Welcome back to the Citizens Life Sciences Conference. Next up on our MedTech track, we're joined by AtriCure. With us here is CFO Angie Wirick. Angie, thank you for coming and.
Thank you.
Welcome to Miami.
Thank you.
I guess, just to start, you know, you gave initial 2026 guidance at the beginning of the year. Organic growth expectations are 12%-14% on the top line, another year of double-digit growth.
Yep.
I was hoping you could just give us a little more color on what is going into those assumptions, what gets you to the high end of the range, what's baked into the low end of the range. Any puts and takes there would be great.
Yeah. When you think about our business, the 12%-14%, just for perspective, a slight uptick from what we guided to start 2025. You know, our guidance philosophy unchanged from prior years. We do expect that given a couple of really strong product launches in our main areas of focus for the company, that that's gonna really drive, you know, accelerated adoption in 2026. We saw that a bit in 2025, but expanding further in 2026. Pain management as a franchise, this is an area where we had a couple of new product launches within the past year, expecting that to outpace kind of the other franchise growth rates there. Still low penetration within our thoracic market.
We're also launching a new device to cover pain management in amputation procedures, so that's another area of upside, I think for the business as we continue to develop and mature that market. Within our open heart surgery area, so cardiac surgery, when you're treating a patient concomitant to, you know, a principal procedure there, our ablation and our appendage management tools, both of those have benefited from, you know, I can't call it a new launch anymore. The EnCompass clamp has been around for a while, has benefited from really steady continued adoption. In our AtriClip or appendage management area, that particular area has benefited from a new product launch. We continue to see heightened adoption, also an ASP uplift in that area. That area expected to be kind of in line with the company guide overall.
Rounding out the full business would be our standalone treatment of Afib, so our hybrid business. Expect that to be a headwind, but less so than what we saw in 2025. Still down, but declining less than we saw in 2025. You know, we're hopeful as we exit 2026 that the outlook here looks brighter than it did, you know, kind of starting this year.
Great. No, it's a perfect segue as wanted to focus on the segments.
Yeah
With that in mind. Open ablation, you know, grew high teens in 2025. That was an acceleration over 2024, so really impressive growth. On the EnCompass clamp, which you mentioned, that, you know, launched in 2022, so really long tail of growth.
Not a new product launch anymore, right?
What's that?
Not a new product launch anymore, correct?
Not anymore, but it's, you know, volume's still great and still contributing.
Yeah
really nicely. You mentioned, you know, seeing really strong adoption there, but I guess could you talk a little bit more about those dynamics? I know you're in, I think around 830 accounts or so.
Yes.
Where could that go, and how should we think about that moving forward?
EnCompass clamp, you know, if you take a step back, what that product did when we launched was take a pretty difficult procedure, very effective procedure, but a more difficult one and time-consuming. 30-45 minutes was kind of the legacy open ablation procedure. Skilled surgeons, easy for them to do, but this was, we heard consistently, a barrier to adoption. You've opened a patient's chest, you're doing something else on a structural heart basis. The Afib treatment was concomitant to that, so secondary to that. Making it easier to treat Afib, so it became less of a question, should I do it or not, is exactly what the EnCompass clamp does. It takes a 30-45-minute procedure down to eight to 10 minutes.
You know, very easy to position the clamp and then do the ablation, and you get a you know effective procedure by doing that. I think EnCompass has broadened our ability to go and chase, you know, areas of cardiac surgery, CABG in particular, refined bypass procedures, less likely to treat Afib concomitant to that procedure. It gives a reason to have that discussion again with those surgeons and say, "Look, what you know of treating Afib concomitant to open heart surgery, it can look different. It can be very easy to do.
Right. On that point, for the CABG surgeons, you know, where does that sit today versus valve-focused procedures concomitantly? You know, has that been faster growing and-
Yeah
At any point, do you feel that there could be a mix shift or just any more information on the CABG side of the market would be great.
Yeah. When you think about cardiac surgery, three main areas, mitral valve, aortic valve, and then CABG. Very high penetration and probably the highest rate of preoperative Afib in a mitral valve patient. That's the area I'd say where the company had initial and very good success. Those surgeons, incredibly skilled, they're able to do kind of that legacy procedure with ease. That led to the highest rate of adoption prior to the EnCompass clamp. In those procedures, you are getting both an ablation and you're managing the appendage. Aortic valve, I'd say, you know, kinda same trajectory, but maybe lesser adoption there, closer to, you know, 40%, 50% adoption within aortic surgery. In CABG procedures, we would tell you for a very long time before EnCompass, less than 10% penetration, yet in cardiac surgery, that is the biggest part of the market.
Most of those patients tend to just have their appendage managed. What EnCompass enables us to do is say, "Look, we've made it very easy to treat these patients, and the best thing you can do for a patient who has Afib is both ablate and manage their appendage." Most of the growth that you've seen in our open heart business has been from CABG surgeons. We're seeing an uptick there, and I'd say as we exited 2025, felt in the U.S. we were around 20% penetrated.
Okay. I'll come back to the open side of the business.
Sure.
I do wanna hit on pain management since it's such a large driver of growth both-
Yeah
Last year, it's, you know, been really stellar to watch. You launched cryoSPHERE+ and cryoSPHERE MAX last year or, you know, 12-18 months ago.
Yeah
Those have really been still great growth drivers. I guess could you just, you know, talk about what you're seeing in terms of adoption, and what's the feedback, and, you know, why are you seeing such a lift there, and any differentiation that you think is really driving that?
Yeah. It's parallel to what we just talked about in EnCompass. When you make something really easy to do and make it really fast, I think that can drive adoption. In our pain management franchise, we launched a dedicated device in 2019, our cryoSPHERE probe. What we heard from surgeons, it was an automatic feedback loop. They would try the device, they could see the impact on the patient. I'd say fairly consistent what we heard in terms of feedback is we know it's an effective use, but when you're spending two minutes freezing each nerve and can add up to 25-30 minutes in a procedure, I think for a fair number of surgeons, they felt like that was too long.
If you could speed the procedure up, we know it works incredibly well, your technology works great, has a benefit to a patient, but that's a lot of time to think about. Some of those procedures, which we're talking primarily in a thoracic market, there is some dead time within the procedures where they were able to do it and say time doesn't matter as much. I think we understood fairly quickly that to really grow and penetrate this market, you're gonna need to speed up the procedure. cryoSPHERE MAX did that, reduced a two-minute per nerve freeze time down to a minute and a half. cryoSPHERE MAX was even better, cut the time in half. A minute per nerve, and I think that's ultimately what has led to adoption. I mean, the technology works great.
You can see an immediate feedback loop on your patients, and you've made a procedure time that many of them have been conditioned to say, okay, 25, 30 minutes cut in half. I think that that's incredibly compelling.
Got it. Yeah. It works great. It's less time.
Yes.
Are there any gating factors at this point? I mean, maybe reimbursement or price, or is it really just an awareness, you know, issue at this point?
Yeah. I'd say broadly in the market reimbursement, you know, I think is going to be a headwind for us. We've seen excellent growth despite that. That is one of the efforts that we've been working on. How do you continue to put out data from a lot of different angles to ultimately convince that there's a reason for there to be reimbursement? We're growing elsewhere, but I do think that this is one that is an extra cost in a procedure. I think the, you know, cryoSPHERE MAX, given what it represents in terms of the percentage of our revenue in the U.S., there aren't really gating factors at this point for adoption there. I think it's a pretty easy switch for most surgeons to say that they want the better device.
Do you see any other devices similar to this that would be competitive or any that could enter just 'cause I know opioids would be kind of the direct competitor that's on kind of like the downturn?
Yeah.
This is a lot better solution without having to, you know, do opioids or painkillers. Could anyone else kind of come into this market with a cryo approach, or have you seen anything like that?
Yeah. I think companies could develop a product. I mean, cryoanalgesia is not new or novel in this current market. We do see some competitors outside the U.S. You know, they haven't had, I'd say, great success at this point in time. I think our technology is differentiated in the right ways, you know, in terms of the impact to patients and what surgeons see, ease of use. I think too, if you said, what would it take to get into this market? You're talking about a fairly heavy capital investment across the board to put generators and accounts, ultimately that will, you know, help with the disposable side of the equation.
You know, I'd say our, you know, our thoughts, I think, on competition. Maybe this is a segue to a question later on, but I think competition helps raise awareness in any market that you're in.
It's good foresight but we'll get there.
I'm guessing we'll get there. Yes.
You know, you also mentioned cryoXT.
Yeah.
That's a new area within pain panagement. It launched in the fall. 2026 is gonna be a more concerted effort to, for as far as the launch. Can you just talk about that market a little bit, the post-op amputation pain, and why did you decide to move into that area, and any dynamics there?
Yeah. Amputations annually, let's just talk about kind of the U.S., which is where our launch is focused at this point in time. About 180,000 amputations annually in the U.S. That number is growing. The biggest subsegment of that market is lower limb, 100,000-110,000 annually. Talking about patients who have vascular disease, diabetes, you know, that's an area where we're seeing, unfortunately, a fair amount of growth in the number of the procedures. We got into the market, you know, so big opportunity here. We got into the market because we had thoracic surgeons working with general surgeons in a couple of accounts.
Thoracic surgeons who had adopted the pain management device working with general surgeons who had amputation patients come in and they said, "I see great results when I'm doing this on my thoracic patients. There might be an opportunity." You're talking about in a surgical procedure, large nerves are exposed. That's where our device works the best. Tried it, had great initial success with the cryoSPHERE device. I think through the process of hearing that feedback, like there is another opportunity out there where AtriCure could have a great position, be a leader in the market. Worked with the physicians, ultimately developed a dedicated device. The end tip is the differentiator here. When you think about the cryoSPHERE product and when you're talking about nerves in a chest cavity, very easy to press up against and do a freeze.
When you talk about an amputation, nerves have been severed. This device allows you just to wrap the nerve around the device, do your freeze. It's a couple of nerves in each amputation procedure, and the initial results are excellent.
Great. We're looking forward to tracking that for the remainder of the year.
Yeah.
I guess we'll turn to AtriClip. 2025 is another great year, nearly 20% growth.
Yeah.
A lot of that was driven by your AtriClip FLEX-Mini device. Could you talk about that a little bit more? It was launched in 2024. Still contributing meaningfully. Just any progress there and what we can expect for 2026.
Yeah, I think the launch of the AtriClip FLEX-Mini, much like the cryoSPHERE MAX, surprised us to the upside. You know, we were talking to start the year in 2025, expect kind of a slow and steady ramp. I think we made more progress within the year than we had anticipated. You know, the AtriClip FLEX-Mini device, this is, you know, our fourth open AtriClip device that we've launched, you know, over the past decade plus in this particular market. The consistent theme that we've heard as we've developed new technology from surgeons, make the device smaller. You know, if you could continue to make the device smaller, that's what they were looking for. The AtriClip FLEX-Mini, you don't need to be an engineer or see measurements for you to believe just seeing the device significantly smaller than the other devices that are on the market.
I think it gives just a comfort when you're talking about leaving something on an appendage in a patient's body. I think that gives surgeons comfort that it's not gonna touch adjacent structures there. AtriClip FLEX-Mini has been a great launch for us. You know, we look at this and saying continue to innovate in a very important market for AtriCure.
Great. I know in 2025 it had a little bit of an ASP lift, but.
Yes
you know, just looking at the results, it seems like that was really maybe more volume driven as a factor. Could you kind of speak to that? Was it more volume? I know there's a little bit of price, but.
Yep
You know, as far as your surgeons that already use some of your prior devices, are they, you know, adopting it quicker or just anything around there would be great.
Yeah. I mean, majority of the growth is volume-based. There is definitely a price appreciation on the new product launch. Any product that we're developing within research and development, one of our objectives is if you're putting the time and effort, if the company is making the investment to ultimately see ASP uplift when you launch those devices. We want gross margin improvement, ideally ASP uplift when we think about new product launches. This is another one where I'd say the market is telling us that there is value in that uplift, you know, which is why we've been so successful launching the AtriClip FLEX-Mini at this point in time. Most of the conversions that we've seen and, you know, our sales team is clearly focused on accounts and surgeons who believe in managing the appendage. That's where they're gonna go, you know, initially to start.
Most of the surgeons have been AtriClip FLEX•V users, which would've been the predicate launch that we did, and saying, look, they're high treaters, you know, excited about new technology and probably more importantly, very, very small profile. I think we talked a lot about this when we initially launched the AtriClip FLEX-Mini. Even surgeons who we initially targeted said, "Look, your AtriClip FLEX•V is an excellent device. It's great. It's very small profile already." I think once they've used the AtriClip FLEX-Mini, it's tiny, it works incredibly well. They're compelled to change.
Great. Staying with appendage management, product development and iterating your product has been a huge core pillar-
Yeah
of the company. I just wanted to ask about the AtriClip PRO-Mini. I know that's a little bit different given that it's, I believe, more minimally invasive procedures.
Yeah.
I guess just could you talk about that and any trends you're seeing and how to think about that for the year ahead?
Yeah. The AtriClip PRO-Mini takes all the benefits that we just talked about for AtriClip FLEX-Mini and says you can use that in a closed chest procedure, which is in our hybrid procedures. I'd say, you know, very similarly, you know, closed chest procedure visibility is incredibly important, having a super low profile device, very important in those procedures. We've seen good conversion to the AtriClip PRO-Mini. I think this is one nice ASP uplift, but we need the underlying procedure growth to ultimately drive true growth in this particular area of the business and with the pressure we're expecting in our hybrid business in 2026. I think ASP could probably get you to around flat for, you know, the minimally invasive appendage management area of the business, but our expectation is a decline.
Okay. Just last point on the appendage management business. Most recent competitive entrant.
Yep.
You've seen this before. I think it was right after I initially launched on the company.
Right.
A little bit of déjà vu, but would love to just hear at a high level how do you look at this most recent announcement? I know you talked about it on your most recent call, but you know, what is similar to the previous entrant and what is different? How is this time, you know, just a little bit novel?
Yeah. I think going back to what I said earlier, we look at competition in our markets. It's a validation of the opportunity. Like if you're one of the big MedTech players and you've picked a market to innovate in and join, you look and say there's reasonable growth for all parties involved even with a very strong incumbent, you know, with a pretty strong foothold and leadership position, there's opportunity still within this market. I think it's a validation of the opportunity within our cardiac surgery markets. I'll say that first and foremost. I think what's. You know, we continue to innovate, we continue to invest in clinical science. That is a common thread, whether it's the, you know, the previous entrant or this current entrant that will differentiate AtriCure against both of those companies.
I think what may be different is kind of the positioning of the second player, within the market, and we understand that. I'd say innovation in the end, we found, was ultimately what won, you know, kind of our position and helped us defend incredibly well. I think the fact that you've got three major cardiac companies talking about managing appendage in cardiac surgery patient hopefully means long term our vision comes true, which is every patient that undergoes cardiac surgery has their appendage managed, and it's a benefit to them over their lifetime.
Yeah. Great. We'll get to some of the clinical work you're doing.
Yeah.
Just last segment, I wanted to focus on the minimally invasive ablation piece. Obviously in-
Sure
... 2025, bit of a lag or just due to the PFA headwinds. In 2026, still gonna see some decline, but at a more moderated pace if-
Yep
If I'm remembering correctly. I guess could you just talk about some of the dynamics here? Are you starting to see some of these complex Afib patients starting to come through the funnel after, you know, failing PFA one to three times and, you know, any early green shoots that we could point to or that you're seeing. I know you're being conservative with the full year.
Yep.
Just what have you seen into the end of 2025 and as you're here today?
Yeah. The profile of accounts where we're seeing revenue contribution today typically have adopted PFA that became first line therapy for call it virtually all of the patients with Afib that they were treating. They've had multiple failures, and EPs, I think, have come to the realization that there might need to be something else for some of these patients. It may not work.
Mm.
The same for every patient that comes in and that we need to treat. Still a level of selection, and I think PFA, our expectation is it will be used predominantly as a first line therapy. When you've had multiple failures, if you're looking for a way to make sure that there's a durable option for patients who have been in Afib, so long-standing persistent Afib, really advanced cases of Afib, that's exactly where our CONVERGE procedure comes in and can be beneficial to patients. Green shoots, you know, we talked about the fourth quarter. We saw sequential growth in the U.S. from Q3 to Q4. You know, that reversed a trend that we had been on for about two years in terms of the kind of the quarterly activities there. I'd like to say that that's enough.
I think we're looking for multiple quarters, robust, continued kind of flatlining before we're willing to project growth. Our expectation, what went into the guide for 2026, you know, just to be clear, we are expecting a decline in this area of the business, less than the decline that we saw in 2025, so less of a headwind. Still firmly believe long term, you know, when you start to think more and more PFA failures accumulate in the funnel, I think EPs will, you know, find other reasons to select the CONVERGE procedure, and we think long term that this could be a growth engine for us.
Okay. I'm curious on the international side.
Yeah.
You know, that is a lot different of a market obviously, but it did see the introduction of PFA a little bit earlier. Are you seeing kind of a similarity in how it's progressed or, you know, any findings that you can draw from that?
Yeah. I'd say within our European market, PFA was launching around the time that we had our data from the CONVERGE trial. It was very difficult to even start up a center to have interest in wanting to be trained and to start programs. I think what we saw in Europe was PFA was tried, couple of failures and less, I'd say, less appetite to try multiple different PFA devices. They saw the failures, said, "Look, it doesn't work for everybody," and moved on to wanting to start up CONVERGE programs.
We've seen really good growth in that particular area of the business in Europe, outside of some pressure that we saw in the U.K., which was kind of a stronghold for us in our hybrid business, the back half of 2025, but saw really good growth there and continue to see a lot of interest in wanting to do something. I think, again, a little bit less appetite in Europe to try multiple different devices saying, "Look, for these long-standing persistent Afib patients, we just need to move on to a more robust procedure.
Great. I wanna pivot to clinical-
Sure.
Efforts we spoke about a little bit, but another pillar of the company in driving, you know, your appendage management as well as your open ablation. First on LeAAPS prophylactic stroke using AtriClip, you know, could you talk about the timing there and maybe even just, you know, the interest that it's garnering from surgeons? How much of a market could it open up? I know it's pretty vast, but, you know.
Yeah.
What more specific and focused, what patients could this really be good for on the other side? Just any other commentary you wanna add to that.
Yeah. We'll start very high level. Around 2 million patients every year undergo cardiac surgery. About 30% of them have a preexisting Afib diagnosis. The LeAAPS trial was focused on the 70% of patients who do not have an Afib diagnosis, so that was our kinda the patient population we were studying. Massive market opportunity that we're talking about here. The trial itself was 6,500 patients, the largest cardiac surgery trial. We started enrollment in January 2023 and finished in July 2025, so about two years faster than we had anticipated given the size of the trial, and part of that is, you know, the amount of interest that we saw from our investigators. Over 500 surgeons enrolled in the trial, so very big interest within the surgeon community here.
I think that ultimately tells you, look, we believe that the results will be positive, event-driven trial, so need to accumulate a certain number of events. We talked on the most recent quarter that we had hit the 50% mark, so things are marching along as we would expect, you know, ahead of schedule given kind of the pace in which we enrolled. I think at the end of the day, it says, you know, those 70% of cardiac surgery patients who don't have an Afib diagnosis, their appendage should be managed. We think the data will be that definitive and ultimately lead to that type of adoption. I mean, prior to the trial being run, we had a fair number of surgeons, you know, across our customer base in the United States that already were doing this.
They believed in the science before, you know, the trial was run. They believe there is a benefit to managing the appendage. Patient's chest is open. You're right there in the procedure, very easy to do. I think ultimately this will validate kinda that early thinking and have some very good, robust clinical data behind it to prove that.
Great. I guess just in addition, the BoxX-NoAF trial, post-op Afib prevention.
Yep.
Similar question, you know, what's the opportunity? What's the timing? Any early learnings from surgeon interest or anything like that would be great.
Yeah. BoxX-NoAF is same patient population, non-Afib patients. The reason that we're running this trial is one of the most common outcomes from cardiac surgery if you didn't have Afib going into surgery, is that you would develop postoperative Afib. Depending on the primary procedure, as high as 50% of those patients will develop post-op Afib. If you hear a surgeon talk, they say this is a really problematic complication coming out of cardiac surgery. I think I've done something good for the patient's heart. They're coming out, and it feels, you know, more damaged than when they kinda came in. Same, you know, population. We're using a lot of the same LeAAPS sites in the BoxX-NoAF trial. Super pleased with the enrollment here.
I think, you know, very similar to LeAAPS, what BoxX-NoAF we believe will show very definitively is there's a benefit for all cardiac surgery patients. You know, at the end of the day, whether you have Afib or not, ablating, managing an appendage will have a benefit over those patients' lifetime.
Great. I think we're out of time.
Okay.
you know, thank you again for being here and a lot going on with the company in 2026 and beyond, as, you know, we've talked about, especially, it was great that we ended on the clinical trial. Thank you for coming and really appreciate it.
I appreciate the invitation.
Thanks a lot.