David Neale, Arga Medtech - Cardiac Ablation System | LSI Europe '22

Transcription

David Neale  0:09  

Well, I guess it's, it's good coming after Kevin and Arvind, because a lot of my introduction here has been done already on AF. I am CEO, Co Founder Varga medtech, the another company exploring their posture ablation for cardiac ablation. And I will walk you through some of the differences of what we're doing compared to what competition is, is doing out there. Brief Introduction to the company. We're a very new company, just over two years old that raise its first round, six months after incorporation a 10 million euro and in two weeks time we will be starting at first in human so a phenomenal progress and very capital efficient, but only possible really off. Okay, Mr. Slide, only possible because of the great team we have. The slide is skipping but we've assembled a team with I think every single member of ours has vast experience in EP. Some of the companies where they work before recited before as ablation frontiers cryo CAT laboratories, Medtronic we have people from Abbott as well, that have enabled us to bring this product in such a fast way to first inhuman. Obviously, we're doing ablation right now we're working for to treat AF and other arrhythmias, AF is explained is the largest of the arrhythmias and anyone with AF a safe times the probability of contracting stroke or three heart failure. But most important, it's number two for causes of stroke. Okay, so what we must not ever forget, however, is that with all of this diminished quality of life is frequent. And so as a treatment, it's growing incredibly fast. 33 million is a number commonly cited in literature, I see people before here, putting 46 million that just proves the point of how fast it's growing, and current established market of 5 billion already. Very competitive environment. Few companies control this market, few companies have grown their franchise by acquisition, and here are just a few of the 33 billion over the past 20 years. But recently, until the deal of a Farah, the last four deals done in the last two years were pre pre revenue and at 260. Our federal loan was like 930, for Medtronic in this in this field. So what do we do with ablation? As Kevin explained, we try and segment the heart with a certain number of lesions. And by doing so we redirect or reestablish the normal heart rhythm in the atrium, right? But it's not easy. In order to do so lesions have to be transmural have to be continuous. You saw in a previous slide here presented that doing a focal ablation point by point makes it very complicated, require skills. Cryo has a one shot device but also has its shortcomings. And we've tried to address all of this in one. And a side note here, ablation is becoming first line therapy. So it just adds to the what I said of a fast growing business. Despite the 20 years and ablation, since I really started doing all of this, the outcomes are still not not acceptable, right, I mean, post a post one procedure, patients have usually below 40% success rate after a second procedure, more complex procedure, they can achieve a higher one, but these results drop in line in time. The reason for this is the nature of the energy source that they're using. They're using thermal energy that in this doesn't discriminate between the tissue you're trying to ablate and any neighboring tissues. So what happens is if you're under dose, you don't do the transmit reality you don't do the full lesion if you overdose, you create some safety problems, right. And this is illustrated here. Pulse field ablation very different. The easiest way to think of pulse field ablation is to imagine that you put the cells or the cardiomyocytes in this electrical field. And this electrical field kind of alters the membrane permeability punches holes into it and leads that cell to a natural death through apoptosis. It's very interesting because it's at the same time very tissue specific, because the thresholds needed to kill a cardiomyocyte are much lower than what is needed for other neighboring tissue like red blood, red blood cells, vascular smooth muscle, endothelial more, or even the nerves as you can see up there. So it makes it easy to dose it makes it easier to find the safety profile and makes for a much safer procedure than the current ones. At Arga Medtech. We have taken a different approach than conventional companies doing pulsed field ablation today. pulsed field ablation has been used in oncology for many years, and everybody has kind of adapted the systems used for oncology to to the cardiac needs, we have gone further with adapt with created from scratch and new technology that makes use of a sine wave, or a coherent sine wave instead of a traditional square wave gets very technical here, but in a nutshell, what this allows us to do is to titrate for depth, okay, so we can in a bipolar mode have a very similar lesion to what is achieved today with the current systems. But with combining bipolar unipolar and the phasing of the coherent sine wave, I can achieve depth, okay, but a generator, Excel itself is not a solution, a system needs to be developed as a system. So we also put some thought into what people are using today. And what do people need in the MDR, right, so in the P lab, so single shot devices, as explained earlier, is a fastest growing segment. Because it's allows for very fast isolation of the PVS. However, 40 50% of cases require other lesions. And this is where we've built a catheter that can address all those lesions without having to bring a new catheter into the, into the to the surgery. So we've got a circular one to do PVI is as good as any other circular catheter out there, or PVI, we've got it can morph into a linear, and this linear steerable. And it can also work as a focal, so it will allow us to address any kind of lesion, be it in the atrium or the ventricle. Here's a proof of concept paper that we presented in HRS, I just want to highlight some of the principles as you see in the middle part here that the current sine wave, I can have a summing effect or subtracting effect of the wave. And that allows me to tight titrate the depth here. So the normal one that people achieve, and the variations that we can achieve with our technology. We have been able to achieve lesions. Beyond one and a half centimeters already, we're in a quite safe profile, we're still working on that we don't need those for AF, but shows the potential that we have for other applications. And finally, here, what what we're doing here today is really introducing the idea of the company we're privately funded with funded until a good part of next year. But as we finish the first inhuman that, as I said, will start in two weeks from now, we will start then raising funds to do our biggest studies in the US and in Europe, as needed, as outlined here. So we're looking to just put the word out that we will be soon searching funds for the next four years here to conclude this clinicals. And finally, why why invest in Arga? Number one here it's yes, a unique company addressing underserved population 33-46 million people globally growing very fast, first in human starting in two weeks very capital efficient to be able to take and build all this technology and start a first inhuman in less than 24 months. So actually 20-21 months, adoption and reimbursement and nobody's spoken so far, very important. The introduction of this technology changes nothing in the routine of the hospitals, no extra billing codes or anything. It integrates smoothly into the system, right, and a portfolio of products that we're working on which we're focusing right now for the AF and that's why we would be raising funds very soon. But we have in the pipeline, a VT and for the flexibility that our generator creates, we could be expanding this into other therapies eventually. That's it. That's what I had for now. I appreciate your time and seven seconds to go