Anteris Technologies Limited (ASX:AVR) CEO & Managing Director Wayne Paterson presents on DurAVR, the company's durable and clinically superior heart valve, and the ADAPT technology.Good morning everybody. My name is Wayne Paterson and I'm here to talk to you about Anteris
(ASX:AVR). Anteris is a structural heart company, that's the sector we operate in, and I want you to focus in on three very unique technologies that we have. We operate in the US$10 billion market, so it's quite a big space. The first technology we have is called ADAPT. Now ADAPT is an Australian invention. Was invented by Prof. Leon Neethling, a cardiothoracic surgeon in Australia. And it is a unique anti-calcification treatment platform. That's really important to understand because the disease we treat, aortic stenosis, is a disease where calcium builds up on the aortic valve. So this anti-calcification treatment becomes very important. ADAPT, however, has been used in other settings in surgical repair, so it's not experimental. Biocompatibility is approved and it is FDA approved.
So we've got about 20,000 patients around the world with ADAPT products inside. So this is a great product, took about 20 years to develop, and it is hands down the best anti-calcification treatment in the world, with the longest data sets. We have a published data set over 10 years in humans showing no calcification in the surgical setting and many other publications as well, which to my knowledge, no one else has. We then took that ADAPT material and turned it into the second technology called DurAVR, durable AVR, aortic valve replacement. This is very novel as well as the technology. It's a 3D single piece valve and in fact, it's the only 3D single piece valve out there. The competitive valves in the market at the moment are made of three pieces of tissue sewn together. They're highly complex. The first generation technologies.
The third piece of technology that we have is the delivery system itself, the catheter. We now have fully developed a balloon, expanding catheter with commissure alignment. Now commissure alignment is a technical term for how we place the valve, but suffice to say, there is not a product in the market right now that has commissure alignment. The demands of that was driven by the physicians on our advisory board. So we have three very unique and novel technologies, all protected by IP. Where do you place Anteris? The answer converges between the MedTech and the biotech space and has characteristics from both sides. Now of course, in biotech, I've spent 25 years of my career in big pharma globally. I have launched a lot of drugs around the world. Now biotech is well known to me. There are very long lead times in biotech drugs, and the chance of success is often fairly low at the early stage phase one phase two, about 95 per cent chance of failure.
However, they're very big market caps of course, and it's just this mystery around the chemical that's being developed with the molecule. We go to the MedTech side, there's a perception of long lead times. Of course, lead times with MedTech are much, much shorter than biotech or pharma. But often there are problems looking for solutions. Engineers create great products and mechanical. Often my doctors say, "What do I do with this product?" So there's a bit of that and they're in smaller spaces. The biotech side, of course, has potential multi-billion dollar markets. MedTech often smaller, more often than not mechanical products rather than biochemical products. And then Anteris sits in the middle. We have ADAPT, which is a chemical process. So that is our biotech part of the story. It's very novel and unique. We operate in a very big biotech sized space at US$10 billion.
We are highly clinically differentiated at this point and this is obviously very important. And as important, we fill a current gap in the market that is around having valves that are lasting longer and more durable than what's available today, for reasons that I'll demonstrate in a minute. Now I've launched many drugs globally in big pharma and I can tell you there are three things you actually absolutely must have to succeed in the medical space. The first one, of course, is clinical superiority. That would seem to be a no brainer, not always the case but we clearly have clinical superiority at this point with our product. Number two, meeting a need in the market. When you launch a product like this, you've got to obviously address a problem in the market. And we do that very well, in fact, and the problem that we address is for valves that lasts longer. And in fact, not only lasts longer, but work better.
And thirdly, you must always have an advisory board of physicians who are highly credible on the podiums, well published of course, and known globally to help support and give credibility to your science. And of course we have some of the brightest minds in the TAVR space working with us on our advisory board and have been working with us for a couple of years now. So a little bit about the disease very quickly. Aortic stenosis is a disease where your aortic valve starts to calcify heavily to the point where it no longer functions very well. And in fact, it narrows the opening a lot and to the point where the blood pressures get very high. So as an example, the mean gradient blood pressure you would present with, and when you have severe stenosis is 50 millimetres of mercury, just for context, normal is five. So it comes up by an order of magnitude over a period of time.
Now, up until very recently, the way they dealt with this disease of course, was to crack your chest. It's an open heart procedure bypass procedure and replace the valve with another valve generally made from animal collagen because it has the right physical characteristics for a valve to open and close. Now this procedure of course is very complicated, takes several hours to perform. And it takes many, many weeks to recover from. Now, the limitations of this procedure were that patients above about 85, which is often where this patient group was, weren't really good candidates for this kind of surgery. In fact, the risk of mortality was way too high and more often than not, the doctor would send them home and tell them to get their affairs in order because there wasn't really a solution.
Now, some years back, two of the MedTech companies here in the States acquired other companies that had worked out a way to put this replacement valve onto a catheter and rather than cracking your chest up, they would stick that catheter through the femoral artery down near your groin, in your leg and drive it up over the aorta and put the valve in place that way. So this is a fantastic breakthrough for patients who otherwise did not have any other solutions. The limitations of this procedure, that the valves were never designed with longevity in mind and the patients who were getting these were quite elderly in the first place. The valve and the patient probably had about the same lifespan, maybe five years, but that all changed.
That all changed in 2019, when there were a couple of big studies that were done here in the States. One of them was led by Dr. Michael Reeden, who's on our advisory board where they demonstrated the use of the TAVR devices in younger patients, so-called low-risk group, were as effective as a surgical approach. So this was a huge, because that meant suddenly the patients were getting the valves who are much younger. So the mean age of patients went from 85 to 73 in one year. The picture you can see there on the right is actually a commercial valve. And maybe these valves retail for about $35,000 each US, and that's one that's come out after a few years heavily calcified. So the replacement valves suffer from two problems. One, they calcify again in an environment that has a lot of calcium and two, they mechanically wear out. Then they were never really designed to go the long distance. Suddenly we're in a position where we need valves, not only to go five years, but 10 or 15 years.
And on top of that, they need to work better because these patients are much more active than the previous population of patients who are getting these valves. So what's this all mean. A lifetime management of the patient is now a really key element here. That patient age has come down into the 70s and heading into the 60s. Life expectancy, obviously going up. Now, these patients are a lot younger and a lot more active. They're playing golf. They're walking around the block, and so on. The prior population was more elderly. So they really need a next-generation valve that lasts longer, but also works better. So the current valves, the current TAVR products attempt to address four areas. Probably addressed two of them really well. And the other two that don't address so well. First of all, is predictable procedure.
So I think these devices have been around long enough that we understand that how to place the valve with a catheter and get it in the right place, generally. Optimal hemodynamics, the first-generation valves, of course, worked but they never brought you out of the disease state. So you came down from severe stenosis where your blood pressures were 50 millimetres of mercury, and you've landed about 15 millimetres of mercury when you came off the table. So that's mild stenosis, when normal is five. So it didn't really get you back in the normal range and if you're an older patient, you're less active, maybe this was less of a problem. But as these valves being used in younger patients, of course, this becomes a real issue. And of course, these valves also start to deteriorate. So that pressure goes up fairly quickly.
So these valves are not maintaining that function for five years. They're starting to decline. Pretty soon you'll end up in moderate and sometimes back into severe stenosis with that replacement valve. And sometimes they'll have to put another valve on top of that, which is not very optimal. Next one is a low incidence of complications. I think, again, these devices have been around long enough that that everybody understands the complications and most of the picks for those complications, pacemaker rates, perivalvular leak and so on. The last one is durability. Now this is the big one because valves didn't necessarily have to be super durable up until the last couple of years because they were in older patients. Now they're in younger patients, they just have to last longer and they were never really designed to do that.
So DurAVR, we believe, addresses all four of these areas at the moment. Predictable procedure: we have a balloon expandable catheter with commissural alignment, and that's the preferred option for most physicians. The commissural alignment is a new technology. And that's going to be quite a breakthrough for doctors as well. Optimal hemodynamic performance: we know that our valve by design is different. We use the only 3D single piece valve, but of course, you're born with a 3D single piece valve, not a complex, three piece valve like the others. So this is more anatomically correct, but on the bench and in animals and in humans, we have seen our valve take people back to the pre-disease state rather than leaving them in mild stenosis.
And I'll show you some examples of that. And we're yet to see that in the TAVR because we have an FDA TAVR study coming up this year. Complications: I think we'll be on a par or better than what's available at the moment and durability: this is the big one. We have the best anti-calcification treatment, that's one of the killers of these replacement valves, but also because of the single piece design we mechanically wear out far more slowly, and I'll show you the examples of that. That anatomical correctness gives an 85 per cent increase in leaflet coarctation area. So we've got a much broader opening area, therefore, you get better blood flows than the complex three-piece first-generation valves. But we also have 35 per cent reduction in leaflet stress as a result of this design. So it's not a random event where we're getting better results by design, because this is a novel and unique valve.
And as a result of all of that, we're getting superior hemodynamic function. So just better blood flow, putting out patients back into the normal pre-disease range. So when you tie up these three technologies, you've got the first 3D single piece valve that's giving normal blood flows at the moment, which means exercise capacity is going to be better for patients. The younger patients who are still playing golf and who are active. We've got the anti calcification treatment ADAPT, which is the only one proven over 10 years in humans published and has zero DNA on the scaffold, so we know why it's different. So that's your ability component is quite high and improving for us and of course the delivery system that I think is also quite novel and unique. So very quickly why the replacement valves calcify. Remember what I said, this is a disease of calcification, aortic stenosis, and that's another commercial valve we're looking at there, but the one critical issue, there are several, but the big one is DNA.
The collagen, the material that these valves are made from is coming from animals and it's then treated certainly through a process of maintenance or a valve. We are the only material with ADAPT, where we've been able to remove all or most of the DNA off the scaffold. When we look at the other materials under the microscope, we can certainly see that there is DNA there. We know that they calcify, we know that we don't. And that DNA causes an immunological response, which causes inflammation, which leads to calcification. So that's a big one. And in fact, we've gone head to head with two of the market leaders in very controlled statistically powered studies. One of those is just being read out again at the moment. Results look fantastic as we would expect. So that's a very real impact. Of course, we've seen it in patients, in the clinic, in the surgical setting as well. The material does not calcify by design, it has no DNA.
Now it did take 20 years for Prof. Neethling to develop this and he developed this process with a specific aim of getting rid of calcification in the surgical setting. And he certainly achieved that. It took a couple of decades, but he got there, but that's not the only problem with these valves. The other problem is mechanical wear and tear as well. Now, these valves are made from three pieces of tissue houses, not as a 3D single piece valve. It's got a much wider opening area, but it has about 35 per cent less wear and tear as well. That's really important. These other valves are made up from up to 600 sutures when they seal that tissue window frame. It's very complex. Now those sutures, of course, put holes into the valve. Every time you sew a suture, you're putting a hole. Physicians have known this for many years, but the holes weaken those valves as well.
So they mechanically wear out far more quickly. We have an order of magnitude, less sutures. So many, many ways. That has an impact on production as well down the track. It takes about two days to make one of the competitor valves, about two hours to make a DurAVR valve. Now all of that probably doesn't mean a lot unless you can really show a valve is mechanically working. Now, nobody has 15 years of data in humans, but we all have these bench tests. These machines that accelerate the aging of the valve called cycle testers. One cycle is one beat. So you accelerate the agent. It's not a calcium test, it's just mechanical wear and tear. There's fluid being pumped through the valve. You can see on the right side, that's a beautiful picture of a DurAVR 3D single piece valve in it's frame with fluid pumping in and out of it as if it ripples in the body.
Now what's interesting is the FDA requires you have to have pass at least 200 million cycles. About five years of human use to get approved. We've got our longest ones going out to 700, in fact, we crossed over 700 million cycles last week. To my knowledge, I'm not aware of anyone publishing data out that far at the moment, but what's really interesting is that from day one to year 15, 16 at the moment, the function about balance is not deteriorating. That opening area, the EOA, is pretty much maintaining its full function. So not only is it about the lasting 15 years, but it's maintaining its full function from day one. Now this has to be proven in humans over 15 years, and nobody's done that yet. We have tried a couple of competitive valves on the bench and we saw one shred itself at about 150 million cycles.
So they certainly don't go the distance. We're going to do some structured studies around that and publish that data. Of course, bench is great, but as many shareholders now have gone into human studies in 2020, right at the beginning of COVID. Unfortunately, OR's were being opened and closed and it's been quite a tough time as we know in the Northern hemisphere. This is one of our patients. This is a DurAVR valve you're looking at here. Now it was placed surgically, so there is a difference. However, we have essentially the same valve in the surgical setting or the TAVR setting and down the track, we will of course commercialised DurAVR in the surgical setting because there was still a billion dollar market for that. But the point of what we're showing here is the hemodynamics. Now remember 50 millimetres of mercury is how you present with severe stenosis and five is normal.
You can see here these patients are typically coming out with five with an opening of about 2.9 to three. And that opening area and so-called EOA is measured in centimetres squared. That's the dilatation of the valve when it's fully open. Normal range is about three. Now the count of our valves leave you at about 1.5 to 1.8, then I get you up to three. And as a result, that's why the blood pressures don't bring you back to the normal range. Prof. Meuris is the surgeon who really has done a lot of early valve work for a lot of companies, so he knows this space very well. And he came out publicly and said, he hadn't seen these results with commercially available valves before, because nobody has developed a valve that puts you in a pre-disease state or in a normal state so far.
And so that's a big validation for DurAVR but of course, again, it's by design. It's the only 3D single piece valve out there. Now, as a result of that, we were awarded the best innovation award at PCR London Valves last year. This is a very prestigious global academic clinical conference normally held in-person. Of course, last year it was held virtually and the best innovation process is a very competitive one. And of course it's judged by a panel of cardiologists. We won that award simply because our valve is performing better and differently and giving these kinds of results. So it's a huge validation of the technology and science. We are supported by a very incredible advisory board and I would say that you can Google these doctors. They're all very well known in the podiums, well-known globally in this space and are opinion leaders in the TAVR world.
So in closing, we have three components of the TAVR worked out. We have the anti-calcification treatment with ADAPT, showing 10 years of no calcification in humans. We have DurAVR, the 3D single-piece valve, the only one of its kind with an 85 per cent greater dilatation area and 35 per cent less wear and tear. And we now have a catheter that is balloon expandable with commissural alignment, really designed by our physicians on the advisory board, which will help deliver this valve where it needs to go. We have an FDA study coming up. We're looking for approval for that study very shortly and that study of course will commence this year, as well as several other studies that are being read out at the moment. So at that point, I would pause the presentation. Thank you for your time and attention.
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