Artivion at Canaccord Conference: Strategic Growth and Innovation

On Wednesday, 13 August 2025, Artivion Inc. (NYSE:AORT) presented at Canaccord Genuity’s 45th Annual Growth Conference, detailing strategic plans that underscore significant growth opportunities. The company aims for double-digit revenue growth, propelled by innovations in aortic valves and aneurysms, while addressing challenges like regulatory hurdles. Artivion’s leadership outlined a focused approach to expanding market share and enhancing profitability.

Key Takeaways

• Artivion projects double-digit revenue growth, with On-X valve growth at 24% and stent business at 22%.
• The company raised its 2025 revenue guidance to 12-14% and EBITDA guidance to $21-28 million.
• Key product developments include the AMDS stent, Nexus, and SIVO, with significant PMA approvals expected by 2026.
• Artivion is considering acquiring Endospan for $135 million, contingent on FDA approval of the Nexus device.
• The company is focused on deleveraging and expanding its market presence in the U.S. and Japan.

Financial Results

• 2025 Revenue Guidance: Increased to 12-14% growth, up from an initial 10-14%.
• Q2 Revenue Growth: Achieved a 14% increase.
• EBITDA Guidance: Narrowed to $21 million - $28 million, with a target of $86 million - $91 million EBITDA.
• Free Cash Flow: Expected to be positive in 2025.
• Leverage Ratio: Currently at 2.2, with a focus on further reduction.
• Gross and EBITDA Margins: Both are expanding, supporting profitability.

Operational Updates

• AMDS Launch: Approved under Humanitarian Device Exemption, requiring IRB approval at hospitals. PMA approval expected in the second half of 2026.
• On-X Valve Growth: Driven by clinical data showing mortality benefits for mechanical valves over tissue valves in patients under 60.
• Pipeline Progress: Nexus and SIVO devices are key focus areas, with significant market potential upon FDA approvals.

Future Outlook

• Pipeline and Product Strategy: Five PMAs in the pipeline, representing a billion-dollar market opportunity.
• Market Expansion: Targeting the $100 million tissue valve market with the On-X valve.
• Financial Strategy: Continued focus on deleveraging and potential acquisition of Endospan.

Q&A Highlights

• AMDS Sales: Initial revenue from stocking, with growth expected as adoption increases.
• On-X Valve: Growth attributed to new clinical data, with plans to expand into the tissue valve market over five years.
• Pipeline Data: One-year data for Nexus to be presented at STS in January, with promising results.

In conclusion, Artivion’s presentation at the Canaccord Conference highlighted its strategic focus on innovation and market expansion. For further details, readers are encouraged to refer to the full transcript.

Full transcript - Canaccord Genuity’s 45th Annual Growth Conference:

Bill Plovanic, Senior Medical Device Analyst, Canaccord: Right. Good morning. My name is Bill Plovanic. I’m a senior medical device analyst here with Canaccord. Welcome to our forty fifth annual growth conference.

With us next, we have Artivia, and we have Pat MacKin, CEO and Lansbury, CFO and recently promoted to COO. Our, format today is going to be a five to ten minute presentation followed by a fireside chat with, both executives. And with that, I’m gonna hand it over to Pat.

Pat Mack, CEO, Artivian: Thanks, Bill, and, thanks for having us here at the conference. So, my name is Pat Mack, and I’m the CEO here. I’ve been here the eleven years Labor Day. It’s gone by quite quickly. Forward looking statements, you guys can see those on the web.

Really, Artivian as a company has a very tight focus. We do two things. We focus on aortic valves in patients 65, and we focus on aneurysms and dissections, particularly in the aortic arch. We’ve got a great leadership team. Lance is with here with me today.

I had a chance to get to know Lance when I was on the board at Wright. I brought a bunch of senior execs from Medtronic, but we got a really, I think, excellent leadership team that’s helped build the company. I think one of the things that’s very unique about the company is we’ve got a highly attractive business model. If you look at the blue boxes, right, we have a base business that’s highly differentiated, profitable and growing. But then we add to it originally it was going to be the stent business, which is going be our high growth business.

It looks like our On X valves are also turning into a high growth business, which I’ll highlight here in a minute. And then you combine that with our highly leveraged infrastructure of our channels, our G and A as well as our manufacturing capacity. You add those three things together, we have a business model where we can grow revenue double digits on the top line and then twice as fast on the bottom line for the foreseeable future. So I think this is a very unique kind of value proposition for a med tech company of our size. I’m going to first talk about Onyx because this is really, you know, this is our fastest grow.

We grew 24% in the quarter. On X for the last decade has grown 13%. If you look at the bottom box there in green, what really separated On X apart from the competition is we were the only company that had done the clinical evidence to do a low INR, which is less blood thinner. You could take about half the blood thinner versus other mechanical valves. We took a bunch of share, had been growing nicely.

About a year ago, we had a second trial. This was a post approval trial from the FDA in about five hundred valves that showed about an eighty seven percent reduction in major bleeding. We saw some indications that we could potentially start going after bioprosthetic or tissue valves off of that trial. We’re in the midst of doing that, and then the middle paper came out in January, is published in JAC, the Journal of American College of Cardiology, that showed that with ten years of data that if you got a tissue valve under the age of 60, you took a mortality hit versus a mechanical valve. One hundred and nine thousand patients had ten year follow-up.

So this is a very big piece of news. We’ve since done market research on that. That shows that we are now going to be going heavily after $100,000,000 tissue valve market opportunity. And then the last one is that TAVR doesn’t do great in patients 65 either. So this On X business has been a 13% grower for us, but it is accelerating and we are very excited about that and that’s fairly new.

The second piece is we have a really nice pipeline. Before I get into it, if you look at the products on the left, that is our stent business, which is our other fastest growing business. It grew 22% in the quarter. All those products you see on the left are approved in Europe and in many international markets around the world. But really this pipeline is bringing those products to The U.

S. And Japan. We have to do the clinical work, obviously PMA clinical trials that’ll get us access both to The U. S. And Japan.

What’s unique about those products on the left, these are highly differentiated, all PMA’s. In The U. S, the pricing on those are anywhere between 25,000 and $50,000 at 90% gross margin largely through the same sales force. The other thing that’s really nice about the pipeline, it’s heavily de risked. In most cases, have clinical data out of Europe or other parts of the world that are basically the same size of the FDA trial.

So this is not a super risky pipeline. We do have to do the work and get the approvals, but you can see we have a nice cadence of products over the next five years where we’re literally bringing a PMA every two years. And you can see roughly the market size is set up. That’s about a billion dollar pipeline opportunity. Just really quickly to touch on each one of the three next PMAs.

AMDS, this is our stent for acute type A dissection. So if you see on the left, that’s the current standard of care. If you see on the right, that’s the AMDS. You basically do the standard of care operation and then just add a stent. Very easy, very simple.

The green is the results of the US FDA trial. We showed a massive reduction in mortality and major adverse events kind of across the board. We’re in the middle of launching this, and that helped to contribute to the twenty two percent growth for stents in the quarter. The next product is called Nexus. This is a total catheter delivery to replace the aortic arch.

This is the thirty day data that was presented in May. Really phenomenal results. What I really draw your attention to is the bars on the right. The blue is the FDA hurdle, the green were the results. So we have an option to acquire this company called Endospan as soon as they get FDA approval, and we’re expecting that in the 2026.

So we’re super excited about this technology. Again, another technology advanced technology in the arch. And then the third is our SIVO. This is our next generation frozen elephant trunk, which is a total replacement of the aortic arch. We just got this trial approved by the FDA and we will start enrolling that trial before the end of the year.

You see it’s about 120 patients. We licensed some technology here. We already sell a version of this internationally, but you can see in the kind of call out picture, it’ll be the first frozen elephant trunk with a branch stent on it. We licensed that technology from the Cleveland Clinic and we’re super excited about this trial. So when you put all that together from a financial standpoint, you can see we’ve been accelerating our adjusted EBITDA margin and we expect to do that going forward.

We’ve also been delevering rapidly. We obviously levered up pretty heavily to acquire all these companies, but now we’ve put them all together and now that we’re starting to generate revenue from those PMAs, we’re around a 2.2 now and expect to see that to continue to go down. From a 2025 guidance standpoint, we came out at the beginning of the year on the revenue with a 10% to 14%. We keep narrowing and now we’re at 12% to 14%. We feel like the growth in stents, the growth in On X and the launch of AMDS will continue to drive that revenue.

As you saw, we grew 14% in the second quarter. Similarly on the EBITDA side, we came out with initial guidance of 18,000,000 to $28,000,000 We’ve narrowed that to 21,000,000 to 28 And so we’re on target to be in 86,000,000 to $91,000,000 on the EBITDA and also free cash flow positive. So in summary, we are a leader in the advanced segment of the aorta. We’ve got a dedicated team with a ton of experience, highly attractive business model, double digit revenue growth, twice as fast on the EBITDA side. We’ve got five PMA’s in the pipeline with a billion dollars worth of opportunity.

And then from a financial standpoint, cash flow positive, expanding gross margins, expanding EBITDA margins, and delivering deleveraging the balance sheet. So with that, I’ll turn it back over to Bill for the for our fireside chat.

Bill Plovanic, Senior Medical Device Analyst, Canaccord: Great. And let’s invite Lance up as well. I’m gonna we’ll we’ll put Lance on the hot seat and start with the financial numbers first. And so, you raised the guidance, as you said, in the last slide, what the revenue and the EBITDA. What are you seeing in the business that gives you the confidence to to raise the guidance?

Lance Lansbury, CFO/COO, Artivian: Well, I think first thing, just, you know, we’re halfway through the year, and things are playing out like we anticipated. So that’s good. AMDS is off to a good start, which was one of the big swing factors on the guidance for the year with a a new product launch. But then also Pat talked about the On X performance in q two, which I think honestly was a little bit of a positive surprise for us as well. So I think all those things together are giving us confidence that, we can really come in toward the the upper half of our original guidance range for the year.

Bill Plovanic, Senior Medical Device Analyst, Canaccord: And as you think about it, I think, I think when you originally gave guidance in the you mentioned the AMDS, it was one to 2% of the year over year growth. How are you thinking about that today?

Lance Lansbury, CFO/COO, Artivian: Yeah. I mean, I think, again, I think you probably, assume we’re trending towards the higher end of that range given what we’ve done with the overall guidance. It’s still early, but, we have a lot of good things going on with AMD and really good about it.

Bill Plovanic, Senior Medical Device Analyst, Canaccord: Okay. I mean, the on the balance sheet, you got a lot of cash. You’ve done a lot of work to delever that, balance sheet, and you’re proving the cash position and the cash flow. Outside of converting the convert from debt to shares, how else did you bring what else were the drivers of bringing that leverage ratio down?

Lance Lansbury, CFO/COO, Artivian: Yeah. I mean, really, if you just look you know, Pat had a slide that showed the EBITDA margin expansion over the past, you know, three or four years. The company’s done a great job of growing EBITDA really fast, which has helped with that leverage ratio. And then, you know, going forward, I think now we’re in a position where we can start to be more meaningfully cash flow positive when you actually start trying to pay debt debt down.

Bill Plovanic, Senior Medical Device Analyst, Canaccord: So the future use of cash is to continue to delever?

Lance Lansbury, CFO/COO, Artivian: That and hopefully the Endospan acquisition. So as Pat talked about, we have an option to purchase this company Endospan. Mhmm. If their nexus device is FDA approved, That’s about a $135,000,000 upfront purchase price if we exercise that option. So that we need to fund that.

But other than that, yes, we would be looking to pay down debt.

Bill Plovanic, Senior Medical Device Analyst, Canaccord: And is there any limitations on your debt that would limit you from using that debt for the Endospan and the free cash flow?

Lance Lansbury, CFO/COO, Artivian: We have private debt in place now. I mean, there there’s there’s covenants we’d have to work with our lender on that. But, honestly, I think they would be thrilled if we came and asked them for a little bit more money. So I I think that’d be fine.

Bill Plovanic, Senior Medical Device Analyst, Canaccord: Fantastic. So I’m gonna switch to the product on the MDS that launched in the first quarter of this year. I think approval late last year under the HDE, the human humanitarian device exemption. Can you help us understand what are the limitations of commercializing under an HDE?

Pat Mack, CEO, Artivian: Yes. So the the real requirement for an HDE is, one is the you have to get an IRB, which is it’s just unique in early on in the launch. It was confusing for hospital because typically you get an IRB for a clinical trial. That’s really the only limitation. The second one is the number of cases you can do a year is like eight thousand.

The total market for acute type a dissections in The US is like six thousand. So practically, it’s not really limitation in this case.

Bill Plovanic, Senior Medical Device Analyst, Canaccord: So I was saying HDE search maybe one of those every couple of years. See, I can see the hospitals would be confusing for you.

Pat Mack, CEO, Artivian: And

Bill Plovanic, Senior Medical Device Analyst, Canaccord: what does competition look like in the AMD’s DS space?

Pat Mack, CEO, Artivian: Yeah. I mean, we really don’t have a direct I mean, the the competition is you see in the picture, it’s the standard of care on the left, which is 50 years old. They basically fix the tear and then leave the rest of the aorta kinda delaminated. Whereas, when you put a stent in with AMDS, you kinda push that flap back against the the kinda native aortic wall. So that’s really the only competition.

I think the other one in in if you jump up to Arecibo, which is the trial we’re about to start, you know, about ten percent of the surgeons in the country can actually replace the entire entire arch. It’s a it’s a pretty complex procedure. Like I said, ninety percent of the guys can’t do it. So you could say this is tangentially a competitor. We’re gonna have that as well, and we do internationally, but it really isn’t it’s it’s kind of a different segment because most guys can’t do this one.

Bill Plovanic, Senior Medical Device Analyst, Canaccord: Yeah. What is physician feedback then on the AMD product? I mean, we did our doc calls, but I’d love to hear if you get a lot more than the doc calls I did.

Pat Mack, CEO, Artivian: I mean, it’s been excellent. We have a training program that we do. It’s very easy. I mean, I could we could train people in here how to do it in, you know, an hour. We do, you know, a lot of, you know, clinical work with them.

We do a lot of education, but it’s a one day program or we can do it at the at the center. The feedback’s been outstanding. I mean, it’s you know, if if you look at the clinical data, I mean, this is the part that’s so impressive about this technology. I mean, mortality in this trial went from thirty five to ten, under ten. And the idea of malperfusion, if people aren’t familiar with it, is basically blood’s not going where it’s supposed to go.

So if you put a stent in and blood starts going where it’s supposed to go, you have less strokes, less less people need dialysis. And so it’s really an amazing technology, you know, I think people and we saw it in the trial as well, just really excellent feedback.

Bill Plovanic, Senior Medical Device Analyst, Canaccord: I think from our doc calls, the one thing that really stuck in my mind was just the simple easy use was so simple to use. And I think the comment one of the docs said, leading doc was like, community guy can do this. Like, it really democratizes.

Pat Mack, CEO, Artivian: It’s the word. It’s democratized. We did this when I was in Medtronic with some ablation technology. We’re democratizing the procedure. So guys in the community center can get results as good as the big academic centers with this technology.

Bill Plovanic, Senior Medical Device Analyst, Canaccord: And how important is the final PMA approval and when’s it coming?

Pat Mack, CEO, Artivian: Yeah. I mean, we’re expecting about a year from now, second second half or the ’26. We’re on track for that. The only thing it’s really going to do is eliminate the the IRB. Also, we’re gonna go for a broader indication.

I personally don’t think it’s that big of a deal. It’s not gonna I don’t think it’s gonna be a big catalyst because we have a malperfusion indication right now, which is about forty percent of the market. We’re gonna go after the full market. But once this is approved and on the shelf, surgeons can do what they want. We won’t market off the label, but, you know, we know from just hearing what they say that they’re gonna use it in non malperfusion cases.

So I I don’t think the PMA other than getting rid of the IRB

Bill Plovanic, Senior Medical Device Analyst, Canaccord: million dollars revenue for the quarter. I know Lance will comment on that. But if you think of the second quarter revenues, how the question I’ve gotten from investors is how much do you think of that was stocking and how much was sell through?

Lance Lansbury, CFO/COO, Artivian: Yeah. I mean, realistically, right now, most of the revenue is stocking. So we don’t consign this product. There’s four sizes. If an account wants access to it, they have to buy one of each and put it on the shelf.

So right now, you know, most of the revenue is coming from that. And it’s just it’s just gonna build. You know, once you get it on the shelf, then you start driving adoption. So we’ll see both of those things continue to grow over the course of the year. But, yes, right now, most of the revenue is from stocking.

Bill Plovanic, Senior Medical Device Analyst, Canaccord: And I’m gonna switch over to On X. You mentioned that the growth accelerated there. Yeah. In the studies you showed and but what do you really think is the driver of On X? I mean, it’s to have a product that’s been on the market forever and, you know, it’s been taking share, but it’s to accelerate at this stage of the game is pretty unique.

Pat Mack, CEO, Artivian: Yeah. And I think it’s I mean, it’s not uncommon in class three implantable devices for markets to move on big clinical data. I mean, that that’s, you know, what I’ve been doing for thirty years. I mean, we we had a great platform with On X because we’re the only mechanical valve that you can take half the blood thinner and get a 6060% reduction in bleeding, the original trial. And I mentioned we ran the post approval trial It got even more bleeding reduction in in a lot bigger centers or, like, 60 centers around the country.

Even community centers were involved. So we thought that was pretty good because the bleeding reduction got better, and we thought that could be a little bit of a catalyst. The real change is this Jack paper that came out. It came out of UCLA. We had nothing to do with it.

Hundred nine thousand patients with 10 follow-up showing mortality benefit to mechanical valves versus tissue valves under 60. There’s a bunch of there’s a bunch of tissue valves used under 60, about a $100,000,000 worth. That that’s what’s driving this, is we’ve got a great sales team. We’re highly focused on the aortic customer. We’re launching AMDS.

We’re training all these guys, and we’re get we haven’t even started marketing the data to cardiologists. So this is a this is a five year opportunity on On X to get this data out to cardiologists and, you know, go after that big slice of the tissue valves, which is a great thing for patients.

Bill Plovanic, Senior Medical Device Analyst, Canaccord: And I think, you know, when we were visiting a couple months ago, we were talking talking and you mentioned you’re you’re doing training sessions every month on the EMDS. And I think one of the the things that resonated with me as you you talked about that was just you’re bringing these docs in and you’re cross training them. And how much of an impact do you think that’s had on the business or continue to have on the business?

Lance Lansbury, CFO/COO, Artivian: Yeah. I mean, I think the the best evidence you can say of that is we have true new account creation for Onyx. So this product’s been on the market for, you know, a decade, and we’re opening new accounts with it. Now I do think that having the data to present when you’re doing the cross selling is is a huge factor. But, you know, we’re we’re also we’re the people innovating around this space.

You know, for these aorta focused surgeons, we’re the people bringing innovation to them, and I think it’s just getting us more and more of an audience with them, and we have a lot of things to talk to them about.

Bill Plovanic, Senior Medical Device Analyst, Canaccord: And will will you end up cannibalizing some of your bioprosthetic tissues?

Pat Mack, CEO, Artivian: So we we have we have a pulmonary valve, our for the Ross procedure. Very, very different. So that started in kids and we’re in every pediatric center in the country. There’s been a big acceleration into kind of young adults, like 50. I consider that young.

I do too. No. So so whether we cannibalized or not, we’re we’re constrained on the volume of our pulmonary valves just from donation. So it’s just it’s not that big a deal. And frankly, we’re kind of agnostic.

I mean, we sell the pulmonary valve for $25,000 So, I mean, if they want to get a Ross, that’s great. If they want to get a mechanical valve, that’s great. We’re kind of agnostic on it.

Bill Plovanic, Senior Medical Device Analyst, Canaccord: All right. Let’s move to the pipeline for the next product NEXUS, which is I think second half of next year. We’ve seen the thirty day data. What data the next dataset we’re gonna see and what should we expect out of that? How will it be different or what what more will we learn or not learn?

Pat Mack, CEO, Artivian: Yeah. So you could this is the thirty day data. And all these all these aortic trials look the same stuff. It’s mortality. It’s stroke.

It’s dialysis. Paraplegia. And and these results were excellent. You we should expect to see the one year data at STS at the January. So, you know, kind of in the similar kind of layout as this.

There’s one competitive product that recently got approved, and you’ll be able to kinda look at apples to apples. It’s in a different indication, kind of in the same ZIP code, but a different indication. But you’ll be able to tell how how this device performs in that kind of anatomy versus the other device. So I think that’ll tell us a lot.

Bill Plovanic, Senior Medical Device Analyst, Canaccord: And I think you mentioned like a lot of these products have been used in Europe. So you’re kind of asking questions to answers you already know. But I think Arecibo is a little different.

Pat Mack, CEO, Artivian: Not really. So Arecibo, I mean, is again, this is our next generation frozen elephant trunk. This is the device pictured here up on screen. We sell a version looks exactly like that except it doesn’t have a subclavian branch, that little branch that sticks up. It just has a surgical graft.

We ran a trial in Europe in a 160 patients. It’s already been published. We compare it to the other product in the market, and we have better results with that device. This trial is a 117 patients. So the only thing that’s really gonna be, you know, new is this branch of Klavian, which we think is gonna cut time off the procedure.

Bill Plovanic, Senior Medical Device Analyst, Canaccord: Okay.

Pat Mack, CEO, Artivian: And time is outcome. So I I think to your point, we we have to do the trial. We have to get the approval. But I think it’s heavily derisked. We’ve already run trials, you know, one and a half times sizes.

Bill Plovanic, Senior Medical Device Analyst, Canaccord: So they would be sewing their own subclavian branch on or with another product or

Pat Mack, CEO, Artivian: how In our existing product, they’d have to sew the subclavian branch, which is typically very deep and very hard to get access to. In this device, it’s catheter deployed from above and delivered directly into the subclavian. So it should save time.

Bill Plovanic, Senior Medical Device Analyst, Canaccord: And in terms of competition, you mentioned just in this space, who are your main competitors and kind of what are they doing? You mentioned a new product came on the market.

Pat Mack, CEO, Artivian: Yeah. I mean, it depends on which segment. So in this segment, Terumo has got a device approved in U. S. This segment, Gore’s got just got a device approved on The US.

In AMDS, there’s nothing really. Heart valves is Abbott. So that’s kind of the names everybody. The names. Yeah.

It’s kind of a hodgepodge. I mean, we’re we’re a a company that’s focused on the aorta and heart and vascular surgeons. So we bumped into a bunch of different competitors, but there’s really no one that looks exactly like us.

Bill Plovanic, Senior Medical Device Analyst, Canaccord: And then just going back to On X for What a second percent of the mechanical valve market do you have? And if combine the bioprosthetic tissue and mechanical valve, what kind of percent of that market do you think? Because it’s you’re two different TAMs, but if you’re gonna be going into the bioprosthetic

Pat Mack, CEO, Artivian: So I I would say and, again, it gets complicated, like, international. Like, US, we probably have about 60% mechanical share. We probably have, like, 15% SABR share. So tissue plus mechanical. So you can see that this is the math.

There’s a much bigger opportunity when you put the tissue in.

Bill Plovanic, Senior Medical Device Analyst, Canaccord: Yep. Alright. Any questions from the audience? We have about a minute left. Alright.

I’ve gone through my whole question list. Anything you’d like to, finish with?

Pat Mack, CEO, Artivian: No.

Bill Plovanic, Senior Medical Device Analyst, Canaccord: Alright. Good morning. COO. Our, format today is going to be a five to ten minute presentation followed by a fireside chat with, both executives. And with that, I’m gonna hand it over to Pat.

Pat Mack, CEO, Artivian: Thanks, Bill, and, thanks for having us here at the conference. So, my name is Pat Mack, and I’m the CEO here. I’ve been here the eleven years Labor Day. It’s gone by quite quickly. Forward looking statements, you guys can see those on the web.

Really, Artivian as a company has a very tight focus. We do two things. We focus on aortic valves in patients 65 and we focus on aneurysms and dissections, particularly in the aortic arch. We’ve got a great leadership team. Lance is with here with me today.

I had a chance to get to know Lance when I was on the board at Wright. I brought a bunch of senior execs from Medtronic, but we got a really I think excellent leadership team that’s helped build the company. I think one of the things that’s very unique about the company is we’ve got a highly attractive business model. If you look at the blue boxes, right, we have a base business that’s highly differentiated, profitable and growing. But then we add to it originally it was going to be the stent business, which is going be our high growth business.

It looks like our On X valves are also turning into a high growth business, which I’ll highlight here in a minute. And then you combine that with our high re leveraged infrastructure of our channels, our G and A as well as our manufacturing capacity. You add those three things together, we have a business model where we can grow revenue double digits on the top line and then twice as fast on the bottom line for the foreseeable future. So I think this is a very unique kind of value proposition for a med tech company of our size. I’m going first talk about On X because this is really, this is our fastest grower.

We grew 24% in the quarter. On X for the last decade has grown 13%. If you look at the bottom box there in green, what really separated On X apart from the competition is we were the only company that had done the clinical evidence to do a low INR, which is less blood thinner. You could take about half the blood thinner versus other mechanical valves. We took a bunch of share, have been growing nicely.

About a year ago, we had a second trial. This was a post approval trial from the FDA in about 500 valves that showed about an 87% reduction in major bleeding. We saw some indications that we could potentially start going after bioprosthetic or tissue valves off of that trial. We’re in the midst of doing that, and then the middle paper came out in January, which is published in JAC, the Journal of American College of Cardiology, that showed that with ten years of data that if you got a tissue valve under the age of 60, you took a mortality hit versus a mechanical valve. One hundred and nine thousand patients had ten year follow-up.

So this is a very big piece of news. We’ve since done market research on that. That shows that we are now going to be going heavily after $100,000,000 tissue valve market opportunity. And then the last one is that TAVR doesn’t do great in patients 65 either. So this On X business has been a 13% grower for us, but it is accelerating and we are very excited about that and that’s fairly new.

The second piece is we have a really nice pipeline. Before I get into it, if you look at the products on the left, that is our stent business, which is our other fastest growing business. It grew 22% in the quarter. All those products you see on the left are approved in Europe and in many international markets around the world. But really this pipeline is bringing those products to The U.

S. And Japan. We have to do the clinical work, obviously PMA clinical trials that’ll get us access both to The U. S. And Japan.

What’s unique about those products on the left, these are highly differentiated, all PMAs. In The U. S, the pricing on those are anywhere between 25,000 and $50,000 at 90% gross margin largely through the same sales force. The other thing that’s really nice about the pipeline, it’s heavily de risked. In most cases, have clinical data out of Europe or other parts of the world that are basically the same size of the FDA trial.

So this is not a super risky pipeline. We do have to do the work and get the approvals, but you can see we have a nice cadence of products over the next five years where we’re literally bringing a PMA every two years. And you can see roughly the market size is set up. That’s about a billion dollar pipeline opportunity. Just really quickly to touch on each one of the three next PMAs.

AMDS, this is our stent for acute type A dissection. So if you see on the left, that’s the current standard of care. If you see on the right, that’s the AMDS. You basically do the standard of care operation and then just add a stent. Very easy, very simple.

The green is the result of the US FDA trial. We showed a massive reduction in mortality and major adverse events kind of across the board. We’re in the middle of launching this and that helped to contribute to the twenty two percent growth for stents in the quarter. The next product is called Nexus. This is a total catheter delivery to replace the aortic arch.

This is the thirty day data that was presented in May. Really phenomenal results. What I really draw your attention to is the bars on the right. The blue is the FDA hurdle. The green were the results.

So we have an option to acquire this company called Endospan as soon as they get FDA approval, and we’re expecting that in the 2026. So we’re super excited about this technology. Again, another technology advanced technology in the arch. And then the third is our SIVO. This is our next generation frozen elephant trunk, which is a total replacement of the aortic arch.

We just got this trial approved by the FDA and we will start enrolling that trial before the end of the year. You see it’s about 120 patients. We licensed some technology here. We already sell a version of this internationally, but you can see in the kind of call out picture, it’ll be the first frozen elephant trunk with a branch stent on it. We licensed that technology from the Cleveland Clinic and we’re super excited about this trial.

So when you put all that together from a financial standpoint, you can see we’ve been accelerating our adjusted EBITDA margin and we expect to do that going forward. We’ve also been delevering rapidly. We obviously levered up pretty heavily to acquire all these companies, but now we’ve put them all together and now that we’re starting to generate revenue from those PMA’s, we’re around a 2.2 now and expect to see that to continue to go down. From a 2025 guidance standpoint, we came out at the beginning of the year on the revenue with a 10 to 14. We keep narrowing and now we’re at 12 to 14.

We feel like the growth in stents, the growth in On X and the launch of AMDS will continue to drive that revenue. As you saw, we grew 14% in the second quarter. Similarly on the EBITDA side, we came out with initial guidance of 18 to 28,000,000 We’ve narrowed that to 21,000,000 to $28,000,000 And so we’re on target to be in 86,000,000 to $91,000,000 on the EBITDA and also free cash flow positive. So in summary, we are a leader in the advanced segment of the aorta. We’ve got a dedicated team with a ton of experience, highly attractive business model, double digit revenue growth, twice as fast on the EBITDA side.

We’ve got five PMAs in the pipeline with a billion dollars worth of opportunity. And then from a financial standpoint, cash flow positive, expanding gross margins, expanding EBITDA margins, and delivering deleveraging the balance sheet. So with that, I’ll turn it back over to Bill for the for our fireside chat.

Bill Plovanic, Senior Medical Device Analyst, Canaccord: Great. And let’s invite Lance up as well. I’m gonna we’ll we’ll put Lance on the hot seat and start with the financial numbers first. And, so, you raised the guidance, as you said in the last slide, whether the revenue and the EBITDA. What are you seeing in the business that gives you the confidence to to raise the guidance?

Lance Lansbury, CFO/COO, Artivian: Well, I think first thing, just, you know, we’re halfway through the year, and things are playing out like we anticipated. So that’s good. AMDS is off to a good start, which was one of the big swing factors on the guidance for the year with a a new product launch. But then also Pat talked about the On X performance in q two, which I think honestly was a little bit of a positive surprise for us as well. So I think all those things together are giving us confidence that, we can really come in toward the the upper half of our original guidance range for the year.

Bill Plovanic, Senior Medical Device Analyst, Canaccord: And as you think about it, I think, I think when you originally gave guidance in the you mentioned the AMDS, it was one to 2% of the year over year growth. How are you thinking about that today?

Lance Lansbury, CFO/COO, Artivian: Yeah. I mean, I think, again, I think you probably, assume we’re trending towards the higher end of that range given what we’ve done with the overall guidance. It’s still early, but, we have a lot of good things going on with AMD and feel really good about it.

Bill Plovanic, Senior Medical Device Analyst, Canaccord: Okay. I mean, the on the balance sheet, you got a lot of cash. You’ve done a lot of work to delever that, balance sheet, and you’re proving the cash position and the cash flow. Outside of converting the convert from debt to shares, how else did you bring what else were the drivers of bringing that leverage ratio down?

Lance Lansbury, CFO/COO, Artivian: Yeah. I mean, really, if you just look, you know, Pat had a slide that showed the EBITDA margin expansion over the past, you know, three or four years. The company’s done a great job of growing EBITDA really fast, which has helped with that leverage ratio. And then, you know, going forward, I think now we’re in a position where we can start to be more meaningfully cash flow positive. We can actually start trying to pay debt debt down.

Bill Plovanic, Senior Medical Device Analyst, Canaccord: So the future use of cash is to continue to delever?

Lance Lansbury, CFO/COO, Artivian: That and hopefully the Endospan acquisition. So as Pat talked about, we have an option to purchase this company, Endospan, if their nexus device is FDA approved. That’s about a $135,000,000 upfront purchase price if we exercise that option. So that we need to fund that. But other than that, yes, we would be looking to pay down debt.

Bill Plovanic, Senior Medical Device Analyst, Canaccord: And is there any limitations on your debt that would limit you from using that debt for the Endospan and the free cash flow?

Lance Lansbury, CFO/COO, Artivian: We have private debt in place now. I mean, there there’s there’s covenants. We’d have to work with our lender on that. But, honestly, I think they would be thrilled if we came and asked them for a little bit more money. So I I think that’d be fine.

Bill Plovanic, Senior Medical Device Analyst, Canaccord: Fantastic. So I’m gonna switch to the product on AMDS that launched in the first quarter of this year. I think approval late last year under the HDE, the human humanitarian device exemption. Can you help us understand what are the limitations of commercializing commercializing under under an an HDE HDE path?

Pat Mack, CEO, Artivian: Yeah. So the the real requirement for an HDE is one is the you have to get an IRB, which is it’s just unique in early on in the launch. It was confusing for hospital because typically, you get an IRB for a clinical trial. That’s really the only limitation. The second one is the number of cases you can do a year is like eight thousand.

The total market for acute type a dissections in The US is like six thousand. So practically, it’s not really limitation in this case.

Bill Plovanic, Senior Medical Device Analyst, Canaccord: So I was saying HDE search maybe one of those every couple of years. So, yeah, I can see the hospitals would be confusing for you.

Pat Mack, CEO, Artivian: And

Bill Plovanic, Senior Medical Device Analyst, Canaccord: what does competition look like in the AMD’s DS space?

Pat Mack, CEO, Artivian: Yeah. I mean, we really don’t have a direct I mean, the the competition is you see in the picture, it’s the standard of care on the left, which is 50 years old. They basically fix the tear and then leave the rest of the aorta kinda delaminated. Whereas, when you put a stent in with AMDS, you kinda push that flap back against the the kinda native aortic wall. So that’s really the only competition.

I think the other one in in if you jump up to Arecibo, which is the trial we’re about to start, you know, about ten percent of the surgeons in the country can actually replace the entire entire arch. It’s a it’s a pretty complex procedure. Like I said, ninety percent of the guys can’t do it. So you could say this is tangentially a competitor. We’re gonna have that as well, and we do internationally, but it really isn’t it’s it’s kind of a different segment because most guys can’t do this one.

Bill Plovanic, Senior Medical Device Analyst, Canaccord: Yeah. What is physician feedback then on the AMDS product? I mean, we did our doc calls, but I’d love to hear if you get more than the doc calls I did.

Pat Mack, CEO, Artivian: I mean, it’s been excellent. We have a training program that we do. It’s very easy. I mean, we could train people in here how to do it in an hour. We do, you know, a lot of, you know, clinical work with them.

We do a lot of education, but it’s a one day program or we can do it at the at the center. The feedback’s been outstanding. I mean, it’s you know, if if you look at the clinical data, I mean, this is the part that’s so impressive about this technology. I mean, mortality in this trial went from thirty five to ten, under ten. And the idea of malperfusion, if people aren’t familiar with it, is basically blood’s not going where it’s supposed to go.

So if you put a stent in and blood starts going where it’s supposed to go, you have less strokes, less less people need dialysis. And so it’s really an amazing technology. And, you know, I think people and we saw it in the trial as well, just really excellent feedback.

Bill Plovanic, Senior Medical Device Analyst, Canaccord: I think from our doc calls, the one thing that really stuck in my mind was just the simple easy use was so simple to use. And I think the comment one of the docs said, a leading doc was like, community guy can do this. Like, it really democratizes. You

Pat Mack, CEO, Artivian: know, it’s it’s the word. It’s it’s democratized. We did this, you know, when I was in Medtronic with with some ablation technology. We’re democratizing the procedure. So guys in the community center can get results as good as

Bill Plovanic, Senior Medical Device Analyst, Canaccord: the big academic centers with this technology. And how important is the final PMA approval and when does it come in?

Pat Mack, CEO, Artivian: Yeah. I mean, we’re expecting about a year from now, half or the ’26. We’re on track for that. The only thing it’s really gonna do is eliminate the the IRB. Also, we’re gonna go for a broader indication.

I personally don’t think it’s that big of a deal. It’s not gonna I don’t think it’s gonna be a big catalyst because we have a malperfusion indication right now, which is about forty percent of the market. We’re gonna go after the full market. But once this is approved and on the shelf, surgeons can do what they want. We won’t market off the label, but, you know, we know from just hearing what they say that they’re gonna use it in non malperfusion cases.

So I I don’t think the PMA other than getting rid of the IRB and then getting the PMA and, you know, not having to worry about that is is the point.

Bill Plovanic, Senior Medical Device Analyst, Canaccord: So I think, you know, we put some estimates together. I estimated about a million 9 in revenue for the quarter. I know Lance won’t comment on that. But if you think of the second quarter revenues, how the question I’ve gotten from investors is how much do you think of that was stocking and how much was sell through?

Lance Lansbury, CFO/COO, Artivian: Yeah. I mean, realistically, right now, most of the revenue is stocking. So we don’t consign this product. There’s four sizes. If if an account wants access to it, they have to buy one of each and put it on the shelf.

So right now, you know, most of the revenue is coming from that. And it’s just it’s just gonna build. You know, once you get it on the shelf, then you start driving adoption. So we’ll see both of those things continue to grow over the course of the year. But, yes, right now, most of the revenue is from stocking.

Bill Plovanic, Senior Medical Device Analyst, Canaccord: And I’m gonna switch over to On X. You mentioned that the growth accelerated there. Yeah. In the studies you showed and but what do you really think is the driver of On X? I mean, it’s to have a product that’s been on the market forever and, you know, it’s been taking share, but it’s to accelerate at this stage of the game is pretty unique.

Pat Mack, CEO, Artivian: Yeah. And I think it’s I mean, it’s not uncommon in class three implantable devices for markets to move on big clinical data. I mean, that that’s, you know, what I’ve been doing for thirty years. I mean, we we had a great platform with On X because we’re the only mechanical valve that you can take half the blood thinner and get a 6060% reduction in bleeding, the original trial. And I mentioned we ran the post approval trial and got even more bleeding reduction in in a lot bigger centers or, like, 60 centers around the country, even community centers were involved.

So we thought that was pretty good because the bleeding reduction got better, and we thought that could be a little bit of a catalyst. The real change is this Jack paper that came out. It came out of UCLA. We had nothing to do with it. Hundred nine thousand patients with ten years follow-up showing mortality benefit to mechanical valves versus tissue valves under 60.

There’s a bunch of there’s a bunch of tissue valves used under 60, about a $100,000,000 worth. That that’s what’s driving this, is we’ve got a great sales team. We’re highly focused on the aortic customer. We’re launching AMDS. We’re training all these guys, and we’re get we haven’t even started marketing the data to cardiologists.

So this is a this is a five year opportunity on On X to get this data out to cardiologists and, you know, go after that big slice of the tissue valves, which is a great thing for patients.

Bill Plovanic, Senior Medical Device Analyst, Canaccord: And I think, you know, when we were visiting a couple months ago, we were talking and you mentioned you’re you’re doing training sessions every month on the EMDS. I think one of the the things that resonated with me as you you talked about that was just you’re bringing these docs in and you’re cross training them. And how much of an impact do you think that’s had on the business or continue to have on the business?

Lance Lansbury, CFO/COO, Artivian: Yeah. I mean, I think the the best evidence you can say of that is we have true new account creation for On X. So this product’s been on the market for, you know, a decade, and we’re opening new accounts with it. Now I do think that having the data to present when you’re doing the cross selling is is a huge factor. But, you know, we’re we’re also we’re the people innovating around this space, you know, for these aorta focused surgeons.

We’re the people bringing innovation to them, and I think it’s just getting us more and more of an audience with them. And we have a lot of things to talk to them about.

Bill Plovanic, Senior Medical Device Analyst, Canaccord: And will will you end up cannibalizing some of your bioprosthetic tissues?

Pat Mack, CEO, Artivian: So we we have we have a pulmonary valve, our for the Ross procedure. Very, very different. So that that started in kids, and we’re in every pediatric center in the country. There’s been a big acceleration into kinda young adults, like 50. I consider that young.

I do too. No. So so whether we cannibalized or not, we’re we’re constrained on the volume of our pulmonary valves just from donation. So it’s just, it’s not that big of a deal. And frankly, we’re kind of agnostic.

I mean, we sell the pulmonary valve for $25,000 So, I mean, if they wanna get a Ross, that’s great. If they wanna get a mechanical valve, that’s great. We’re kind of agnostic on it.

Bill Plovanic, Senior Medical Device Analyst, Canaccord: All right. Let’s move to the pipeline for the next product Nexus, which is I think second half of next year. We’ve seen the thirty day data. What data, the next dataset we’re going to see and what should we expect out of that? How will it be different, or what what more will we learn or not learn?

Pat Mack, CEO, Artivian: Yeah. So you could this is the thirty day data. And all these all these aortic trials look at the same stuff. It’s mortality. It’s stroke.

It’s dialysis. Paraplegia. And and these results were excellent. You we should expect to see the one year data at STS at the January. So, you know, kind of in the similar kind of layout as this, There’s one competitive product that recently got approved, and you’ll be able to kinda look at apples to apples.

It’s in a different indication, kind of in the same ZIP code, but a different indication. But you’ll be able to tell how how this device performs in that kind of anatomy versus the other device. So I think that’ll tell us a lot.

Bill Plovanic, Senior Medical Device Analyst, Canaccord: And I think you mentioned like a lot of these products have been used in Europe. So you’re kind of asking questions to answers you already know. But I think our Sivo is a little different.

Pat Mack, CEO, Artivian: Not really. So Arecibo I mean, this is, again, this is our next generation frozen elephant trunk. This is the device pictured here up on the screen. We sell a version looks exactly like that except it doesn’t have a subclavian branch, that little branch that sticks up. It just has a surgical graft.

We ran a trial in Europe in a 160 patients. It’s already been published. We compare it to the other product in the market, and we have better results with that device. This trial is a 117 patients. So the only thing that’s really gonna be, you know, new is this brand subclavian, which we think is gonna cut time off the procedure.

Bill Plovanic, Senior Medical Device Analyst, Canaccord: Okay.

Pat Mack, CEO, Artivian: And time is outcome. So I I think to your point, we we have to do the trial. We have to get the approval. But I think it’s heavily derisked. We’ve already run trials, you know, one and a half times sizes.

Bill Plovanic, Senior Medical Device Analyst, Canaccord: So they would be sewing their own subclavian branch on or with another product or

Pat Mack, CEO, Artivian: how In our product, they’d have to sew the subclavian branch, which is typically very deep and very hard to get access to. In this device, it’s catheter deployed from above and delivered directly into the subclavian. So it should save time.

Bill Plovanic, Senior Medical Device Analyst, Canaccord: And in terms of competition, you mentioned just in this space,

Pat Mack, CEO, Artivian: who

Bill Plovanic, Senior Medical Device Analyst, Canaccord: are your main competitors and kind of what are they doing? You mentioned the new product came on the market.

Pat Mack, CEO, Artivian: Yeah. I mean, it it depends on which segment. So in this segment, Terumo has got a device approved in the in The US. This segment, Gore’s got just got a device approved on The US. In AMDS, there’s nothing really.

Heart valves is Abbott. So that’s kind of the names everybody. The names. Yeah. It’s kind of a hodgepodge.

I mean, we’re we’re a a company that’s focused on the aorta and heart and vascular surgeons. So we bumped into a bunch of different competitors, but there’s really no one that looks exactly like us.

Bill Plovanic, Senior Medical Device Analyst, Canaccord: And then just going back to On X for a What second percent of the mechanical valve market do you have? And if you if you combine the the bioprosthetic tissue and mechanical valve, what what kind of percent of that market do you think? Because it’s you’re two different TAMs, but if you’re gonna be going into the bioprosthetic

Pat Mack, CEO, Artivian: So I I would say and, again, it gets complicated, like, international. Like, US, we probably have about 60% mechanical share. We probably have, like, 15% SABR share. So tissue plus mechanical. So you can see that this is the math.

There’s a much bigger opportunity when you put the tissue in.

Bill Plovanic, Senior Medical Device Analyst, Canaccord: Yep. Alright. Any questions from the audience? We have about a minute left. Alright.

I’ve gone through my whole question list. Anything you’d like to, finish with?

Pat Mack, CEO, Artivian: No. You just appreciate the invite to the meeting. It’s been great.

Bill Plovanic, Senior Medical Device Analyst, Canaccord: Thanks, man. Thanks, Lance. Appreciate it.

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