AtriCure at Wells Fargo Conference: Strategic Growth Insights

On Wednesday, 03 September 2025, AtriCure (NASDAQ:ATRC) presented at the Wells Fargo 20th Annual Healthcare Conference 2025, revealing both challenges and promising strategies. The company reported notable growth in recent quarters, driven by new product launches, while also addressing international market pressures on gross margins.

Key Takeaways

• AtriCure’s Q2 growth accelerated to 17.1%, up from 13.6% in Q1, fueled by new products like Cryosphere Max and AtriClip Flex Mini.
• The company aims for $1 billion in revenue and a 20%+ EBITDA margin by 2030, emphasizing innovation and market expansion.
• International growth posed a challenge to gross margins, but U.S. product launches are expected to counterbalance this.
• AtriCure is optimistic about the hybrid business rebound, citing PFA limitations and potential in hybrid procedures.
• Expansion into pain management and cardiac surgery markets is a key focus, with clinical trials set to broaden their reach.

Financial Results

• Q2 Growth: AtriCure’s growth accelerated to 17.1% in Q2, compared to 13.6% in Q1, primarily due to new product launches.
• Drivers: Products like Cryosphere Max and AtriClip Flex Mini significantly contributed to growth, alongside increased adoption of the Encompass clamp.
• Margin Pressures: International growth exceeded U.S. growth, creating headwinds for gross margins.
• Long-term Goals: The company targets $1 billion in revenue and a 20%+ EBITDA margin by 2030, with a focus on innovation and strategic investments.

Operational Updates

• Encompass Clamp: This product has improved ablation procedures, reducing time from 40 minutes to under 10 minutes, with a 40% penetration in AFib patients.
• Market Expansion: Clinical trials like BOX-NOAF and LEAPS aim to expand the cardiac surgery market beyond AFib patients.
• Hybrid Business: Although under pressure from PFA, AtriCure expects a rebound due to PFA’s limitations.
• Pain Management: Growth is being driven by expansion into sternotomy and extremity amputations.
• Product Launches: New products are expected to drive growth for 5 to 7 years.

Future Outlook

• Growth Catalysts: Products like CryoMax and Flex Mini, along with upcoming clinical trials, are expected to drive future growth.
• Hybrid Rebound: The company anticipates a rebound in the hybrid business as PFA failures become apparent.
• Market Opportunities: AtriCure sees potential in a $10 billion market by 2030, driven by expansion in cardiac surgery and pain management.

Q&A Highlights

• Competition: In the LAA clip market, AtriCure’s technological advancements and clinical evidence from the LEAPS trial differentiate it from competitors.
• Clinical Trials: Results from the BOX-NOAF trial are expected soon after its completion, while the LEAPS trial will take approximately five years.
• Innovation Leadership: AtriCure aims to maintain its leadership in pain management, leveraging its first-mover advantage.

The full transcript of the conference call provides further details on AtriCure’s strategic initiatives and financial performance.

Full transcript - Wells Fargo 20th Annual Healthcare Conference 2025:

Nathan Traybeck, Medical Device Analyst, Wells Fargo: Okay. Well, good afternoon, everyone. I’m Nathan Traybeck, one of the Medical Device Analysts at Wells Fargo. I’m happy to have management from AtriCure with us for our first day of the Healthcare Conference. With us we have Mike Carroll, President and CEO and Angie Wyrig, CFO.

Thank you for joining us.

Mike Carroll, President and CEO, AtriCure: Thanks for having us.

Nathan Traybeck, Medical Device Analyst, Wells Fargo: Great. So let’s kick things off with your recent performance and what it means for the rest of the year. So growth accelerated from 13.6% in Q1 to 17.1% in Q2. Can you remind us what were the drivers of this acceleration and to what extent is higher growth sustainable? And how have recent months informed your approach to raise guidance for the year?

Angie Wyrig, CFO, AtriCure: I’d say the second quarter really reflects strength and product launches. I think a couple of notable areas in our business, pain management, our open appendage management, you saw nice inflection in growth and that’s because of new products, mainly Cryosphere Max, as well as our AtriClip Flex Mini, both of those driving not only improved pricing on the devices, but also increased volume, which we think is a really nice sustainable growth plan. Another area that you saw and I think this is a testament to our innovation was our Encompass clamp. The Encompass clamp is a device we launched multiple years ago. And what you’ve seen is continued adoption and penetration within this market.

And that’s led to a really nice growth pattern in an area of our business that if you went back prior to the Encompass clamp, we may have been talking about kind of low double digit, high single digit growth and what you’ve seen in the most recent quarter would say, mid teens, upper teens growth coming out of that area of the business. So new product innovation really driving that really solid and continued top line number. When we think about the second half of the year and what informed kind of the guidance raise, I’d say it’s the conviction that we have around the new product launches, the adoption that we’re seeing there and that the totality of our business, the ability for us to continue to drive really nice strong top line results.

Nathan Traybeck, Medical Device Analyst, Wells Fargo: Okay, great. And we’ll definitely touch on the products. Just on the margins, is there a step down in incremental margins implied in your guidance in the second half? Can you talk about the key considerations for margins for the remainder of the year, you can just walk through the puts and takes?

Angie Wyrig, CFO, AtriCure: If you think about we’ll start with gross margin then hit OpEx margin. When you think about gross margin, I’d say our biggest headwind has been that our international business has outpaced The U. S. Growth and that comes as a headwind for impacting our overall gross margin. I think given the new product launches that we just touched on in The US, those actually were beneficial to gross margin masked a little bit in the quarter by the such a strong international quarter in Q2.

So we do expect as the new product launches in The US continue, the adoption continues of those products for that to be beneficial to gross margin over a long term basis. And then from an OpEx perspective, seeing nice leverage, particularly in SG and A, It’s an area of the P and L where we said we’re really focused on driving efficiency in our business. But I’d say also the philosophy on bottom line. So when you think about the guide that we gave for adjusted EBITDA for the rest of the year, no different from our philosophy from top line, which is we want to put out numbers out there that we feel really good about not just achieving, but that there’s a pathway to beat as well. So some conservatism baked into the guide there.

Nathan Traybeck, Medical Device Analyst, Wells Fargo: Okay, great. You talked about the Encompass clamp. Any way to frame, I guess, what’s supporting the strong growth there? And how durable is this growth as we think about the second half and into ’twenty six?

Mike Carroll, President and CEO, AtriCure: Yes. I mean, what you’re seeing is Encompass clamp was originally came out about three years ago, as Angie talked about. And the whole concept behind it was to make it easier for people to do an ablation. So to basically take the technical difficulty out of it. And what we’ve seen is basically going from about 40 a procedure down to less than ten minutes per procedure by using the Encompass clamp and for coronary bypass surgeons to be able to have been a much more approachable therapy for them to basically treat.

And we’ve started to see that you combine that with reimbursement change over

Nathan Traybeck, Medical Device Analyst, Wells Fargo: the last several years that

Mike Carroll, President and CEO, AtriCure: have happened. Now we’ve taken down a couple of barriers that have allowed it to really kind of get into the market. We’re still only at forty percent penetration in AFib patients, let alone non AFib patients that we think could also benefit from an ablation. And so we think we’ve got lots of years of growth in front of us. One is just continued adoption education of those people about the reimbursement, about the treatment algorithms that basically are there and helping them leverage Encompass.

And then longer term going after and expanding the market to non Afib patients that can benefit from it.

Nathan Traybeck, Medical Device Analyst, Wells Fargo: Perfect. I know you’re not going to guide to ’26, but as we think out to next year, what are some of the key development and commercial milestones that investors should be aware of?

Mike Carroll, President and CEO, AtriCure: Well, big piece and Angie kind of alluded to it is that when you look at all of our new products, when we roll out our new product, you’re not just getting a benefit for one year. Historically, you’ll see that that will drive growth rates up for five, six, seven years as we get market penetration within those areas. So with the new CryoMax that we just rolled out last year, just gaining traction right now, add that with our Flex Mini, which is our new AtriClip device. Those are going to drive a lot of growth into next year. Combine that with another new set of products like XT, which is for extremities for pain management, getting into that amputation space, a whole brand new market for us.

As we look to turn into 2026, we think those are all going to be big growth drivers in addition to what we just talked about, which is the Encompass clamp. We’re still so severely underpenetrated in that area.

Nathan Traybeck, Medical Device Analyst, Wells Fargo: Okay. I wanted to touch on your LRP. So you’re calling for $1,000,000,000 of revenue and 20% plus EBITDA margin by 2,030. Can you just walk us through all the catalysts and I guess the cadence to get to that target?

Angie Wyrig, CFO, AtriCure: I’d say in the near term, so we gave two different numbers out there, something kind of midway twenty twenty eight and then the $1,000,000,000 in 02/1930. When you think about the near term, it’s more about innovation continuing to drive adoption to continuing to drive growth. But then we have a couple of clinical trials, notably our box, no AF, which is looking at prophylactic ablation on non AFib patients. So two thirds of cardiac surgery patients that undergo procedures each year don’t have a pre op AFib diagnosis, but a pretty high percentage of them as a result of that procedure come out of the procedure having AFib. So looking at postoperative AFib basically treating all cardiac surgery patients, whether or not they have AFib with an ablation and an AtriClip.

LEAPS is the other part of this story, which is looking at the benefits in non AFib patients, the same patient population in a stroke reduction benefit if you manage the appendage at the time of open cardiac surgery. So near term, it’s innovation, when you think ’twenty eight, ’twenty ’9, ’twenty thirty, you’re starting to see the results of those clinical trials read into the numbers and start to expand the markets and expand growth.

Nathan Traybeck, Medical Device Analyst, Wells Fargo: Okay, that’s helpful. At your Investor Day, you stated that the products currently represent, I believe $5,000,000,000 plus market opportunity growing to $10,000,000,000 by 02/1930. Can you just walk us through, I guess the building blocks or the bridge from that 5,000,000,000 to $10,000,000,000 what are the key attributes to the market expansion?

Mike Carroll, President and CEO, AtriCure: Yes, so when you let’s look at each one of those different areas. In cardiac surgery, the build goes from right now all we are selling to you is patients, if you go into cardiac surgery, and you have a fib, that’s the market that we’re treating, which is about thirty percent of all patients to undergo cardiac surgery. The market expansion is, as Angie was just describing, both of the trials that we’ve run, one which we just completed enrollment and the other one we’re starting enrollment in BOX and LEAPS, they basically triple the size of that TAM. And so they basically take it an existing TAM of call it two million patients that undergo cardiac surgery a year, six hundred thousand had atrial fibrillation. Now that six hundred thousand goes up to a two million TAM to patient opportunity that basically sits there.

If you sell an Encompass clamp, you combine that with AtriClip and possibly even a crown nerve block at some point in you’re talking about $8 to $10,000 per procedure. You start to do the math on that, that’s like a $20,000,000,000 market. Obviously, we’re not going to say we’re going to 100% penetration, but it begins to show you the size and scale. So we discount back from that kind of 18,000,000,000 to $20,000,000,000 number down quite considerably and say not everybody is going to do it, but if you can get to 50% of that, you’re starting to kind of approach close to $10,000,000,000 just within cardiac surgery. If you look at then our hybrid business, which is under a lot of pressure right now because of PFA, we are less than one percent, less than zero five percent of the total population of AFib that gets treated on a standalone basis.

If you just move the needle on that just quite a little bit on that front, you begin to get into a very large population around that. We’re not expanding that market, that market exists today. That market today is already a $3,000,000,000 plus market opportunity. Pain is where we also expand though quite dramatically from now till the end of the year. Right now, our market is primarily the 185,000 or so thoracotomies in The U.

S, call it 300 or 400,000 when you look at it internationally. As we’re expanding that indication and the usage into sternotomy, which more than doubles the size of it, then you get another doubling by amputation of a leg and you think about other extremities that are there, you’re now beginning to take it from a call it 750000000 to $1,000,000,000 market up to about a 2,000,000,000 to $3,000,000,000 market, which gets you over that $10,000,000,000 market number. So obviously lots of opportunity to market expansion and new areas and new therapies we’re going after.

Nathan Traybeck, Medical Device Analyst, Wells Fargo: Okay. Is there in terms of the products you kind of talked about, so Cryo XP, Pro Mini, PSA enabled, Encompass, I guess, is there a focus for you right now in the near term on any specific product or are you kind of focused all across the board?

Mike Carroll, President and CEO, AtriCure: Well, it’s within each category. So again, think of it as three different franchises. In cardiac surgery, we have the products for the near term, which are our existing Encompass clamp with the new clip products. Basically have the Flex Mini now and then there will be a new product that comes out in early twenty twenty seven, which is a V clip product that’s very similar in terms of size and scope on that. That’s kind of in within that area.

The major areas and catalysts in that are the existing clip products Encompass and then longer term, it’s the clinical trials that we talked about earlier. On the hybrid side, there’s not we’re not doing much innovation per se other than adding PFA to those technologies. That’s a very long term play. That doesn’t affect there’s no catalytic event in any kind of short term on that front. It’s really just making that procedure a lot quicker, taking it from, call it, a ninety minute procedure down to about a forty five minute procedure or so.

So cutting it in half, maybe even more in terms of procedure time. Again, there’s nothing in the near term for that. That’s more of a longer term investment. On the cryo side of our business, MAX is the big one we’re pushing right now. It’s over 50% of our revenue in just over six months on the market.

And then getting into XT is the other piece. But then those are the areas. So within each one, we have a catalyst within each area to focus on. It’s not like one trumps or the other because we’ve got different sales forces as well. Yes.

Nathan Traybeck, Medical Device Analyst, Wells Fargo: I mean, it was more about just the cadence of how the products roll out, but it seems like they’re all kind of contributing.

Angie Wyrig, CFO, AtriCure: Yes, I think a big part of our DNA as a company is continued innovation. I mean, we I don’t think we’ve reached an end state, so to speak, in any of the markets that we’re in. I think we’re looking for ways to continue to make it easier for our surgeon partners to use our devices, which ultimately will drive enhanced adoption. As part of that, you’re also looking at what ways may be a logical add on. So, you think about cardiac surgery, the company started really with a focus just on Afib patients.

Now we’re sitting here today saying, look, this is a much bigger market than we originally thought. You’re taking technology that we’ve made incredibly easy for a surgeon to use that can expand the market. Doing that without that technology complement, I think would have been difficult. Cryo nerve blocks, another great example, started with something that we knew would work incredibly well in thoracic procedures. I think we’ve multiplied the opportunity by looking at different places where, okay, the same technology or the same idea behind the technology maybe in different forms, easier to use, faster, more efficient is ultimately opening up new market opportunities and helping us expand growth.

Nathan Traybeck, Medical Device Analyst, Wells Fargo: Okay. If we could just touch on hybrid. So, you alluded to the fact that PSA has been a headwind for you. Why are you confident in the eventual rebound of your hybrid business? And I guess, as you’re thinking about timelines, should we expect kind of an inflection in that business?

Mike Carroll, President and CEO, AtriCure: Yes. So at a real macro scale, if you think about catheter ablation just in The U. For a moment, and there’s about 600,000 catheter ablations this year, obviously that market is growing incredibly fast for AFib patients. We do about 2,000 procedures. So as I mentioned earlier, we’re less than zero point five percent of that total market, Yet long standing persistent patients represent forty five percent of that overall market.

And the failure rates of those six hundred thousand, even with PFA, PFA is a great technology and is going to continue to grow at a very fast pace, as everybody knows, you’re still going to see a failure rate. And even if they have to do a second one and have secondary failures, they’re still only getting sixty five percent, seventy percent success rates. Those numbers drop eventually out of the funnel, there are going to be patients that are available that are not responding to the PFA. That’s really where we come in. We are the that didn’t work.

Now let’s add to that. We’re not trying to replace it. We understand the benefits of that. And so when you try to do the math on those, take the 600,000, seventy percent success, thirty percent aren’t responding rates, those numbers become very big numbers and enable us to, we think, have a huge market opportunity sitting in front of us for growth. Now, the patients have to go through the funnel.

So that’s not going to happen overnight. It’s not like a patient comes in for a catheter today and then the seventy percent are going to be successful. So that’s going to that’s awesome for that particular patient. And you’re never going to kind of see that person, but the thirty percent are going to eventually come down that funnel. Usually, it’s like a year to two years or so that you’re going to start to see a lot of those kind of non responders.

You’re not going to see it within three to six months. That’s not what you’re seeing in the clinical evidence. But you are seeing a lot of non responders for the year, and that number falling off quite precipitously at eighteen months. That’s why we’ve got confidence that we’ll eventually see some of those patients, because what are they going to do with them? If they’ve done everything they can with multiple catheter ablations with the PFA, they have to look for another solution.

And we’re the only ones on the market with another like that next solution for that foundation and it’s a large patient population. Timing, we’re not ready to get. We said at the back of this year, we’re still under pressure from PFA. We think that’s going to continue. We do we’re hopeful for next year, but we’re not ready to give kind of guidance.

I think we’re going to see kind of how the next three or four months go. What we do see is while we’re not seeing in our numbers yet, we do see sites that went to PFA 100% and are now starting to refer patients, not referring as many as they did before, but they’re now starting to see those secondary failures, they’re now starting to see it. So that gives us confidence that you’re going to start to see that funnel begin to build over the coming year or two that we can begin to see some nice growth in that business again. And we saw that over in Europe as well. So you’ve got something because they started a little bit earlier on PFA.

So we saw some of that in Europe. Now they’re not exactly apples to apples comparison between the two markets. But it does tell you that there is enough of a non responding basis that should build more than enough of a market for us long term.

Nathan Traybeck, Medical Device Analyst, Wells Fargo: Okay, that makes sense. How much is hybrid a contributor to your LRP?

Angie Wyrig, CFO, AtriCure: Yeah, what we said at our Investor Day is our expectation is that this will rebound to become a growth engine for the company. But I think what you’ve seen in the second quarter is you’re not relying on that to happen for the company to be able to hit the numbers that we put out there. So our belief is long term, that will be the case, but don’t need it to necessarily make the LRP work.

Mike Carroll, President and CEO, AtriCure: And to get to look at the numbers, like we grew 17% in the second quarter. The LRP is at 13.6% from kind of the March timeframe through the end of 2030s. We’re obviously already ahead of our plan. So we’re ahead of our plan on the top line than we even expected just kind of what two quarters in on the LRP.

Nathan Traybeck, Medical Device Analyst, Wells Fargo: Okay. I think you alluded to this, but the hybrid performance in The U. And Europe, there is a difference. And can you just talk about the trends you’re seeing in these two markets, why the performance has diverged? Maybe it seems like you’re saying PFA came out earlier in Europe.

Is there anything else going on there? Well, I think

Mike Carroll, President and CEO, AtriCure: the primary piece is that the PFA came out earlier in Europe. But in Europe, you also have, I’d say, less technology. They’re shopping around and going from the FerriPulse to the Afera and checking out, well, it didn’t work with FerriPulse, maybe I’ll try it with Afera, then they’re going like they’re basically like, okay, PFA is kind of PFA generically. And then they’re seeing some of those failure rates kind of happen. So therefore, they’re beginning to start programs specifically so they can serve a population that can’t serve with PFA.

And they identified that. And it took them about twenty four months to get to that point. So they were a little bit ahead of The U. S, like a couple of years. You have that some piece of that.

I do think The U. S. May take a little bit longer than Europe because they’re willing to try a second or a third technology before they kind of see it kind of fall to the end of the funnel. And I’d say those are probably the two primary kind of differences between the two. Don’t you add anything

Nathan Traybeck, Medical Device Analyst, Wells Fargo: to that? No. And you still anticipate Europe hybrid growth to be a contributor to growth this year?

Angie Wyrig, CFO, AtriCure: Yes. Across the international business, every franchise is contributing to growth. Okay.

Nathan Traybeck, Medical Device Analyst, Wells Fargo: How do you see electrophysiologists evolving in their identification of patients for hybrid? And what is your outlook on its long term adoption and success in treating long standing persistent AFib?

Mike Carroll, President and CEO, AtriCure: We’ve got great relationships with EPs and electrophysiologists and HRS. I mean, there’s a we’re an additive procedure. We’re not trying to take away from what they do today. So over the last ten years, we’ve really built deep relationships with those physicians. And so I feel like that’s really helped us out.

Even though our it’s pressure there, I do think it enables us that when things begin to come back, as they try the technology, they should try new technologies and they should go down that path. So we’re not saying don’t do that, but we are there with those relationships that we do anticipate that we’re having conversations with them. Okay, well, let’s talk about this patient’s failed twice, what are you going to do if they fail this next time or the patient failed once and maybe I’ll just start sending my secondary failures right to Convergent. We’re having those conversations with them right now. But each site is a little different.

Each EP has a little different algorithm in their head and we’re kind of developing along with them. So we’ve got great relationships. We’re in the field. We’ve got really good coverage on that front so that when we’re there to have those discussions to hopefully drive their behavior in the coming years. Got you.

Nathan Traybeck, Medical Device Analyst, Wells Fargo: Okay. Maybe let’s shift to LAA and concomitant. So the LAA clip market has had realized and rumored competitive entries. What are your views on competition and innovation in the clip space? How does Agecure maintain its leadership?

And talk about if there are any key barriers that would be difficult for new entrants to compete against?

Mike Carroll, President and CEO, AtriCure: I love this conversation. Because obviously, was a new entrant that came in the market almost two years ago. We built a franchise that we feel like is a very strong franchise for a variety of different reasons. Number one is that we’ve got the best technology in the market and we haven’t stopped innovating. If you just look at our history, we didn’t just rest on our laurels and say the original clip was the best clip that was in the market.

It was, but we also said, well, we can do better. And since then, we’ve rolled it. We’re now on our third generation of the clip. It’s 60% smaller than anything that’s on the market or even planned to come to market from any rumored competitors. It is an incredibly well researched product with over 700,000 implants with an impeccable safety record that works every single time with almost 100% closure every time.

And there’s immense clinical evidence that we’ve invested in the last ten years to get to that point. On top of that, we’ve built a we’ve done a trial recently called LEAPS that Angie alluded to, which is the largest ever cardiac surgery trial to demonstrate that our product specifically can reduce stroke and will be the only PMA level product in the market with that. We think that creates great differentiation to be able to demonstrate, yes, our product by itself will be able to reduce that stroke rate for non AFib patients. So it’s opening up the market, but also creates a defensive mindset against competition to come to market. So it was offensive to expand the market, but defensive to ensure that as competition comes up, we’re raising the bar clinically for what they have to prove to be able to say, hey, you’re going to basically get that kind of price, you’re to get a product that works that well.

How do you know that product works as well as the AtriClip on that front? And so we think we’ve set some of those barriers up from a technical standpoint, because of all the innovation from a clinical standpoint. And then finally, if you our team is incredibly well versed, like we have hundreds of people around the globe that understand how the heart works, they’ve seen how the appendage works in terms of the placement of it, how to place it, how it works, how you treat Afib. People are coming to us for that value. We train our team very specifically on that.

Other companies are trying to come into the market. They’re just looking for an easy win to generate a little bit more revenue. And they’re never and aren’t going to and aren’t doing the investment necessary to have a team that’s educated and training people in the field is in the OR. They want us in the OR to help us help them with how to do the procedure and what to do there. And so I think that we have a huge differentiation and advantage with the team we’ve got in place, how knowledgeable they are and how well trained they’ve been, not just like in the last six months.

We’re talking about a team that’s been trained for years in this particular space. And then finally, would say that we’re dealing with the holistic nature of the disease. So if you’re just coming out of the clip and trying to sell the clip by itself, you’re just solving one aspect of it. We solve the whole aspect. You have the Encompass clamp combined with this, combined with the cryo work that we do to treat the holistic AFib while you’re in cardiac surgery.

That is a huge differentiator for us, because we’re obviously already in the cases as a leader in that space. And we also invested a lot of money in clinical evidence in that area. And so you combine all that together, I think that gives us a big differentiation. Now to answer your question, how do we view competition? We welcome it, because we think that competition is one validation and recognition that it’s a big enough market for someone else to put some investment in.

Even though they may not put as much investment as we’re putting in, they’re going to put some investment they’re putting some investment and they’re recognizing there’s real growth in revenue there. And it’s got to be meaningful enough because the competition we’re talking about are not small players. These are big players that are trying to come in. And they know that there’s a recognized market leader that’s invested in things that are important to the market. And so by them trying to come in, it validates the space, it raises awareness.

And if you don’t believe me, just look at what happened when the competition came in the last time. They got some market share, because we had 100%. So over the last call it six quarters, what have you seen since they’ve been in the market? The first quarter they were in 15% growth for us, 17% growth, 20% growth, 21% growth, 24% growth, 30% growth. Now you can attribute some of that to our innovation coming out with new product.

But a lot of that is that the market has just actually grown, like unit volumes have actually gone up, because there’s more recognition in the market. And they’re getting some share too. So we’re growing in the midst of all that where so I think that that is kind of how we view the competition. We welcome it and we think it’s validating to our space overall. Great.

Can you

Nathan Traybeck, Medical Device Analyst, Wells Fargo: talk about the results you’re seeing with Flex Mini and Pro Mini? How rapid has the adoption been? And how much is the price differential relative to your prior generation AtriClip devices driving the growth?

Angie Wyrig, CFO, AtriCure: Yeah, I think Flex Mini has surprised us to the positive this year. We said, look, we think it’s going to take some time before you see even kind of 20% of the volume in Flex Mini. Well, that’s where we landed in the second quarter. So I said ahead of where we thought we would be at this point in the launch. As a reminder for everyone, we launched the device late in the 2024, minimal contribution in 2024 overall and have seen some nice progress here.

It is a pricing uplift depending on which device open appendage management device you’re using today for us. I’d say most of the cannibalization has come from our Flex B. And that’s about a $17.50 dollars price point versus the 2,002 and $50 on the Flex Mini. So our goal with each new innovation is to be paid for that innovation. We’re bringing something to the market that’s differentiated, which is why we weren’t we believe warrants a higher price.

If you’re using the original AtriClip device, which there’s still kind of a base of users that use that device, you’re closer to about 1,100. Again, most of the transfer over has come from Flex C at this point in time. But as Mike talked about, we’ve also seen nice growth overall in procedure volumes. So while 30% growth in our open appendage management revenue in the second quarter, it’s little over 20% volume growth. So I think this is a device that’s helping us continue to penetrate a very large market.

ProMini just early innings here, I’d say this one also get a nice price uplift too. It’s again differentiated technology. We’ve put some innovation into that device without there being growth in the ablation side. So in our CONVERGE procedures, tough for us to see significant growth coming out of Pro Mini. When you think about what the Pro Mini does, though, more so than in an open heart procedure, the low profile clip is super beneficial when you think about in a closed chest setting in a minimally invasive setting.

So we look at this and say long term, this will be this will help us augment growth in a nice way as well. Great.

Nathan Traybeck, Medical Device Analyst, Wells Fargo: I believe you finished enrolling in LEAPS. Can you outline this trial for those who may not be familiar with it and the opportunity that it presents?

Mike Carroll, President and CEO, AtriCure: Sure. So the LEAPS trial for those that don’t aren’t aware of it, as I mentioned earlier, it’s the largest cardiac surgery trial that has ever been done. It’s 6,500 patients and it’s for patients that are undergoing cardiac surgery that do not have atrial fibrillation. And the reason for that is that those that have atrial fibrillation, there was a trial done many years ago that said you must manage appendage on it and approved a stroke reduction in AFib patients. And we said, well, wait, there’s almost seventy five percent of patients don’t have AFib.

So what about those patients? And are they going to benefit from prophylactically doing something on them? So the trial is designed that half the patients get an AtriClip and half the patients get nothing. And then we basically look at event rates and say, how many events happen? And then when we get up to four seventy events, which we anticipate is going to take five years to get to now that we’re fully enrolled, that we look at the data and we say, is the control arm have more strokes than you’ve got in the treatment arm.

And we believe based on all the feasibility studies we’ve done and all the trials that have been done since then that there will be a big differential between then and that we should win. We feel very confident in that. We do know that the safety profile is excellent, like there’s no safety noise, we know that because we already know the safety data since we’re fully enrolled in the trial. And so the safety is kind of off the table at this point. It’s just looking at the efficacy aspect of it.

And so that’s what the trial is about. It opens up the market basically and triples the size of the overall kind of addressable market for us for stroke reduction for every patient that undergoes cardiac surgery.

Nathan Traybeck, Medical Device Analyst, Wells Fargo: Okay. I guess what are the next key milestones? And do you like is it structured like is there going be an interim readout and when can

Mike Carroll, President and CEO, AtriCure: we expect that? Good question. So right now we’re in a little bit of a waiting game, a lot of what’s happening is we’re going to be producing papers around what are the demographics of the trial look like to kind of keep it top of mind as we’re kind of going through this. But the milestones from getting visibility to it is that we will be able to look at the data at 50% of the events and 75%. I will say that, I mean, the numbers you have to hit for differentials between the two arms at 5075%, just the powering of that means you have I mean, the differential has to be quite frankly something that I don’t think that you’re we’re going to achieve on that front.

But I do believe we’ll achieve it by the time we get to 100. So anticipate five years, could be sooner. I mean, we’re hopeful that it’s going be sooner, but right now we’re looking at it in five years, but we might have an early look possibly.

Nathan Traybeck, Medical Device Analyst, Wells Fargo: Okay. I believe some physicians are using AtriClip per the leads label today in cardiac surgery patients without history of ACF. Can you talk about I guess the incremental opportunity like is it already being used in a substantial part of the market or do you believe there’s still a significant portion that’s not addressed today?

Mike Carroll, President and CEO, AtriCure: It’s being used, I wouldn’t say in a substantial part of the market. I mean, I think that if you look at the overall addressable market, we’re in The U. S. Less than twenty percent penetrated when you look at all cardiac surgery patients that are undergoing cardiac surgery that would qualify in the LEAPS labeling call it. It’s less than twenty percent overall today.

So there’s still a huge avenue for growth once we get that label. In OUS, it’s even bigger because we’re less than ten percent on an OUS basis and LEAPS was an international trial. We had 10 countries in it that were represented throughout Europe and Asia and The Americas. So we feel like we’ve got a very good cross section of patients that we’re going to be able to kind of lobby to the different reimbursement organizations in the different countries around the world as well.

Angie Wyrig, CFO, AtriCure: Yes, I think if you take a step back, there’s a stat that our internal team gave, which was over 500 physicians, 500 surgeons who participated in the trial over 100 sites, over 500 surgeons. I think that alone tells you the interest that the clinical community has in driving this data and making it successful. I think it’s also an indication there are treaters today who are saying, look, whether or not I’ve got the data, I believe it’s the right thing to do. But I think it’s a nice number that tells us look, pace of enrollment, the interest that we have from physicians in the trial, I think this says long term, you’re going to be really successful within this market.

Nathan Traybeck, Medical Device Analyst, Wells Fargo: You highlighted the BOX- NOAF trial for investors. Can you just outline what the trial is about, what the opportunity is? And I guess similar question, is there an interim readout for this trial as well?

Mike Carroll, President and CEO, AtriCure: This trial is the same exact patient population. This is a patient that does not have AFib going into cardiac surgery. And the reason we’re addressing is because again, the AFib patients level one guidelines and reimbursement everything already exists in a big way for that patient population. However, patients the other patients undergo cardiac surgery, thirty five percent to forty percent of them go into what they call postoperative AFib, which is very debilitating to that patient, but also to the physician. They’ve got to put them on amiodarone, they’ve got to manage their heparin drips, they’ve got to keep them in hospital for a longer period of time.

By we believe and through several studies that we’ve done kind of feasibility studies in Vance, you can reduce that thirty five percent, forty percent down to less than ten percent, which is considerable savings to the healthcare system and to that patient. So that’s the kind of premise behind it. And then to look at that patient, do you stunt the progression of Afib long term as well, every one of them will have ILRs and you look at them over a three year period. So the trial is randomized nine sixty patients, one to one ratio, very similar to LEAPS. And we believe we can enroll that in a couple of year period of time.

The good news about this is that post op AFib is measured in that first 30. So you don’t have to wait for all those strokes to accrue over a five year period. We’ll enroll in two years, thirty days later, we’ll pretty much know the answer to it. So it’s going to be a lot quicker to the answer relative to this particular trial for that first primary endpoint. We’ll probably have to adjudicate and look at the data and probably, yes, it’s thirty days, but maybe it’s, call it, three or six months later, we’ll probably have data to be able to present at that time.

Nathan Traybeck, Medical Device Analyst, Wells Fargo: Great. Can you talk about your PSA development program? And I guess, what are some of the next key milestones?

Angie Wyrig, CFO, AtriCure: Yes, so the PSA development program, I’d say take a step back as a leader in the AFib space. We said we needed to offer different tools for surgeons in order to fully capture this market. So we’re investing in PSA and two different paths. So the first one is an open cardiac surgery, enabling our Encompass clamp with PSA to further enhance quick procedure time in that area. One of the big milestones would be a first in human use later this year.

So that’s a big step for us. Then expect to start clinical trial development in 2026 and kick something off there. This will require clinical trial. In the same path as saying, okay, then look at the standalone AFib market. So our hybrid procedure, looking at the device that we have there, the EPISENSE device or something similar to that in a minimally invasive application, if you were to enable PFA, you could drive quite a significant time savings in those procedures.

That similar thing follow on first in human sometime likely in 2026 and then kick off a trial later on.

Nathan Traybeck, Medical Device Analyst, Wells Fargo: Okay. In the last few minutes, we’re going to shift to pain management. You talked about it briefly, but can you just talk about the long term outlook for the pain management business, including drivers of growth, upcoming expansion into the extremity amputations?

Angie Wyrig, CFO, AtriCure: Am I allowed to say awesome? I think the long term outlook is really good here. This is an area where we had early success. We debuted the product in 2019. I’ve had really good success in thoracic procedures.

Now you’ve seen development of a new device, which takes the CryoStereMax, which takes the time to do the CryoNerve block down in half. So that’s clearly driving accelerated growth. You saw that in the first and in the second quarter in our results in The U. S. Where the device is available.

Also exciting to look at different areas and different procedures where we can apply CryoNerve block. Starting to see some early success in sternotomy, so open chest procedures. We had tried with the previous device. And I think the feedback we got from surgeons was if you’re leaving a patient’s chest open for an extra twenty five, thirty minutes, that’s a little long. I’m not sure that we want to do that.

The benefit may not be there. With CryoSphere Max cutting the time in half, we’re starting to see some early success in sternotomy. Still have a ways to go there. But then the development and launch of our Cryo XT specifically for amputations, that’s a completely new market, not a revenue stream for us today. AtriCure is the leader in this space too.

I think the outlook pretty awesome here when you start to think about the areas that we’re accumulating to a really nice market size overall, and being the leader in the space as you have first mover advantage. And we’re not stopping there, continue to look at places where CryoNerve blocks. So think a surgical procedure, the nerve is exposed, I think that’s where we really differentiate and we’ve got a head start on anybody else in the space.

Nathan Traybeck, Medical Device Analyst, Wells Fargo: Great. Well, I think we have about forty seconds left. Mike, Angie, any closing remarks? Just thanks for having us here today and being able

Mike Carroll, President and CEO, AtriCure: to talk about what we believe is a really exciting business over the next five to ten years. Appreciate you. You. Awesome.

Angie Wyrig, CFO, AtriCure: Thank you. It’s really nice to meet you. Well done.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.