iRhythm at 2025 Truist Securities MedTech Conference: Strategic Growth Plans

On Tuesday, 17 June 2025, iRhythm Technologies Inc (NASDAQ:IRTC) showcased its strategic vision at the 2025 Truist Securities MedTech Conference. The company highlighted its accelerated growth, driven by its leadership in long-term continuous monitoring (LTCM) and innovative market strategies. While iRhythm is capitalizing on its strengths, the company also faces challenges such as FDA remediation efforts.

Key Takeaways

• iRhythm’s growth exceeded 20% in Q1, with a strong presence in the LTCM segment.
• The company plans to submit Zio MCT to the FDA by Q3 2025.
• iRhythm is expanding into primary care, targeting 15.5 million symptomatic patients.
• Strategic partnerships aim to monitor asymptomatic patients and prevent costly events.
• FDA remediation is over 80% complete, with ongoing improvements.

Financial Results

• Growth accelerated through most of 2024, with over 20% growth in Q1 2025.
• iRhythm holds a 30% share of its core market, with over 70% in LTCM.
• The company retained 85% of business gained during a competitor disruption.
• A third of prescriptions in the most recent quarter came from primary care.

Operational Updates

• ZioMonitor has been a success in the LTCM market for two years.
• Zio AT is performing well in the MCT category, with a 14-day wear time.
• Zio MCT, with a 21-day wear time, is on track for FDA submission in Q3 2025.
• Sales strategy focuses on a "land and expand" model.
• Over 80% of FDA remediation activities are completed, with finalization expected in Q3.

Future Outlook

• iRhythm aims to convert traditional Holter monitor users to LTCM.
• The company seeks to increase its MCT market share.
• Expansion into primary care is expected to capture more upstream patients.
• Pilots for sleep apnea and multi-vital sign monitoring are planned for later this year.

Q&A Highlights

• Clinical studies like Camelot and Avalon are enhancing market share and payer access.
• A significant market access win allows patients to bypass short-term Holter monitoring.
• The company is committed to FDA remediation and the timely submission of Zio MCT.
• Innovative partnerships are being developed to monitor asymptomatic patients.

For more details, please refer to the full conference call transcript below.

Full transcript - 2025 Truist Securities MedTech Conference:

Rich, Interviewer: Thank you. Okay. We’re gonna start the next this one? Gonna start the next thank you. Next fireside here with iRhythm.

And we have Dan Wilson, CFO, and Stephanie Zitkiewicz. Sorry, Stephanie. I always always fumble over that. But thanks for joining us, both of you, and looking forward to a good discussion here. If anyone has questions throughout the course our fireside, please raise your hand and we’ll try to try to get you to get you a mic.

So Dan, I, you know, guys are coming off, well, not really coming off anymore. We’re almost done with 2Q, but you know, the last major public update from you guys was your 1Q. Very strong quarter, growth accelerated. Would love to just get a high level view to kick us off on the market, kind of the LTCM market and kind of where we are in terms of runway. I know you have 70% share there.

Kind of what’s the what’s the runway? What drove some of those, you know, what seemed like a strengthening trends in the first first quarter and then we can dive in deeper.

Dan Wilson, CFO, iRhythm: Yep. Sounds great. Well, thank you, Rich, and thanks for having us. Excited to be here. So you’re you’re right.

We are seeing really good momentum in the business and actually an acceleration and really saw that through most of 2024 as we were executing through 2024, saw growth kind of stepping up each quarter, which speaks to the momentum in the business. And then exiting 2024 and into Q1 this year, growing in excess of 20%. So really excited about the momentum in the business, what we’re seeing. From a market opportunity standpoint, for a long time, we’ve pointed to our core market of 6,500,000 tests. That is still our core market.

We have, call it, 30% share of that market. The fastest growing segment within that market is long term continuous monitoring where we have over 70% share. So naturally, as we see more and more share shift into long term continuous monitoring, we’re in a great position to capture that and we’re really driving that transition in the market. Despite all of our success over the last ten plus years being commercial, there’s still a million and a half tests per year that are short term Holter monitors. So legacy traditional technology where the clinical evidence is very clear that is an inferior technology relative to long term continuous monitoring with Zio.

So a big opportunity to continue to drive share shift into long term continuous monitoring and grow our share in that market. And then, of course, there’s the MCT segment, also a growing segment within that 6,500,000 tests overall. There we have, call it, low teens, mid teens market share and a real opportunity for us to grow the market share there more in line with the 70 that we have in long term continuous monitoring. So a lot of opportunity still in our core market. We see growth opportunities beyond our core market.

I imagine we’ll get into that as we get into the Q and A.

Rich, Interviewer: Got it. So just maybe sticking with LTCM, long term continuous monitoring 70% share. What are the biggest hurdles you think to growing in that segment and where can that 70% get to or can we just think of you kind of holding that type of share maybe even losing a little and that portion of the market is just sustaining? And what’s the growth curve for you if that happens?

Dan Wilson, CFO, iRhythm: Yeah. So maybe two parts to that. In terms of continuing to shift away from traditional Holter monitors to long term continuous monitoring, so more of shift and then I’ll talk about our positioning within that segment. So million and a half short term Holter is still being done. Inertia and kind of changing behaviors in health care is always the barrier to bringing in new technologies.

That remains true in our case. And really, it’s generally an education, right? We’re moving more and more into primary care, as I’m sure we’ll talk about. Educating those physicians on ambulatory cardiac monitoring and the benefits of long term continuous monitoring. That’s where the opportunity is.

We’ve been generating a lot of clinical evidence to support that. We will continue to do that. And then actually, we’re seeing a lot of our cardiology customers, electrophysiology customers helping drive upstream into primary care as well and they’re aiding us in terms of the education of primary care physicians as well. So that’s in terms of the share shift. In terms of our positioning within long term continuous monitoring, you mentioned 70%.

We’ve actually seen that step up a point or two over the last couple of years. So maintaining, if not growing, our share of that market and really like our position there. We’ll probably talk about some of the clinical evidence, but Camelot and Avalon clinical data that we’ve put out there over the last couple of years. And then our new form factor ZioMonitor, which we’re now in the has been in the market, call it two years. You know, those have been pretty foundational to our success and and growing our share in the market and, you know, we’re gonna continue to innovate and win as much share of the market as we can.

Rich, Interviewer: Maybe on Camelot and Avalon, how are you leveraging those studies both in the marketplace for share and market attention, but also with payers?

Dan Wilson, CFO, iRhythm: Yeah, good question. So in our history, we’ve always generated clinical evidence, you know, to demonstrate the superiority of long term continuous monitoring relative to traditional Holters as we were talking about. It wasn’t really until Camelot and Avalon that we started to distinguish Zio from other long term continuous monitoring technologies. And I think our competitors actually did a reasonably good job, you know, up until a couple years ago to kind of draft on our success and, you know, point to our clinical evidence as if it was their own clinical evidence. Camelot and Avalon start to, you know, break that down.

And between the two, across Medicare and commercial populations, over 700,000 patients in those two study sets, and clearly showing Zio having the highest diagnostic yield, lowest retest rate, lowest health care resource utilization, and actually the best patient outcomes as well. So pretty powerful clinical evidence. It has been a great tool in the bag of our commercial team and, you know, the evidence kind of speaks for itself. So certainly with clinicians, it’s a powerful tool, absolutely with payers as well. And we’ve we’ve gotten some good market access wins on the the basis of Camelot as well.

So very important clinical data sets will continue to add to that, you know, and that’s always been part of our DNA.

Rich, Interviewer: Just when you say a market access win, can you elaborate on that? Like what exactly is that opening up and can you describe that?

Dan Wilson, CFO, iRhythm: Yeah, one good example, it was a legacy national payer, the last one to fall, but they still had a requirement where for a patient to go on to long term continuous monitoring, they had to start with a short term Holter. So they had to do a one to two day monitor first and if that came back empty or unclear, then they can move on to a long term continuous monitoring. On the basis of presenting the Camelot data, they took out that requirement and now those patients, which I think were that payer specifically was 10,000,000 covered lives, those patients can go directly to long term continuous monitoring, you know, first line.

Rich, Interviewer: Got it. Okay. That makes sense. And then, you know, just jumping to MCT for a minute, forgetting about the timing and everything, just what does that do for you competitively as you kind of sell your portfolio? You just describe kind of how and where you’re potentially kind of at a disadvantage today and leaving money on the table, if you will?

And where this will kind of hopefully allow you to get up to that LTCM type share?

Dan Wilson, CFO, iRhythm: Yes. Good question. So I mentioned the overall market. The two segments that are really growing are long term continuous monitoring and MCT. So having the two products in the growing segments of the market, I think we’re well positioned from a portfolio standpoint.

With AT, our current product in that MCT category, it is a good product and we’re seeing very good success and specifically in the last couple of quarters with Zio AT. It does have competitive advantages that our teams are doing a really good job, you know, effectively selling selling against and and really good momentum there. Zio MCT, our next generation product, is absolutely the better product and there’s a couple of factors there, Extending the wear time out from fourteen days to twenty one days. That’s important for a couple different reasons. Clinicians have a view that MCT does need to be closer to that thirty days.

Twenty one days moves us meaningfully in that direction versus fourteen days for for AT as well. It’ll be on the new form factor as well, which ZioMonitor is on and I pointed to that recent, you know, as a recent driver of the success we’re having in long term continuous. So having both of those products on that same hardware platform. I

Rich, Interviewer: just ask one thing on that? So is 21 close enough to 30 that there’s some on this or is there still a perceived disadvantage of being ten days shorter wear?

Dan Wilson, CFO, iRhythm: Yeah. I think twenty one days absolutely gets us a good chunk of the market that may not be accessible to us today. We can serve the folks that believe firmly that needs to be thirty days, we can essentially offer back to back monitors twenty one days and then another nine days to get to thirty days. So there’s other ways to serve that market. Twenty one days is sufficient for the vast majority of the market.

The ironic thing is here, you look at competitive devices that are prescribed for up to thirty days, to get to thirty days a patient has to swap out the device, the adhesive, recharge, the gateway, a lot of what we call patient manipulations that introduces friction that means the patient isn’t going to get out to thirty days. They’re gonna find it too cumbersome, they’re not gonna put it on the third or fourth time they need to versus our product with AT and MCT. Patient puts it on, that’s all they have to do and they can wear it continuously for fourteen days with AT and eventually twenty one days with MCT.

Rich, Interviewer: Okay. Now I’m gonna ask you on timing and how, you know, any updates that you can provide on Zio MCT. Do you remain on track still to submit that to the FDA by pre through ’25? What are the biggest risks to that timing then eventually approval in your view?

Dan Wilson, CFO, iRhythm: Yep. Yeah. So still tracking towards that q three submission. That’s a top priority for the company. FDA remediation remains the highest priority and ZU MCT, you know, right behind it.

So tracking to the Q3 submission, feel good about getting there. You know, still some blocking and tackling to be done, but nothing that we see that’s going to prevent us from submitting in Q3. You know, in terms of kind of after submission clearance, we’re not going to guide to that. We’ll certainly try to provide more visibility once we’re submitted and with the FDA. But ultimately what we control is submitting it to the FDA, so we’re comfortable guiding to that.

I’d say fortunately with AT and the strength that we’re seeing with that product, when we launch ZUMCT, we’re going be launching it from a position of strength. So really excited about getting that product out to market. I think that the overall opportunity doesn’t change even with the AT strength that we’re seeing. You know, as I mentioned, low mid teens percent share of that MCT market, there’s a tremendous opportunity to grow our share more meaningfully there and we believe Zio MCT is going be an important driver of that.

Rich, Interviewer: And then just within primary care, the penetration there is a priority. You’ve talked about kind of that being a key growth driver for you currently and into the future. And it feels like it’s under penetrated. So there should be some runway there. Can you size can you put some quantification around that for us from an market opportunity size for you, kind of where you are?

I think you said a third of your volumes run through the Correct. Can that go? And the pace of adoption there. Is there anything, is it just steady or is there anything that’s potentially reflecting?

Dan Wilson, CFO, iRhythm: Yeah, good question. So a bunch of different things to answer that question. So you mentioned a third of volume. That was in our most recent quarter, a third of volume being prescribed out of primary care. We last gave that metric for full year 2023, which was twenty one percent.

So that gives us a sense of how that’s grown over the last twelve plus months. We see that continuing to grow. In terms of increasing. We do. It’s a big push and we’re coming at it in two different approaches which I’ll touch on in a minute.

When you look at claims data, there’s fifteen point five million patients showing up in primary care every year with cardiac palpitations noted in their medical record. All of those are candidates for long term continuous monitoring, yet only six and a half million tests across all modalities, all care settings are taking place. So we do believe as we’re pushing into primary care, we’re going to be well positioned to capture more of those patients upstream and earlier.

Rich, Interviewer: That was fifteen point five million.

Dan Wilson, CFO, iRhythm: Fifteen point five million. And those are symptomatic patients. And I’m sure we’ll start to talk about asymptomatic and undiagnosed monitoring as well. That’s an incremental opportunity beyond the 15.5. So we believe it’s an important growth driver for our business and opening up, expanding the market and really getting patients and their clinicians answers sooner to avoid downstream impact as well.

Rich, Interviewer: Got it. And then what are the are the efforts that are underway Yeah. To to drive that faster?

Dan Wilson, CFO, iRhythm: Yep. Yeah. Good question. So I mentioned a two pronged strategy. So we’ve always had a land and expand kind of part of our business model where we would open an account typically through cardiology or electrophysiology as the clinical champion.

And then we would look for opportunities to expand within that network and it could be emergency room, neurology, nephrology, other other departments, but primary care is a big one as well. So we’ve always had that model. We’ve gotten more kind of organized and strategic in terms of how we execute on that strategy. We have structured our sales force to really deliver that land and expand model. We have territory managers that are responsible for opening up new accounts and then we have a group, key account managers and other kind of support functions that are responsible for expanding penetration within those accounts.

There’s a number of different things we could do to drive, you know, expansion there. EHR integration is a big one. That’s always been part of our, you know, part of our strategy and integrating an account into EHR just makes Zio even more seamless in terms of integrated into workflows, easier to adopt, provides access to all prescribers in that account.

Rich, Interviewer: When you talk about innovative channel partners, is that what you’re referring to?

Dan Wilson, CFO, iRhythm: That that was the second part of the two pronged strategy. So I’ll jump there. So innovative channel is now kind of a more recent development and And I would say this was always viewed as a when, not if part of our business, but really have started to see this show up starting twelve, eighteen months ago and seeing really positive early signs. And these are groups, kind of value based care entities and the common denominator is they own the risk of the patient and make the decision, you know, the clinical decisions for those patients in an integrated, you know, payer and provider type of organization. They are, certainly they can adopt Zio for symptomatic patients.

They’re seeing symptomatic patients and they’re generally primary care physicians. But what we’re seeing more and more of is now taking the step to proactively monitor asymptomatic or undiagnosed patients. And there’s a lot of clinical evidence that has been generated. We’ll continue to generate clinical evidence to show you monitor these patients, you are going to find undiagnosed arrhythmias. And importantly, if you you could either choose to proactively monitor these patients and diagnose them with Zio, you know, upstream before a clinical event, or you can do nothing and these patients are likely going to show up in the emergency room and get diagnosed there.

That’ll cost you $15,000, right? So moving this upstream, finding the undiagnosed arrhythmias earlier to prevent these clinical events and reduce hospital utilization has been a meaningful driver behind this. Again, we believe we’re early, but see the opportunity.

Rich, Interviewer: Is that the Signify?

Dan Wilson, CFO, iRhythm: And That’s one of them. Yeah.

Rich, Interviewer: What are just remind me some of the others that we should be focused on or any Yeah. Anything?

Dan Wilson, CFO, iRhythm: Yeah. Some context I can give there. So there’s kind of five accounts that we’ve named publicly, Signify being one of them. I’d say probably a dozen that we have that we’re actively either in programs with or contracting with. That’s kind of the near term group that is contributing to growth this year.

There’s another group, call it forty, that is kind of our near term pipeline, the group that we’re actively engaging with and looking to sell these programs into. And then a full population identified, call it 100 accounts. So believe we’re just getting started. What’s what is unique about these groups is they’re managing, you know, a large number of patient lives and it it is a one to many selling model for us where we’re selling into the top of these groups top of these groups. They’re making the determination to, you know, monitor a certain portion of their population and driving that education and utilization from the top down.

So a really powerful model for us, and I’d say we’re uniquely positioned there given our scale and our ability to meet some of these volumes that are, you know, that these accounts are looking for. And I would say that’s a differentiator for us relative to our competitors that is true today that maybe wasn’t true, call

Rich, Interviewer: it two or three years ago. And as I think of some of the opportunities outside of symptomatic, you know, the asymptomatic and then even thinking through sleep apnea. Can you talk a little bit about which are the closest at hand and what it’s going to take to unlock those? And when we should realistically start to be thinking about those?

Dan Wilson, CFO, iRhythm: Yeah, good question. So that’s the other great thing about moving into primary care. I mean, that is a strategically important initiative to open up additional patients to us, right? Unlike cardiology, primary care physicians are seeing kind of all patient types. So as we’re successful there and continue to be successful there, there’s going to be other adjacent market opportunities opening up for us.

I’d say sleep is probably the nearest term one and we’ve been talking about that. We’ll have pilots launching there later this year. And then I’d point to multi vital sign monitoring and think about that as our next generation beyond Zio MCT. And this is where we’ll start to bring other vital sign or other monitoring parameters onto the platform, onto the device where we can be monitoring for SpO2, blood pressure potentially, respiratory rate, parameters, other signals that allow us to give deeper insights and broader insights. So that will be the platform that helps open up these adjacent markets from a channel standpoint.

Think about primary care as the channel to open up those opportunities.

Rich, Interviewer: Do we think of all of those additional parameter offerings as internally developed or these are things you need to go and supplement with external DD?

Dan Wilson, CFO, iRhythm: We did do a licensing transaction last year with a company called BioIntellisense. We licensed technology to some of those parameters. Believe that’s going to move us down the path and have internal teams working on the development there. It is Zio FDA remediation and Zio MCT are higher priority. But we do have teams actively working on this.

If we see something external from iRhythm that is gonna move us, you know, faster down the path, we’ll certainly consider that and maybe a little bit like how we saw the opportunity with BioIntellisense last year. So believe we have enough to move this forward internally, but certainly we’re going to look externally and won’t be shy if there’s an opportunity that moves us down the path meaningfully.

Rich, Interviewer: Just going back to the 1Q and 4Q to 1Q, what feels like a step up in growth and it’s kind of consistent now, it’s two quarters in a row and it’s I guess, one, investors have asked me, hey, how much of that is due to some competitor issues that just might be spilling over from Phillips? Where are we on that? And then two, not that this is a bad thing or that it’s transient, but there is PFA kind of going on in the backdrop. That’s an extremely fast growth category. I would imagine that as you have more procedures, EP procedures, because there is some incremental procedure contribution from that new product category that might be spilling over to more monitoring, right?

So can you just help us think through those more secular tailwinds and the degree to which those are benefiting you and how durable or sustainable they might be?

Dan Wilson, CFO, iRhythm: Yeah. Yeah. I’ll come back to the PFA one. So as we as we, you know, set up the year, we saw, your point, a competitor competitive disruption, you know, in the q three, q four time frame, really really centered in the q four time frame. Won a good amount of business during that disruption and did a lot to retain that business.

And but as we set up the year, you know, and set initial guidance for the year, we were only a couple months into that and wanted to be careful not to get ahead of ourselves. We wanted to make sure we were able to retain that business before really baking it in. Through q one, you know, we estimate we retained, call it, 85% of the business that we won during that disruption. So feel really good about that sustaining through the remainder of the year. We did factor that into guidance when we updated guidance in May.

And then I would also say, even independent of that, you know, competitor disruption, we are winning good, you know, good business with AT kind of independent of that disruption. So feel really good about the momentum in AT and that sustaining through the year, which is why we, you know, updated guidance the way we the way we did. In terms of PFA as a driver of the business, absolutely, it’s a tailwind. The volume, you know, numbers or procedure volumes, it’s on the lower side when you think about our total market size of six and a half million tests. So I would I would stop short of pointing that to, you know, as the number one driver of our overall market and and growth.

But it is is absolutely a tailwind. There’s energy and excitement in electrophysiology that hasn’t been there for some time and, you know, there is motivation to find patients that are candidates for PFA. So absolutely a tailwind. I wouldn’t point that out as kind of the number one driver of our business, but certainly helpful.

Rich, Interviewer: So Dan, aren’t you glad that 90% of the conversation so far has not been about remediation compared to this time last Happy

Dan Wilson, CFO, iRhythm: to go there but Okay.

Rich, Interviewer: I’m gonna put the last few minutes on because it’s very important. Maybe just update us on where you guys are on the remediation efforts. What milestones, if any, we should be thinking about or on the lookout for as the FDA comes back and reinspects and things of that sort? How do we think about any of those potentially impacting MCT?

Dan Wilson, CFO, iRhythm: Yeah. Yep. Good question. And happy to spend time here. It is our number one corporate priority, as I mentioned.

You know, when the four eighty three observations came that July, August time frame last year, you know, we we took the position this needs to be number one corporate priority. You know, we can continue to innovate, but none of that’s gonna matter unless, we have the foundation as strong as it needs to be. So we have really made that a priority over the last ten, twelve months. We brought in a new head of quality and regulatory that has been an incredible value add to the business and making sure we’re meeting our timelines and commitments that we’ve laid out to the FDA. In response to the four eighty three observations back in August, we did submit a twelve month remediation plan to the FDA.

We’ve continued to execute and hit every timeline and commitment, you know, that we laid out to the FDA at that time. We’re over 80% completed with those activities and should have that wrapped up in the q three time frame. We are going above and beyond that. So there will be kind of more remediation work or really think about it, you know, really transforming our quality management system holistically and working with an independent outside firm, highly reputable, that will help us do that last bit, which by the way was all voluntary. This was not part of what the FDA asked for, but we wanted to show our commitment and really build that foundation, as I was mentioning.

Those activities will take us through the remainder of the year and feel good about, you know, continuing to hit all those timelines.

Rich, Interviewer: I’m just curious on that last piece. Is it possible the FDA comes in before you’ve begun to implement those above and beyond steps that I would presume were anticipatory of where the FDA could go down the road, so why be reactive? Let’s be proactive. Is there a chance that the FDA comes in, looks at what you’re doing, says fine and still issues observations pertaining to those things that you haven’t yet been able to implement or is more of a dialogue? The FDA knows what you’re doing, they can see that.

So that probably is less likely.

Dan Wilson, CFO, iRhythm: You started to ask the question, is it possible? Yes. Everything’s possible. Everything’s possible, certainly. I do think, you know, we are highly communicative with the FDA.

We’ve had good meetings, recent meetings with the FDA. We are keeping them updated in terms of our plans and intentions and, you know, I’d say the tone there is very positive and I think they see our commitment, understand that we’re going above and beyond. So, you know, feel good about really what’s in our control, which is executing against that plan. And until they tell us something different, you know, that’s that will remain our plan.

Rich, Interviewer: And just relating all this to MCT. Yeah. Is it like, how how would MCT be delayed if at all from these remediation efforts and or setback? Like, are they somewhat separated?

Dan Wilson, CFO, iRhythm: Yes, somewhat separated. Keep in mind we did push out ZOMCT timing from what we were originally thinking because of the remediation activities and what we kind of heard from the FDA. So we took additional steps, again voluntarily, to work in some additional testing, make the submission more robust and make it, you know, in line with how we believe the FDA is viewing things. So, you know, continue to feel good about that Q3 submission and then we’ll get feedback from the FDA following the submission.

Rich, Interviewer: Great. We’re rushing up against time here. Not really enough for another question, but thank you Stephanie, Dan. Really appreciate you being here. Thank you.

Dan Wilson, CFO, iRhythm: Thank

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