I think we can go ahead and get started. Hi, everyone. My name is Rohan Patel. I work on the medical devices research team here at JP Morgan. It's my pleasure to have iRhythm Technologies here with us today. And without further ado, I'll introduce CEO Quentin Blackford.
Thank you, Rohan. It's great to be here with you guys. Thanks for making the time to be with us this afternoon. We look forward to sharing the iRhythm story with each of you guys and what has us excited about the future here at the company. Just quickly, I'll remind you, we'll be using forward-looking statements during the course of this presentation. I'd refer you to our quarterly filings or annual report for any further information you might be looking for relative to our forward-looking statements. iRhythm is a digital healthcare company that is focused on transforming the way that cardiac arrhythmias are diagnosed. If you think about the current standard of care in this space, it's utilizing a short-term duration monitor, generally 24 to 48 hours on average. Yet we know that most arrhythmias are episodic.
They're not continuous, which means you need to be monitoring for a longer duration to find these arrhythmias. Data would tell us, on average, five to eight days is about that period of time to find most arrhythmias. Our goal is to monitor beyond that. We use a platform that we've put together that leverages a wearable biosensor that goes out to 14 days, continuous single use. It gives us almost two million heartbeats from that patient. We then leverage deep-learned neural networks from an AI perspective to take and review those scripts and identify what arrhythmias are present. We know that we're best in class. We've got nearly 40 peer-reviewed independent articles that stand behind and publications that stand behind the value of our AI, demonstrating our differentiation.
We know that physicians will agree with us 99% of the time in terms of the recommendations that we identify in these reports. And importantly, the patients that wear our device, 98% will wear it out to the full 14 days. So we've got a platform here that allows us to capture a lot of incremental data relative to our competition, a differentiated AI capability that gives us best-in-class ability to identify these arrhythmias. And then we bring it all together in a digital platform. We know that working with us needs to be as easy as possible, as smooth as possible. You're going to hear me talk about moving up the care pathway into primary care. It's absolutely critical that we are very easy to work with, that easy to do business with. And we'll talk about what this digital platform looks like into the future.
With that platform in place, we have big aspirations here at the company. Our goal is to ultimately move beyond cardiac arrhythmia. We think there are adjacent markets like sleep disease, hypertension that becomes very attainable with the platform that we've created. With our biosensor, we're able to capture better data. With our AI capability, we're able to leverage better insights and ultimately treat far more patients than just the cardiac patients that we serve. And again, I'll talk about how we think about expanding the company into the future. A bit of a snapshot with respect to who iRhythm is today. So coming into the quarter, we guided revenue of $582.5 million to $587.5 million. We put out a release this morning. We expect revenue to exceed the high end of that $587.5 million figure.
We did not comment on profitability, although we did put out profitability guidance at the beginning of the quarter. We continue to feel good about that guidance range. There's been nothing that indicates for us to think anything differently. Obviously, we'll provide a final update in the February earnings call that we have. At this point, we've published over two million reports on an annual basis. So the momentum in the business is picking up significantly. We've published nearly 10 million reports total. So nearly 20% of our history has come in the last 12 months, to speaking to the momentum that continues to grow in the company. But at the same time, we're only 30% penetrated in the market as we know it today in terms of the opportunity that sits in front of us.
We ultimately do believe patch-based technology will become the standard of care in ambulatory cardiac monitoring. We're in the very early stages. Yet we see the market even differently as we move into the future. While there's 6.5 million tests in the U.S. being performed today, there's nearly 27 million patients showing up in primary care with cardiac palpitations or completely unaware that they likely have an arrhythmia present. And I'll talk about how we get into the 27 million and what we're doing to open that up. But we think the market is much bigger than the way the current ACM market is defined today. And then we're just now stepping into the international space as well. We just launched into four new countries in the back part of 2024 in the E.U. region. And we have regulatory approval for the Japanese market. We're working on getting reimbursement established.
We'll be stepping into that Japanese market here in the mid-part of 2025, and then we've got a tremendous amount of data that stands behind our product. So while I can sit here and tell you about the benefits of iRhythm and Zio in particular, we've got nearly 100 scientific research papers that speak to the differentiation of our capabilities, and again, more than 40 independent peer-reviewed publications that stand out there. Look, the cardiac arrhythmia burden is immense in the U.S. We know there are 11 million folks diagnosed with arrhythmias. We know that as you surpass the age of 55, your likelihood of AFib increases by nearly 40%. And if you're diagnosed with AFib, we know that your risk of stroke is going to grow immensely, nearly five times higher. And if you have risk of stroke, obviously the outcomes of that can be absolutely catastrophic.
We can bend that curve. That's what we're after. When we think about the market today, there are 6.5 million ACM ambulatory cardiac monitoring tests being performed each and every year in the United States alone. About half of those are coming through patch-based technologies, of which we have 70% of that market today. I would argue over the course of 2024, our data would tell us we probably took a share point or two in that 70%. I think we're back to even gaining share in a dominant share position. At the same time, within the 6.5 million tests being performed, there's about a million MCT tests, mobile cardiac telemetry tests. This is duration out to 30 days. This is a second product in our portfolio that we launched a few years ago.
We have a very small part of the market, only 10% of that market. I'll talk about how we think we can gain market share in that particular space. But every 10 points of share in the MCT space is roughly $80-$100 million of incremental annual revenue to us that we believe we can get after. I talked about moving into the international markets. Nearly five million tests, primarily Holter monitors today, are being performed in the markets that we've targeted, that being the U.K., the E.U., the four countries that we're in, and Japan. But again, back to the real opportunity, we see it as very different.
Nearly 27 million folks showing up in the primary care physician's office today with either cardiac palpitations already noted in their medical records, or if you look at the mSToPS data that was published just a couple of years ago, looking at populations over the age of 65 with comorbid conditions, undiagnosed arrhythmias are estimated to be roughly 20%-25% of that population. It would tell us there's another 16 million folks to get after. We are making a hard push in the company to move further up the care pathway into primary care. We believe with our device being as easy as it is to apply and as accurate as it is with 99% physician agreement, we can move up into that primary care pathway and begin to monitor these patient populations at a far greater degree than what has been historically.
And we're now seeing north of 20% of all the prescriptions that we take into the company in 2024 alone came through the primary care channel. I'll talk about what we're doing to really open up that aspect. Historically, moving into this space, you were targeting a cardiologist or an EP. Going forward, we think there's a real opportunity to move into primary care. That becomes very, very important when you think about nearly half of all the counties in the United States alone don't even have a cardiologist available or an EP available. Many folks get referred on to cardiology without any sort of formal testing being performed, meaning a lot of the folks that ultimately get to a cardiologist or EP potentially maybe should never have been referred on there. We can start to become that rule-in, rule-out diagnostic test that gets applied earlier in the care journey.
We're seeing a lot of our large IDNs begin to use the tool in that exact way. At the same time, we're finding other ways to open up that 27 million patient population. We're doing a lot of work with artificial intelligence to get into these data sets of connected disease states. So think about diabetics, COPD, CKD, sleep apnea. We know there's a large correlation of other disease states with arrhythmias. Sleep apnea alone, if you have AFib, your likelihood of sleep apnea is 80%. So a lot of cross-correlation between the two. We believe we can begin to open up these opportunities through the use and power of AI.
And when we start to look into some of these disease states, take COPD or diabetes as an example, the majority of time that these folks who are unaware of arrhythmias become aware that they had an arrhythmia is when they visit the ER because they've had some sort of cardiovascular event or a syncopal event where they fall, they pass out, they break a limb. If we can find those patients earlier in the care journey, we can avoid those downstream costs. And the AI that we're leveraging in these spaces is starting to identify these patients with a high degree of accuracy to where we're putting patches on them sooner in the care journey, identifying that arrhythmia is present, treat them for that, and avoid the downstream cost of caring for these folks.
You can see in the chart here just the incremental cost of those folks who become aware of an arrhythmia versus those folks who do not have an arrhythmia. It's immense. It's getting a lot of traction as we move into caring for the patient earlier in the care pathway. As we think about primary care and how we move into primary care, we're really going after it from two different angles, if you will. The first is going right through the large IDNs that we're already a part of. So when we made our foray into this space, we were approaching the cardiologists and the EPs and convincing them of the need to look at cardiac arrhythmia monitoring in a different way using a patch-based technology.
We're now leveraging those relationships with our cardiologists and EPs to where they're bringing the primary care physician within their own network to the table and articulating the value of putting the patch on the patients earlier in that care journey. At times, we'll get a primary care physician who will say, "Look, I'm not comfortable diagnosing an arrhythmia myself. I'm fine prescribing the device, but I don't want to diagnose it." Through our digital platform, we can publish that report after the primary care physician prescribes the device, publish the report right into Zio Suite. The cardiologist, the EP, without ever seeing a patient, can go in there, review the report, and determine do they want to see that patient or do they not. They can do the diagnosis right there.
At this point, after making the concerted effort to really move up the care pathway in these IDNs, over 50% of all the IDNs that we're working with today now have a prescribing primary care physician in their network. So we are seeing it move up here, up this care pathway in a quite aggressive way. The other way that we're coming at primary care, frankly, is from a top-down approach. We're going right at these large national primary care networks, the likes of One Medical, Signify Health, and Oak Street Health, MDVIP, PCC, you name it. And we're convincing them of the value of proactively monitoring through precision-based medical applications.
So again, looking at patient subsets, medical records, identifying those patients who are at high risk of having an arrhythmia and going and putting a patch on those patients to find these arrhythmias before the downstream cost of dealing with an arrhythmia that becomes known from some catastrophic event. What's interesting is through the algorithms that we've developed, we've seen in these pilots that at a rate of nearly 80% yield, we can dial in the accuracy of finding the patients. Now, a lot of these large primary care networks who are taking risks will come back and say, "Look, we need the yield to be somewhere around 25%-30% for this program to really make sense. Anything north of that is just incremental profit." In many cases, and we've seen this with some of the partners right here, 80% is much higher than what they want to see.
They want to open the aperture and find more patients. So 40% yield is good for them. We can fine-tune that algorithm or we can dial in that algorithm to open that aperture and begin monitoring for more patients so we're finding more of these arrhythmias that are out there. Of course, moving up the care pathway into primary care workflow is incredibly important to us. We know that most primary care physicians do not have the time to see more patients or to spend more time with those patients in their office applying a patch or working through the workflow of getting a patch ordered, following up on the reports, and ensuring it's all in the EHR. This is a big part of why we partnered with Epic. We're the first medical device on the Aura platform.
They've been a wonderful partner for us, and they're bringing us into many of these accounts with much easier integrations into the EHR. We can reduce nearly 75% of the integration effort or time spent integrating accounts through the Aura platform. I like to think of the Aura opportunity sort of as a path in the front door with our accounts. So we have customers who are Epic users today want to leverage the power of Aura. They can order Zio right through it. It's the only cardiac rhythm monitor available in the Aura platform. So when they see that drop-down menu to order a cardiac monitor, Zio is all that they're going to see. I also like to think about it coming in the back door. There's a lot of accounts out there that we don't have a Zio presence in today, but they're Epic users. They're Aura users.
They're going to see the ability to order a Zio right through their own Aura instance, even though they're not a current customer of ours. It doesn't mean that they can't continue to order a monitor outside of Zio or iRhythm solution if they'd like to, but they're going to have to work outside of their integrated workflow to be able to do that. It becomes a very manual effort, manual process for them to do it. So super excited by what we're seeing in the early stages of Aura. We launched our first handful of accounts in the fourth quarter. Great success. We'll continue to integrate our accounts over the course of 2025 into 2026 and far into the future. Another opportunity is the MCT category. So I mentioned this earlier, nearly a million procedures each and every year with mobile cardiac telemetry.
We probably have about 10% of that market opportunity today. When the company was founded, we led with long-term cardiac patch up to 14 days. We have over 70% of that market today. But what's interesting is the same physicians who are prescribing the long-term patch are prescribing somebody else's MCT product today. Part of that is our MCT product was sort of a second-generation product that we brought after our original patch. It's not quite competitive to the degree that we would like it to be. It's a 14-day patch. Most MCT products are out to 30 days. Physicians want to see monitoring get beyond at least 20 days based upon the market research that we've done. We will submit a new MCT product with the FDA in the third quarter of 2025.
Look to have that in the market in 2026 that we believe will close the competitive differentiation that we see in the products and ultimately allow us to start to take share in this category in a pretty meaningful way. I don't anticipate that we ever get to the 70% share that we see in LTCM, but for every 10 points of share gains that we can garner in MCT, that's $80 million-$100 million of incremental annual revenue to us. I do think it's realistic to think that we can get to 30%-35% share here. International is also another big opportunity. I've touched on this briefly. We're in the U.K. today, having great success in that market, continuing to work on getting public reimbursement established for the public system. But we're having great success from a unit volume traction perspective, also growing in the private sector.
We just launched into the four E.U. countries, Switzerland, Spain, Austria, and Netherlands. We'll begin to target additional countries into the future, but we're excited about what we're seeing in the early days there, and we have regulatory approval for the Japanese market. We earned that in the fourth quarter of 2024. We're now working with them to get reimbursement established to define the price in that local market. We expect to have that sometime around the March timeframe of this year and to be in that market by the mid-part of the year. This is the second largest market in the world, 1.6 million ACM tests. Nearly all Holter monitors are being utilized today. As part of that regulatory approval, we were designated with High Medical Needs designation, which generally gets applied to a category in that Japanese market.
What's interesting is, in our case, it was made specific to the Zio product, not patch-based monitoring, but specifically the Zio monitor, and we're the first AI-enabled monitoring device in that market as well, so we're excited by the opportunity that sits there. Innovation is critical to how we think about moving the company forward. We have over 2 billion hours of heartbeat data in our data sets that are powering our algorithms today. We're leveraging the power of that to begin to open up new opportunities like prediction. If we have somebody wear the patch today and we don't see AFib present, but we can see markers that it's likely to be present in the future, we can begin to identify that, make the physician, make the patient aware of it.
Ultimately, that becomes another customer downstream when they apply a second patch to find that AFib, call it six, seven, eight, nine months later. We think there's a lot of correlation in terms of EKG and coupling that with other sensing capabilities, which I'll talk about in a second, that open up things like sleep. We think that we can get to sleep diagnostics off of the same platform in the future. The call point of the cardiologist, the EP, is where the majority of sleep patients ultimately originate from before they get referred on to a sleep doctor. We think we have an opportunity to diagnose sleep disease right there at that call point, ultimately with our product platform that we're building out. In the middle of 2024, we did a licensing agreement with a company by the name of BioIntelliSense.
This is a big part of how we think about building out the platform in front of us. They bring to the table a capability to put PPG alongside EKG right off the chest, opening up things like getting pulse oxygen levels or pulse oximetry right off of the chest itself, coupled with accelerometry, which starts to bring things like movement and activity, heart rate variability. You can go down the list of things that all of this starts to enable. But ultimately, it gives us a device that is multi-sensing, multi-modal sensing capability, which enhances the value that we're offering to our core customers today. So if we can do more off of the exact same device, we believe that that enriches the value that we're bringing to our customer set, but also increases the revenue opportunity for the company into the future.
If we can identify sleep apnea alongside cardiac arrhythmias, there's multiple revenue streams available to the company far into the future. You can see here sort of what we're after with this multi-modal sensing capability. I think when you start to bring things onto the device like heart rate, heart rate variability, respiration rate, oxygen saturation, you start to open up many other channels of opportunity into the future of the company where it's not just cardiology, it's not just primary care, hospital, hospital into the home is a big opportunity that we believe that we can disrupt. I think one of the hidden gems of the company is the IDTF capability that we have behind the company. So we've probably got the largest cardiac IDTF in the world at this point in time.
Leveraging those technicians with other data points, finding other things that we can diagnose, I think we have a real right to win in this space and something that we're very excited about as we move into the future. Of course, to take advantage of that growth, the company needs to be positioned in a way that is ready to get after it and deliver on it. We have made significant transitions and transformations around the leadership team. Nearly 90% of the leadership team is new to the company in the last, call it 24 months, bringing capabilities and skill sets of having been to where we're trying to get to. So large experience sets, we've done the same thing with the boards. We continue to evolve the capabilities and the skill sets around the boardroom.
Operational transformation. We've completely transformed from an operational perspective how we think about running the company. We've set up a global capability in the Philippines that we're leveraging to a high degree. Several hundred employees there now operating at a much lower cost profile. We've introduced automation in our manufacturing lines, allowing us to scale manufacturing to levels that support the company at twice the volumes that we're at today. So think about that as four million or five million units a year, giving us quite a bit of runway and allowing us to leverage the financial profile of the company far into the future, which is a big part of what we're focused on. If you look at the last 24 months, we've delivered almost 2,000 basis points of improvement in the profitability profile from an adjusted EBITDA perspective.
Our goal is to get to roughly 15% EBITDA levels at about $1 billion in revenue. We think ultimately we can get into the mid-20s as we exceed that. We have a pretty clear path of how we ultimately get there, and then also working on delivering a best-in-class quality management system. As we've created this new market, the FDA is trying to figure out how they want to regulate this space. We've been working very closely with them as we define exactly what that looks like. Ultimately, coming out of this, we will have a best-in-class QMS system that I think will become a competitive differentiator for us as the FDA figures out how they want to regulate this new market. But we're making great progress from that front as well.
2024 was a big year of accomplishments. There was a lot that we got done, a lot of momentum in the business. If you look at the growth in the business, it picked up every single quarter of the year. So from Q1 to Q2, Q3, and Q4, the growth rate from a unit volume perspective increased, the growth rate from a revenue dollar perspective increased, and we made tremendous headway into that primary care channel that I think gives us great runway far into the future. We continue to define and enhance our customer experience. The Epic Aura integration is a big part of how we enable opportunities in the future. We're seeing a lot of external recognition around the product itself begin to be realized, which is exciting to see. We continue to invest on the clinical side. Data is powerful.
There is nobody in this space who's invested in the clinical data to demonstrate the differentiation like iRhythm has. So we're excited by what we continue to see there. The CAMELOT data that got put out is having a lot of traction with payers, influencing policy decision, influencing access, which is critical to us. We want to make sure all patients have access to our product. Right now, about 93% of all commercial lives can get onto the Zio product, which is important to us. Then continuing to stay focused on the operational discipline. With that, think about 2025. We put out guidance this morning. We expect revenue of $675 million to $685 million for the year. That's coming off of at least $587.5 million or a bit better in 2024, with a lot of tailwinds that continue to exist in the business.
We did not put out profitability guidance at this point in time, although I'll tell you, we know where the street sits at. We're aligned with where the street's at. Don't expect any meaningful surprises relative to that. It's just a bit early at this point as we continue to close out 2024 to give financial or earnings guidance at this point in time. With that, I'll just leave you with a slide. I think the company is incredibly well positioned to get after opportunities that are in front of us. I think we address many of the focal points of healthcare as we move into the future, whether that's AI, whether that's preventive care, precision-based medicine. We're checking all of those boxes, which is exciting.
We're operating in core markets where we're only 30% penetrated in the existing market as you define it today, but the opportunity to expand it in a meaningful way is significant. I talked about the 27 million folks in the U.S. alone. I think that's a real opportunity as you get up into primary care to be monitoring against that population. And while we're focused on revenue growth, we're also focused on profitability growth. We want our revenue growth to be profitable revenue growth. We see a path into that 15%, but more importantly, onto the mid-20s from an EBITDA perspective as we get the company to scale. So with that, happy to take any questions that you might have.
All right, thanks for the presentation. I guess I just wanted to start with fourth quarter. I know you guys obviously pre-announced a slight beat in the quarter, and you had record account openings for both AT and monitor. So maybe just talk through what you saw in fourth quarter, how you expect that to trend into 2025, and was there any kind of, I'd say, clawback of sales following third quarter or anything like that to ca ll out?
I don't think there were no anomalies in the fourth quarter other than we saw just terrific momentum in the business. You commented on the fact that we put in our press release, we saw a record number of new accounts in both the XT and the AT business. I think this is very important because while XT has continued to perform quite well, as we were navigating some of the regulatory questions around AT, we actually saw that business line slow a bit. In the third quarter, we made comment on the fact that we saw AT account openings get back to sort of the levels that we were at prior to the field advisory notice we put out. The fourth quarter came back in a very powerful way in terms of new account openings where it was a record quarter on the AT side as well.
So we're seeing good momentum across both XT. When you think about XT, think about that as Zio Monitor. That's really what we're transitioning into, but as well as the AT business. A lot of that was fueled by primary care, right? We have well north of 20% of our prescriptions, almost 500,000 prescriptions in 2024 alone came out of the primary care channel, which I think is, again, validating our focus on moving further up into primary care. So I guess the last thing I'd point you to is just the momentum in the business is strong. Q1, we saw a step up into Q2, we saw Q3 step up, and then Q4 step up again in terms of absolute growth rates, both on unit basis and dollar basis, putting us in a good position as we head into 2025.
I think from a 2025 perspective, a lot of good tailwinds. At this point, we're just not going to get ahead of ourselves with respect to expectations. We feel good with where the street's at. We bracketed sort of the street with the guidance, and if the tailwinds play off, it's going to be a terrific year for the company.
And can you kind of talk through some of the puts and takes in 2025, I guess, starting just with the cadence that you'd expect throughout the year and maybe just your assumptions around international, Epic and anything else or partnerships that you had?
The team should feel free to jump in, but Epic is a tremendous enabler for us. We're very excited by that collaboration. We've got into four networks in the fourth quarter. We're going to be ramping that up over the course of 2025. I think you're going to see that start to contribute nicely in the back half of the year. One of the things that we get asked a lot is when you integrate with Aura, what do you expect in terms of volume increases in your core accounts? It's too early to tell, although I would tell you one of the very first accounts that we brought on board. We had the baseline of that business before we did the integration. We have seen it step up post-integration. So the workflow is very, very important.
The ease of prescribing, ordering is very, very important, and I think that we will see a benefit in the back part of the year. We're just now stepping into the four E.U. countries in the back part of 2024. Having a full year of contribution in 2025 is going to be a nice tailwind for us. We haven't seen meaningful growth contribution come from the international markets for a few years recently. I do expect you to see growth benefit come from international in 2025. Japan is a massive opportunity for us. Today, Holter monitors are reimbursed at a higher rate in Japan than what they are reimbursed in the U.S. I think that bodes very well for the reimbursement rate we're likely to see get established in the Japanese market for long-term patching.
Again, we're going to learn that in the March timeframe. I'm bullish on what Japan could be, but at the same time, that's a market that takes a little bit longer to ramp than some other markets. But I think once they see the value of the technology at 1.6 million tests being performed each and every year, second largest market out there, I think there's a tremendous opportunity.
Great. And I guess just something from the presentation. I mean, I noticed that it was kind of the first time you were really discussing making a new sensor platform for additional life signs. So maybe if you could just talk about that. I mean, it's not terribly unsurprising, but just maybe discuss what that looks like from a qualitative standpoint today, maybe from a margin standpoint as well relative to the other products. How are you thinking about that platform?
Well, the BioIntelliSense licensing agreement is a huge enabler of this, right? Bringing PPG capability right alongside EKG capability right off of the chest. We don't want to create a situation where a patient's wearing multiple iRhythm sensors. Really, we want to do everything off of a single sensor, single platform. And we think that BioIntelliSense enables that. So a lot of the development efforts that we're embarking on right now are bringing those two platforms together onto an iRhythm single platform. We think that gives us the opportunity then through software to sort of flip on and flip off what it is that we're monitoring for. If you want to monitor for a home sleep test, we can enable that. You want to monitor hypertension continuously, we can enable that. You want to do cardiac rhythm, we can enable that. You want to do RPM, we can do that.
You want to transition a patient from the hospital into the home setting, we can monitor from that perspective. I think having the IDTF in the background, where we're bringing in these incremental sensing capabilities, gives us a real opportunity to be unique and different from most other RPM companies that are out there. We have the IDTF capabilities set up, already established. So that is a big area of focus for us. Our first priority is getting MCT on file with the FDA. Once we get MCT on file with the FDA, we will pivot to bringing the two platforms together with the licensing agreement that we have from BioIntelliSense. So that gets exciting to us. I can imagine you think about cardiology today. That's where the majority of patients originate from that move on into the sleep space to go see a sleep doctor.
If you could create an ease of use to where you prescribe one patch and for the first two days you might be monitoring for sleep disease at night, and for the next 14 days we're going to monitor for cardiac arrhythmia in a single wear experience, a single device with that patient, you're enhancing the value tremendously for that physician and for that patient. And you're increasing the revenue opportunity without changing your cost profile at all. So that gets pretty attractive from a margin perspective, but those are further opportunities out in the future, but that's what we're focused on building with the multi-sensing capability.
Got it. And I guess just pivoting a little bit, you've continued to make progress towards addressing the Warning Letter and the FDA 483s that you have. And obviously now with the two 510(k) submissions approved, do you have any kind of color you can provide on timelines to resolution and just your general communications with the FDA?
Yeah. We are committed to resolving the concerns they have noted in the 483s. I would say in the warning letter we received back early part of 2023 when that came through, we've addressed all of those concerns to the point where they've now approved two 510(k)s that we had submitted as part of the remediation efforts to address their concerns. However, to close out the warning letter, they do need to come back and do a final inspection. My sense is they probably don't come back until we've addressed their concerns in the 483 observations. We are reporting back to the FDA every single month the progress we're making against those items identified in the 483s. By the mid part of 2025, we will have remediated everything we've committed to and made the FDA aware that we were committed to relative to those 483s.
So at this point in time, there's really no feedback directly from the FDA to share. We are providing those updates. They acknowledge receipt of it. They let us know that if we have any questions, we'll be back to you. They have not come back to us with any questions at this point in time. So feel good about the progress that we're making. I can't tell you exactly when the FDA would be back to potentially lift the warning letter. I think it's probably after we finalize the last of the 483 remediation efforts. But again, I don't want to speak on behalf of the agency, but we'll be ready for them.
One of the things we committed to the FDA was that we would engage a third-party firm who would essentially do a complete review audit of our entire quality management system, of which we'd be happy to share results with the FDA. Their work will actually begin here in a couple of months doing that formal review so making great progress around it. The other thing I would note is I think it's become pretty apparent now. We are not the only player in this space who's subjected to the scrutiny of the FDA. I think we've got other players now who are starting to come underneath the lens of the FDA. There's other competitive players who are noting some of the similar requirements around documentation of the CCT being part of the product that I'm pretty certain this isn't an iRhythm specific thing.
It's more of the agency trying to figure out how they want to monitor the broader category.
And then I guess just pivoting a little bit to Zio Monitor, you continue to see some pretty strong steady uptake here and driving growth through adoption in the primary care setting. So maybe if you could just talk through your assumptions around primary care penetration in 2025 and just the growth algorithm here with new accounts, I think that would be helpful.
Yeah. I think the overall penetration in the primary care is very, very low at this point, right? I mean, there's 300,000 plus primary care physicians out there. We're nowhere near working with the majority of those folks. What we do know is more than 50% of our IDNs where we have relationships with cardiologists and EPs are now seeing prescribing take place through a primary care physician. And when we look at those counts, the growth rate in those counts exceeds the growth rate in the counts where we don't have primary care prescribing. So that's encouraging to see. I mentioned nearly 500,000 prescriptions out of our total 2 million plus came out of the primary care channel this year, right?
So we're seeing that grow quite aggressively. We've tried to make it as easy as possible to prescribe in that channel. And I think that we found a way to make it a realistic opportunity. So we're excited about what we're seeing there.
Yeah. It's a great question. On primary care, we sort of think about it in the ways Quentin segmented it. So you take your enterprise or large healthcare system, Epic, Aura, what we do with integration allows upstream. The value of upstream is you don't clog up cardiology with patients who effectively have negative studies, so we always talk about diagnostic yield, but there's value of what we don't find in ruling patients out. What that has done that we've seen is it's increased the awareness among PCPs to prescribe, so it's not that you're just displacing unit volume from one specialty to another. You're seeing growth organically in that primary care setting. The guidelines have allowed that. Payers don't restrict by specialty.
That used to be the case in a few, so that's a huge opportunity, and then on the kind of Medicare Advantage side and innovative care models, they don't have cardiologists. The opportunity there is that we provide that full service to them. Simple risk-based scores of age 65 or this X, Y, and Z comorbidities work. The AI has allowed us to really, with a high level of precision, tailor the yield that they want in the healthcare system. As Quentin said, that aperture widens because they don't want 80%. If they're getting 80%, there must be many who have disease that we're not seeing. So it's through those mechanisms.
Got it. No, that's really helpful. Just to be conscious of the time, I want to bring you into the conversation a little bit, Dan. Maybe talking about you're obviously recent new CFO, maybe just discuss. I can appreciate you guys are not providing formal 2025 guidance down the P&L, but maybe if you could just talk through some of the priorities for 2025 to drive leverage and where that's going to come from, that'd be helpful.
Yeah. So as Quentin noted, we have yet to provide 2025 profitability guidance. We'll do that when we report Q4 and full year results in February. We feel really good about the setup and where the street is from a profitability standpoint. If you look at the profitability expansion we've delivered over the last couple of years, we feel really good about continuing to deliver that cadence. We're building that discipline in the company. And again, Quentin mentioned profitable growth. That really is our focus. We're still a growth company. The opportunities are incredibly immense. We want to continue to invest in those opportunities to grow the company, but we want to do so efficiently. And we're seeing it across the board in terms of the focus areas. A lot of it is good just operational blocking and tackling.
Some of it is more kind of structural things that we've done to drive leverage in the future, but feel really good about the setup from a profitability standpoint.
Great. Well, maybe Quentin, I'll leave it to you. If you have any kind of final remarks you want to make or anything that we missed you want to talk to.
I don't think that we missed anything. I think we're incredibly bullish on the future opportunities of the company. Primary care is a significant door opener for us. I think the further up the care pathway we can get to, the more preventative care, the more precision-based medicine that we can apply with the algorithms that we're defining really validates sort of the market is much bigger than the 6.5 million tests that are being prescribed each and every year. So we're excited by that. I think the profitability side is nothing to be taken for granted. We're absolutely committed to it.
When you look at the growth potential that sits in front of us with these adjacent markets, the adjacent channels, and couple that with the improvements in the financial profile that we expect to deliver, I think it's a situation that just sets up for a lot of value creation, which we get super excited about delivering on. Obviously, we know we need to clear the FDA overhang. We're committed to doing that. We will be best in class from a QMS perspective, but the growth potential, the earnings potential is phenomenal. We're excited by that, so.
Great. Well, thank you very much. Thanks, everyone.
Thanks so much. Appreciate it.