Idgar van Kippersluis Presents AMT Medical at LSI Europe '23

Transcription

Idgar van Kippersluis  0:05  
Hi, good morning, everyone. My name is Idgar. And I'm here to talk today about a wonderful new technology that has the potential to radically change the world of heart bypass surgery. Technology is called Alanna, and it's developed by a company called AMT Medical in the Netherlands. So I want to start out today by showing you a picture of my father. Because he's really the reason and the motivation for me to actually do this work. He suffered from severe heart issue several years ago, and had to undergo heart bypass surgery. And that proved to be a very invasive and also have traumatic experience, as multiple complications occurred, and he had to stay in the intensive care units for over a week. After that experience, he never fully recovered to his old self. And that got me thinking if shouldn't be, wouldn't it be really nice if there was a way to make this procedure much less invasive, and less dramatic for patients, such as him. And this, of course, is just the example of my father. But if you look at today's society, coronary artery disease is the single largest killer in the world today. And about 50% of men, and 30% of women over 40 will be affected by it, there's about a million heart bypass surgeries that are performed every year worldwide. So there's actually a very high likelihood that many of us here in the room today will be affected by this or someone close to us. And if you look at the procedure, it's actually quite shocking. To observe that it hasn't really changed much at all, in the last 30 or 40 years. The techniques are still the same as about 30 years ago. Now, what is the problem with the way cardiac bypass surgery is conducted today, of course, the main issue for patients is that it's just incredibly invasive, the chest is being opened, the hardest stops, the blood flow is stopped. And all of that leads to high risks of complications, and also very, very long recovery times. But also, for surgeons, it's still a very complicated procedure to perform. That requires a lot of skill and a lot of training. And so therefore, there's really a need both on the side of patients, as well as on the side of surgeons to get some innovation in a field that is still very, very large, but hasn't seen much innovation. Now, we hope that that this is about to change, we want to take the field of bypass surgery, from today's gold standard of using hand suturing. Just a thread and needle, just a surgeon, very manual process involves an open chest involves the heart being stopped, we want to move that world to tomorrow's world with a new gold standard, using our technology that is a clip and a laser catheter that can make the procedure much less invasive, and ultimately minimally invasive, and it will be performed on a beating heart. So that should take you know the situation of this patient on the left to something that looks more to the patient on the right, which of course as you can imagine will drastically reduce the recovery times from three to four months today, down to one to two weeks.

So we're developing our value proposition step by step. In the first instance, we are proving to technology that technology works in an open setting. And there's already some clear benefits in an open setting. Especially on the clinical side, our technology is really an enabler for an off balm way of conducting the procedure, which leads to a lower incidence of strokes. And it's also an enabler of using a fully arts arterial solution. Moreover, it's a standardized procedure. So you always get the same quality of the connection, which is of course is very different from today's standard of each surgeon just doing hand suturing which by definition leads to different outcomes every time. The second step would then be to take it to the minimal invasive setting. Of course the benefits are very clear When when the surgery is being conducted through small incisions between the ribs, there will be much less room for complications because the chest is not open, there will be a lot lower risk involved in that. And of course, the recovery times revalidation times will be dramatically reduced for patients. The third and final step on this on this journey would then be to use it with robotics, which our technology actually lends itself very well to that. Now, where does this originate? The invention of the technology itself was was made by a brain surgeon, Professor teleca, who was actually the father of our current CEO was in the in the room here today as well. And CE marking and FDA approval were already obtained back in 2011. For this, it proved to be a very good and life saving technology. But it was just relevant for a very small number of patients. So the commercially, the market was too small. And it was then decided to transfer the intellectual property into a new company, AMT medical, to then develop it for the heart. Now, since then, we've been working on adapting the technology, of course, for for the heart for cardiac surgery. Our first main breakthrough was achieved last year when we did our first 10 patients in in the Netherlands and Germany. And that went very well. And on the back of that we started a larger clinical trial of 75 patients also in Europe, which is currently ongoing. Actually, yesterday, two new patients were operated with this procedure. And we're in advanced discussions with the FDA as well to launch a first early safety feasibility study in the US with 10 patients early next year. So this is our roadmap, quite quite quite sort of we mapped it out quite clearly, we did the first in human already last year. And now of course, this clinical trial is ongoing. Also starting to work on some minimal invasive trials, first in animals and in humans in Germany. And, and starting up in the US early next year. If you look at the team, we have a team at AMC medical of about 20 people, young, old but all very, very motivated to work on this. But we're also backed by a very strong group of clinical advisors, both from from hospitals in Berlin, but also in the Netherlands since several in the in the US. And it's always very encouraging for us to see how many of these top notch professionals in the cardiac fields truly believe in our solution and are willing to help us and support us. Now this brings me to the final points in our presentation. We have advanced quite a bit over the years. And we are now at a point where we've got financing in place until the summer of 24. But we're going to be opening up our rounds very soon to raise 25 million for the two years beyond that. So from mid 24 to mid 26. That's the period in which we can conduct our pivotal trials also in the US. So within with that rounds, we should be able to get both CE marking as well as FDA approval. And we are looking for and talking to investors who are, you know, willing to join us on this journey to radically change the field of bypass surgery and make it much less invasive and much better. Thank you.