Of that group, there's 200 million unique PCP visits annually. Within that setting, there's 16% prevalence of palpitations, and of those, 43% are cardiac-related. Non-cardiac related would include medication, anxiety, and things like caffeine, which arises at 14 million symptomatic patients in the PCP setting alone that there's a potential to monitor. It's an absolutely incredible opportunity. But I don't wanna make this sound like we're losing focus of cardiology. It's the core, it's our heritage, and it continues to be important. Our ability to drive further into PCP is intrinsically linked to our ability to continue progress with cardiologists. We've made great progress.
Our current cardiology penetration sits at 30% and continues to grow nicely. When we look at our top 50 health systems, we see a much higher clip at 42% penetration, and we're seeing a higher clip of registrations come through those more consolidated accounts. It's really great to see that the prescriptions per cardiologist have grown tremendously since 2019 as prescribers and systems see the value and effectiveness of our solution. We have this massive population that needs testing. How do we address it? Well, it starts with the understanding that the path to care begins with testing, and cardiac monitoring is absolutely a gateway to any cardiovascular program. The monitoring service the stakeholders choose can either enhance or inhibit their ability to drive outcomes, whether it's patient satisfaction, prescriber and staff satisfaction, cost of care, or clinical outcomes.
If you think about the addressable opportunity that I talked about in the last couple of slides, it has an amplifying effect of choosing the right partner. We certainly believe that we are that partner. The Zio service provides a comprehensive platform to address patient needs across the spectrum. Mintu talked a lot more about this, but regardless of how a prescriber identifies that need, we have a platform that ensures they receive the same high-quality patient compliance, high diagnostic yield, quality data, and physician agreement with our findings. Zio XT is retrospective, and Zio AT allows transmissions during the patient's wear time based on criteria established by their physician, and both with the same easy-to-wear, clinically proven design and service that helps organizations meet their goals. How does it stack up versus other options in the monitoring space?
I like to look at this yield cost curve, which showcases diagnostic yield versus reimbursement rate, which in this case is CMS. You can see that Holter event monitors can actually have a negative impact on those outcomes. Three out of every four times, a patient on a Holter event monitor does not get a diagnosis the first time. As Quentin said, it's truly antiquated technology that is the standard of care today. Most MCTs place a heavy burden on the patient during the wear time, often requiring manipulations and interactions throughout their wear time, which A, patients don't wanna do, and B, provides challenges during that wear time, which often results in low compliance, patient dissatisfaction, as well as missed time, which then leads to either missed or delayed diagnosis.
With proper discovery, many customers are finding that our solution can displace a large percentage of what they currently use, whether it's Holter, MCT or events. Mintu hit on this, but it continues to be a lifeblood of everything we do commercially in the US that we see the proof of our technological advantage play out in clinical research. It's a critical part of our US strategy, not only from a sales and marketing perspective, but our ability to unlock access. The clinical superiority has certainly been recognized by payers. Today, most commercial health plans include Zio as an in-network benefit, and our Medicare beneficiaries access nationwide through Advantage plans or fee-for-service. Quentin talked about the fee-for-service challenges. We hope that those are truly behind us.
Meanwhile, we remain absolutely focused on continuing the important work in delivering Zio XT to millions that need it. We have this amazing product. We have great clinical evidence. We have broad access. What are we doing and where are we focused commercially to pull it through? The first area I wanna touch on is our continued differentiation as a true partner. Beyond the amazing product and service, we have a wraparound approach to setting ourselves apart as being the partner of choice when looking at monitoring. As this space becomes more crowded, commoditized, and frankly confusing, this will be a core value driver for us.
We've really taken a different approach to the space, offering customers a suite of engagement opportunities to help them address their pain points, whatever they may be, whether it's establishing a referral network, workflow optimization, and certainly integration. It's a data-driven, standardized approach to increasing productivity, scalability, and accelerating our customers' value. We continue to increase our capacity here. We've grown our engagements over 3x in the past year, and we have the capacity to do much more. One area I wanna specifically highlight is our EHR integration. We're incredibly proud about the work that we've done here, and it's a standout success. Almost 30% of our registrations by the end of the year will be going through accounts that are EHR integrated.
Our customers see an almost immediate value proposition there, and it allows them to continue their capacity, and we're seeing our same-store registrations grow as a result. If you think about our ability to go deeper within these systems, this is absolutely a must-have and will enable us to go much deeper, in particular in primary care. It's actually the place that we're seeing the vast amount of growth in our primary care is these integrated systems. That leads me to my next focus area, which is driving prescriber expansion just beyond cardiologists. We discussed that there's millions seeing PCP that deserve monitoring, and it's a strategy we've already begun, and we're already seeing success, including in innovative primary care groups and groups tied specifically to IDNs. You see some of the stats here.
We're growing our prescriber base year-over-year, and we're forecasting to see double-digit growth again this year. Our penetration yet still sits at 11%, so providing a massive runway for us in the future. Our PCP volume year-to-date is growing as well, and it's great to see that the volume contribution is also growing. It's an accelerator to our baseline volume that we're seeing grow year in and year out, and we expect to continue to see that throughout the planning horizon. Last but not least, something I'm very passionate about is building brands, and building world-class brands. We're gonna be spending a lot of time thinking about the way that we build this brand over the future.
We have such a unique opportunity as a trailblazing and innovative company to create a brand that has a really discreet positioning in the marketplace. It's not just the brand as well, it's the marketing capabilities that will enable us to serve millions of customers and hundreds of thousands of prescribers over time. Through increased advertising, we'll continue to position Zio as a market leader within both of our current base as well as a way to introduce Zio to tens of thousands of new prescribers. An important companion to this is the technology stack that we're incubating and developing. We're gonna enable a smarter, more personalized, and scalable platform for effectively communicating with our customers, and that's both our prescribers and ultimately our end users.
If you think about what that enables scalability-wise, we're able to service our customers, answer their questions, and have a relationship with them that does not require a phone call into iRhythm or a visit from a rep. It's truly a capability that can be leveraged across many of the adjacent areas like Quentin and Mintu talked about. In summary, we could not be more bullish about the future here in the U.S., and we're well-positioned for accelerated growth. All of the ingredients are there. We have a large expandable audience. We have a pro-product platform that is meeting the needs today as well as into the future.
We have the right evidence that's unlocking the right access, and we have the best commercial team in the business pulling it through, focused on providing an experience that's value-based and value-added, focused on prescriber expansion and building a world-class brand and building the capabilities underneath to support our scale. I couldn't be more excited to be here. Thanks for your time. The future is bright. With that, I would like to introduce Sandrine Moirez, our international general manager.
Good morning, everyone. Bonjour à tous. I'm Sandrine Moirez. I'm the International General Manager for iRhythm, and I'm extremely excited to be with you today. Expansion beyond the U.S. is a key growth pillar for iRhythm. Within my 20 years of international business experience in healthcare, I have always advocated for better market access for innovative technologies, and my passion and commitment are to provide equitable access around the globe. I feel honored and privileged to oversee iRhythm international expansion. iRhythm is committed to accelerating the international expansion and therefore investing in operations, infrastructure, and resources to deliver on our international mission. The mission works to fulfill our corporate vision towards better data, better insights, and better health for all. The opportunity that lies ahead of us is massive.
With more than $5 million of total addressable market in the prioritized markets across Europe, Middle East and Asia Pacific, we have developed a plan that will allow us to enter key markets in the next coming years. Currently, we've been selling Zio in the U.K. market. As we are expecting to expand and grow in target countries, near-term investments will be deployed to set the foundation for scale with the objective to deliver around 8% of iRhythm's total revenue by 2027, and meaningful growth up to 25% of our total revenue in time. How are we going to expand?
Our international program entails a clearly defined process to assess the markets that we will prioritize, starting with a discovery phase, assessing market opportunity, understanding the patient and customer journeys by market, the pain points with Holter, identifying also funding mechanisms as well as assessing the competitive environment. In parallel, connecting and engaging with key opinion leaders, ministries of health and heart rhythm societies to understand the full opportunity for investment. At the end of the discovery phase, there will be a go, no-go decision based on our findings. Most of the European markets are composed of a public sector funded by the national healthcare systems and a private sector funded by private insurance. The current procedure volume split between public and private is around 75-25, but closer to 60-40 in revenue.
The private market is growing everywhere in Western Europe due to budget challenges, backlogs, and inefficiencies in the public system. The second step of our process will focus on two areas in parallel. The market priming, where we will be looking at setting up the operations and generating early revenue, specifically in the private sector where funding is more readily available. Market access effort in parallel, where we will be looking at submitting health technology assessments in key markets to secure long-term sustainable reimbursement in the public sector. The full commercial launch at scale will only occur once we have national reimbursement mechanisms in place. Every health system is different, and they all have various reimbursement processes and mechanisms, as well as different clinical evidence requirements.
Therefore, a market access strategy will be developed by country and based on the level of complexity and timing these activity will be prioritized. Where are we intending to play within the next five years? We are already present in two markets outside the U.S.. In the U.K., we are selling already, and our focus is actively seeking for long-term funding. I will provide more details on a U.K.. Specific slide. In Japan, we've been working on regulatory approval for the past year and preparing for reimbursement submissions. We are now starting the discovery phase in five new markets, three smaller markets, Netherlands, Sweden and Switzerland, with shorter routes to national reimbursement, as well as the biggest medical device markets in Europe, France and Germany, with longer pathway to national funding.
In the U.K., atrial fibrillation is the most common sustained heart arrhythmia and a major preventable cause of stroke. Atrial fibrillation alone kills around 100,000 people every year in the U.K. and affects 1.4 million people and is the cause of 20% of all strokes. It is predicted that it will account for 1.6% of all NHS expenditures in the coming years. Over the coming years, atrial fibrillation is likely to impose a growing cost on NHS budget and the wider U.K. healthcare system unless hospitalizations are reduced. We've been selling Zio XT with direct commercialization for about five years.
Our Zio XT service has proven to address major customer pain points, specifically important inefficiencies in AFib patient management with significant patient backlog and lack of reliable and timely fibrillation patient diagnostics. In the last couple of years, Zio XT has become the only long-term continuous ambulatory cardiac monitor with positive NICE guidance and was the winner of the AI in Health and Care Award. In the public sector, we've been working with seven AI Award trusts to transform the patient pathway for atrial fibrillation, producing real-world evidence proving their.
A recent clinical study presented at the European Society of Cardiology in Barcelona has shown that the Zio XT is able to improve detection, reduce waiting times and repeat testing while improving the utilization of clinician time and resources, reducing inefficiencies across the Liverpool Heart and Chest Hospital as part of the trial with the AI award. We are currently working on securing the business continuity in these key centers of excellence that have partnered with us creating the real-world evidence, pursuing in conjunction short-term and long-term funding mechanisms with the commissioners and with NICE. In parallel to this work in the public sector, we've been focused in the past six months on the private sector in the U.K., and we've had strong growth, more than +30% versus last year, and increased penetration.
We've been successful in the last couple of months securing the top two private hospitals group with a preferred vendor status. We also established a newly created reimbursement code for private insurance that will facilitate the growing adoption of Zio in the private hospitals. The competitive landscape in the U.K. is quite dynamic. We're dealing with several competitors, both small players and larger players. However, iRhythm is the only proprietary patch and AI solution, and our strategy is to focus on articulating the value we provide thanks to the clinical and economic real-world evidence that we've been able to generate with the AI Awards trust. Our major target for the international expansion is Western Europe, with 1.8 million total addressable market in the five prioritized markets. The clinical need is clear. Arrhythmia detection in symptomatic patient and stroke patients.
Both are the agenda priorities of most European ministries of health. The targeted market are Netherlands, Sweden, and Switzerland in the short term, France and Germany in the middle term. Why did we choose these markets specifically? Netherlands, Sweden, and Switzerland are smaller markets with easier market access. They are known for being open to innovation. They have developed several value-based healthcare programs and innovative procurement methods. They also represent attracting markets in term of pricing. France and Germany are the largest market and basically represent the main opportunity for volume growth in Europe. However, they have longer route to reimbursement with superior evidence requirement and increased operational complexity. The market access phase could take several years in those markets, but we are working alongside experts to determine the fastest, most appropriate path forwards as we create a new monitoring category.
We've started creating market awareness in all these markets through KOL engagement, and we are planning for an international advisory board by the end of this year to better understand both patient and customer journeys by market as well as market access process. Speed to market is an important factor. Being the first in those markets will help us in the global expansion, and our initial opportunity will be in the private sector. At the annual European Society of Cardiology, we interact with a number of cardiologists and physicians, and it became apparent that the awareness of Zio in Europe is actually prevalent amongst this physicians community, and this across the EMEA region. We specifically notice huge interest on top of the targeted countries from the Southern European markets and the GCC countries. Japan, with its $1.5 billion total addressable market, represents an exciting growth opportunity for iRhythm.
The cardiovascular disease burden is significant due to the rapidly aging population. The standard of care is Holter with important resources required for ECG analysis, and there's limited innovation adoption, which results in almost nonexistent competition. We've hired a country leader for about a year who has been working with the support of the global team on the submission of the regulatory dossier with the Pharmaceuticals and Medical Devices Agency. Thanks to our active engagement with the Japanese Heart Rhythm Society, they've been extremely supportive and provided a favorable endorsement for our regulatory dossier. In alignment with the Japanese process, the reimbursement dossier will be submitted to the Ministry of Health, Labor, and Welfare once we have the regulatory approval. The team will focus on continuously building our brand and awareness in the market and engage with KOLs.
In the meantime, we're also working on planning our commercial strategy for that market. While we are preparing for market priming, we are looking at different options for the go-to-market plan. Various strategies are explored to accelerate our market entry and penetration. As mentioned before, it became obvious through our customers' interaction that there is a strong awareness across the international physician community, specifically on the superior quality of the solutions and services for arrhythmia detection and diagnostic reporting, creating therefore a strong market demand. In most of these markets, the only options that are available to the cardiologists today are Holter or ILRs. There is nothing in between. The achievement of the NICE guidance and winning the AI award in the U.K. has created a stronger recognition in the international markets and will facilitate and speed up our market access.
Our commercial model will depend on the market's dynamics and local requirements. Direct sales will be considered in some countries versus indirect models in others. We are planning to recruit international experts in market access and business development to accelerate our plan. Inorganic activities will be explored, such as potential med tech sales channel partnership to access cardiologists, neurologists or heart rhythm specialists faster. All of this reinforces our confidence to be able to achieve our objective to reach 25% of the total company revenue with international expansion in time. Thank you for your attention. Moving to questions.
Thank you, Sandrine. We will have our prior speakers available for a Q&A session. We have mics ready to pass around the room. Margaret.
Perfect. Good morning, everyone. Thanks for hosting this for us. A couple questions, you know, maybe just to start on the LRP. You guys guided to that 20% top-line growth from the core. So I was curious if you can provide what the market penetration is in 2027 at that point. Are you assuming any kind of bending of that growth curve that you can maybe drive to as you add on other features and products and so on?
Yeah. At around 2027, we're getting to roughly 50% of the market using Zio in some way, right? That's a combination of sort of the long-term monitoring market as well as that MCT space. We aren't as penetrated in the MCT space in our market models, although I do think we can begin to close that gap with our AT product and some of the enhancements that we think about there. That's really just the core market as we think about it today, the 5.6 million ACM tests growing at 4% a year or so. If we really can open up that 14 million patient opportunity, you're talking about no more than roughly 20% of the market potentially using our product, right? I really do believe we can open up that channel.
You see it in our data already. You understand that primary care physicians are prescribing this product. I do think the market's gonna expand, which leaves even more opportunity to go after in greenfield there. In terms of the cadence, I think the best way to think about it right now is sort of on a linear perspective. I do think there are some things coming together that we're very excited about that could accelerate that in time, but we're not gonna get ahead of ourselves. That's the one thing we don't wanna do. We wanna deliver a plan to you that we're highly confident in being able to execute upon and deliver. As we find ways to navigate through opening new markets or going deeper into particular channels, things like, you know, the hospital channel, very interesting to us.
Post-procedure monitoring, very interesting to us. We don't have avenues into those particular areas today. I think those can be opened up, and they could accelerate. They could supplement what we're doing. Does that happen in the next 12 months? Probably not. Does it happen over the planning horizon? Probably so, right? I would expect, you know, think about it linearly for the time being, and if we could accelerate it, we will.
Okay. You know, you touched a little bit on adjacencies, you know, and obviously some very large ones that were referenced earlier. Those are not included in guidance. I guess the question becomes, when do you gain that confidence to include them in guidance? Are these existing markets sort of like the way that you took over Holter and ACMs, or are these new markets that you truly have to create, you know, including new codes and everything else?
Yeah. Well, I think the reimbursement aspect in terms of the codes and all that's associated there depends on sort of how we go into the market and what the offering is that we put into that space. In some cases, yeah, I could see the need to develop a reimbursement code. The watch, for example. That's gonna take a reimbursement pathway that we need to navigate down and get a code put in place for. Could we possibly operate underneath existing codes? Potentially. It might be more attractive to spend the time to get a specific reimbursement code put in place for that.
When I think about, you know, things like silent AF, we're gonna learn a lot in this pilot that we're gonna launch in the back part of this year, and that's not the only pilot that we're gonna end up launching. There's a lot of activity around this, and I don't wanna steal Sara's thunder. There's a lot of interest here, and I think we're gonna learn a ton from these pilots, which is gonna validate whether or not the silent AF space is really gonna open up. As we learn coming through those pilots, that will be a time to begin to reflect expectations that include contributions coming from that sort of effort.
My approach has always generally been around those sort of things, like, let's prove it, let's validate it's there, and then we can begin to work it into our expectations. I view it more as upside versus creating a scenario where that we then have downside and we have negative surprises. That's not what we wanna create here. We wanna you know, a plan that we're very confident in and then find ways to exceed it. On the sleep side, the thing that really excites me around sleep is just the correlation between sleep disease and arrhythmias. There's so much overlap there, and what can we find in the datasets that we already have that becomes interesting and compelling to the existing physicians that we already address?
When you get out and you speak with physicians, and Mintu Turakhia may be able to speak more to this, but there's a real interest in learning more around the sleep aspect of their patients, right? We think about the whole sleep channel and just how muddy it is in terms of the sleep clinics and inefficient that it can be. If we can better streamline sort of that patient flow, and I think we can do that with the dataset in terms of, you know, whether it's risk scores, classification of sleep apnea in terms of its severity. There's different things that I think we can do there, but again, we need to validate that it's real, and then we can include it in expectations. Until we do, I just don't wanna get ahead of ourselves. I don't know if there's anything you wanna add.
No. The only quick thing to note is I think we're gonna continue to see increasing clinical interest in sleep. Obviously not only for the kind of economic pressures and the practices that I described, but the American Heart Association just changed their Life's Simple 7 of all the things you're supposed to do well to Life's Simple 8, and the last is sleep. There's also been statements, as we all know, about sleep-disordered breathing and AFib and heart failure and other arrhythmias. If you take the wellness aspect of sleep plus the clinical disease management of sleep, we think there's tremendous opportunity.
Thanks. Joanne Wuensch from Citibank. Two questions. First one has to do with investments. There's a lot of projects going on, and I appreciate that your guidance does not include it on the top line, but does include it on the bottom line. How do you prioritize those products, and how should we think about the pace of them, of the investments over the LRP?
It's a great question. It's one of the most significant challenges that we have in the organization is prioritization, right? When you have so many different exciting opportunities, how do you decide which ones you're gonna pursue and when, you know, while forgoing maybe some other opportunities? We have mechanisms we've set up in the organization that feed up sort of out from an innovation perspective that refine sort of how to win in these spaces, and that then directs the teams in terms of the attention we put onto it. Today, we spend probably 1.5% of revenue in and around sort of these opportunities. Our long-range plan presumes that it gets to roughly 2.5%, right? That may ebb and flow over the planning horizon.
We may see opportunities to go faster and invest a bit more in a particular year. We may see situations where it doesn't require us to invest as much, and so it's a bit less in a particular year. That's sort of how we think about it at this point in time. It's gonna fluctuate a bit, think about it 1.5%-2.5% per year.
If I understand from your answer to the previous question, assume 50% penetration by 2027, that's U.S. number, I would assume. How do you think about penetration outside the United States?
I think we're just scratching the surface there. You know, we're talking about 8% of total revenue being represented by our international business with plans to get closer to 25% in time. One of the things that we're navigating through, and Sandrine described it very well, we're approaching the private sector first, and we're working through getting reimbursement established in that public sector, but that takes a period of time. I really think you're gonna see a bigger inflection in the international business once we get beyond the 2027 timeframe. You're gonna see a lot of good activity in these next five years. Getting reimbursement established in the public systems is what's gonna really enable us to take volume and share further out in the future. It's minimal.
We're very early and just scratching the surface, but we're setting the stage for what I think can be pretty significant. It's just it probably, while it starts to contribute in the five-year timeframe, even more so over a 10-year period.
Thanks.
Hi. Thank you for hosting this. Marie Thibault from BTIG. Wanted to ask a question here specifically on the gross margin guidance, and tell me if I need to wait for more detail from Bryce later. Noticing that, you're talking about a long-range plan of 73%, you're already possibly gonna be at about 70% in Q4. Would love to hear a little bit about how we should think about it linearly, or is there gonna be jumps back and forth? Certainly it sounds like you're making good unit cost improvements.
I would say let's wait till we get through Bryce's presentation. He's gonna actually show you some detailed sort of bridge schedules that show you how we actually go beyond 73%, but then afford ourselves the ability to absorb some of the pricing, you know, low single-digit pressure that we talk about, which will give you a better idea of where we think we can take this. If we can navigate that to a better extent, then great. There's upside to the number, right? Again, we're not gonna get ahead of ourselves with it.
Okay, fair enough. Maybe a quick question here on the EHR integration. We've always heard from customers that is something that certainly makes iRhythm and Zio sticky and drives volume. 30% of registration is going through it now. What are the hurdles? Why aren't hospitals trying to integrate a little bit faster?
I'll answer this, but I'll let give Mintu the opportunity on the first line of defense here to talk about it from a prescriber perspective.
Mm-hmm.
Yeah. I think Chad set it up nicely in terms of where we are. I will speak on the kind of healthcare side. A lot of healthcare systems, particularly large ones, just didn't have their houses in order to facilitate integration, right? You're seeing integration play across different other areas as well, cath lab, radiology, a few other areas. The machinery, as Chad will tell you, is primed, and our pace of deployment in terms of our internal KPIs are very, very strong. We think there's huge opportunity, right? You can turn on athenahealth almost with a flip of a switch. The Epic builds take a lot longer. You know, we are very well-positioned, and Chad will get into to do that. That's why we see the pace picking up.
We're getting better at it. Our current kind of cycle time is around 12 weeks, which we believe is absolutely best in class. Those other engagements on the CX side, around 45 days, kind of standardized, and we continue to make progress over time in being more efficient, which in essence is creating leverage for us so that our field sales team can prioritize going after new accounts and opening up new prescribers. It's a work in progress, and but we continue to be better than the rest, and create a competitive differentiation.
Thanks. Mike Polark from Wolfe Research. Just one topic for me. I just heard from, or I think we all just heard from Mintu and Chad, lots of fast followers in space. It's crowded, noisy, commoditized and confusing. You know, those two individuals made the same comment and felt like a new tone around that, and I can't help but you know, observe that three of your key platform competitors, even if they're behind on XT or the similar product, they're now part of larger companies. You know, what is the nature of competition these days? I guess why you know, those three or four descriptors are not. They suggest some challenges and friction in the market, and so I'd love to kind of better understand what you see out there and kind of is something changing?
Yeah.
-recently.
I think you're reading into the comments too much. That's certainly not what we're trying to articulate. I don't see anything different, and Chad's been out on the road quite a bit here in the last couple of weeks. He can speak to this. Anything or unique or different from a competitive perspective, I don't see it. When you go out and you sit down and you talk to accounts, there's not a specific competitor that will consistently rise to the top in terms of who you're competing against. It's very one-off, account by account. I view it much more as sort of sales relationships in those accounts versus a competitive offering to us. The difference continues to be sort of the clinical data that stands behind our technology.
We have to continue to do a better job of telling that story and compelling folks to understand that. Everybody simply points to iRhythm as, "We're just like iRhythm. We have data science just like iRhythm." They don't. Anecdotally, you get out into the field, you'll realize that while 99% of the time physicians will agree with our recommendations, from a competitive perspective, as much as 30% or more of the time, they're making their own recommendation and moving beyond or not following the recommendation of those competitors. It's a very differentiated capability that we have and offering that we have in the marketplace. We're certainly not changing our tone from a competitive perspective. I don't see anything changing with respect to that. I don't think the noise level is any different.
In many ways, I view larger players getting involved in this space. One, they validate the opportunity that we see sitting here, for sure, but they also create awareness around the importance of monitoring. I think a rising tide lifts all boats if you wanna look at it from that perspective. I don't think about it any differently from a competitive perspective or see anything out there that really concerns us or worries us. You guys are welcome to add anything about that.
Yeah. I'd agree. Remember that monitoring acquisition by a cardiac rhythm company, this is not the first time we've seen it, right? Corventis story, that didn't pan out. I think one of the lessons is that the decision-makers, the stakeholders, speaking as an EP, for implanted devices are not the same as the whole pathway and sales channels and cycle to get into these accounts, whether it relates to purchasing, device selection, EHR integration. They're very, very different. Again, we remain best in class, and that really comment is, yeah, there are these small followers. They haven't gotten anywhere, and we continue to sort of dominate in that area. We stick to our principles, our strategies, as Quentin has outlined, and we think we're very, very strong.
I guess the only thing I would add is, in being out in the field, a number of large systems that have bought the bill of goods from some of these smaller competitors are now calling us saying, "When can you be back here?" and that's happening all over the country. Again, I think what's being presented and articulated by our competitors is ultimately proving out to not be true.
Great. Bill Plovanic, Canaccord. In regards to the long range plan, can you help us just delineate volume versus price, you know, percent share that iRhythm will have in that penetration of the overall market as it transitions from Holter to the patches? Just the ASP of $250 in CMS, you know, how do we think about that? Is that a worst case? Is that a base case? kind of what were the inputs into that? Thanks.
Yeah. I think you're gonna see in Bryce's presentation, we actually get a little bit of a benefit from an ASP perspective. It's not significant in terms of moving the needle all that much, but the puts and takes come out to where with some mixed benefits of the AT business becoming a bigger % of the overall contribution of revenue at a higher ASP, you actually get an average ASP in the business that elevates up just a bit. Again, it's not significant, but it helps offset some of the low single-digit pricing pressure that we're thinking about.
If I miss a part of it, Bill, remind me of what it is, but on the 250 ASP, I feel very good with where things sit right now with respect to the CMS proposed rule and how that process is playing out and the level of engagement we've had throughout that process. I feel good about that. In many ways, I'm looking forward to get that final rate put in place because at that point we can just focus on the business and run the company versus dealing with sort of the noise that's out there. I feel very good about where that's at.
One of the levers that we ultimately have, and it's gonna come down, and Doug will talk a little bit about this, is how do we maximize the efficiencies of our workflows and where we do the work, right? Right now, you know, the contribution is there's a little bit more than half of the work being done through our San Francisco IDTF over the planning horizon, and the remainder is split almost evenly between Houston and Chicago. If we find there are greater workflow efficiencies, and it makes sense to shift that in time, we can look at that. Right now, our model does not contemplate that. We'll evaluate it as we go and see, you know, what we can accomplish there. Right now, we assume that it's sort of steady case.
We go with what we know today and sort of how we're designing the business. I look at that as a potential, you know, opportunity, and we'll just have to evaluate it in time. In terms of the penetration, I think that was the last part, the market share. Again, right around 50% of the overall market, a bit less than that when you include MCT and everything in there, but you're starting to approach 50%. If you just presume it's the symptomatic, again, this is U.S. numbers I'm referring to, 5.6 million growing 4% a year, is kind of how we think about the overall market. I do think the long-term monitoring grows a whole lot faster than Holter, so you start to see a shift between the two.
I do think there's a mixed dynamic playing out there. Holters will always have a place, I believe. I just think it's gonna be much, much smaller when you look at the value of long-term monitoring. But I think we have roughly 50% of that market over the planning horizon. If we can open up primary care, like we say, I think the opportunity is a whole lot less or a whole lot more. The volume versus mix, so Bryce will get into that. He's got a couple specific slides that show you volume and price and mix.
Hey, David Rescott with Truist Securities. I wanna, I guess, first start on the core U.S. market. You talked about 5.6 million ACM tests in the U.S., 14 million primary care referrals for specifically cardiac palpitations. Just wondering, what do you think the reason is that penetration within the overall market is so low today? I mean, is it something to do with the form factor, the way in which physicians are prescribing these devices? How do you think that your offering enables you to expand into that $14 million or 14 million patient-
Mm-hmm
... opportunity? Just trying to understand what the, how heavy of a lift it is to get to 14 million beyond just taking share in the 5.6 million today.
Yeah. I think a lot of it comes down to education around the value and frankly how easy it is to do long-term monitoring. To apply the patch is incredibly simple. I think when you look at the Holter technology, it's cumbersome, it's clumsy, it's not incredibly accurate. Primary care physicians don't have a lot of time to pour into that sort of effort. In many cases, patients get referred on to the cardiologist, or the cardiologist is who's really been looking for these arrhythmias. You're starting to see a whole lot more pressure coming from sort of the top-down approach, whether it's the IDNs themselves.
I mean, I had a discussion with a one of the largest payers in the States not too long ago that talked about the fact that they're gonna start to require more and more to move up the care pathway and for things like monitoring to be done in the primary care physician setting. You're starting to see pressure come from a top-down approach that's requiring that primary care physician to begin to look for these sort of things. When you put a solution together, like we have, home enrollment, for example, you can actually make it very effective and efficient for a primary care physician to have this applied and learn what they can with respect to that patient versus taking up more office time. We all know they don't have time in the office to do a lot of monitoring.
I think that's part of why they've kind of turned away from it in the past and not really been interested. We can now address that. I think that becomes, you know, a real opportunity. I think the top-down approach is absolutely gonna happen. Some of these networks, interestingly, you know, part of how they look at this is how do they control the patient downstream? You know, a lot of these specialist offices have backlogs of three, four months before they can even see a patient. The risk is you ultimately see that patient go into somebody else's network, and you lose the ability to care for them.
If you move it further upstream to where they can be seen by that primary care physician, have a patch put on, the interpretations or the recommendations or the way that patch is read is actually flowed through to the cardiologist. They can keep them right in the network and control the flow of that patient, where they actually, you know, can take advantage of the economics in terms of caring for the customer. I think there's a lot of reasons why you're gonna see it start to move into this channel, but I think a lot of it is us educating on the value that we can deliver, the ease of use, and how we can streamline workflows. I think the patients are gonna.
Sorry, the payers and the at-risk entities, and you're seeing more and more, you know, private equity move into this space, for example, that owns physician networks. They're gonna require more and more to be done up in the primary care channel. If there's anything you'd like to add, Sophie.
Yeah. Yeah, it's not form factor of the device, it's form factor of the workflow, right? There's a lot to learn with early adopters of Zio. If you look at Stanford and some of the VAs, it starts in cardiology, but once you're EHR integrated, you see everyone order it. To the extent that in a lot of hospitals that are integrated, the reading physician might be a cardiologist. The overwhelming prescriptions are not done by cardiology, they're done upstream by primary care. There's that. With fragmented care and for small practices before, if a primary care doctor ordered it, they owned the interpretation of it. That report didn't go over with the patient to the cardiologist, et cetera.
EHR integration solves that, aggregation of healthcare system solves that, and it's just an opportunity as well as upstream management, as Quinn said, that will happen. It's not that they're not using Zio, it's that they're not doing anything, and then once they're in the system, the upstream prescriptions will start regardless of who is the reading physician.
Okay. Thanks. That's helpful. Just on the 15% kind of long-term opportunity or goal for the adjusted EBITDA, you made a decision to include the investment in that guide but not the revenue contribution. Just one, I guess, what led to the decision internally to do that? And two, beyond, I guess, obviously pulling in the revenue from that opportunity, outside of the investment, as you just look at the P&L over the next several years, you know, do you think or are you able to identify areas that we could see potentially something driving more of a bullish case beyond what you're now describing as a bear or, sorry, a base case for 2027?
Yeah, certainly a base case. I wouldn't call it bearish. I think yeah, 20% CAGR getting to $1 billion is a terrific outcome in just the core markets with tremendous opportunities to supplement that in some of these new opportunities. The decision behind it, quite honestly, is we're spending dollars today to open up some of these market opportunities, so it's in our run rate of spend. We're gonna continue to invest into these areas. We wanted to put a financial plan out there that instilled a lot of confidence in terms of what we could deliver without a whole lot of risk around it, and then we can accelerate it as we open up these channels. I think the plan allows us to do just that.
At the same time, if we can't open up the channels, if we don't see an opportunity to create value, we can pull back on the lever, and we can improve that financial profile, the profitability profile of adjusted EBITDA. It gives us the flexibility to continue to invest, get after big white spaces that have the potential to be terrific for us and additive to what we're doing without adding a lot of risk to the financial plan that we've laid out. We like that setup. We like that scenario. I think a big part of who we wanna be is an organization that does what we say we're gonna do. We want there to be credibility in what we say. We don't want there to be negative surprises along the way.
I'd much rather navigate potential challenges or headwinds and let there be upside versus negative surprises. That's how we're approaching it.
All right. Thank you. We will break there. We will have chance for more Q&A at the end of the day. Let's plan on reconvening at 11:15 Eastern. Thank you.
Check, check. Sure. Okay. Yeah, of course. Check, check. Good? Perfect. Got it. Yo. Okay, perfect. Thank you.
All right, great. Welcome back. I would like to go ahead and get started. It is my pleasure to introduce Sara Bender, iRhythm's Chief of Staff, who will be introducing Know Your Rhythm.
Thank you, Dan, and good morning or good afternoon. I'm not quite sure what time it is, to all of you. It's a pleasure to be here with you today, and I'm really excited to share with you a lot of the tremendous progress that we have made on one of our most important growth pillars, Silent AF. Silent AF really helps us live into part of our vision statement, right? Of delivering better health for all. We couldn't be more excited about the progress that we've made. Just to frame this up for you, and I know most of you have seen the statistics and are very familiar with what's on the page in front of you, and Mintu mentioned most of this in his presentation.
I wanted to give you a feel for how our health plans and our at-risk providers think about AFib, the risk of AFib, and the burden that it brings to the healthcare system. Starting with lifetime risk. Your lifetime risk as a U.S. citizen is one in four for developing AFib. This increases to one in three with age and other comorbidities. If we think about adjacent disease states like diabetes, your lifetime risk for diabetes is one in three , breast cancer is one in eight , colon cancer is 1 in 24. For other disease states where we already have preventative measures, we're asking ourselves at this point, why don't we have more preventative measures in place for AFib and other heart arrhythmias? Especially as the risk for AFib increases risk for other cardiovascular complications like heart failure.
Your risk for heart failure as a male is 3 x greater when you have an underlying diagnosis of AFib. For women, it's 11 x greater. AFib is the underlying cause of up to 30% of strokes. In 2021 alone, 500,000 hospitalizations cited AFib as the primary diagnosis, and up to $35 billion per year are spent in direct costs related to stroke. Your risk of stroke increases by five times with an underlying diagnosis of AFib, and stroke continues to be the 5th leading cause of death. These are the types of statistics that our health plans are looking at daily, that they're trying to get after with preventative measures like early detection of AFib and other heart arrhythmias, especially given silent AF, where up to one-third of individuals who are diagnosed with AFib are completely asymptomatic at the time of diagnosis.
Moreover, not just the asymptomatic silent AF, but also the symptomatic AF, where many patients have symptoms for long periods of time, and the first time we hear about is when an adverse cardiac event occurs. How do we move up the care continuum to identify these arrhythmias earlier, prevent unforeseen cardiac events, and reduce the burden to the healthcare system and really truly impact lives? That's the clinical framing and the health economic burden that our health plans look at. Now let's talk a little bit about the treatment pathway. Detection would not be as important if we didn't have an already established treatment pathway for AFib and other heart arrhythmias. As Mintu mentioned, anticoagulants continue to be the mainstay of AFib treatment, especially to reduce the risk of stroke.
There have been many clinical trials that have demonstrated new therapies, new ways of looking at AFib and other heart arrhythmias that can significantly reduce ongoing complications from the disease. Trials are showing that a restoration of sinus rhythm can reduce the risk of heart failure, stroke, hospitalization, and death. Reducing other risk factors that associate with AFib and heart arrhythmias like diabetes, like sleep apnea, like hypertension can also significantly reduce the risk and the impact of AFib and other heart arrhythmias. These clinical trials are already starting to significantly impact society guidelines and, most importantly, clinical practice. We know the burden is high. We know the downstream impact of the disease is great. We know that there's treatment in place. What do we do about it?
Well, what we've seen in the mSToPS clinical trial, that putting Zio patches on at-risk individuals earlier on in the care continuum creates a 2.6 x greater detection rate of AF and other heart arrhythmias versus usual care. Usual care means a patient showing up in primary care or cardiology with symptoms and getting patched, or means showing up in the hospital with an adverse cardiac event where an heart arrhythmia is diagnosed. 2.6 x greater detection when we preventatively put patches on patients. What this translates to in terms of published outcomes is a reduction of emergency department visits by 24%, a reduction of hospitalizations by 23%, and a combined lower cardiac event rate of 39%.
Tremendous results from the mSToPS clinical trial that are also collaborated and cooperated with other screening trials that we've seen, such as GUARD-AF, SAFER Study, AMALFI, SCREEN-AF, et cetera. There is a lot of momentum behind the clinical efficacy of early upfront preventative measures as it relates to AFib and other heart arrhythmias. As Mintu stated in his presentation, we already see the European Society of Cardiology recommending upfront early identification of heart arrhythmias as a standard practice of care. With the clinical trials that support early identification, with the rate of identification being increased with Zio patching, with the clinical burden that we're trying to overcome here with early identification, we think that the time is now for early identification of heart arrhythmias. With that, I want to reintroduce you and relaunch our Know Your Rhythm program by Zio.
We couldn't be more excited and more thrilled to introduce this groundbreaking program for the early detection of heart arrhythmias. If asymptomatic and undiagnosed arrhythmias are the problem, Know Your Rhythm by Zio is absolutely the solution. Know Your Rhythm by Zio is a turnkey population health management program. We start by enabling health plans and at-risk providers to provide this service to their members and to those individuals from the comfort of their homes. Know Your Rhythm by Zio will be enabled with telehealth services. We first start by helping members and individuals understand their risk for heart arrhythmias, helping them understand how the Zio Patch can help them understand what's the underlying cause of some of their potential symptoms or issues that they may be having.
Moreover, we demonstrate the value to these individuals and the ease of use for the Zio patch, in that you can wear it while you're sleeping, you can wear it while you're exercising, you can wear it while you're taking a shower, et cetera. We get those members enrolled upfront in the Know Your Rhythm program, and we provide them with a telehealth visit to understand if they are able to wear the Zio patch. A Zio patch is then provided to their homes, and they are also provided with telehealth support on the back end to help them understand their results and also to help their providers understand their results to get them into the right care pathway.
For our initial pilot for Know Your Rhythm, we are very excited to partner with a new and innovative system and a new and innovative company called Heartbeat Health. If you're not familiar with Heartbeat Health, Heartbeat Health is a virtual-first cardiology provider. They leverage real-time clinical data and device connectivity to diagnose and deliver proactive heart care. Heartbeat Health is our initial partner in our initial pilots. We are really excited to partner with them to facilitate patient care and communication and care to the patient and the provider. We think that the model that we're creating with Heartbeat Health has a tremendous opportunity to expand beyond our initial early identification program and into other areas of our core business. Our partnership with Heartbeat Health will help us identify these risks early on for patients.
For our initial go-to-market strategy with the Know Your Rhythm program, we are going to leverage the Zio XT patch. The reason that we love the Zio XT patch for the Know Your Rhythm program is that with a diagnosis of AFib, another type of heart arrhythmia usually follows. What we saw in the mSToPS clinical data is that 40% of the arrhythmias that were diagnosed in mSToPS were non-AFib, were other types of heart arrhythmias. As you may already know, the Zio XT patch detects up to 14 different types of heart arrhythmias. Those additional heart arrhythmias that accompany AFib often change the trajectory of the care plan and management of that patient.
It's really important to us, especially in an early detection program like Know Your Rhythm, to leverage a product that enables us to see those other heart arrhythmias and enables care providers to provide the right level of care depending on what the patient has. We're very excited about the business model that we've created for Know Your Rhythm to expand into other products and services, especially as iRhythm continues to progress in our detection technology. But for our initial go-to-market, we will be leveraging the XT patch. With that, let's talk a little bit more about the overall go-to-market strategy and how we intend to bring Know Your Rhythm into the market. As age is the primary risk factor for AFib and other heart arrhythmias, our Know Your Rhythm program will start with Medicare Advantage.
Medicare Advantage, as most of you know, takes on capitated risk from CMS, right? They have a dedicated pool of money that they leverage to manage the health and well-being of individuals under their care. In addition to that, they are already doing innovative programs very similar to Know Your Rhythm in the health, wellness, and preventative space and adjacent categories. Medicare Advantage, as you probably already know, is estimated to be about 29.1 million individuals per year enrolled and is growing at a rate of 8% as more and more fee-for-service patients opt for this commercial service. Based on conservative clinical trial data, as Quentin shared earlier, we estimate that approximately 20% of these Medicare Advantage members, or just over 5.8 million individuals, are at risk for an arrhythmia according to age and comorbidities like sleep apnea, hypertension, and diabetes.
Medicare Advantage is also the fastest-growing book of business for our health plan customers, which means it is an extremely competitive landscape for health plans. They are constantly looking for services and solutions that help them drive member satisfaction, retention, and growth. Know Your Rhythm is perfectly positioned to help deliver on that member satisfaction and to deliver the health outcomes that are important for the health plan and the statistics that they need to properly manage their population. I will say, you know, we do expect Know Your Rhythm to be the gateway into early real-world implementation and evidence to support the impact of early detection of heart arrhythmias, which will influence a broader pathway for market penetration. We know that the USPSTF, the United States Preventive Services Task Force, will remain the gating factor for traditional reimbursement through fee-for-service Medicare.
We know and have seen that health plans on the commercial side tend to adopt innovative programs long before Medicare fee-for-service makes a call. We do anticipate our Medicare Advantage plans being much more proactive in early risk identification of heart arrhythmias versus traditional fee-for-service Medicare. Okay, the market opportunity is great. Let me share with you a little bit about our success metrics and the progress that we're gonna make over the next coming months. You have heard us talk about silent AF for some time. The phenomenon or the trend of silent AF is very well known by cardiologists, and it's very well known by any medical professional in the emergency department.
However, the solution to getting after silent AF has been elusive. With the Q4 2021 publication of the mSToPS clinical outcomes, we at iRhythm said it is time to deliver on a solution for the marketplace. In November of 2021, we started our strategy for early detection. We then went into concept design and customer research, and then finally into program build and outreach in the May timeframe of 2022. As Quentin mentioned this morning, we are very excited to now in September be in a term sheet pilot phase for our customer. Over a 12-month horizon, we went from strategy, concept, build, and design into a term sheet process for a completely new and groundbreaking program. We're really excited about the results that we've been able to show in such a short timeframe.
As Quentin mentioned, we have signed our first term sheet with our first pilot customer, called Physician Care Centers. We're really excited to be partnering with such a new and innovative solution like Physician Care Centers brings to the market. Physician Care Centers is an experienced Medicare provider. We like to call them PCC, so I'll shorten it to PCC for you guys. PCC is a high-touch primary care provider which manages risk for approximately 30 Medicare individuals and growing. They've got over 76 locations, 60 providers, and have been in market for over 10 years. They make member health their priority and build long-lasting relationships with the communities they serve. To quote their COO or Chief Operating Officer, Logan Steele, "In a value-based environment, it is imperative that we drive toward patient outcomes.
iRhythm has thoughtfully positioned Know Your Rhythm to do just that by effectively partnering with at-risk provider groups in a way that just makes sense. They drive value for better outcomes versus the typical models that we see, and we look forward to utilizing the Know Your Rhythm solution to improve patient outcomes and treat threatening arrhythmias in their infancy, ensuring patients live the lives they so richly deserve." We couldn't think of a better partner than PCC to help us introduce Know Your Rhythm to the market and really validate our end-to-end user experience that we've created with the Know Your Rhythm program. We intend to leverage this pilot to measure member engagement and satisfaction and demonstrate health outcomes associated with the early detection of heart arrhythmias.
We anticipate an early 2023 to mid 2023 launch with the pilot of PCC, and we really look forward to sharing those success factors and results with you, as well as success with our other partners. In closing, I would like to say that thus far in our commercial process with the Know Your Rhythm program, we have not heard no from a single customer yet. We are on a great pathway and a great trajectory to introducing Know Your Rhythm to more and more customers and clients and look forward to sharing those results with you soon. With that, I would like to introduce our next speaker, which is Mark Day, our Chief Technology Officer at iRhythm. Thank you.
Well, good morning, and thank you for the opportunity to kind of talk about what we think the future looks like a little bit from the R&D perspective. I think it's really a nice complement to thinking about innovation. Sara just walked through what we're doing from a business model perspective in terms of innovation, and then now I can change the focus and talk more about the product side. Maybe the way to start that is to kind of explain how we think about innovation and driving differentiation and really maintaining our leadership position in the space. The innovation stack really starts with these three central pillars. I'll start by explaining biosensor technology, which I do think it's important to reiterate that we were the first to introduce patches for long-term ambulatory monitoring in 2010.
Indeed, the idea came out of the Stanford Biodesign program about four years prior to that. Since that time, we've continued to invest and innovate and learn and patent and grow around what we're doing in that space. I'll be happy to share more details about what we're doing in the biosensor space a little bit later in the presentation. With a diagnostic that collects over two weeks of data, which basically confers about 1.5 million heartbeats of information, you need to put just as significant investment into the information systems and the workflow tools that provide the basis of the analysis and the service that we operate. That's really the next pillar of the innovation stack. We do consider ourselves a data business, a digital health business.
Our product is not the medical device, the biosensor, but rather the data that we provide to our clinics and customers and physicians. Doing so in a way that delights them, delights our patients, delights the providers that use our service, is really our goal. We do that by having a very keen sense of focus on the user experience. We have a lot of tricks that we have up our sleeve in terms of people on board that really help us research, identify, and design solutions that deliver on that delight. We do that in the form of secure and efficient platforms. You heard from Mintu a little bit earlier talking about our mobile apps, but our EHR connections, our websites, all of the things that are designed to address the workflow and the needs of our customers.
In terms of data analysis, there's probably nothing more seminal and groundbreaking and kind of foundational than our approach to algorithms. Our approach and the journey I'll go into a little bit more this morning in terms of what we've done in terms of growing from where we started to where we are now, which is a full embrace of deep learning and the broader field of AI.
I want to explain a little bit about how that works, and I promise it won't be a technical explanation, but I just want to give you a broader understanding of what it means and how to think about AI in this space. Because broadly speaking, the potential is really, really strong, not just to analyze what we've done retrospectively, the data that we've collected retrospectively, but also as Quentin and Mintu both talked about, moving it a little bit into the future and being prospective, predictive and looking towards what AI can do in that realm. I'll touch on that a little bit in the presentation. With these three core pillars, there's two others to add before we get to the full innovation stack. The patient database, and Quentin touched on this.
It's very common for companies and the environment in general to have access to tremendous computing power and storage capabilities, but it's very uncommon to have the type of depth and breadth of data that we have in the sense that our data is not just ECG that we collected over 1 billion hours, but is actually labeled data set. It was curated by algorithms and then reviewed and corrected and improved by humans. That is a tremendous asset to be able to leverage. I'll explain a little bit about where we see that leverage and the power of that AI, the power of that data that gives to AI in the talk this morning. All this and the last piece is really the clinical evidence.
Fundamentally, what we do is we build solutions to address unmet needs, and often you can kind of think about that as an innovator's dilemma in healthcare. When you do something that's unmet, it by definition means that you have to prove that it works, and very often you have to establish new reimbursement because you're basically doing something that's not been done before. The path to that, the path to success in that, is to have a really strong basis in clinical evidence generation. Mintu talked about that, and it's really what fundamentally drives this entire innovation stack. In terms of diving into the details now, I'm gonna cover the biosensor first and give you a little bit of a perspective on our journey that has gotten us to this point.
This is just a qualitative description, talking about how we've moved over time to improve patient compliance and comfort. Dr. Kumar is in the background there, our founder, and I like to give him a little bit of a hard time that the product design or the product that came to us, the concept that came to us from the Biodesign program at Stanford where we were founded, was basically a glorified hockey puck. I mean, it just would not have adhered to the human chest for longer than a few minutes. And it looked great. It was a really interesting idea, and it was great idea, but it took a tremendous amount of innovation, invention, dedication, and effort to figure out how to take that initial idea and turn it into something that's commercializable and in fact, very patient compliant.
That resulted in 2010 in what we affectionately call the Blue Patch, our first generation, and it really performed very, very well as far as a first gen went. It's still the basis of a lot of our clinical evidence and certainly the evidence that opened up the door for us, both from a reimbursement as well as a clinical adoption perspective. We learned a lot from that commercialization, though. As you can imagine, a first generation, especially of something new, is really a platform to learn from. We learned how to improve our customer compliance, the comfort, the signal quality, and the manufacturability, and all of that went into our second generation, the Zio XT device that we commercialize today.
To date, we've done more than five million of these devices, so we really understand about how to scale it, and as you might imagine, we've learned a lot from that experience. We haven't just rested on these laurels in terms of a device that is still leading the industry in terms of performance in the field. We're raising the bar further. We're putting all the learning in terms of what we can do to improve patient compliance, comfort, manufacturing, and protecting ourselves for the future with our third generation, the Zio monitor. I wanna go into a few more details about how that works and what the platform means for us. The best way to do this is to start off with the Zio XT device. Draw a circle around the housing of that device and then superimpose the Zio monitor.
What you can see in that is what is reflected in the numbers. This is a dramatically smaller platform. By the numbers, 55% lighter, which is what really matters from a patient comfort and compliance perspective. It's also 20% thinner and supports a new breathable housing and also is completely waterproof, submersible. This was cleared last year by the FDA, and we're already underway in terms of introducing it, and I'm happy to share details on the performance that we just saw over this summer. As you might imagine, this summer, I think we all experienced was extremely hot. Certainly when you're thinking about adhering something to the human body in that type of form factor in the upper chest, this is a challenge.
You don't need to be riding the subways in New York City to understand that people sweat regularly when it gets this hot. It's to establish performance. The first thing to note is that the Zio XT device is very, very well-performing in the field in these conditions. The Zio monitor does a little bit better when you look at median wear time on 14-day prescriptions. All the data I'm showing here is for 14-day prescriptions. Where you see a little bit more of a differentiation is in the mean wear time. Still Zio XT very strong, but Zio monitor a little better. What's driving that when you think about a mean is that you can't go beyond 14 days, which these both platforms are really supporting and getting close to.
You can see a very small percentage of short wear times that drive down, particularly the Zio XT performance number. When we look at short wear times, we do see that the Zio XT has a presence of short wear times, but the Zio monitor really almost entirely eliminates that as a category, and that's really what's driving the improved wear time. The insight that we understand is that patient satisfaction is directly correlated to the average wear time of the platform. In that sense, we're really excited about what the Zio monitor means for us from a patient comfort, compliance, satisfaction perspective, which is just so fundamental to the data that builds the trust with our customers. On the biosensor side, the other thing to think about is the platform in terms of what we're developing and creating.
Currently, with Zio XT and AT, we have two different products that have the exact same form factor in terms of a biosensor application process. That's a great benefit for our customers. If they understand how to apply one, it's very intuitive about how to apply the second. But underneath the hood, they're entirely different. The Zio AT device has a Bluetooth capability that enables that kind of timely monitoring capability of the platform. The Zio XT does not. With our future platform that we're introducing and rolling out now, first manifestation being the Zio monitor that I just talked about, Bluetooth will be present on every one of those sensors. As a platform, it's capable of not just providing XT-like functionality, but also AT-like functionality.
This will be the platform that we commercialize, and in consolidating everything under one hardware platform with different firmware on it to operate the different functions of the device, we do two things. First, we simplify a lot of the manufacturing process, and we enable a lot of scalability. One of the key things that was done from a design perspective is to enable automation, and Doug will talk about that shortly. Second, this really allows us a pathway for the future. We understand that right now, if you think about the consumer space, it's ridiculous to offer some type of product that doesn't connect, doesn't communicate. Healthcare doesn't really work that way. It works a little bit more slowly, but we wanna protect ourselves for that future, understanding that the expectations from the consumer space will feed into medical diagnostics and testing.
This platform, in terms of enabling Bluetooth on every one of our devices, protects us for that future and allows us to enable and continue to innovate what happens in terms of driving the future for our industry and really driving the definition of what it means to keep being an innovator and basically driving the growth and the definition of what it means to be a monitoring platform. All that's enabled through this new hardware platform for us. The data that's collected off these, though, is tremendous. If you think about, again, that 1.5 million heartbeats, that's collected over 14 days. That's really kind of a nice feed into talking about deep learning, 'cause you need advanced algorithms and curation systems, and indeed a human component, to actually be able to curate that massive amount of information that's collected.
What I'd like to do is, and I promise again, this won't be technical, it'll just be educational, but we'll take a little journey into the deep so you understand what we mean by deep learning and the broader field of AI and why we're particularly excited about it. The first place to start is just with a very simple paradigm of how you can develop algorithms. You can either develop them from a rules perspective or a data perspective. In fact, there are permutations in between these two extents. When we started the business, just like many of our competitors, the state-of-the-art in roughly 2010 was what we call expert rule-based algorithms. Indeed, our founder,
Dr. Uday Kumar would sit down with our algorithm engineer and try and confer rules that he would use to diagnose arrhythmias, things like rate and morphology, width of a QRS complex, things like this that would be put into a lot of if-then-else statements by the algorithm engineer. That is an expert rule approach, and they work pretty well. But it was around the middle of the last decade, roughly about 2015, that machine learning leveraged more data. Around the same time, a lot of research was coming out showing the power of deep learning, which is otherwise you hear terms like deep neural networks or convolutional neural networks. It's really techniques that are basically designed to learn from data alone as really being the disruptive potential for what algorithms are capable of doing.
Collectively, machine learning and deep learning are referred to as artificial intelligence, which is one of the reasons that this gets a little confusing, 'cause you hear all these terms used interchangeably. I wanna help clarify that a little bit and explain how they're different. I also wanna leave you with this one simple analogy so you can think about deep learning. For those of you with small children at home, I think this will resonate a lot, which is when we teach them, our children, how to speak a language, especially in a language as complex as English with respect to all the different permutations in the language, you simply talk to them. You give them data. You absolutely don't start with grammar, in other words, rules.
The human brain is very, very good at taking all that data in, synthesizing it, and learning from it. Deep learning, as far as an algorithm approach, is exactly designed to learn the way that our brains do. In that sense, you get tremendous power and capability from the platform. 'Cause anything a human can do, and in fact, even in some cases more than what a human can do, are possible with this new technology. To kind of explain a little bit of the framework of performance here in terms of these algorithms, we can look at a relationship between the available data that's provided to an algorithm process and its performance. Here we're measuring it in terms of sensitivity, which is just a word that means our odds or probability of finding something if it exists in a record.
Say, a 4-beat arrhythmia out of 1.5 million heartbeats. What's our probability of finding that? The relationship from an expert rule perspective is that you get a very rapid improvement with just a little bit of data. This made sense in the early 2000s, when data sets were measured in the hundreds in terms of access. A human can really only balance about 100 different things in terms of trade-offs that they're trying to make to achieve an algorithm performance. You see a very steep curve, but then it fairly generally plateaus, and additional data doesn't really get you very far. With machine learning, we saw the approach to improve on that baseline, and at the time, we were really excited about that. It seemed like it was a new forefront, a new capability, and it was.
It was meaningful in terms of being able to provide yet more data than certainly a human could consume. There were still some rules involved, but again, we saw improved performance with that. It wasn't really until deep learning was introduced that we saw the potential to really approach that expert human level of performance. Our experience with deep learning was to partner very early on in late 2016 with Stanford's AI laboratory and some of the seminal leaders that had come from Google and started the deep learning program, Dr. Andrew Ng in particular, and his lab and his Ph.D. students, was really where we started. The outcome of that was this Nature Medicine paper, which was published in early 2019, and basically reflected the performance of our first generation of deep learning algorithm.
In this paper, it essentially showed that the deep learning approach, deep neural network-based approach, was capable of performance in annotating arrhythmias at a level very comparable to individual cardiologists. In other words, it did achieve that expert-level performance and was clinically validated in this Nature Medicine paper. What was really fascinating about the results was not just that the performance was very similar in terms of detection to cardiologists, but also where the algorithm made mistakes or got confused, as we like to say in terms of thinking about a confusion matrix, what errors it made. It actually made the very similar errors to what the cardiologists did. Not just in terms of detection, but also where it needed improvement, very, very similar on both sides.
It kind of makes sense, because definitely the things that humans struggle with in terms of annotating and providing that data to the algorithm are reflected in the algorithm results. From this start, we can look at this kind of framework of, again, algorithm sensitivity and understand that with this clinical literature and this Nature Medicine paper, we can establish the same baseline and say that cardiologist-level detection was roughly equivalent to our first generation of AI-based algorithm and deep learning-based algorithm. We can take that data set that we used to confirm that performance and indeed get FDA clearance for it and run it backwards on our old algorithms. When we do that, this is what we saw. Expert rule was where we started, and again, we basically saw that performance improvement in terms of machine learning.
It wasn't until we got to deep learning that we saw that real step function in performance. What was really amazing about this is that typically there's a trade-off between sensitivity, that is your odds of finding something, and specificity, your odds of being right in what you find. Typically, prior to deep learning, those things were trade-offs. You could do one, but you had to give a little bit on the other. With deep learning, it really became the capability where you could promote both at the same time, and that was what was so powerful about this.
One thing I want to just be very clear with you on is that it wasn't that our performance of our service in terms of clinical accuracy and building trust with our customers was poor before this algorithm was introduced, but rather that we were putting a tremendous burden on our clinical operations team, the certified cardiographic technicians that curate our data. We were putting the burden on them to correct and ensure the accuracy of the report. With AI and deep learning, we now have a platform that can scale much, much more efficiently, and Doug will talk about this a little bit. We can do that at the level of clinical quality that's expected of us and that we understand is the basis of trust that we have with our customers.
Of course, it wasn't just that we were done with the first version. We, in 2021, introduced a second generation of deep learning and had that FDA cleared early last year and introduced this to see yet more improvements from this baseline of the first generation. We're not done there. We still have in research right now and moving into more product kind of development ideas about how to improve yet further by leveraging new AI-based techniques, more data that we have, and indeed more clinical evidence and understanding that we have internally. We can keep pushing and improving this bar, which is all a basis of building trust. It is not a basis of replacing any cardiologist. I just wanna be absolutely clear on that.
Our goal here is to curate the massive amounts of information that they have coming into them and make sure that they're more effective so that they can focus more on patient care, which is why they're there. They shouldn't be responsible for curating all this information. That's our job. With these algorithms, we can do that better than we ever have, and indeed can keep pushing this bar further and further up in future. I wanna just kind of wrap up and give you four different pieces of a framework to think about AI, because this is a busy space. Lots of people make claims. Few people are actually delivering on the reality. Here are four kind of different measures to think about. First is the approach.
Was this actually developed by the company that's claiming to have AI, or did they just license it from somebody else? This is really fundamental because when you build it from the ground up, you understand how it integrates with your technology and actually plays into the regulatory clearance, which we'll touch on in a second. For our perspective, we started with the best. We started with the seminal leaders of deep learning, learned from them, and then built an entire team around that, and that's the capability that we have today. The second is clinical evidence. Have they proven that this thing works? Have they validated it in clinical peer-reviewed literature? Very important to do to make sure that the technology is validated and actually can perform. But at the same time, research is not commercial experience.
There are two different aspects of getting to that commercial experience that are really important. The first is FDA clearance, and that's a key question to ask. Is this just research, or have you actually got this through the FDA? Because quite rightly, the FDA is building up a lot of capabilities internally to vet these algorithms, and it's a very exhaustive and demanding process to get through that with the FDA. Quite rightly, these are very powerful algorithms, and they wanna make sure that they're effective in the intended use population. That takes not just a great data science capability and performance, but it takes clinical evidence, and it also takes regulatory science expertise internally in terms of how to get through that stage. Then the fourth aspect of this is commercial use.
Even if you get through FDA, then you have to figure out how to actually deploy these algorithms and do it at scale. On that side, I'm very pleased to tell you that we've had more than four million records analyzed using this technology, and it's proven. The results that we saw in clinical literature are reflected in our commercial experience. With that, I wanna kind of touch on how we're leveraging this AI capability internally in terms of expanding our portfolio, and specifically, we'll do this in the context of the Zio Watch. I do wanna though anchor by beginning with the unmet need, which is how we think about things. We're not particularly interested in developing products that other people have just to try and copy what they have. That's not the opportunity as we see it.
It's really to come and develop solutions that address something that is absent in the market. As we think about the atrial fibrillation opportunity, the silent AF opportunity that you've been hearing about this morning, we saw this kind of categorization of unmet need, which is that in the market, there was a lack of a long-term and patient-compliant solution that was also non-invasive and low cost. Certainly, that description, while implantable loop recorders, for example, are certainly very long-term and patient-compliant, they're invasive and are quite costly to the healthcare system. They're wonderful products, but they should be used for only a small segment of the population that really needs them. Certainly, these first four criteria are indicative of consumer-level devices as well. There are two problems with the consumer devices.
While they're very capable in the pre-diagnostic mode that Mintu talked about earlier, fundamentally, they are not operating at a clinical grade of performance, nor are they providing something that's integrated into the healthcare system. If you think about the alerts that you get off an Apple Watch, they go to a consumer, and then the consumer has to figure out what to do with that. They'll make a process, they'll make an approach, and they'll figure out the odyssey of what it means to go from a symptom all the way to a diagnosis, but there's some fallout of that. There's also this aspect of information being just thrown at physicians, and it's indeed an equity aspect as well, that some patients, if they have a relationship with their physician, they know how to text them or email them, they can get that data to the physician.
That is not common across all different parts of this country. What we're interested in doing is creating something that is backed by our service, is prescribed and therefore integrated into the healthcare system, and can provide a truly equitable and very effective clinical-grade diagnosis over a long period of time at a low cost. We do this by leveraging a lot of AI techniques and capabilities. It's not just for the detection of atrial fibrillation, it's also for the characterization of atrial fibrillation. Understanding that it's one thing to say that you have atrial fibrillation. The very next question is how much? Characterizing the disease. That's what really moves it more into a clinical-grade diagnostic solution.
I'm happy to show you the results of a clinical study that we operated, specifically focusing on this burden of care, this aspect of characterization in AF burden estimation. What I'm showing here is a plot of a 117-patient study that we operated in collaboration with Verily and was the basis of our clearance that we received on the Zio Watch. The reference point here is Zio XT. A two-week ECG-based diagnosis backed by AI based algorithms that I've talked about and curated by humans to ensure the accuracy and the precision of that result. It's a very strong reference point. On the y-axis and the dots are the AF burden estimation that came from the automated PPG-based algorithm.
PPG is a wonderful technology in terms of being patient compliant, but is not at the level of signal quality that we'd expect off an ECG. What you can see in this chart is the very close, in fact, clinical grade-like approximation of burden that's achievable off the Zio Watch. This is the basis of a lot of our interest and excitement about what this form factor can do when you apply the right data sets, the right learning, and the right clinical evidence to it. We're just starting on this journey, but we've got a lot to do here, and we're really excited about what the possibilities are for where the biosensor and wearable kind of technology could go in terms of a complement to our portfolio.
I wanna close by talking a little bit about still in this concept of AI, what we're doing to kind of drive the future, which we see firmly as a movement from more retrospective analysis to adding a focus of outcome and prediction, much to complement what Mintu talked about earlier. The framework I wanna start here with is just looking at atrial fibrillation across our record set. On a daily basis, roughly about 15% of the reports that we publish have atrial fibrillation present in the two-week recording. That's roughly a balance of 50/50 between paroxysmal, that is intermittent, and chronic, that is continuous. For the other 85%, we find all kinds of other stuff, like the 13 other arrhythmia categories, for example, but at least from this lens, it's non-atrial fibrillation.
One of the things that is extremely powerful about our data set for this 15% of patients that have atrial fibrillation is that we have not just over five million records, but those records go back in time at meaningful numbers. Which means that we can look at the overlap between our data set and a payer database and go back years and then track the outcome of those patients in a retrospective clinical study kind of framework. In one such example of this that we're involved with right now, we see a greater than 200,000-patient overlap going back five years. Of those 200,000 patients, two things were true in this initial cut of the data that we did. First, 45,000 of those had atrial fibrillation in our report findings.
Second, when we look at the outcome side, we saw more than 1,800 strokes in that population. That is a very, very powerful type of database to work with to leverage AI techniques, to leverage statistical, like more common statistical modeling techniques, with the goal of providing something that can be a validated, clinically researched and evidence-based approach to developing customized models on a patient basis that would help categorize the risk of that patient of developing a stroke based on their two-week findings from our Zio report, or hospitalization, heart failure, or mortality as compared to a baseline. We have a lot of work to do here, not only to develop the algorithms, but to get them cleared through the FDA and commercialized and in fact, the evidence behind them.
I wanna give you this peek of what we're doing to ensure that we keep raising the bar on what the performance is expected and the clinical insight expected from a diagnostic service like ours. For the 85% of patients that did not have atrial fibrillation present on the report, a really tangible question that many others, including ourselves, are focused on trying to answer is can you predict, can you leverage AI to predict the likelihood of that patient having atrial fibrillation in the future? How much at risk are they? If we can develop, and again, clinically validate and get that regulatory clearance of such an algorithm, then we could use it as a basis for supporting, again, with evidence, the use of diagnostics like our Zio Watch to monitor that patient over an extended period of time.
If it's a more acute type of risk, perhaps a Zio monitor type wear time would be more appropriate. This is all in terms of the future of what we're trying to drive. That kind of gets me to this framework where I'll just wrap the presentation, which is one way to look at healthcare, and I think it very much applies to our segment, which is that healthcare today is a fee-for-service generated type platform or an approach is largely both reactive, we're reacting to patients that come and present symptoms, and it's also intermittent. It depends on them coming, and then once they're treated, they're off until they come back with more symptoms. That is not a terribly effective way to manage population health.
In terms of what we're trying to do to drive the future, to move from a more intermittent to a more continuous kind of modality, this is indeed why we were created to do this from a more two-day Holter to a more 14-day kind of diagnostic. We see with wearables the potential to go longer, and with AI, the potential to be able to curate that data from that massive amount of data now that you're developing and creating very accurately and very thoughtfully in terms of ensuring that it's actionable for the physician community. On the x-axis though, really the potential that we see here is to drive what we're doing in terms of our ECG database, the research that I talked about.
You can add in EHR connections that Mintu talked about earlier in terms of data sources to leverage around AI capabilities and evidence generation to really drive the perspective from a strictly only retrospective analysis to including more predictive or proactive type of technologies and approaches and clinical insight that we can provide as a basis of our service. That's really where we see the future. We're very well-positioned, again, from a data perspective, a core competence in AI perspective, and a clinical evidence generation perspective, to deliver on this. With that, I'll conclude, and I'll pass it on to Doug Devine, our Chief Operating Officer.
Thanks, Mark. Okay, it's good afternoon now. We've crossed lunchtime. As I said, I'm Doug Devine, I'm the Chief Operating Officer. Today I'm gonna be talking about the strategies we're taking to scale the business to enhance the experience for our service for our patients and providers, and improving the efficiency and reducing the cost of delivering our service. First, you know, apologies, this is a little bit of a complicated chart if you are, particularly if you're not looking at your own screen. But wanna take you through a bit of the journey of the Zio monitor. We start with supply chain, understanding the demand for our product. There's a couple aspects. There's the clinical staffing and then semiconductors.
Many of the semiconductors we use have 12-month or longer lead times, so we've developed a much more sophisticated supply chain model to ensure that we always have adequate inventory, long lead semiconductors, raw materials, and finished goods. From there, you move down to manufacture. We're doing all of our manufacturing in a new facility in Orange County. We just opened that this year. More on that later. You get down to, you know, two lines here, two different ways we deliver the product to the customer, I mean, to the patient. One is our direct-to-patient flow, one is our in-clinic flow. Let's start with the in-clinic flow. With the in-clinic flow, we stock between two and six weeks of inventory at the clinic site.
The patient comes in, sees the cardiologist or more like, more likely the cardiologist, and they're prescribed the Zio right there. The clinic staff will apply the Zio. They'll send the patient home with the return mailer, so they can send it back to us at the end of the wear time. With the direct-to-patient flow, this one is usually gonna start with a telemedicine, a video appointment with your doctor, which we all know are becoming steadily more common. Once the Zio is prescribed, it's then going to be mailed to the patient along with instructions on how to apply the patch, and then still, the return mailer. A few comparisons and contrasts between the two flows.
You know, first of all, we're currently doing about 80% of our business on the in-clinic flow. When we look at further penetration into primary care and, you know, programs such as Know Your Rhythm, we definitely expect that, you know, over time, the percentage that's going through the direct-to-patient flow is going to increase. When you look at in-clinic, kind of the overhead in processing time is about seven days beyond the wear time. You know, if a patient is wearing it for 14 days, then the physician is gonna get the report back about 21 days after the initial prescription. You have shipping, and you have the time for us to do, you know, process the device and do the clinical report.
With the direct-to-patient flow today, it's currently about two weeks or so, a week longer than the in-clinic flow. Some of that is the outbound shipping, where we're shipping the device directly to the patient's house, but some of that is also definitely that the patient is taking their time to put the device on. It sometimes sits on the kitchen or the bathroom counter for a bit of time. From there, you know, we have the device back. Our device is single use. You know, there's an adhesive, there's a plastic housing, et cetera. All of that is single use, which will either be recycled or disposed of as appropriate. Then you've got the electronics inside. The electronics, we pull them out after we take the data off the device.
We retest it, we reuse it. On average, our electronics is getting reused 12 times. Now, honestly, the electronics can go much further than 12 times. The most likely cause of, I don't know if you'd call it failure, but most likely cause of failure for the electronics is the patient not returning the device. One of the other comments is that, you know, the patient, you know, the patient non-return of the device is higher in that direct-to-patient flow than it is in the in-clinic flow.
You know, we have two intake centers, one in Orange County, one in Chicago, where the data is then uploaded to the cloud so that then our technicians anywhere in the country, anywhere in the world, can download the data to curate the report. As you're familiar, we operate out of three IDTFs. We have one in San Francisco, one in Houston, and then one in Chicago. The clinical operations team, with the assistance of our proprietary artificial intelligence deep learning algorithm, will curate the report for the physician. As you're gonna see over the next couple pages, this represents about half of our cost, the curating the report represents about half of our cost, which is why some of the efficiency improvements that Mark Day was talking about are so important.
To give you the perspective, the clinical operations team at iRhythm is currently over 600 people, the largest group within the company. Finally, we go through a revenue cycle where our team then collects the patient insurance and submits the claims to the payers. Throughout the entire process, we have customer care available 24/7 to both the patients and the providers. Moving on a little bit. The last few years have been a rapid scale-up. You can see from 2018 to 2022, this chart is shipped volume. We've tripled our shipments over this time period. The comment is that this growth has been primarily manual, adding resources to manual processes.
There are significant opportunities for us to scale more efficiently and improve the operations and reduce costs here. This next slide is an interesting one, and I think this is more detail than we've given you in the past on the breakdown of costs. What this slide is it's our cost of goods sold divided by our revenue units for the quarters in question. Looking at the bottom, you've got in the blue, that is the clinical report. You can see that is about half our total cost. These are ordered in terms of size. Next, you have the manufacturer of the device, followed by shipping, both the inbound and the outbound shipping.
Although, again, that's another point that, you know, when you're in the direct-to-patient flow, the shipping is more expensive than in the in-clinic flow. The white, which is a little hard to see, is customer care. Finally, you get to the gray bar at the top, which is the cost of patients not returning the device. A couple comments you'll see here is, I mean, first of all, it hasn't been going in the right direction. This is not the trend we wanna see in the long term, and this is not the trend that we're going to drive in the long term. You can also very much see the impact of many of you will remember that over the summer of 2021, we did get backlogged in clinical operations.
Our lead times extended by a little bit over a week. So, you know, in response to that, you know, we were certainly using a lot of overtime. We did a lot of hiring and, you know, we have a very rigid training process for our clinical operations team. They do not touch a live patient record for at least the first 90 days after we employ them. So what you see is it's kind of that overtime cost and that cost of building a new, more robust staffing model for our clinical operations reflected in that, you know, second half 2021 timeframe. That now is that, you know, large group of new technicians that we hired in is making great progress, moving up their training curve and becoming more productive.
You now see that clinical cost, you know, starting to move on a steady downward trend on a per unit basis. As we look ahead to what we're doing, you know, three pillars that we're focusing on: how do we continue to scale the business and improve the business continuity? How do we improve the patient and provider experience? And how do we lower the cost structure? First, I'm gonna go through some of the recent wins that we've done over the last year before I get into kind of the next three years of plans. First is this year we launched our new manufacturing facility in Orange County. This has enabled us to triple our potential manufacturing capacity. This new facility, without automation, can get up to five million units.
Second, we've introduced the next generation Zio Platform. You know, Mark Day spoke about this one. You know, much better falloff properties, inherently designed for automation. A much stronger supply chain, much better availability of parts, particularly on the semiconductor side, is gonna give us great benefits as we ramp it up. You know, we've started the initial manufacturing of that product, with great feedback from both patients and providers. Clinical capacity. I touched on this already. We've both upgraded many of the tools that our clinical operations team uses. We've upgraded the models we use for planning our clinical operations capacity. We've been hitting our service level agreements now continuously since September of 2021.
In 2022, we've been extremely consistently getting more than 95% of our reports out within three days. That also gives you the feel as you look at that roughly seven-day turnaround time from end of wear period, which is, I mean, first, the patient has to actually get the thing in the mail, and they're not always the most prompt there. Then it's got to go through the shipping back to us, and then the report generation, issuing the report. You see a little less than half of that time is made up by, you know, us actually curating the report. A couple other wins.
We've upgraded our phone technology from to a cloud technology, which has increased our productivity of our customer care team on outbound calls by 50%, and has laid the technology foundation for increasing the sophistication of our communication with our patients. You know, and then finally, we've restructured the operations of the company. As many of you are familiar, I moved into the chief operating officer role in December. We've moved all the operations groups under me. And as part of this, you know, we're operating much more cross-functionally, setting goals, but we're also operating much more data and metric-based. We're now tracking literally hundreds of different metrics on a weekly, sometimes on a daily basis.
You know, I mean, these are ranging from manufacturing quality to customer service call metrics, to clinical efficiency and accuracy, to the initial quality of insurance claims, when we submit them to payers. Now we're gonna move into some of the plans that we're looking at for the next three years. Let me see. We're hyper-focused on increasing automation, driving efficiencies in every part of our operations. The first two here on this chart, I'm gonna go into a little bit more of a deep dive, so I'll just hit on them very briefly. We're gonna take advantage of the Shasta, of the Zio monitor design. Sorry, I momentarily gave you the internal code name for the product.
That's gonna enable us to more than double the capacity of our existing facilities to 10 million units a year, and net of the automation cost is gonna give us more than $1 a unit reduction. Clinical efficiency, we'll go through this more on the next couple of pages, but you know, the punchline of many of the things that Mark Day was talking about is that we expect to realize more than a 25% reduction in our cost of curating the clinical reports. Another one of our big plans, we're expanding our logistics network. We currently have one outbound shipping and two inbound receiving locations.
Particularly with the direct-to-patient flow, that does give us some longer time frames, and that is part of that reason for the, you know, the two-week versus one week. By expanding to three locations, we're basically gonna be able to serve the vast majority of the United States, in two days or less on both inbound and outbound. It'll give us a little over one day of weighted average improvement in logistics time. On the direct-to-patient flow, it's gonna be a couple of days improvement time, which is important as we look at potentially scaling up that process. Revenue cycle automation, we're working hard on introducing robotic process automation to improve our workflows and the patient experience.
Here, we're talking about things like how we improve first-time right claims submissions, denials performance, and providing better and earlier information to our patients on coverage. The other areas that we're talking about, the benefit is gonna show up in the cost of goods sold line. This one is gonna show up in both the revenue line by improving contractual allowances and in the OpEx line by reducing our cost of claims and improving our bad debt metrics. We talked about the next generation Zio monitor. We're also going to be expanding that to MCT, and that's gonna be a significant win. It gives us a much better supply chain, a better ability to ramp the product.
The bigger point would be that currently we use a separate monitor for Zio AT, which is fairly low volume. When we convert this over to a common platform, that's gonna give us a real step function improvement in the cost of the MCT monitor. Finally, we're working on, you know, implementing what we call omni-channel communications to enhance the patient communications. This is going to be increased use of text, chat, email, et cetera. You know, looking at, you know, I mean, applying the robotic process automation to here as well.
When you look at patient non-return of device, when you look at the timeframe for the patient return to device, we think there's considerable opportunities to improve these metrics by making our communications with our patients more sophisticated. Now I'm gonna move on to just a couple of breakouts before I wrap up. Manufacturing. As I mentioned before, we've already got all the equipment on order, and we'll be ramping it up along with the Zio monitor in 2023 to fully automate the assembly and the packaging of the new Zio monitor.
This allows us to take capacity from five million units to 10 million units in the same space, reduces cost by over $1, reduces our labor touch content by 50%. One of the interesting things here is that, you know, when we need to respond to changes in market demand right now, you know, the limiting factor is labor and how much labor we can get in. Once the automation's put in place, it's just gonna be limited by the amount of raw materials we have in stock because, you know, we're gonna default run two eight-hour shifts a day. You know, if there's a spike in demand, it's very easy.
Just run a third eight-hour shift and we have burst capacity which we don't have in a very labor-intensive model today. Of course, you know, by moving this to a very automated process, we're gonna see quality and yield improvements. Moving on to the clinical reports. You know, three different aspects of how we're gonna improve the cost here. First is, as Mark touched on, enhancing the quality of the reports, reducing the variability, improving the algorithm results, expanding the insights to ultimately deliver more value to our patients and providers. The second, improving efficiency.
This is really improving our tools and, you know, as Mark Day highlighted to me, the tools that we currently have that we're primarily using were developed back when we were in the expert rule phase. They haven't taken full advantage of where we are with the deep learning. You can look at this as just going through and saying, in order for our technicians to curate a report, how many mouse clicks do they have to do? How many screens do they have to look at? How many times do they have to input data or check something? You know, as we've moved from expert rules to deep learning, there's considerable opportunities to streamline there as well. We've also got the air traffic control aspect, you know.
Our artificial intelligence classifies the reports into five different levels of complexity of the report. We in turn have our technicians classified into almost that many levels as well, depending on their expertise, how long they've been with us, et cetera. By air traffic control, this is routing the right report to the right level of complexity of report to the right level of expertise of the clinical technician, which is another opportunity for efficiency. Finally, we're gonna build out our clinical operations team globally to match our planned global business footprint. Wrapping up and giving you the punchline. You can see our forecasted cost structure broken down in the same categories in 2027.
We're expecting a 25%-30% reduction in the cost of providing the Zio XT service over this time period. You can see that the largest reduction is in that generational clinical report. There's meaningful reductions across the board in all the categories. With that, thank you, and I will turn you over to Bryce, our Chief Financial Officer.
All right. Thank you so much, Doug. Appreciate it. All right. You can hear me okay? Perfect. Wonderful. All right. For those of you I've not met yet, I'm Bryce Bobzien, the new Chief Financial Officer here at iRhythm Technologies, and I couldn't be more excited to be here. First off, I'd like to thank the leaders before me for walking you through the incredible initiatives going on here at iRhythm and the tremendous momentum we're experiencing and expect to experience into the future. I'm excited to walk you through our long-range plan with a five-year financial target and goals to deliver strong financial performance.
As disclosed previously, our guidance for 2022, which we continue to believe is achievable, is $415 million-$420 million on the top line, which represents a tremendous 29.5% growth year-over-year. Gross margin at 68%-69%, with the midpoint at 68.5, which is about 250 basis points improvement versus 2021. Adjusted EBITDA at -$12.5 million to -$17.5 million or 3.5% of revenue, which is a tremendous, again, 760 basis points improvement versus 2021. First time in a while, we've disclosed our blended ASPs. 2021, it was about $258 per unit. In 2022, it's $279 per unit.
I'll get into more detail on the ASPs in the future slides, but you can see that was a nice improvement from 2021 to 2022. That's really a result is the stability in the CMS price, as well as stable pricing on the commercial front as well. With 2022 as the baseline, we see tremendous growth ahead, coupled with improving financial profile that'll create significant value for you, the shareholders, as well as our patients, our customers, as well as the global healthcare system, around the world. 2027, as Quentin alluded to previously, about a 20% CAGR over the planning horizon, getting us to that $1 billion+. Again, it's important to note that's the core symptomatic business in the U.S., as well as international expansion that we've talked about previously.
At that billion-dollar range, we expect a gross margin of 73%, which is approximately 450 basis points improvement versus 2022, and adjusted EBITDA at 1850 basis points. Adjusted EBITDA at 15%, which is 1850 basis point improvement. Stability in the ASP side. There's some puts and takes here, and we'll get into the details of those over the planning horizon. You see us going from roughly $279 per unit to $286. Again, roughly noise in the system, but there's opportunities that offset that low single-digit pricing pressure that we expect in the commercial business. How are we gonna create financial flexibility to capitalize on our opportunity? First of all, revenue growth.
With continued penetration in the core US market with Zio XT, Zio AT, moving to Zio monitor, as we've talked about, international expansion in the new markets or within new markets, disciplined evaluation with partnerships and business development opportunities that could ultimately accelerate our growth as we leverage those different opportunities, and then upside through new technologies and adjacent markets. Just as importantly as looking at that revenue growth, is us being good financial stewards of the business. That includes product efficiencies that Doug walked us through with things like manufacturing automation, design for manufacturability, which Zio monitor did, full scale utilization of our existing equipment and facilities, RPA, and the globalized workforce. We also recognize there's real opportunity on the OpEx side as well.
Optimized efficiencies within our back office, most notably within the G&A function as we scale and develop processes, then ultimately automate some of those back-office functions, including revenue cycle management. That'll allow us to redirect some of that investment from G&A into R&D and sales and marketing, but it'll also obviously improve our profitability profile over the planning horizon. Same thing holds true here. RPA, use of bots, globalized workforce are all opportunities that not only are able to impact COGS, but also impact OpEx as well. Let's talk a little bit more about our revenue trajectory over the planning horizon. First, I'm gonna direct your attention to the right-hand side, where you see we're at $418 as it stands now, call it $417.5 at the midpoint.
We expect about $500 million of incremental revenue dollars over the planning horizon within the US core business. Another $70 million or so internationally. That works out to that 7.5%-8% of our total business that we talked about previously on the international side. Price and mix, there's really some off-offsetting components here that allow us the trajectory into that $1 billion over the planning horizon. Looking at the volume side, expect to do about 1.5 million units in 2022. Growth over the planning horizon in the US core space of about 1.75 billion and another 250,000 incremental units in the international side, taking this to about 3.5 million units over the planning horizon.
A little bit more detail on the ASP side, and again, I'll go into an even further level of detail in the next slide. $279 per unit. We do expect some pricing pressure. That's low single digits on the U.S. commercial side, but we have channel mix and product mix, potential tailwinds that more than offset that over the planning horizon. That includes AT becoming a bigger percentage of our business. That also includes us putting contracts in place in certain segments of the business, most notably our Medicaid population. Opportunities for net ASP improvement. There's two things I wanna walk you through here. First off is the volume distribution of our business, as well as what the ASPs are in those respective channels. First off, volume distribution.
Again, please note this is greater than 48 hours for Zio XT in the U.S.. Currently CMS is about 21% of our business. This is based off our 2022 guide, by the way. CMS is 21% of our business. Commercial is at 55% of our business, and non-contracted is at 13% of our business. That ladders up to about 90% of the total. There's another 10% that are other small channels, which includes less than 48 hours, Zio AT, and the U.K.. This is by far the bulk of the business that's running through currently. The ASPs within these given channels, CMS is sitting at about $250 per unit, as we've talked about previously. Quentin alluded to that, earlier. Commercial sits at about $310 per unit.
That's on a blended basis, which is about a 24% premium versus what we see in our CMS business. We believe that's actually really reasonable for where it's at now and probably a little bit lower than what most folks realized. We feel good about that current premium from a private payer versus a public payer perspective. Obviously, we do anticipate a little bit of pressure on the US commercial side over time, but at 24% premium, we feel pretty good here. Non-contracted sits at about $115 per unit. Another opportunity for us, and we'll walk through what that means here in a second. We have the opportunity to expand coverage, obviously, to Medicaid. That currently sits in that non-contracted bucket.
As we get contracts in place with those local and state Medicaid plans, that ultimately will potentially provide a tailwind to us. Conversion of other non-contracted commercial payers. Also, thinking about things like billing for home enrollment. There's a code out there that we can bill for home enrollment. as we build that infrastructure and put that in place, that's an opportunity and a tailwind for us on the ASP side. Revenue cycle management, Doug alluded to previously. As we do things a little bit earlier on the process, it reduces billing friction, but also allows us to reduce that contractual all-allowance over time as we have that data available to us that ultimately will improve and provide a tailwind for ASPs. then the last thing I wanted to note is wear times at less than 48 hours.
This is not a huge percentage of our business, but the reimbursement landscape for less than 48 hours is sometimes 20% or less than those ASPs that I outlined for you. Using commercial as the example, commercial sitting at a blended $310 per unit, less than 48 hours is less than $60 from a reimbursement standpoint per unit. There's a huge opportunity as we navigate through that. We have two different ways to impact that. There's the prescriber base as we continue to educate our prescribers on the huge benefits of XT and the seven- to 14-day wear period, but also the falloffs. Mark alluded to previously, the new patch, the new technology will start to mitigate falloffs. Again, huge opportunity for us to really get after a blended ASP over the planning horizon.
Not only is it just as important as thinking about what is going on with the revenue side, ASP, reimbursement landscape, [but] us being good financial stewards of the business, right? This includes unlocking value and enabling scalability. We've got a lot of things on the horizon, better leverage of analytics, process improvements, digital transformation, automation, globalization, bending that unit cost economic curve. All of these things have the opportunity to appreciate about $250 million of gross annual savings by 2027. Now, that's about 25 percentage points of the overall spend profile as it stands. I'll walk you through a little bit more of what this means.
One thing that's important to note is this includes not only things that are ultimately gonna impact adjusted EBITDA, but this is how it's gonna ultimately lever operating expenses and operating margin over time. That includes non-cash items like stock-based compensation as well as depreciation and amortization that are pulled out of your adjusted EBITDA calculation. Let's talk a little bit more about the gross profit profile. 2021, 66.2%. 2022, 68.5 at midpoint, about 230 basis points of improvement year-over-year. We've started to bend that curve. You saw the first 2 quarters where that unit cost reduction started to play through the numbers. You see it hitting the gross margin line.
We have opportunities both within the device side as well as the service side to improve gross margin about 850 basis points over the planning horizon. I'll talk a little bit more about what that means. Driving manufacturing automation, design for manufacturability, scale and facility leverage, supply chain excellence, all of these things have the opportunity to impact the cost of that device. We also have an opportunity, as Doug alluded to previously, to start to really impact the cost of issuing the report. That includes AI, that includes globalization of the commercial operations organization, freight and shipping expenses. There are a few things that are gonna provide headwinds to the gross margin. That includes US commercial pricing, that low single digits that I talked about.
Also, one interesting dynamic that we need to make sure we're aware of is, though Zio AT becoming a bigger portion of our business helps the blended ASP over time, it does come at a lower gross margin profile, which ultimately puts a bit of pressure on gross margin over the planning horizon. Doug mentioned it previously. As we move into this MCT space, we leverage the technology. There's a chance for us to continue to get after that as well. As it planned now, it's about 400 basis points between those two items as a headwind associated with gross margin. What's that mean for adjusted EBITDA? Where we came from, 11.1% in 2021. Where we're at now at midpoint, about -3.5%. 760 basis point improvement over the last year. Tremendous progress being made.
We're starting to really think about being good operators and good stewards of the business. That's just the tip of the iceberg of where we can ultimately go. I talked about the 450 basis points of leverage expected from gross margin. We're gonna get after OpEx as well. R&D. R&D is a little unique. It's an interesting one. We anticipate R&D will stay at approximately 12% over the planning horizon. That doesn't mean we're not trying to impact the spend profile within that organization. What we're doing is we're instituting disciplined portfolio prioritization. As Mintu and Mark mentioned, we're setting up a cross-functional innovation committee that's focused on evaluating these individual projects and making sure they're ultimately going to drive that revenue growth that we're expecting. Those things that do not are gonna be pruned.
Those things that do, including those adjacent market research opportunities, are gonna be the ones that we invest in. All told, we'll stay at about where we're at from a spend perspective, but we're definitely impacting this R&D organization. Sales and marketing. Again, massive investments going into sales and marketing. You show about 100 basis points of leverage over the planning horizon, but there's big investments that are being made. Where there's opportunities on the sales force side, we're gonna make those investments. Build out of the global brand. Chad mentioned it earlier. That's a main focus for us. We're building out that brand awareness over time. Thinking about opportunities on the direct consumer marketing side, we're doing that as well. International expansion opportunities, investments that are being made.
What we're able to do here is scale the infrastructure that's currently in place, think a little bit differently about the sales force efficiencies, territory mapping, getting a little bit more thoughtful about how our call point looks. Those are things that will provide efficiencies for us over time that will allow us to make those massive investments that we know need to be made on the sales and marketing side. Finally, G&A. G&A at 50% of our overall cost structure now is not where we wanna be, and it's not where we're gonna be over time. We're gonna get to about 30% over the planning horizon. It represents about 1,300 basis points of improvement from an adjusted EBITDA perspective.
It's even more than that when you think about what it means for the OpEx profile and what it means for operating margin. It's closer to 2,100 basis points. There's about 700-800 basis points of scale that's gonna happen through those non-cash items that are pulled out from an adjusted EBITDA perspective. I talked about that stock comp, depreciation, and amortization being the primary items there. It's gonna be done through digital transformation, continuous process improvement, globalization, thinking different, scaling our current organization. We've built the infrastructure on the G&A side. Now we can scale over time and ultimately leverage that infrastructure that's been put into place. Whoops. All right. What's that mean in aggregate?
We have an aggressive but high confidence five-year plan, getting to $1 billion and 20% CAGR over the planning horizon, just driven by our core U.S. business and our international expansion. There are opportunities with the adjacent markets and potential upside to this business, and we will absolutely invest in those and drive at those hard.
Significant leverage from gross margin, significant cost savings, most notably on the G&A side, getting us to the 15% adjusted EBITDA over the planning horizon and with $200+ million in anticipated move to profitability over the medium term. You see why we're incredibly excited about what we're ultimately driving here on the financial side at iRhythm. With that, I'll turn it back over to Quentin, and we'll open it up to Q&A. Thank you so much.
Of course.
Thanks, everyone. We'll take questions here before we wrap for the day. I'll invite Quentin and Mintu back up with us.
[Armughan], J.P. Morgan. I just had one quick question on the silent AF opportunity first. We've clearly seen quite a lot of data at this point, from mSToPS being, I think, probably the biggest and most important, but we do still have that cost-benefit data coming out in November. We still have GUARD-AF, as you said, hopefully getting a more thorough read-through in 2023. I guess, what are you looking for from those datasets that, you know, we haven't already gotten from the multiple years of data that we've seen so far? And what do you really need to see to, you know, further penetrate the kind of asymptomatic opportunity?
I'll start, but I'd like Mintu to weigh in on a bit as well. I think, you know, what you're seeing already in the mSToPS data is the value of monitoring, right? We can find the dangerous arrhythmias or the AFib that sits out there. We demonstrate the need for monitoring and managing that population. What I'm looking forward to seeing is how we start to put an economic benefit to finding and earlier diagnosing those sort of conditions. Mintu, you can add more to it, but I think adding the economic value is gonna be really important to us.
Yeah. I agree. The reason we're excited about this is we're doing this in tandem with the ongoing data. You've seen what we showed you about the European guidelines and the US guidelines. I'm pretty confident the US guidelines will move over time as evidence comes. The reason this program is so well-positioned is we're taking on risk directly. We will definitely learn from the pilots and make sure that those results calibrate with mSToPS as it is expected to based on a risk pool that we're using in Know Your Rhythm, and Sara can discuss that more. The health economic benefits are really gonna help drive what is mediating the potential benefits or potential increase in expenditures. Again, I don't wanna leave you in suspense here.
That is what is happening, what is happening to the AFib, what is happening to all the incidental stuff you find. Can you? What is the type or the mix of healthcare utilization that you see following? Because this was a controlled trial, it's the best place to get that kind of information. We will learn from that. We will see the GUARD-AF results looking at clinical outcomes. We already know with STROKESTOP in Europe, you had a signal that showed a benefit for stroke reduction, and you have indirect evidence not tied to early identification that early intervention of AFib works. As these pieces all come together, we will start seeing the professional societies and USPSTF move, in my opinion. The point of Know Your Rhythm now is we're willing to take that risk on with our payers and partners now.
Then just a quick question on the profitability side of things. So when we think about your 15% target, you've talked about how you're including roughly $250 million of spend into, you know, your adjacent markets while excluding the revenues. But how should we think about, you know, as you get, you know, as you validate those opportunities, how should we think about the need to, you know, invest further into really building out those opportunities? How much of that is really contemplated in the model? And should we think about, you know, potential reinvestment of any revenue upside back into the business to, you know, even if you do generate revenues from these adjacencies, you know, maybe not let all of that drop through as upside to the 15% target you have today?
Yeah. Just to be clear, you mentioned $250 million. It's call it 2.5 percentage points revenue, so it's more like $25 million, right? Per year. I just wanna make sure we're thinking about it in the right context. I believe that's the right level of spend for us to be putting into what I look at as sort of these advanced research exploration sort of opportunities to really open up new and adjacent spaces. Once we validate a business model, and we get into true commercialization phase and those sort of things, there could be a bit more investment. That's gonna be very clear to you guys in terms of here's the revenue opportunity. We validated it.
Here's how we're gonna play in the market, and here's how we begin to scale the commercial operations, right? I think it'd be very clear to you when we get to that point in terms of what the commercial model looks like and how we generate value out of those areas. As we add to it, you know, it feels like the 2.5% level of spend and those sort of opportunities feels about right to me. As we generate incremental revenue beyond that, I think a good amount of that begins to flow through, right? It becomes incremental to the bottom line and drives some nice profitability improvements. There could be early stages as, again, you're getting these businesses off the ground where the contribution margin's a little bit, you know, wider.
As you get to scale, it really opens up and contributes nicely. I think the biggest thing is if we can open these up, they could be real needle movers for us on that top line and ultimately be complementary to the profitability profile over time.
Cecilia Furlong, Morgan Stanley. I wanted to ask about just your ASP outlook. If you could walk through both how you're contemplating mix within Medicare across IDTFs, what's included from an international standpoint, AT volume, and then how you're also thinking about the Zio Watch, if that is inclusive or if that is a separate business model outside of the ASPs you provided.
Hey, Cecilia. I'll start there. Quentin, clarify anything that I need to. We're thinking on the CMS side, it stays at that roughly $250 dollar range over the planning horizon. Obviously, we'll try to optimize where those ultimate reports are read, but we expect it's gonna be about $250 over the planning horizon.
As far as you're gonna have to help me here, Cecilia. I know you mentioned international. Internationally, you can do the back of the envelope math and see what that means. We have about $68 million of incremental revenue dollars and 250,000 units. You work into that $270 dollar range. Now, I will tell you, it's gonna be different whether it's public or private over the planning horizon, and it's also gonna be different depending on which market we enter first. That's where we have it planned now, but we'll certainly continue to work those as we enter those markets, whether it first comes from private, which is that early onset, and then moves into public, what does that mean for the blended ASPs? That's how we have it thought about and plugged in as it stands now. Remind me again, what was the other question?
AT and then also just the Zio Watch as well.
Yeah. AT CMS rate is out there. It's about $1,150. That's a good proxy. It's a relatively small amount, so we don't wanna give a ton of color on that, and there's some competitive reasons we're thinking that way. Use the CMS rate as a reasonable proxy, as you know, where that AT business was. Then last one.
Zio Watch.
Zio Watch. There is a small contribution of Zio Watch baked into the overall plan. As Mintu alluded to, we don't really plan to see revenue contribution till 2025. It's a relatively small contributor over the planning horizon, but there's a small amount of revenue in the plan from that perspective.
Okay, great. If I could follow up, too, just patient compliance that you talked about in terms of optimizing, patient either, adhesion, sending it back, all of those different dynamics. Can you just talk through your approach to optimizing that? Then as you think about just your projections for home enrollment as a percentage of your overall business, the ability to optimize that and then how that flows through your business model. Thank you.
Sure. Doug, you wanna take that one?
Okay. There was a few components to that. You know, in terms of patient return of the device, you know, that's really increasing our tracking capability. I mean, studying at what point, having communications with them. I mean, we do, you know. One of the things we do is we try to identify higher-risk patient populations for compliance. I'll tell you straight off that under age 40 you know massively increases the risk.
You know, I mean, first hitting them with incoming communication before or when they're putting the device on, and then we get the most bang for the buck if we hit them like two days before their wear time should be ending, and then we hit them again two days after their wear time is ending. You know, we're doing a lot of studying on what which patients respond better to chat, to text, to email, to phone call, which would be an older population, and at what point are the efficient. I mean, you know, studying what are the efficient points to communicate with them to maximize the return of the device and maximize, you know, patient compliance with the wear period, et cetera. Remind me, what it-
Just your outlook for volumes, direct-to-patient volumes, and then just the ability to further optimize, patient compliance and how it flows into your outlook for the.
Yeah, I think, well, I mean, I think what you look at is, you know, our device has a 90-day, I mean, has a six-month field life right now. When you're talking about a high-volume clinic, you would, you know, it's easy to stock volume and have that work for. When you're talking about primary care, where the prescriptions are much lower, that's a case where you really have to move to the direct-to-patient flow, you know, because you can't afford to stock all those devices at 100,000 primary care physician sites. I think, you know, how quickly we penetrate into primary care is gonna be one of the factors that's gonna drive direct-to-patient. The other one is, it's well beyond us.
It's how well telemedicine becomes accepted post-pandemic. You know, the stronger that, you know, the more primary care and cardiologists that are doing the telemedicine prescriptions, the more that's gonna drive direct-to-patient. I would more say we're not trying to drive it to a specific number. We just want an efficient delivery of the service. In anticipation that it is gonna go higher, you know, we're taking very concrete steps to make that a much better flow from, you know, both the logistics to how we communicate. As Bryce emphasized, we're not currently doing the home enrollment hookup, which should more than cover any incremental costs that we have on the direct-to-patient flow and that's something that we're gonna get on, you know, over the next year or two as well.
I think that creates a nice incremental benefit for us from an ASP perspective, right? We're not charging that hookup fee today in the home enrollment opportunity that sits there. The other thing we didn't talk a lot about but gets me super excited when I think about the future along the lines of Know Your Rhythm is, does it end up being an opportunity to go direct to the patient and provide a telehealth opportunity to prescribe the product where you don't have to be in a physician's office, right? Now, the one challenge that you have with that is you wanna make sure you have patient access from a payer perspective to the product. You don't wanna create a bunch of awareness around it, and then they can't get onto the product, and they're frustrated and disappointed.
If you solve the access challenges, which we're pretty far down that path, you begin to go directly to patients in particular pockets. Provide a telehealth solution. It's gonna be interesting to see how you can open up that direct-to-patient opportunity, right? That could move the needle on home enrollment, for example. I think there's a lot of interesting opportunities out there in the business model that we continue to evolve, but I know Suraj is-
Suraj Kalia, Oppenheimer. Lots of detail provided in this presentation. Do appreciate it. One question for Dr. Turakhia and one for Mark. Dr. Turakhia, for silent AF, would love to get some additional parameters how should we think about the economics of monitoring silent AF? And also Quentin. You know, just given where we are with the datasets. Mark, loved the presentation. If I could go one layer deep, whether you wanna look at false positive, false negatives or the specificity, where are we today with the algorithms and where does DL take us, you know, X period of time down the line? Thank you.
You wanna start?
Yeah, I'll jump in. From an economic perspective, the way we're thinking about that Know Your Rhythm program is the intent is to monitor as many patients who are at risk as possible. The challenge with it from a payer perspective is they don't wanna pay to put the device on an entire population when AFib or dangerous arrhythmias may not exist in that entire population. For us, the question is how do we narrow down a patient population to truly be those that are at most risk? Then we'll take the financial burden of putting the device onto that patient population. When we find it and when we diagnose that AFib or dangerous arrhythmias exist, there's a fee that would be charged in that sort of finding, and that's different than just the single patch fee that you would normally put on a patient.
It would be a higher fee. We're taking on the risk. We ought to be able to attract a higher fee. It still needs to be attractive to the at-risk group, but when you look at the downstream cost that you can avoid and better manage in that pop, you know, that patient population, there's a whole lot of room there to have it make financial sense to pay a higher fee. To Sara's point, we haven't had a single partner sitting on the other side of the table yet tell us no. We continue to work through it. I think it's a model where we take on some risk. We stand behind the technology and what we say we claim we can do.
We know we can do it very, very well, and there's a model there that can make sense for all of us. At the end of the day, the patient wins in this, right? We're getting access to more and more patients who maybe couldn't have afforded it or didn't have a path to get to it, but needed to be monitored. That's why I love the program. It sits squarely down the path of our vision, better health for all. Like, we wanna address as much of the population that needs this technology as we possibly can, and I think Know Your Rhythm is a brilliant way to get at it. So that's my thoughts. Mintu, you can add to that.
Yeah. I mean, I'm gonna say the same thing in a different way, Suraj. Look, we're not at the point where when you get your Welcome to Medicare kit with a colonoscopy, it's not gonna come with a Zio Patch right now, right? Even if you had those trials, there will be a lag in implementation. We're doing it now. The reason we're confident in this is we're sharing risk. We have the KPIs. We'll see the return. It actually also goes to time horizon. You can do the academic exercise of a societal cost-effectiveness analysis. Obviously, that is not what a short-cycle payer would use. Medicare would use that for a lifetime. A VA would use that. A Kaiser might use that. We have those models.
If you look at the one to three-year horizon, okay, or three to five, depending on what kind of MA provider you are, you wanna see the benefit there. What I was signaling is we're seeing in the trial data the benefits coming at the 12-month mark or earlier and certainly by year 2 or year three. This is not only stroke. This is actually the other stuff that's very expensive, which is hospital admissions for heart failure, additional testing and other things. Inevitably, patients with AFib progress to heart failure and have a decline, and then their expenditures go way up between diagnostics, prescriptions, and therapeutic strategies.
Again, the point of this exercise is to demonstrate that the trial data we see with AF intervention will be recapitulated with a real-world Medicare Advantage population, and that's how we're thinking about this exercise in the one to three-year horizon with these patients.
Suraj, to your question about how we approach algorithm performance and thinking. I made the comment in the presentation about how with deep learning it's possible to both push simultaneously sensitivity and specificity or false positive rate at the same time, which is really powerful. But all that being said, our focus is on sensitivity. We wanna make sure that we can provide the findings to our clinical team to then curate the results of the algorithm into a really comprehensive and trusted report. That's the focus. We do bias it towards sensitivity, and it comes at the cost of a few more false positives in the recording, which is not a big deal, and that's actually not what drives the majority of our clinical operations time.
That's a fairly straightforward exercise for somebody, a human to do to realize that somebody who's wearing their patch on their left chest and brushes their teeth manually, that actually looks a lot like a ventricular tachycardia. The algorithm will still call it that because it wants to be sure that a human can look at that and make sure that it's correct. We don't think that's a major problem, and it's certainly not limiting us. It is just to answer your question, more of a bias on sensitivity and pushing that as high as we can, and then the positive predictive value is still strong, but a little bit lower.
Thank you so much for squeezing me in. Marie Thibault from BTIG. Bryce, I'm just gonna try to restate my question from before. Thanks for all the context on gross margin. Just wanna understand the journey from 70% to 73%. It certainly sounds like there might be some plateauing. If you could talk to us about the cadence of the gross margins. On the Zio AT growth, certainly seems to me that having it on a two-on-one platform could drive some acceleration. Any thoughts on that as well? Thanks again.
Sure. Good question, Marie. I think it was important to note in Doug's presentation. He laid out a one to three-year journey. There is going to be some improvements in that one to three-year range. Maybe it's a little bit earlier on. I think, you know, we'll give more color around 2023 specifically as we issue guidance, you know, coming into February. It may be a little bit earlier on in the time horizon that we start to see that, whereas we start to see some of the pressure over the full five-year horizon. Then on the AT side, absolutely it's something we're thinking about. That moving onto the same platform over time allows us tremendous opportunity from a procurement standpoint, but also just from a servicing standpoint. You know, folks are used to using that same platform.
That isn't necessarily contemplated in the long-range plan, and that would be potential upside over the long term as we start to have AT become a bigger portion of our business and we move on to that new platform.
Great. Thanks. Bill Plovanic at Canaccord Genuity. I know I'm keeping everybody from lunch here. My first question. Sara, I just wanted to say congratulations. From concept to customer in 10 months is. That's impressive for you and the team. That's really impressive. How do we think about? I mean, in your commentary regarding that, nobody said no yet.
Mm-hmm.
How do we think about what the upside is for this as we, you know, if these people do start saying yes, how does that kind of flow into what you're thinking? How much of that was baked into guidance? My second question to make this really quick, 'cause Bryce may be on the hook for two here, is you're taking G&A from $50 to $30. You're still 2 x the average company, probably your size roughly. Why can't that go lower faster and kind of what's the hold up there? Thanks.
Yeah, great question. Just to reiterate, the Silent AF opportunity and Know Your Rhythm is not baked into our base case, and the reason is this is a brand-new product. It's a brand-new solution. We're revolutionizing the way that our health plans and our customers look at cardiac arrhythmias and trying to move that up into the care continuum. We don't wanna get out ahead of ourselves, right? We've got some things to prove. We've got to get the user experience tested, and we've got to make sure that we're delivering on the end stops results that we saw. We also know with health plans, as most of you know, they take a long time to do things. Unfortunately, when you're in front of a health plan, you're looking at a 1-year sales cycle at minimum. We're in front of health plans today.
We're already introducing the Know Your Rhythm program. We're already in term sheet with other smaller customers. To move those big health plans that control the majority of the Medicare Advantage population, it's gonna take some time to get them moving in that direction, which is why we haven't included in our base case analysis. Hopefully, that answers your question.
Real quickly on that point too, and you heard Doug talk about this. You saw it also in Bryce's presentation, getting to roughly 3.5 million, you know, units on an annual basis, but building the capacity to get to 10 million or more, right? Part of this is preparing the organization to open up those sort of opportunities and be able to meet the need or the demand that's generated from it, and then grade its upside to the top line if we can make that come through, right? But we're investing to make sure that the opportunity can be realized if it's there. Your question on 15%, that's a good one. Why can't we get there faster, you know, on G&A?
I think that the biggest issue is you got to realize over the matter of the next five years, we're setting up global capabilities, right? As you're investing to open up new markets, new channels, there's a cost involved with that as well, and that's not always the most efficient as you're first stepping into those opportunities or first stepping into a new country, for example. That'll leverage over time, which means that, yeah, into the future, I'm confident we can take it a whole lot further than what we've dialed into here. If we can go faster, we'll look to go faster, right? I wanna make sure that we're putting something out there that we can deliver on and you feel good about it, we feel good about it, and if we can beat it, we'll beat it. That's the plan. All right.
Well, we're gonna wrap up. Look, I just wanna take a quick opportunity. Thank you guys again for making it a priority in your day to be here with us. I hope you took a lot away from the presentation. From our point of view, there are endless opportunities that sit in front of this company and the platform that's been created by Mark, the team that have invested into this over the years, and we couldn't be more excited about it. The goal was to put a core base plan out there that you could all feel very confident we can deliver to, and we can execute against, and find ways to add and supplement that over the next five years, which I'm confident we can do. Again, thanks for being here. Thanks for making the time, and we'll adjourn. Thanks so much.