Kevin Mayberry Presents Endospan at LSI Europe '23

Transcription

Kevin Mayberry  0:05  
My name is Kevin Mayberry, I'm the CEO of Endospan, we are a company that is transforming the the treatment of aortic arch disease. We are an Israeli based company, where, as I mentioned, we're focused on the aortic arch, which we see as a $1 billion market plus around the world. Now, the aortic arch, the order comes out of the heart, and it loops around and then it comes down and feeds the rest of your body for with blood. And so the arch is that top part that feeds your extremities, and also your head. We are a pre commercial company in the United States, we're running an FDA trial, which I'll get into. And then in the EU or Europe, we have sales through our partnership with Artivian, which is a large strategic, and we're in a very unique position, and that we have an agreement to be purchased upon FDA approval for $350 million. So what is aortic arch disease, there's two different types of aortic arch disease. The first one is is a type a dissection. This one is one that comes up immediately, and all of a sudden, the symptoms are actually very similar to a heart attack. The this is when the intima, which is the inner layer of the aorta separates from the aorta. And instead of having one lumen in your artery, like as normal, you would then have to, this has an effect that it weakens the wall of the aorta and can cause a rupture. They say that the mortality rate is 2% per hour, that is not that they're not treated. So after one day, about 50% of the patients will die. The second disease that we treat an aortic arch is the aortic arch aneurysm. Now, this is a very different one, because it's called the ticking time bomb or a silent killer, because most of the patients don't even realize they have an aneurysm. This is detected through some other means, or modality of pickup in ultrasound or a CT scan that they get for another reason. And this is a ticking time bound because it can go off and anytime it can rupture, and if it does rupture in the arch, it's a 97% mortality rate. This is a really interesting space for me, I've been in it for over 20 years. And the reason is, is because this is really the last frontier of endovascular medicine. If we look at the abdominal aorta, and the aneurysms and dissections, or TVaR in the thoracic. All of these 20 years ago, were predominantly open surgery that have now shifted to 70 or 80%. Endovascular or minimally invasive. If we look at TAVR TAVI, it's the same, it's the same paradigm shift. What we haven't seen is an aortic arch, it's still a 95% plus open surgery. And this is where we see a shift and Endospan is leading the way. A little bit more about the open surgery. So this is a very difficult, this is a very difficult surgery not only for the patients but also for the surgeons, okay. So it involves an open heart surgery, and body cooling down to 20 degrees C in order to, to cool down your brain to avoid any neurological damage to the patient. In a given hospital that maybe has eight to 10 cardiac surgeons, only one or two of them will perform this surgery on a routine basis because of the difficulty of the surgery. Now on the patient side, it's probably much worse. As you can imagine, the hospital mortality is 20%. The reoperation rate is 35%. And the stroke rate is 17%. At 30 day, their average hospital stay can be up to 30 days. So this is a very difficult procedure for the patients. So what what have we done? This is our stent graft the called the Nexus system, it goes into the brachiocephalic trunk up into your brain. The stent graft is deployed into the target site, you'll see this has an aneurysm on it. And then a second piece is then put just above the valve, and these are connected together in the body. The purpose of this whole stent graft is to take the pressure off of the artery to reduce the risk of rupture for these patients. So to date, we've treated over 275 patients globally. And that number keeps increasing almost on a daily basis as we're commercial here in Europe. We have actually almost 60 patients enrolled in our IDE study in the United States. And I'm going to elaborate a little bit more on that in a minute. This is a study that was done in Europe in order to get CE mark the number of patients we did was 25. What I want to point out to you is that the procedural time on Nexus was on average 68 minutes. This is a far cry from the four to eight hours that the patients normally see and this will also manifest itself when you see The change in the outcomes in comparison to open repair versus the Nexus. Our hospital stays have dropped on Europe down to 13 days. And I can tell you in the US, we're going to see a further drop of about probably to four or five days on average for these patients. stroke rate, we have a 50% reduction down 8%, and a mortality rate change of 60 reduction of 60%. Now, these are very different patients, mind you, we treat high risk patients that are not really eligible for open repair, and we're comparing against those that are open repair, these are healthy patients going in, so we're seeing better results on a much sicker patient population. This is our study that we've got our pivotal study that we've got running in the United States right now. We have two different arms. The first one is the chronic dissection arm, we have our 70% enrolled in that we expect to get full enrollment towards the end of this year. Our second study is the aneurysm which is 85% Roll and we'll have that fully enrolled pretty much every day now. It's broken up into two to two separate endpoints. The first one is device technical failure, I'm not going to get into all the the endpoints, but these are at 30 days. The key takeaway for this and you'll see on the next slide, too, is that we need to stay below 13%. For the FDA, our CE mark results showed 8% So well below it. And we're tracking in a very good way on our trial so far. On our clinical failure, it's a similar story. These are our endpoints, but our CE mark results were at 12%. Our approved US results need to below be below 18%. The competitive landscape, this has been a tough field, you say why have all these other markets shifted to endovascular and not the arch. And it's really because of the challenges. There's challenges of engineering, there's a lot of movement in the arch. And there's also a high risk of stroke because you're now dealing with vessels that go directly to the brain. In fact, most patients will even tell their physicians that they would rather probably rather die than have a stroke because of the disabling effect that can have on them. So when we look at some of the companies and not all of these are even on track to come to approval in the United States, we have an 8% stroke rate. Cook which is not running a trial in the US at all, and has done a few cases in Europe has 17% and Gore has reported a 22% stroke rate. Us and Gore are probably in line for a potential us approval at about the same time. So as we look Endospan has a very unique story, I would say in a way that we're two thirds of the way completed with our IDE trial. Our data has been thus far and two thirds of the way through very good. We have a purchase agreement already in place with Artivian and for 350 a minimum of 350 on the upside of 450 million depending on milestones. And in probably less than two years we see an investment with a return of higher than a 3x on it. I'd like to thank you for your time and if you have any questions feel free to reach out