Okay. Good morning, everyone. My name is Nathan Trebeck. I'm one of the medical device analysts at Wells Fargo. Welcome to day two of our healthcare conference. I'm pleased to introduce management from iRhythm for this session. From the company, we have Quentin Blackford, President and Chief Executive Officer, and Dan Wilson, the Chief Financial Officer. Thank you for joining us.
Yeah, thanks for having us. Looking forward to it.
Yeah. So I thought we could just start with recent comments you made on Q3. Can you just talk about what's going on with volumes? I think you noted some softness in the quarter, and just walk us through what happened in the quarter.
Yeah, I don't know that it's softness in the quarter that we're speaking to. I think, you know, there were some questions asked yesterday, just around how the quarter was trending, and I think, you know, the response was Q3 is always a little bit of a tricky quarter for us through the summer months, right? And so much of Q3 is frankly loaded into September, so it's a bit early to speak directly to it, given the fact that, you know, once families get back into school, volumes always pick up in the September month. So we'll see what that looks like. But the more color commentary was, you know, July started off really nicely. Back part of July, early part of August, was probably a little bit softer than what we historically would see in that period of time.
Then the last week or week and a half or so has been really, really strong, right? So, we'll see how it continues on through September. I think we continue to feel really good about the full year guide that we put out there. We gave some color commentary on the third quarter itself, around 25% of revenue falling into the quarter. Still feel like we're gonna fall right within that range of 25% of the full year, you know, high and low end, so we feel good about that. And the comments specifically around, you know, where consensus is sitting, I see a path into that consensus figure at this point. What I don't see is the typical, you know, maybe $1 million-$2 million beat that we've put up historically.
I don't know that you're gonna see that sort of a beat, but I still see a path into that consensus view. So, those are the color commentaries that we had put out there. I think the underlying business continues to be really, really strong. The onboarding of new accounts continues to be really, really good. There's no question primary care is adopting the technology. It continues to come through in the numbers, and, you know, some of our largest customers are now primary care subscribers. So, I couldn't be more bullish on where the business is at, but, you know, provided some additional color on the quarter, and happy to get further into it if you'd like to, but overall, I feel good about where we're at.
Okay. I think we can move on just to the recently announced license agreement you have with BioIntelliSense. Can you just share what your aspirations are with this agreement, and can you talk about why this particular pulse oximetry IP?
Yeah, I think we've always had a big vision for the company to be much more than a cardiac rhythm monitoring company. We believe we have a platform technology here that can do so much more, and I think part of enabling that is getting PPG onto the chest. BioIntelliSense has a capability that allows us to do that very quickly, and I think it's a best-in-class capability, particularly around pulse oximetry. Within their PPG sensing capability, they add sort of a third light into their technology. So traditionally, PPG is done through a red and green light signal. They add a white light to it that eliminates a lot of the noise and gives you a cleaner signal, the ability to see through skin pigmentation, much more accurately, and to do it right off the chest, which has always been hard to do.
So this really expands the platform in a meaningful way. It gives us access to pulse oximetry off the chest. It gives us access to respiratory rate, really enables us to start to do a lot more of vital sign monitoring off of the chest, which is our vision for this broader platform. So, with that, you now have a pathway into home sleep testing, which is important to us, given the overlap with our call point. And it just-- it really opens up the total addressable market that the company has, sitting in front of it, as we think about the broader platform than, you know, being just a traditional cardiac rhythm monitoring company.
The IP, we spent a lot of time, from an IP perspective, and the whole freedom to operate in and around the pulse ox space, knowing that it, you know, it's got players in there who have it pretty well protected. But I think we feel pretty good around how this technology reads around that or is protected from that perspective, so we feel good about that. Ultimately, the idea is to bring all of that onto our platform and have one platform that can do multimodal sensing.
Okay. You mentioned sleep. As far as other adjacencies we should consider is heart failure. I've done some doc calls, and it seems like multi-vital signs could be beneficial for heart failure patients. But anything else you would call out that this would kind of address?
Yeah. I, I think heart failure is one of those. Sleep is clearly one of those. I think managing hypertension is another one of those areas. You know, one that I think we have the ability to really disrupt is this whole transition of patients out of the hospital into the home setting. Many of our physicians, cardiologists, EPs, are seeing patients in the hospital. Upon discharge, they want to continue to monitor them. If you're able to monitor a patient in that at-home setting, and you're monitoring multiple vital signs, and you start to see deterioration in the patient, and you can get a nurse out to see that patient versus the patient coming back and being re-readmitted into the hospital, you're gonna save that hospital system a tremendous amount of cost.
I think our hospital systems in the U.S., it's estimated somewhere around $25-$26 billion a year is spent across them just in fees associated with readmitting patients back into the hospital and that care. How do you stem the tide of readmittance? I think there's a real opportunity to do that. I think with our call point, with our relationships with these large IDNs that continue to grow and build, I think we have a right to win in that space, and I think we can disrupt that with a monitoring capability that will be best in class, and I think it'll leverage our IDTF in the back end that provides a monitoring service that a lot of times these hospitals don't have that capability in-house.
We bring the IDTF with the technology capability that I think makes us unique and differentiated.
... Okay. Is, with multi-vital sensing ability, is there room for incremental reimbursement, you know, putting aside sleep apnea or heart failure?
There is, although I will tell you, I see it probably very differently than a lot of players in that space see it today. I think RPM, Remote Patient Monitoring, there are already codes established to bill against in that space. For us, that's not really the opportunity. I mean, yes, you could start to seek reimbursement from an RPM perspective, and it's not to say that we wouldn't do that, but the real value opportunity is to go to these hospital systems, provide us monitoring service capability that avoids the cost to them of readmittance, and I think that's a service that these folks would pay for in a meaningful way to avoid that $25-$26 billion a year that they're coming out of pocket for, just because folks are being readmitted back in the hospital.
So how do you stem that tide? Yes, there's the RPM side of it that could be incremental, you know, revenue to it, but it's really about cost avoidance. It's really about value, being delivered to the systems more than anything else in my mind.
Okay. GUARD-AF just wrote out, it was a positive study showing XT screening of asymptomatic AF versus usual care was better. What benefit do you expect from this study, and does this kind of get you closer to that USPSTF guideline recommendation?
Oh, Dan.
Yep, I can address that, so GUARD-AF was specifically designed to ultimately get to a positive recommendation for USPSTF. It was powered at fifty-two thousand patients to show, statistically significant improvement in outcomes, specifically stroke. Unfortunately, COVID hit right as that, trial was kicking off, so ultimately only enrolled twelve thousand, so didn't see that, improvement on the outcomes, but still some good data there. I do think there's an opportunity as GUARD-AF, starts to pool with other clinical trials and that data starts to amass, including real-world evidence from a number of the pilots and, commercial launches that we're running in that, in that segment. I think there is a chance, you know, we ultimately get there.
There's enough of an opportunity in the MA space for us, and, you know, commercial payers aren't waiting for a positive recommendation from the USPSTF, so we're getting after it. Seeing some good early signals there that that market's real for us, and we're excited about it.
Great. You also announced new European launches. Can you quantify the incremental growth opportunity this year and maybe into 2025 , given that some of these regions don't have reimbursement yet?
Yeah, I think ultimately, I expect reimbursement will be put in place for the four EU countries that we spoke about, Netherlands, Switzerland, Austria, Spain, that we'll get into, or frankly, we are now into, here in the back part of this year. We don't need formal reimbursement really, to get into the country. We want that. That'd be nice to have, and like I said, I think we'll get that put in place. We can contract directly with the hospitals, in some of these early, market entry efforts, which is what we've done with some of the leading hospitals in each one of these countries. So, I do think that the reimbursement will be in place as we head into 2025.
Japan is probably the greatest opportunity, so moving outside of the EU, that's the one we're most excited about. Well, I would expect regulatory approval, you know, any day now, really. Probably over the next thirty or so days, I would expect to get that approval. That'll immediately put us into a discussion with them around reimbursement. Should have formal reimbursement in that Japanese market, you know, after the turn of the year, in that first quarter, and then really set us up to launch, you know, commercially in the, in the first half of the year at some point. So that's the second largest market, you know, in the world, 1.5 million ACM tests being prescribed every year.
I think we have a very unique position going into it, where Zio in particular has been identified as a high medical needs product. That's gonna set us up for attractive reimbursement as it gets established, but also, I, I think, give us a, a nice entry directly into that market. So we'll see how that plays out. I think that'll be a nice tailwind for us. The international business, you know, today is, call it, 1% of the, the total business, pushing up on 2%. There's a lot of runway there on the international, contribute in a much larger way, and I think next year's gonna be a year that we can see some good, good growth come out of those international markets.
Can you help us think about the Japan launch? Or we think about as being kind of wrap and ramp, like, do you have the infrastructure in place to roll this out?
So we will partner with the distributor there. We've engaged with them. The distributor's under contract. We're actually doing sales training with them as we speak, so they're fully engaged and ready to go. The Japanese market's always an interesting one. It's a very local market. You're moving mind share. There's the potential that it could go very quickly with a new technology, with a high medical needs designation with it. I think our point of view is it's probably gonna be more of a slow ramp, and if it takes off in a bigger way, terrific. We can talk about that, you know, sort of happening in the moment and with some data behind it, but our expectation is probably more of a gradual ramp at this point.
Okay. If we could just touch on the regulatory issues that are going on, maybe even the new forty-three observations. So these observations extend beyond the warning letter that you have for Zio AT, whereas this extends to Zio XT, Zio Monitor, and your Zeus software. I guess, how significant do you believe these observations are, and can they be remediated in twelve months? And, you know, I guess, do you envision any changes to the business model that will be required?
Yeah. Look, these are meaningful. I mean, they're frankly, the top priority in the entire company at this point to remediate, so we take these things very, very seriously, and we've put in place a lot of activities or actions within the company to address the concerns coming out of the most recent 483s, and we can get into the specifics. I think we're dealing a little bit, you know, with a situation where frankly, there's not a lot of policy around this space at this point in time. It's a rapidly growing, evolving space. We're the market leader in this space. But you go back two or three years ago, it was no different than what we were dealing with with CMS. Frankly, there was no policy around it. We had to work with them to get a code established.
We had to work with them to get national reimbursement put in place, and we ultimately did. Now we're dealing with how to regulate this space, you know? And it's growing rapidly to the point where patch-based technologies are probably about 50% of the overall market, so it's becoming the standard of care. It's elevated up on the sort of the attention level of the FDA, and I think they're trying to figure out how to regulate this space. The entire industry, you know, works very similarly to the way that we do, which at the core of the question that's being wrestled with in those Form 483 observations is, is the CCT, is the IDTF a part of your product or is it not?
In our scenario, you've got a wearable patch, a device that you wear on your chest. It collects data. That data is then run through algorithms, which is then handed over to CCTs, who review, interpret, and put findings into a final report. We've long held the point of view that the CCT is not part of the product, and much of industry works that way. Many of our industry players, frankly, have a device, but they don't even have a CCT or IDTF capability. They send that information off to a third party, who provides a finding and then sends the readings back into their final report, but then makes its way to the customer. We're different in that we own the IDTF. It is all vertically integrated.
We're at the point now where we are not debating with the FDA on whether the IDTF is part of the product or not. We acknowledge their point of view, we agree with their point of view, and we will remediate the entire quality system to accommodate their point of view. So we made that very clear in our response to them. And we'll, you know, we will completely, you know, remediate that entire quality system to address that. So whether that's, you know, document control, design controls, the corrective action, preventive action, or your CAPA systems, whether that's statistical risk analysis, complaint handling, reporting, you name it, we will bring the CCTs in to our processes. So we're not debating that with the FDA any longer.
We see their point of view, we agree to their point of view, and we've made that incredibly clear. I do absolutely believe it's something that can be remediated. I think it's very clear in terms of how to remediate it. It's just gonna take time, effort, and some cost to rebuild those processes, redocument these processes in line with the way that the FDA sees this, but it absolutely can be remediated. You mentioned the warning letter. You know, our work to remediate the warning letter continues on. These two things, while they're somewhat connected, they're also very different, right? The warning letter from last year was really this question around: Is your Zio AT product an MCT product or not?
I think we've proven that with the FDA, that they do align with the fact that it's an MCT product. They ultimately created a brand-new category code, which kind of goes back to defining policy around the space, but they've created a brand-new category code called Ambulatory Cardiac Mobile Cardiac Telemetry. We're the only product that's been put into that new category code. So they do see us as MCT. We're no longer having that debate with them. But now it's about, you know, catching up the letter to files historically and to catch up 510(k), which we had submitted with them. It's about, you know, putting the 510(k), or getting the 510(k) approved for the design enhancements, like the light on the product itself. That's now going through that process.
None of that's being held up as a result of these Form 483s, so that continues to move on, but all of this will be remediated. The question is, you know, what's that timeframe look like? We've committed to the agency to get this remediated within the next twelve months. We've brought in, you know, experts from the outside. We've got consultants who are working with us, advising us through this, so I do see a path through this, but, you know, there couldn't be a larger priority for our company at this point in time than what the FDA remediation is.
Just to follow up on the Form 483. So, you know, the CCTs were definitely called out, but issues with the algorithm were also called out. So just a two-part question: The CCT seems like there's always gonna be a component of subjectivity to reading these reports. How do you get around that, meaning there is room for error there? And the algorithm itself, how significant are the observations? Does there need rejiggering or just a change in the algorithm?
Yeah, I don't think the algorithm is the issue. The question is, when the algorithm produces a result, and the CCT oversees that result and makes a determination on what the arrhythmia is, and that goes into the final report and then is pushed to the physician, what if the physician sees something different? In the observations, you guys have the opportunity to see the 483s. There's a noted item in there that there were 4,000 instances of where the medical doctor saw something different than the cardiac technician. I think it's really important to understand that in the 4,000 instances, that's across a two-year timeframe of 4 million reports being published to physicians, right? So we're talking about a 0.1% of the time where we had a difference.
Now, you have a question, though, of, okay, well, your CCT saw something, your physician saw something different. That doesn't mean that the physician was automatically correct. So how do you govern? How do you govern that situation where you have a difference in the point of view, to determine who was accurate and who was not? And there's probably some third party or an independent review that can be called in in those instances to review that. But then it's in those cases where you deem that, okay, yeah, there was a difference. What are you doing from a complaint handling and reporting perspective to report those correctly, right? Or to remediate those issues correctly. That's really the crux of what we're getting at in that particular finding.
We have to work with the FDA on that because, you know, as they identified it, as we proposed remediation to it, it does beg the question of, okay, what happens when you have a difference of opinion? Who's gonna be the governing official in that case on who was right, who was wrong? We'll figure that out with the FDA, but it poses an interesting question.
The algorithm, any changes to you?
Nothing that we'll do to change the algorithm. The algorithm's designed to work to a particular sensitivity, where it will identify arrhythmias, and then the CCT will oversee that, and if they see anything different, then they can call that out. I think one of the things that's unique to a CCT is they have a professional obligation when they're looking at these data strips coming off the EKG. If they see an arrhythmia, their professional obligation is to call that out. What if they see an arrhythmia that your algorithm isn't even designed to identify? And there are many arrhythmias out there that your algorithms aren't trained to look for. What do you do in that case, right?
Because the product was approved for those thirteen arrhythmias, but, you know, when a CCT sees something different, they have a professional sort of obligation to call that out for the medical doctor. Is that okay? How do you govern over that? I think those are the things we've gotta wrestle with the FDA right now. Not wrestle, just align with the FDA, and I think they see the same challenge, and I think they're working on how to define policy around it, but that's the sort of questions we gotta align with them on or help figure out for the broader industry.
How should we think about the risk of a consent decree? Is the threshold serious injury or death to the patient? In that case, it doesn't seem like the monitors contribute to that. Is that the threshold, or is there something else we need to be thinking about for, you know, the risk around the consent decree?
I think it goes beyond just risk to a patient, which in our entire situation, the risk to the patient is not something that is being discussed, right? There's not concerns being expressed to us of, "Hey, your product is harming patients in a meaningful way." That's not part of the discussion. The discussion is really about process and documentation, right? So how do you again, how do you make that more robust to bring the CCT in? So that's really where it's at. But I think the other aspect of the consent decree is around this whole aspect of a commitment to quality from a cultural perspective.
You wanna embrace a culture of quality, and you need to demonstrate that to the agency very clearly that you take these things very seriously. We are more than committed to that, and I think in the response to the Form 483, the agency will see just how committed we are to that. Whether that's making very, you know, swift changes in and around the quality function itself, from leadership that we'll move on from, to how we structure it internally. You know, and now reports directly into myself. It is the top priority in the company. There is not a priority higher than remediating the FDA concerns at this point in time.
So, we've made that very clear, but at the same time, our actions need to demonstrate that, right? And we will demonstrate that. We'll execute against that with the agency, but that's something that they're gonna be paying attention to.
How should we think about the implications if this becomes another warning letter for you? I mean, we saw your Zio AT volumes kind of, you know, decelerate after the warning letter. If this becomes a warning letter, do you envision your monitor volumes to be at risk? I guess help us think through the implications of another warning letter.
Yeah, I will tell you, this particular issue of dealing with the FDA around the warning letter matter, the Form 483s is not something that comes up in a lot of conversation with customers. We've been very proactive, frankly, in putting it out in front of customers and letting them know exactly what's going on and what we're working through, and why, you know, why, as an example, our CCTs may have a differing point of view than a medical director or a medical doctor, right? And that it happens 0.1% of the time. We're very open about the fact that physicians will agree with us 99% of the time, and it's really closer to 99.9% of the time.
So we talk openly about the fact that we're highly accurate. We don't let physicians overwrite what's in our final report. They can annotate it down in a separate box, but we always keep the original finding versus their finding, so we can see where those differences are. But a lot of the competitors in our space, and physicians will tell you, one of the reasons they will use a competitive product is because they can go in, and they can annotate right over the existing report and change the arrhythmias being identified. We don't allow that, but when you think about where regulation of this industry is going, how are you gonna regulate those situations where physicians are now overriding actual arrhythmias being presented by CCTs in these competitive products?
We hear, you know, anecdotally that as much as 30%-40% of the time, the physician is actually overriding and seeing something different. I believe that if done right, and as we come through this, this can become a competitive advantage for us. I think the barriers to entry become that much higher in a more regulated space, and we will become best-in-class at it. So I do think it ultimately can become a competitive moat for us, but the entire industry is gonna have to come along with it, you know, at some point in time, and we'll see what that looks like.
Okay. You mentioned earlier that the process with the catch-up Form 483s and 510(k)s to address the FDA warning letter progresses, but do you envision these Form 483s as preventing those 510(k)s getting approved? I understand the process is continuing, but do you feel like the approval could be dependent on the Form 483?
I do not, but I also will tell you, that's my own personal opinion, right? I mean, the FDA, you know, they came back and said: Look, we're not gonna approve the 510(k)s until the Form 483s are remediated. I can't stop them from saying that, but they've not given us any indication whatsoever that that's the plan of action. We've responded with our responses to their questions. They've engaged with us back and forth on those. They've even, you know, came back and gave us some feedback on, "Hey, we'd like to add this one statement into the IFU, so please do so." So it's very clear that their review team, which is a very different team than the inspection team, that we're dealing with on the Form 483s now.
is moving down the path of clearing the 510(k)s. So our estimate is, you know, September, October timeframe. So this month, next month, is still the right way to think about an approval on those 510(k)s. If we're given any indication at all from the agency that they're thinking differently, we'll communicate that. But they have not given us any indication to believe anything differently at this point in time.
Okay. And if you could just remind us, timing-wise, you would imagine these five 510(k)s get approved, then the FDA comes back to reinspect and then potentially lifting the warning letter?
Yes. When they come back, I don't know, right? Like, you know, I don't think it's the right expectation to think five 510(k)s get approved, and the following week, the FDA shows up to close out the warning letter. Our original expectations were it's probably somewhere out in Q1 is when they would return to close out the warning letter. But I don't know, we're speculating at that point, right? So, the expectation is clear the five 510(k)s, the FDA will come back as a closeout inspection. I just can't tell you exactly when that would be.
You, you've had pretty good interaction with the FDA around the warning letter. Is there any risk that the 510(k)s get approved, the FDA comes back, and they find something else? I mean, I don't know to what extent you're communicating that the batch of 510(k)s resolve all the issues in the warning letter.
There are activities beyond just the catch-up 510(k)s that we agreed to in the warning letter remediation. So it, it's not just the 510(k)s. These activities, we give an update to the FDA on every single month on here's the progress against those, and most of those are gonna be closed out here, frankly, this month, here in September. So when the FDA comes back, they're, they're gonna review more, in terms of closing out the warning letter, than just the two 510(k) issues themselves. I mean, frankly, those should have been reviewed when they sign off and close and approve the 510(k)s, but they're gonna look at all of the remediation activities we identified and committed to in that warning letter. So they'll, they'll look through all of that.
But I can tell you, you know, we give them updates every single month on the progress. When they came to the Orange County facility in July, the first couple days was evaluating sort of the progress we had been communicating to them on a monthly basis, and their response was, "You know, these remediation efforts all looks good there." And then they turned, you know, their focus to more of the production systems, which was outside the scope of the warning letter. So, I can't tell you when they're gonna come back, but I feel very good about all the progress being made to remediate the particular issues in the warning letter. Now, the Form 483 observations are a little bit different than what was in the warning letter, right?
Okay. Do you have any update on the DOJ subpoena? You know, how to think about best and worst case outcomes here?
I can't. There's nothing really to update, right? I mean, it's been a very broad document request. We've turned over hundreds of thousands of documents going all the way back to two thousand and twelve. I can't tell you where they're focused. There haven't been, you know, directed questions that give us sort of an area that they're really focused on. It's just been very broad data request at this time, and to which we've complied with, you know, nearly every single request that's out there, and provided that information. So there's nothing to update there.
What are the next steps after the DOJ's reply on September sixth to your opposition brief?
Yeah, so that opposition brief is around the three reports, in particular-
Yeah
... that we've asserted attorney-client privilege on. They'll respond on September sixth to our response that we submitted just last week, I believe, or week before that. If they align with us, then I would imagine everything just gets kinda dropped. If they don't, then the court will ultimately step in and start to sort of opine on exactly what position they're gonna take. And we'll either hand over the reports, or the attorney-client privilege will prevail. So we'll see where that goes.
Okay. Maybe we'll just briefly move on to your guidance and LRP. First, are you seeing any changes in competition in the market, given all the regulatory issues, or is competition being more aggressive in the market now?
I wouldn't say. Look, I think particular sales reps here and there get aggressive with it, but from a corporate perspective, I don't see our competitors really taking a hard corporate line of really trying to grab a hold of these regulatory matters and pushing that from a sort of corporate agenda perspective, and I think there's a reason for that. You know, these quality circles are relatively small across industry, and as we talk with other folks who are leading quality functions in our competitors, they'll tell you, "We're all watching what the FDA is doing here with iRhythm, and we're modifying our own quality systems as we go, as we learn how they want to regulate this industry," so this entire industry's paying attention to what's happening.
It's very hard for a competitor to go out and cast stones when they know that they're revamping and remediating their own systems. But you do find, from time to time, a rep, you know, may take the opportunity to really point it out, and we'll go in, and we'll sit down with account and have that conversation. I don't think we've lost, you know, any existing accounts to this.
I think, you know, over the last year, there's a handful of accounts, new accounts, that were targeted that, you know, we felt like were gonna come on over and convert to be an iRhythm user, to where they're, you know, they've said, "Okay, well, we're gonna slow the conversion." So it's more about new accounts onboarding that probably had a bit of an impact in the middle part of last year, but I haven't seen it, you know, I haven't seen that trend change at all. The pipeline's as strong as it's ever been. I think the interesting thing, and we commented on this in Q2, our Zio AT new account onboarding in Q2, was the highest number of new accounts that have come into the company post putting the field action notice out, you know, almost two years ago.
So, that AT business continues to grow well. It doesn't grow anywhere near what I think it can grow with the new MCT product once we close the competitive gaps, but the AT business is growing well.
... Okay. Do you still expect your asymptomatic AF partnerships ramping in the back half of the year? I think I might have misheard, but I think your comments around Signify suggest it might now be pushed into 2025 Is that-
I think Signify, I think their plan for a broader, large nationwide commercial launch is really in . Where we're at with Signify right now is we're expanding the scope of their pilot, so it started in the state of Illinois. We're now opening up New York, New Jersey, Connecticut, so now we're into four states, and the plan is over the course of remainder of the year to really, you know, hone in on the pilot and make it, you know, as good of an experience for the patient as possible and for the Signify physicians or nurses that are out in the field so that they're ready in a broader commercial launch as we roll into 2025 , so I do expect the asymptomatic will continue to grow in the back half of the year.
PCP is seeing great results. The Oak Streets are seeing great results. Signify expect to have great results, but I think, you know, the real opportunity comes in 2025 around this space. And we'll have more news to share around other innovative partners that continue to sign up with these programs and these pilots, you know, that continue to grow in the back part of the year. So I mean, and that's what comes back to why I frankly am so bullish on the primary care opportunity. To Dan's point earlier, yes, we wanna get the USPSTF to ultimately get to the point of recommending proactive preventative screening, but the commercial payers or the commercial at-risk entities, they're not waiting.
They see the value of proactively identifying, these arrhythmias and beginning to treat for them and remove the downstream cost.
Okay. At this point, where we stand now, can you just say where your confidence level is in your 20% LRP? I mean, your Zio volume growth this year has been high teens. You know, we expect continued pricing headwinds, particularly in commercial. So your LRP implies an acceleration from this year. You know, you're gonna have Zio MCT, supposedly, but there has been some pushing out of timelines. I guess, what is your confidence level today?
Yeah. I still feel good about the $1 billion in 2027 from a top-line perspective. I see a path into there. There's no question when we put that goal out there, did we anticipate the regulatory challenges? We did not. We thought we'd have MCT here by now, right? So we're probably a year delayed on MCT. Despite that, when I think about the unit volumes in the business, you know, this year, we're right around 20% unit volume growth in the business. We're a bit higher than what you've indicated. That's with an AT product that's had to hang in the market for an extra year that, you know, frankly, is still growing north of the corporate average, but it's nowhere near the 40% clip that it used to be at.
I think getting MCT in the market is something that can accelerate that again. We have 7% market share in the MCT category. We have 70% market share in the long-term patching category. It's the same exact physician who's prescribing long-term patching, that's prescribing somebody else's MCT product today. I do believe when we get MCT approved, we will close that gap relatively quickly, and that's, that's $200 million of incremental revenue opportunity as we just move market share into the mid-twenties, you know, from where we're at today with 7%. So I do see a path to where MCT really starts to contribute the way we originally envisioned when we put the $1 billion mark out there. It will accelerate unit volume growth. Japan is gonna accelerate unit volume growth.
As PCP opens up and asymptomatic opens up, it will accelerate volume growth. So I do see a path to it. Zio Monitor, frankly, relative to the model we put together when we put the $1 billion out there, is growing very nicely, still in the very high teens. We thought at this point it'd be more, you know, closer to the mid-teens. So it's ahead of where we thought. It's just some of these other headwinds that we didn't anticipate from a regulatory perspective that are pushing out some of the launches that haven't allowed those to contribute yet. But they will ultimately contribute, and they'll be meaningful contributors for us.
Okay. Well, with that, I think that's our time. Quentin, Dan, thank you for joining us.
Appreciate it.
Thanks for having us. Appreciate it.