iRhythm Holdings, Inc. (IRTC) Earnings Call Transcript & Summary

Ladies and gentlemen, thank you for standing by, and welcome to the iRhythm mSToPS Update Call. [Operator Instructions] Please be advised that today's conference is being recorded. [Operator Instructions] I would now like to hand the conference over to your speaker today, Kevin King, CEO. Thank you. Please go ahead, sir.

Thank you, operator. Hi, everyone. Thanks for joining our call this afternoon. Before we get started, I want to remind everyone that we'll be making forward-looking statements during today's presentation, and we encourage you to review the risk factors included in our most recent filings with the SEC. As you already know, iRhythm participates in a large and growing market for the diagnosis of cardiac arrhythmias for symptomatic patients. And that we're making great progress and substantial inroads into becoming the leader -- leading provider of services with our highly differentiated Zio platform. Today, I'm pleased that Dr. Steve Steinhubl is here with us today to discuss the 3-year results of a real-world study, mSToPS, that is focused on a new opportunity, the detection of silent atrial fibrillation in at-risk asymptomatic individuals. We believe this opportunity is possibly several times larger in size than our core markets today. And earlier today, Dr. Steinhubl presented the findings of this 3-year study at American Heart Association Meeting. With that, I'll turn it over to Dr. Steinhubl. Dr. Steinhubl, thanks for joining us today.

Thanks, Kevin. I appreciate the opportunity to discuss the study. And from the beginning, your support of the study. I'm going to start for everybody following the slides on Slide #5 as a background that I'll go through briefly, but I think it's important to understand the scope of the problem. So atrial fibrillation is the most common sustained arrhythmia in the world. When you look at adults over age 55, the lifetime risk of developing atrial fibrillation is about 40%. And even though a lot of the focus on screening for atrial fibrillation, asymptomatic atrial fibrillation is appropriately based on stroke prevention, it's really important to recognize that atrial fibrillation is an independent risk factor for more than just stroke. In fact, it's a stronger independent risk factor for developing heart failure and almost a strong risk factor for cardiovascular mortality. If you look at the slides in the center or the diagrams in the center of this slide, the one on the left is a graph from a real-world evidence of 186,000 Medicare beneficiaries with the new diagnosis of atrial fibrillation with no clinical issues in the 3 months beforehand. So with new onset of atrial fibrillation and looking at over 5 years follow-up, that -- the colors are hard to tell on the slide, but death is by far the highest risk clinical event that occurs. Next is heart failure and third is stroke. So it's really death, heart failure and stroke and then others. But death is a major component of that. And we know from another study shown in the pie chart that cardiac cause of death is by far the leading cause. About 46%, actually less than 6% of death is related to stroke. Because atrial fibrillation is frequently not diagnosed until the time of serious clinical event, so in AFib-related stroke, it's about 20% to 50% depending on the study, and about 21% of people who present with atrial fibrillation heart failure, atrial fibrillation presents at the time -- at the same time as their heart failure does. And the 39% is before the heart failure, so presumably actually contributing to the heart failure. But because those are the episodes we definitely want to avoid, and that's really the main driver of screening asymptomatic individuals for atrial fibrillation so that we can prevent all serious complications of atrial fibrillation. So next, we'll go to Slide 6. The mSToPS trial was actually started maybe 5 years ago, 6 years ago, its primary focus was on looking at the value of the iRhythm Zio patch in screening asymptomatic individuals for atrial fibrillation, that's been reported in JAMA paper in 2018. Today, what I presented at the late-breaking sessions at American Heart Association was a key secondary goal, and that was to determine if screening for atrial fibrillation by wearing a Zio patch can improve clinical outcomes at 3 years after that initiation of screening. On the next slide, on Slide 7, is just a very brief overview of how mSToPS was carried out. Initially where it was done within the Aetna's -- among Aetna member population were individuals who are eligible met inclusion criteria. And I would say it's a moderate risk population, not necessarily a high-risk population that we are studying. Almost all of the study was done digitally, outreach, consent and after enrollment, individuals were sent a Zio patch to their home at the beginning of their monitoring and then 3 months later. So each individual wore 2 Zio patches or vast wore 2 Zio patches, and it turned out on average, it was about 25 days of median time of monitoring on those 2 patches. All the participants were sent their Zio patch results. If they had anything actionable, I talked to them also. And then all participants were asked if that it was okay for us to share with their providers, anybody with anything actionable agreed to that, and then we sent the results to the provider. But importantly, we didn't guide them as to what to do with the results. We just sent them the results as they were. The next slide just shows in the green box, what this analysis and it's somewhat complicated, how we got down there, but it built off of the per-protocol population. The per-protocol population are the individuals who actually wore the heart monitor. One of the mistakes I made in designing the trial is, I didn't account for the gap after people had signed up. And so about 1/3 of people never wore the patch, but that's a failure of my trial design, not a failure of the monitoring. But the key goal that we wanted to look at was looking at the outcomes of monitoring versus no monitoring. And so we looked at the per-protocol population. That turned out to be about 1,718 actively monitored participants. And we compared that with an observational control cohort that was matched for age, sex and CHA2DS2-VASc score. Because of the way the trial was designed, where there wasn't a face-to-face enrollment, which there's good and bad to that. One of the downsides were none of us felt it was ethical to actually send an outreach to somebody and say, "You may be at risk for atrial fibrillation and stroke. We want you to join the study," and then randomizing them to potentially receiving a placebo. So having the observational control, we thought was a key to keeping this trial as being participant centric. On the next slide, Slide 9. Just showing the primary outcomes, which was the time to first event or the combined endpoint of death, stroke, systemic embolism or myocardial infarction. This was determined via claims data at the claims data. We had prespecified that analysis to be carried out in 2 groups in -- first, in everybody who is diagnosed with the atrial fibrillation during that 3-year period. And then secondly, in the overall -- in the entire per-protocol population. The primary safety endpoint was the incidence rate of hospitalization for a primary bleeding diagnosis. The next slide shows the cumulative atrial fibrillation rate. This was over a median of 29 months of follow-up. In the control cohort, the AFib rate was 7.7%, 11.4% in the actively monitored. So actively monitoring associated a significantly higher rate. Difficult to tell on the slides, but after 18 months, the actively monitored rate had approximately a 1% -- absolute 1% lower rate of new AFib than the match control. So we anticipate over the next several years that curves would catch up with each other. It's important in the actively monitoring cohort that 32%, roughly 1/3 of everybody who were diagnosed with new AFib was diagnosed by the patch initially, whereas 2/3 over the 3-year period were diagnosed clinically. You can see by the curves that all of the -- obviously, the patch was very early in that. In individuals who are diagnosed with atrial fibrillation, only about 45% were started on anticoagulation, which unfortunately reflects real-world results and is reflective of care being up to the discretion of the individual's primary regular physician to make that decision or not. In the next slide, which is Slide 11 so these are just the baseline demographics. As I mentioned, we are matched for age, sex and CHA2DS2-VASc score. So in both groups, mean age was roughly 74, about 40% female and median CHA2DS2-VASc score of 3. You noticed that for other comorbidities, there were imbalances in both groups, a higher rate of previous stroke in the actively monitored arm, but a higher rate of prior myocardial infarction in the observational cohort. So these differences, so we focus on the adjusted primary outcome, and we adjusted not only for all the measured baseline comorbidity differences, but also Charlson Comorbidity Index as well as baseline health care utilization. So differences in health care utilization among the different groups. The next slide shows the primary endpoint. On the left is in the entire cohort, about 1 per 100 person year lower. Significantly lower rate of the combined endpoint in individuals in the actively monitored arm that was statistically significant of adjusted hazard ratio of 0.79. The majority of this difference was driven by the difference in individuals who were diagnosed with atrial fibrillation, which was a 5.4 per 100 person year difference with an adjusted hazard ratio of 0.53. When you look at the mode of diagnosis, which is the next slide, Slide 13, and I show this primarily just for mechanistic consideration. But you'll note that not surprisingly that clinically diagnosed, both in the actively monitored arm and control arm had very similar event rates, which we'd expect because they essentially were at the same risk of presenting with atrial fibrillation as at the same time as heart failure at the same time as a stroke or a clinical event. And you'll notice that the people -- the population that really benefited were individuals who were diagnosed early and asymptomatically through the ECG patch. The next slide shows the safety endpoint of -- that showed that active monitoring is actually associated with the significant decrease in hospitalizations for bleeding. Interestingly, even though it's been mentioned, this may seem counterintuitive, actually, this is very consistent with the Scandinavian registry that found in AFib population that when anticoagulations were started as inpatients relative to in the outpatient setting, that inpatient initiation on anticoagulation was associated with a significantly higher rate of hospitalization for bleeding in the following year. And so we anticipate the mechanism for this is because of that initiation more likely as an outpatient than an inpatient. So finally in conclusion, show that our study -- the mSToPS study demonstrated the active screening for atrial fibrillation as part of a prospective, very pragmatic, direct participant, nation wide study was associated with significant improvement in clinical outcomes as well as safety at 3 years relative to routine care. We'd also say that independent replication of these findings is required in order to be confident that aggressive pursuit of diagnosing atrial fibrillation in people at high risk, but without symptoms is warranted. And I'll pass on. Speaker, I think, Dan, you're going to speak next.

Yes. Thank you, Steve. Really appreciate it. First, I would really like to thank you for all of your efforts involved in designing and running an important trial that aims to better the standard of care and improve patients' lives. And a big thank you to all the mSToPS participants as well. Before opening up for questions, we wanted to spend just a couple of minutes to talk through what we see on the horizon from a market development standpoint as well as touch on iRhythm's kind of near and midterm strategy around silent AF. So first, starting with the market opportunity on Slide 17. As you know, and as Kevin mentioned, we operate primarily in the core symptomatic, an ongoing management market today, which we estimate to be more than 5 million ambulatory cardiac monitoring tests annually. We are less than 20% penetrated in this market and continue to focus on driving adoption of Zio and establishing Zio as the standard of care within this market. And what we were talking about today is the silent AF market opportunity or the asymptomatic or undiagnosed AF market. We estimate that there are over 10 million individuals that have risk factors of AF that make them high risk of having undiagnosed AF. And as Steve noted, there is a nearly 40% lifetime risk of AF for individuals over the age of 55. So very, very prevalent. And unfortunately often, not diagnosed until the time of a clinical event such as stroke. Today, proactive monitoring is not done for these individuals. Our effort in this market is to detect AF earlier in a lower cost setting and to avoid devastating downstream clinical events such as stroke, heart failure or death. Now turning this slide here to Slide 18. So looking at where we are from a market development standpoint, developing this market, like any good market in health care, requires generating ample clinical evidence. And specifically, clinical evidence that supports the hypothesis that targeted detection of AF improves clinical outcomes, lowers health care resource utilization and ultimately reduces cost. And that clinical evidence is coming together and certainly advanced meaningfully with today's mSToPS 3-year clinical outcomes. This is the first time that targeted detection has been linked to improved clinical outcomes. And we've seen from earlier studies that targeted detection can have a positive impact on health care resource utilization as well. So making very good inroads, but certainly more evidence is better. And more evidence is likely needed to impact clinical guidelines and to continue to bolster the value proposition that we look to deliver to payers. The good news is that there are a number of trials ongoing, and we have listed a few of them here. I won't go through all of them, but these include STROKESTOP , which could be reading out soon as enrollment has now closed; and GUARD-AF, which we're participating in, which is a large randomized clinical trial that will also report on outcomes. And we're also not done with mSToPS. We are looking forward to the publication of the results presented today and also expect to have the economic outcomes reported sometime next year. And as we look at the clinical evidence being generated by these trials, I think it's important to note that we believe it will also highlight the differentiated value of continuous ECG monitoring with Zio. Over time, we believe that the evidence generated from these trials if positive, can influence clinical guidelines, which are mixed in their current recommendations. As noted on the page here, the European Society of Cardiology recommends opportunistic screening for individuals over the age of 65, those who are hypertensive or have obstructive sleep apnea. And they also recommend systematic ECG screening for those over the age of 75 or at high risk of stroke. The United States Preventative Services Task Force or the USPSTF, however, recommended in 2018 against routine screening, citing insufficient evidence. I would note, though, that the USPSTF recently opened a review and research plan to revisit the evidence. Overall, we are very excited about the clinical evidence that has been generated to this point. And the ongoing interest and engagement from the physician community to continue advancing the standard of care through clinical research. Now turning quickly to our next slide here, covering iRhythm strategy in silent AF. Our initial go-to-market strategy revolves around taking an mSToPS-like model to payers and implementing targeted AF detection programs using Zio. We believe the evidence generated to date, notably, a reduction in health care resource utilization and improved clinical outcomes provides a compelling value proposition for payers. Payers motivated to reduce stroke in their population now have a model to consider to do just that. I would also note that due to COVID, there is more undiagnosed AF in payer populations than there was a year ago. And we know that these individuals, if not diagnosed and treated, have a 5x increased risk of stroke. That's a virtual care pathway that delivers patient care independent of patient location, can help address this unmet need. And this will form the basis of our early commercialization efforts. And as we roll out these programs, we expect to learn a lot, refine our business model and ideally develop a turnkey solution for our customers. Longer term, we're also focused on continuing to strengthen our value proposition, which includes a number of different facets, but essentially boils down to delivering more benefit for every individual monitored. That could be done through better enriching patient populations, through higher detection rates, potentially from longer duration monitoring and better patient engagement that ensures the right follow through, the therapy and intervention. We believe that our strengths and capabilities, including our patient database, our data analytics capabilities and, of course, our long-term continuous monitoring platform position us well to continue to improve the value proposition over time. In closing, I'd like to summarize by highlighting a few points. First, we are really encouraged with the recent developments and are increasingly optimistic on the market opportunity following the mSToPS data today. Second, we have an early go-to-market strategy with a compelling value proposition that improves patient care and reduces health care utilization. And during our initial commercialization efforts, we expect to learn a lot and expect to refine our go-to-market strategy and business model over the next several months. And not only do we see a clear path to the market developing, but we believe our strategy positions us well to be a market leader. And most importantly, we are looking forward to continuing to establish a better standard of care and improve the lives of patients. With that, we would like to turn the call over to questions. Kevin, Judy, Doug, Dr. Steven Steinhubl and myself are all available to answer any questions. Operator?

[Operator Instructions] Our first question comes from the line of David Lewis from Morgan Stanley.

Maybe just one for the doctor and a couple others. Dr. Steven Steinhubl, I just wonder, given the matching dynamics that you kind of walked through here in this trial in the 2 cohorts, what do you see as the strongest piece of clinical evidence that sort of emerged from this trial. And I wonder, do you think it definitively answers the question about whether placing a Zio on a moderate-risk patient is cost effective?

I believe it will prove to be cost-effective, but I think the formal cost analysis will have to look at that. But we showed in our 1-year health care utilization that we did increase cardiology outpatient visits. But at the same time, decreased ER and hospital visits. So it seems like very likely. And then when you look at cost effectiveness, so we not -- there are very few interventions that have been shown to decrease mortality, which we did show in that. And so to me, the strongest outcome of this is the primary outcome and showing we achieved that. I can't remember, you may have asked another part in there, I didn't answer, sorry.

Just in terms of the -- the cost-effective piece, but the strongest pieces of clinical evidence that you think that emerge in this trial were the things that surprised you the most?

Well, I think the mortality benefit surprised me, but I think the strongest evidence because it is the first time this evidence available is that we showed a significant clinical benefit. And this is in a population where historically, one of the benefits of the Zio is you find -- you're able to find lower burden of atrial fibrillation. And the discussion around burden has always bothered me that because it's still a measure of a risk factor or something going on. But even despite the fact that the median burden of less than 1% that we still had a significant impact on clinical outcomes. And also, I'd point out that the way mSToPS was designed, it was really kind of exploratory in the sense that if implementing this clinically, you wouldn't say, okay, we're just going to give somebody 1 Zio or 2 Zios early and then do nothing because you look at the AFib cumulators. So what this tells us is that not only is it beneficial to do it earlier, but even you could do it in a serial way and whether that's every 6 months or every year, where somebody identified the right high-risk person gets identified do that where you could really have a substantially even greater benefit.

Okay. And just maybe a quick one for Kevin and Dan, maybe a couple. The first would just be, obviously, Aetna sponsored this trial. I'm kind of curious Kevin, how you would -- how you plan on engaging payers. Do you think that, on one hand, I say guidelines changing may be necessary to move the payers, but then I've seen with Kaiser KP study in the past you've had impact on specific institutions with Zio data. So to really move this market, is it going to be subpopulations of analysis that are going to be required? Can you move payers with this data? Or is it going to require guidelines moving or studies like GUARD-AF to really move the market into asymptomatic patients?

Yes, sure. David, it's Kevin. Look, I think with the 40% reduction that was demonstrated here, both payers and providers are going to prefer to manage patients in a preventative way than to wait for bad things to happen. And so sort of in the absence of even more data, I think what we've got here is compelling proof or compelling evidence that early detection of AF, one, saves lives, which is what Steve just mentioned on the mortality side; and two, that major adverse events can also be improved upon. And these things are going to be important. And from my understanding of how health care professionals think, they would rather treat people preventatively than to wait for disaster to happen. And this is critically important for providers that may be capitated whether it's a Kaiser or a large integrated delivery system that's capitated or a payer that doesn't want to bear not only the cost, but prevent the downstream adverse events from happening. So I think we've got sufficient evidence here to open up the market. At the same time, I don't think that markets that have 10 million potential patients open up like a light switch just on or off. This is going to be a gradual market development, but there is compelling evidence here. And on the horizon of this will be further economic evidence or data that Dan highlighted as well as other studies that are coming in. Judy or Dan can highlight some of those -- status of some of those studies as well. But Dan or Judy, anything you want to add to those 2 comments?

Yes. No, it's great, Kevin. The other point that I would like to just emphasize is that Aetna had reached out because they had, had a problem with stroke rate in their Medicare Advantage population. So the problem to be solved was how could we really stop the stroke rate in their population. So that's why Aetna reached out to Steve and Eric Topol at Scripps to really help solve for this problem. And so I think that was the genesis. I think as we're looking to health plans, that's the problem to be solved. And again, on the status of the studies, as Dan shared, the AMALFI study, SCREEN AF, mSToPS and GUARD-AF, all our Zio studies are using the continuous ECG, which we believe is very important in screening for AF as well.

Our next question comes from the line of Robbie Marcus from JPMorgan.

This is actually Allen on for Robbie. So I guess I wanted to start off with kind of a question about the timing of like a sales benefit, right? Because I think the tone you guys have taken on today's call has kind of like been the closest to a kind of commercialization mindset, I guess, I would say, than what we've heard from you previously. So you've obviously highlighted that there is going to be like the continuous need for more data and that mSToPS isn't like the final step, but it is a very important one. So how do we think about your ability to kind of start generating revenues in this segment with today's Zio XT? Or do -- as you've highlighted, do we need to see a device with longer wear or like more kind of value-add to patients to really start getting revenues in this segment?

I think what Dan was characterizing was that our market development efforts are now underway. And they are underway with the current technology that we have, Zio. And I think to Steve's point that he made on his prepared remarks, whether it's 1 Zio, 2 Zios or Zios applied sequentially over time or in a predetermined or prespecified time frame, there's value to be created there. Now we're not going to guide here to when we think we can generate revenue, but those market development activities are underway, as Dan had mentioned. And as far as our relationship with Verily in building out our end-to-end system, this is meant to fortify that position that we have where we can continuously monitor patients for even longer periods of time, 4 to 6 months or 7-month period of time. And hopefully, improve upon these rates of detection. Dan, do you want to add anything?

Kevin -- yes. So I would just add a couple of points. And maybe just a finer point. I would characterize our early commercialization efforts more as learning and business model development rather than revenue generating. I would characterize our efforts over the next 12 -- call it, 12 months around those vectors, less so from a revenue generating standpoint. We certainly hope as we learn, and develop the business model that translates to revenue generation, I would suggest it's too early to start building that in.

Got it. And then -- I'm sorry. Just a quick one. On the reimbursement front, would usage in the asymptomatic patient population be something that's kind of already covered under your existing label? Or is that another step that you'd also have to take? Or would that -- is it technically covered from maybe an expansion of the label would help adoption? Anything on that front?

Yes. I think a big part of the market development activities here are first going to be done with payers or capitated health plans. So the idea of submitting claims is less important. It's really about an economic model that provides a return to the health plan in exchange for providing the preventative service that we're providing here with Zio. So I think a bit more like a net risk or a capitated model. It's certainly contemplated in our CPT permanent codes that longer duration, repeat monitoring, things of that nature can be applied. This study here showing 25 days of monitoring certainly helps. At the time of the CPT editorial panel meeting, we presented a study of [ MASUS ] study that was done on individuals that had 28 hours of monitoring, and we'll continue to build that evidence base that long-term continuous monitoring through a wearable sensor will be validated and valued by the appropriate entities over time. But initially, I would think of this more as a capitated at-risk or risk sharing type business model to be developed along the lines of what Dan was saying. This is early market development work for us to figure out how best to not only capture the value, but capture the right revenue streams and so forth. Dan, anything to add there?

No, that was great.

Our next question comes from the line of Joanne Wuensch from Citibank.

A question for the doctor. Could you please talk about the different or individual components of the primary endpoint? I'm most interested in stroke.

So in the overall cohort, there was about a 40% reduction in stroke, but that was not statistically significant. So the p-value was 0.06. In the AFib-only population, it was substantially lower. It was half -- less than half the risk. I'm saying that because I don't remember exactly, but less than half the risk. It was highly statistically significantly different. There was no difference in MIs. There was again, a strong trend towards a decrease in systemic emboli and then a significant reduction in mortality.

And are any of those individual -- the 4 components particularly important to you? Or do you look at the collective and evaluating the success of this trial?

Well, we -- when we designed it, we powered it where we felt like we only had the power to be able to find a significant difference in the combined end points. I'm always thrilled to see a mortality benefit since -- I mean really, there's virtually no cardiovascular intervention or very few cardiovascular interventions, especially something as easy and noninvasive as AFib screening that's been shown to have a mortality benefit. So I could tell you, if you had asked me 5 years ago, if we show a mortality benefit, I would have said probably no way. So I'm excited that, that is. And obviously, stroke reduction is a major part of it, but stroke is a much less common endpoint than mortality. So it's just really in how we were -- a study that ends up being powered based on how many you're going to enroll, what you anticipate. So again, we powered it for the combined endpoint just for that reason.

And then for economic data, can you set the time frame, either management or the doctor, what we should expect and when we should expect it? And do you need that data in order to really move forward in a more constructive way towards commercialization?

Yes. Joanne, it's Dan. On the economic data, I would -- we said sometime next year, I think you can think about mid-next year or later. In terms of whether or not that's needed to go to market, I believe it will certainly help if it does show what we believe it will show. But I think there is still a compelling argument to take the market today. And in fact, if -- now that we've shown statistically significant improvement in clinical outcomes, I think almost lowers the bar for what we need to show from an economic evidence standpoint, even if we're cost neutral, but improving clinical outcomes, I think that there's clearly value in that as well.

Our next question comes from the line of Margaret Kaczor from William Blair.

First one is for the doctor. We're talking a lot about stroke. You've mentioned a few times on the anticoagulants that they maybe weren't used as much as they should have to potentially drive that stroke benefit. But does that say anything on the development of the market? Or are you going to not only need to find these patients, but still figure out the best way to treat them?

There's always a little bit of that. And I think it's a great question, and I could spend a lot of time talking about that. So there's always an issue of the implementation of evidence-based care and making the -- creating that system of care that can do that. I think when you look at many of the other trials, so the SAFER AF trial was recently presented and very recently where they had a much higher, and Judy, perhaps can correct me, but I think it was like close to 90% anticoagulation used in the AFib diagnosed individuals in that. And that is when it's -- the physicians are actually involved in kind of looking for the atrial fibrillation. So in that study, they were involved, whereas ours was a participant-centered, participant-focused and then the information passed on next. And unfortunately, then what happened is the low anticoagulation use was up -- left up to kind of the general practice. I think or I'd easily envision in a system where we kind of actively involve screening and have engagement and buy in by the payer, by a provider that it would be much -- the bar for starting anticoagulation would be much lower. So I don't think it requires much of a nudge, but I think it would require somewhat of a nudge.

And for the iRhythm team, on that same note, do you expect any pushback from payers on that lack of stroke benefits since that's probably more of the cost aspect for them? Or do you think that lower hospitalization utilization can overcome that? And that leads to death and mortality benefit?

Margaret, it's Dan, and Judy and Kevin can chime in here. I do think the overall improvement for clinical outcomes, there was an improvement in stroke, not statistically significant for stroke alone, but overall, with the other endpoints, there was a statistically significant difference. And we believe there's value there. Add to that, the reduction in health care resource utilization that we've shown previously, I think that's another element of value. And then if we can add the economic evidence to that as well, I think there's -- you start putting that all together, and there's very few things left to poke holes in. But like we said in our prepared remarks, we believe there is a compelling value proposition to take to payers today. With a model like mSToPS, we still have a lot to learn as we go into those efforts. But we believe that we are starting with a compelling value proposition. Kevin or Judy, anything you'd add to that?

Yes, I would add or reiterate some of the comments made by Steve and by Judy. So Judy made the comment that Aetna felt the pain and proactively sought us out for the study, right? That they are feeling what Steve described, the 40% lifetime risk. The independent risk factors for heart failure, for cardiac mortality, things of that nature associated with AFib and that's not having a diagnosis until these events occur is problematic for them. So I think there's enough evidence there to continue to have payers continue to initiate these types of studies. And I'm very hopeful and very optimistic that the study here will produce action from payers or by health plans that are capitated. These capitated organizations have to proactively manage patients because the effects of this are disastrous. When you think about heart failure or stroke on the economic system, not undermine the patient pain that happens here as well.