All right, good morning. My name is Bill Plovanic . I'm a Senior Medical Device Analyst here with Canaccord. Welcome to our 45th Annual Growth Conference. With us next, we have Artivion. We have Pat Mackin, CEO, and Lance Berry, CFO and recently promoted to COO. Our format today is going to be a 5 minute-10 minute presentation followed by a fireside chat with both executives. With that, I'm going to hand it over to Pat.
Thanks, Bill, and thanks for having us here at the conference. My name is Pat Mackin. I'm the CEO here. I've been here for 11 years, Labor Day. It's gone by quite quickly. Forward-looking statements, you guys can see those on the web. Really, Artivion as a company has a very tight focus. We do two things. We focus on aortic valves in patients under 65, and we focus on aneurysms and dissections, particularly in the aortic arch. We've got a great leadership team. Lance is 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. 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. We add to it, originally it was going to be the stent business, which was going to 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. You combine that with our highly leveraged infrastructure of our channels, our G&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. 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 On-X because this is really, you know, 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, got 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 was published in JACC, the Journal of the American College of Cardiology, that showed that with 10 years of data that if you got a tissue valve under the age of 60, you took a mortality hit versus a mechanical valve. 109,000 patients at 10-year follow-up. 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 a $100 million tissue valve market opportunity. The last one is that, you know, TAVR doesn't do great in patients under 65 either. This On-X Aortic Heart Valve 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. This pipeline is bringing those products to the U.S. and Japan. We have to do the clinical work, obviously PMA clinical trials that will 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 is 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, we have clinical data out of Europe or other parts of the world that are basically the same size of the FDA trial. This is not a super risky pipeline. We do have to do the work and get the approvals. 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. You can see roughly the market size is set up. That's about a $1 billion pipeline opportunity. Just really quickly to touch on each one of the three next PMAs. AMDS Hybrid Prosthesis, this is our stent for acute type A dissection. If you see on the left, that's the current standard of care. If you see on the right, that's the AMDS Hybrid Prosthesis. 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 U.S. 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 22% 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 30-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. We have an option to acquire this company called Endospan as soon as they get FDA approval. We're expecting that in the second half of 2026. We're super excited about this technology. Again, another technology, advanced technology in the arch. The third is our SEVO.
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. 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. 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- 14. We keep narrowing, and now we're at 12- 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 the initial guidance of 18- 28. We've narrowed that to 21- 28.
We're on target to be in, you know, $86 million- $91 million on the EBITDA and also free cash flow positive. In summary, we are a leader in the advanced segment of 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 $1 billion worth of opportunity. From a financial standpoint, free cash flow positive, expanding gross margins, expanding EBITDA margins, and delivering, deleveraging the balance sheet. With that, I'll turn it back over to Bill for our fireside chat.
Great. Let's invite Lance as well. We'll put Lance in the hot seat and start with the financial numbers first. 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 raise the guidance?
I think first thing, just, you know, we're halfway through the year and things are playing out like we anticipated. 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 new product launch. Pat talked about the On-X performance in Q2, which I think honestly was a little bit of a positive surprise for us as well. I think all those things together are giving us confidence that we can really come in toward the upper half of our original guidance range for the year.
As you think about it, I think when you originally gave guidance in that, you mentioned the AMDS Hybrid Prosthesis, it was 1%- 2% of the year-over-year growth. How are you thinking about that today?
Yeah, I mean, 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 AMDS Hybrid Prosthesis and feel really good about it.
Okay. I mean, on the balance sheet, you got a lot of cash. You've done a lot of work to delever that balance sheet. 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?
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. 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 that debt down.
The future use of cash is to continue to delever.
That and hopefully the Endospan acquisition. 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 million upfront purchase price if we exercise that option. We need to fund that. Other than that, yes, we would be looking to pay down debt.
Is there any limitations on your debt that would limit you from using that debt for the Endospan and the free cash flow?
We have private debt in place now. I mean, there are covenants. We'd have to work with our lender on that. Honestly, I think they would be thrilled if we came and asked them for a little bit more money. I think that'd be fine.
Fantastic. I'm going to 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 Humanitarian Device Exemption. Can you help us understand what are the limitations of commercializing under an HDE?
Yeah, so the real requirement for an HDE is, one is you have to get an IRB, which is unique. 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 8,000. The total market for acute type A dissections in the U.S. is like 6,000. Practically, it's not really a limitation in this case.
I'd say a HDE search, maybe one of those every couple of years. I can see the hospitals would be confusing for it. What does competition look like in the AMDS space?
Yeah, I mean, we really don't have a direct, I mean, the competition is, you see it 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 kind of delaminated. Whereas when you put a stent in with AMDS Hybrid Prosthesis, you kind of push that flap back against the kind of native aortic wall. That's really the only competition. I think the other one, if you jump up to our SEVO, which is the trial we're about to start, about 10% of the surgeons in the country can actually replace the entire arch. It's a pretty complex procedure. Like I said, 90% of the guys can't do it. You could say this is tangentially a competitor.
We're going to have that as well, and we do internationally, but it really isn't, it's kind of a different segment because most guys can't do this one.
Yeah, what has physician feedback been on the AMDS Hybrid Prosthesis 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.
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, you know, an hour. We do a lot of clinical work with them. We do a lot of education, but it's a one-day program, or we can do it at the center. The feedback's been outstanding. If you look at the clinical data, this is the part that's so impressive about this technology. The mortality in this trial went from 35% to under 10%. The idea of malperfusion, if people aren't familiar with it, is basically blood's not going where it's supposed to go. If you put a stent in and blood starts going where it's supposed to go, you have fewer strokes, fewer people need dialysis. It's really an amazing technology.
I think people, and we saw it at the trial as well, just really excellent feedback.
I think from our doc calls, the one thing that really stuck in my mind was just the easy use, was so simple to use. I think the comment one of the docs said, a leading doc was like, "A community guy can do this." It really democratizes.
That's the word. It's democratized. We did this when I was in Medtronic with some ablation technology, democratizing the procedure. Guys in the community center can get results as good as the big academic centers with this technology.
How important is the final PMA approval, and when's it coming?
Yeah, I mean, we're expecting about a year from now, second half or the middle of 2026. We're on track for that. The only thing it's really going to do is eliminate the IRB. Also, we're going to go for a broader indication. I personally don't think it's that big of a deal. I don't think it's going to be a big catalyst because we have a malperfusion indication right now, which is about 40% of the market. We're going to go after the full market. 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 going to use it in non-malperfusion cases.
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 kind of the point.
I think, you know, we put some estimates together. I estimated about $1.9 million in revenue for the quarter. I know Lance will comment on that. If you think of the second quarter revenues, the question I've gotten from investors is how much do you think of that was stocking and how much was sell-through?
Yeah, I mean, realistically, right now, most of the revenue is stocking. 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. Right now, most of the revenue is coming from that, and it's just going to build. Once you get it on the shelf, you start driving adoption. We will see both of those things continue to grow over the course of the year. Yes, right now, most of the revenue is from stocking.
I'm going to switch over to On-X. You mentioned that the growth accelerated there in the studies you showed. 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 it's been taking share, but to accelerate at this stage of the game is pretty unique.
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's, you know, what I've been doing for 30 years. I mean, 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 60% reduction in bleeding, the original trial. I mentioned we ran the post-approval trial and got even more bleeding reduction in a lot bigger centers, or like 60 centers around the country, even community centers were involved. 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 JACC paper that came out. It came out of UCLA. We had nothing to do with it.
109,000 patients with 10 years of follow-up showing a mortality benefit to mechanical valves versus tissue valves under 60. There's a bunch of tissue valves used under 60, about $100 million worth. 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 haven't even started marketing the data to cardiologists. 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.
I think, you know, when we were visiting a couple of months ago, we were talking, and you mentioned you're doing training sessions every month on the AMDS Hybrid Prosthesis. One of the things that resonated with me as you talked about that was just you're bringing these docs in and you're cross-training them. How much of an impact do you think that's had on the business or continued to have on the business?
Yeah, I mean, I think the best evidence you can say of that is we have true new account creation for On-X. So there's a product that's been on the market for, you know, a decade, and we're opening new accounts with it. I do think that having the data to present when you're doing the cross-selling is a huge factor. We're also the people innovating around this space 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. We have a lot of things to talk to them about.
Will you end up cannibalizing some of your bioprosthetic tissues?
We have a pulmonary valve for the ROS procedure. Very, very different. 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 under 50. I consider that young.
I do too.
No, whether we cannibalize or not, we're constrained on the volume of our pulmonary valves just from donation. It's not that big of a deal. Frankly, we're kind of agnostic. I mean, we sell the pulmonary valve for $25,000. If they want to get a ROS, that's great. If they want to get a mechanical valve, that's great. We're kind of agnostic on it.
All right, let's move to the pipeline for the next product, Nexus, which is, I think, the second half of next year. We've seen the 30-day data. What data is the next data set we're going to see, and what should we expect out of that? How will it be different, or what more will we learn or not learn?
Yeah, so you could, this is the 30-day data. All these aortic trials look at the same stuff. It's mortality, it's stroke, it's dialysis, paraplegia. These results were excellent. We should expect to see the one-year data at STS at the end of January. 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 kind of look at apples to apples. It's in a different indication, kind of in the same zip code, but a different indication. You'll be able to tell how this device performs in that kind of anatomy versus the other device. I think that'll tell us a lot.
I think you mentioned a lot of these products have been used in Europe. You're kind of asking questions to answers you already know. I think our SEVO is a little different.
Not really. Our SEVO, I mean, this is, again, our next generation frozen elephant trunk. This is the device pictured here up on the screen. We sell a version that 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 160 patients, started and published. We compare it to the other product in the market, and we had better results with that device. This trial is 117 patients. The only thing that's really going to be new is this branch subclavian, which we think is going to cut time off the procedure.
Okay.
Time is outcome. I think, to your point, we have to do the trial. We have to get the approval. I think it's heavily de-risked because we've already run trials, you know, one and a half times the size of this.
Would they be sewing their own subclavian branch on or with another product, or 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. It should save time.
In terms of competition, you mentioned just in the space, who are your main competitors and kind of what are they doing? You mentioned a new product came on the market.
Yeah, I mean, it depends on which segment. In this segment, Terumo has got a device approved in the U.S. This segment, Gore's just got a device approved in the U.S. In AMDS, there's nothing really. Heart Valves is Abbott. That's kind of the names.
It's missing everybody.
The names, yeah, it's kind of a hodgepodge. I mean, we're a company that's focused on the aorta and heart and vascular surgeons. We bump into a bunch of different competitors, but there's really no one that looks exactly like us.
Going back to On-X for a second here, what percent of the mechanical valve market do you have? If you combine the bioprosthetic tissue and mechanical valve, what kind of percent of that market do you think? You're two different TAMs, but if you're going to be going into the bioprosthetic.
I would say, again, it gets complicated like U.S., international. Like U.S., we probably have about 60% mechanical share. We probably have like 15% SAVR share, so tissue plus mechanical. You can see that just the math is a much bigger opportunity when you put the tissue in.
All right. Any questions from the audience? We have about a minute left. All right. I've gone through my whole question list. Anything you'd like to finish with?
Yeah, yeah.
All right. Good morning. COO. Our format today is going to be a 5 minue-10 minute presentation followed by a fireside chat with both executives. With that, I'm going to hand it over to Pat.
Thanks, Bill, and thanks for having us here at the conference. My name's Pat Mackin. I'm the CEO here. I've been here for 11 years, Labor Day. It's gone by quite quickly. Forward-looking statements, you guys can see those on the web. Artivion is a company that has a very tight focus. We do two things. We focus on aortic valves in patients under 65, and we focus on aneurysms and dissections, particularly in the aortic arch. We've got a great leadership team. Lance is 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. 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, we have a base business that's highly differentiated, profitable, and growing. We add to it, originally it was going to be the stent business, which is going to 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. You combine that with our highly leveraged infrastructure of our channels, our G&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. 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 On-X because this is really, you know, this was 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, got 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 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 JACC, the Journal of the American College of Cardiology, that showed that with 10 years of data, if you got a tissue valve under the age of 60, you took a mortality hit versus a mechanical valve. 109,000 patients at 10-year follow-up. 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 a $100 million tissue valve market opportunity. The last one is that, you know, TAVR doesn't do great in patients under 65 either. This On-X Aortic Heart Valve 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. 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 is 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, we have clinical data out of Europe or other parts of the world that are basically the same size of the FDA trial. This is not a super risky pipeline. We do have to do the work and get the approvals. 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. You can see roughly the market size is set up. That's about a $1 billion pipeline opportunity. Just really quickly to touch on each one of the three next PMAs. AMDS Hybrid Prosthesis, this is our stent for acute type A dissection. If you see on the left, that's the current standard of care. If you see on the right, that's the AMDS Hybrid Prosthesis. 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 U.S. 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 22% 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 30-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. We have an option to acquire this company called Endospan as soon as they get FDA approval. We're expecting that in the second half of 2026. We're super excited about this technology. Again, another technology, advanced technology in the arch. The third is our SEVO.
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. 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. 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 deleveraging 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 continue to go down. From a 2025 guidance standpoint, we came out at the beginning of the year on the revenue with a 10- 14, and we keep narrowing, and now we're at 12- 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 the initial guidance of 18- 28. We've narrowed that to 21- 28.
We're on target to be in, you know, $86 million- $91 million on the EBITDA and also free cash flow positive. In summary, we are a leader in the advanced segment of the aorta. We've got a dedicated team with a ton of experience, a 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 $1 billion worth of opportunity. From a financial standpoint, free cash flow positive, expanding gross margins, expanding EBITDA margins, and delivering, deleveraging the balance sheet. With that, I'll turn it back over to Bill for our fireside chat.
Great. Let's invite Lance up as well. We'll put Lance in the hot seat and start with the financial numbers first. 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 raise the guidance?
I think first thing, just, you know, we're halfway through the year and things are playing out like we anticipated. 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 new product launch. Pat talked about the On-X performance in Q2, which I think honestly was a little bit of a positive surprise for us as well. I think all those things together are giving us confidence that we can really come in toward the upper half of our original guidance range for the year.
As you think about it, I think when you originally gave guidance in that, you mentioned the AMDS Hybrid Prosthesis, it was 1%- 2% of the year-over-year growth. How are you thinking about that today?
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 AMDS and feel really good about it.
Okay. I mean, 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 improving 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?
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. 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 down.
The future use of cash is to continue to delever.
That and hopefully the Endospan acquisition. 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 million upfront purchase price if we exercise that option. We would need to fund that. Other than that, yes, we would be looking to pay down debt.
Are there any limitations on your debt that would limit you from using that debt for Endospan and the free cash flow?
We have private debt in place now. I mean, there are covenants. We'd have to work with our lender on that. Honestly, I think they would be thrilled if we came and asked them for a little bit more money. I think that'd be fine.
Fantastic. I'm going to switch to the product on AMDS that launched in the first quarter of this year. I think approval last year under the HDE, the Humanitarian Device Exemption. Can you help us understand what are the limitations of commercializing under an HDE?
Yeah, so the real requirement for an HDE is, one is you have to get an IRB, which is unique. 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 8,000. The total market for acute type A dissections in the U.S. is like 6,000. Practically, it's not really a limitation in this case.
I'd say a HDE search, maybe one of those every couple of years. I can see the hospitals would be confusing for them. What does competition look like in the AMDS space?
Yeah, I mean, we really don't have a direct, I mean, 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 kind of delaminated. Whereas when you put a stent in with AMDS, you kind of push that flap back against the kind of native aortic wall. That's really the only competition. I think the other one, if you jump up to our SEVO, which is the trial we're about to start, you know, about 10% of the surgeons in the country can actually replace the entire arch. It's a pretty complex procedure. Like I said, 90% of the guys can't do it. You could say this is tangentially a competitor.
We're going to have that as well, and we do internationally, but it really isn't, it's kind of a different segment because most guys can't do this one.
Yeah, what has physician feedback been on the AMDS Hybrid Prosthesis 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.
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 a lot of clinical work with them. We do a lot of education, but it's a one-day program, or we can do it at the center. The feedback's been outstanding. If you look at the clinical data, this is the part that's so impressive about this technology. The mortality in this trial went from 35% to under 10%. The idea of malperfusion, if people aren't familiar with it, is basically blood's not going where it's supposed to go. If you put a stent in and blood starts going where it's supposed to go, you have fewer strokes, fewer people need dialysis. It's really an amazing technology.
I think people, and we saw it in the trial as well, just really excellent feedback.
I think from our doc calls, the one thing that really stuck in my mind was just the easy use, was so simple to use. I think the comment one of the docs said, a leading doc was like, "A community guy can do this." Like it really democratizes.
That's the word. It's democratized. We did this when I was in Medtronic with some ablation technology, democratizing the procedure. Guys in the community center can get results as good as the big academic centers with this technology.
How important is the final PMA approval, and when's it coming?
Yeah, I mean, we're expecting about a year from now, second half or the middle of 2026. We're on track for that. The only thing it's really going to do is eliminate the IRB. Also, we're going to go for a broader indication. I personally don't think it's that big of a deal. It's not going to, I don't think it's going to be a big catalyst because we have a malperfusion indication right now, which is about 40% of the market. We're going to go after the full market. Once this is approved and on the shelf, surgeons can do what they want. We won't market off the label. You know, we know from just hearing what they say that they're going to use it in non-malperfusion cases.
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 kind of the point.
I think, you know, we put some estimates together. I estimated about $1.9 million in revenue for the quarter. I know Lance will comment on that. If you think of the second quarter revenues, the question I've gotten from investors is how much do you think of that was stocking and how much was sell-through?
Yeah, I mean, realistically, right now, most of the revenue is stocking. We don't consign this product. There are four sizes. If an account wants access to it, they have to buy one of each and put it on the shelf. Right now, most of the revenue is coming from that, and it's just going to build. Once you get it on the shelf, you start driving adoption. We will see both of those things continue to grow over the course of the year. Yes, right now, most of the revenue is from stocking.
I'm going to switch over to On-X. You mentioned that the growth accelerated there in the studies you showed. What do you really think is the driver of On-X? I mean, to have a product that's been on the market forever, and it's been taking share, but to accelerate it at this stage of the game is pretty unique.
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's, you know, what I've been doing for 30 years. I mean, 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 60% reduction in bleeding, the original trial. I mentioned we ran the post-approval trial and got even more bleeding reduction in a lot bigger centers, or like 60 centers around the country, even community centers were involved. 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 JACC paper that came out. It came out of UCLA. We had nothing to do with it.
109,000 patients with 10 years of follow-up showing a mortality benefit to mechanical valves versus tissue valves under 60. There's a bunch of tissue valves used under 60, about $100 million worth. 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 haven't even started marketing the data to cardiologists. 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.
I think, you know, when we were visiting a couple of months ago, we were talking, and you mentioned you're doing training sessions every month on the AMDS Hybrid Prosthesis. I think one of the things that resonated with me as you talked about that was just you're bringing these docs in and you're cross-training them. How much of an impact do you think that's had on the business or continued to have on the business?
Yeah, I mean, I think the best evidence you can say of that is we have true new account creation for On-X. This product's been on the market for, you know, a decade, and we're opening new accounts with it. I do think that having the data to present when you're doing the cross-selling is a huge factor. We're also the people innovating around this space, you know, for these aorta-focused surgeons. We're the people bringing innovation to them. 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.
Will you end up cannibalizing some of your bioprosthetic tissues?
We have a pulmonary valve for the ROS procedure. Very, very different. 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 under 50. I consider that young.
I do too.
Whether we cannibalize or not, we're constrained on the volume of our pulmonary valves just from donation. It's just not that big of a deal. Frankly, we're kind of agnostic. I mean, we sell the pulmonary valve for $25,000. If they want to get a ROS, that's great. If they want to get a mechanical valve, that's great. We're kind of agnostic on it.
All right, let's move to the pipeline for the next product, Nexus, which is, I think, the second half of next year. We've seen the 30-day data. What data is the next data set we're going to see, and what should we expect out of that? How will it be different, or what more will we learn or not learn?
Yeah, so you could, this is the 30-day data. All these aortic trials look at the same stuff. It's mortality, it's stroke, it's dialysis, paraplegia. These results were excellent. We should expect to see the one-year data at STS at the end of January. 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 kind of look at apples to apples. It's in a different indication, kind of in the same zip code, but a different indication. You'll be able to tell how this device performs in that kind of anatomy versus the other device. I think that'll tell us a lot.
I think you mentioned a lot of these products have been used in Europe. You're kind of asking questions to answers you already know. I think our SEVO is a little different.
Not really. Our SEVO, I mean, this is, again, our next generation frozen elephant trunk. This is the device pictured here up on the screen. We sell a version that 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 160 patients, started and published. We compare it to the other product in the market, and we had better results with that device. This trial is 117 patients. The only thing that's really going to be new is this branch subclavian, which we think is going to cut time off the procedure.
Okay.
Time is outcome. I think, to your point, we have to do the trial. We have to get the approval. I think it's heavily de-risked because we've already run trials, you know, 1.5 times size this.
Would they be sewing their own subclavian branch on, or with another product, or 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. It should save time.
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.
Yeah, I mean, it depends on which segment. In this segment, Terumo has got a device approved in the U.S. This segment, Gore's just got a device approved in the U.S. In AMDS, there's nothing really. Heart Valves is Abbott. That's kind of the names.
Pretty much everybody.
The names, yeah, it's kind of a hodgepodge. I mean, we're a company that's focused on the aorta and heart and vascular surgeons. We bump into a bunch of different competitors, but there's really no one that looks exactly like us.
Just going back to On-X for a second here, what percent of the mechanical valve market do you have? If you combine the bioprosthetic tissue and mechanical valve, what kind of percent of that market do you think? You're two different TAMs, but if you're going to be going into the bioprosthetic.
I would say, again, it gets complicated like U.S., international. Like U.S., we probably have about 60% mechanical share. We probably have like 15% SAVR share, so tissue plus mechanical. You can see that this is the math. There's a much bigger opportunity when you put the tissue in.
All right. Any questions from the audience? We have about a minute left. All right. I've gone through my whole question list. Anything you'd like to finish with?
No, I just appreciate the invite to the meeting. It's been great.
Thanks, Pat. Thanks, Lance. Appreciate it.