David Neale Presents Argá Medtech at LSI USA '23

Transcription

David Neale  0:06  

Hi, everyone. Pleasure to be here and introduce you to Arga and the exciting world of cardiac ablation. I'll be talking about cardiac ablation a little Arga. cardiac ablation is been around for 40 years. But it's still I guess, going through a revolution right now as we speak and an introduce Passfield ablation, we're one of the companies working in that field. We're very young. We're right now doing our first numina, ending it just just under 23 months of having started the company. So far, we've been funded by a Series A of 10 million that has taken us to first in humans, so very effective Capital Management there. And we seek here to raise our money for the pivotal studies that should be starting later, in the year or early next year. We assembled a very talented team to put this together. Everyone in this team has like 20 plus years in the field of electrophysiology, having passed through several of the companies that have, let's say, succeeded in exiting and other startups as well. I call attention to probably Dr. Anti NH, which is today one of the main users of pulse fueled ablation and a very big advisor to us in getting this technology. So what do we do we treat AFib and atrial fibrillation and why we do it, we do it because patients need it. It's a big important aspect of quality of life. And it is obviously very important from a medical perspective from a healthcare perspective, because patients who have AFib had three times the chance of developing heart failure, and it is the second largest cause of stroke. Okay, market, as I said, after 40 years is already an $8 billion market and growing growing double digits, dominated by a few players there that typically absorb all the new technologies. And that's what I represent here, right? over 33 billion of acquisitions have been done over the years. Just in the recent years here, we've seen four big ones and the 260 million that does not include the Medtronic acquisition of a Farah that was for 1 billion just done late last year in this field as well. So tight race, desperate for technology in order to make the patient's life better. So having said that, I'd like to explore a little what we do, and what makes us different. Here you see representations of the heart. What we try to do in ablation is to create a set of lesions in the heart and accordingly, that would stop irregular signals from triggering additional beats, right tachycardia is above 100 beats per minute competing with the natural sinus rhythm of the heart. We have A, B and C here, which are current strategies that people use, no matter what strategy you use, A is the only one that's a consensus you have to isolate the pulmonary veins from from the heart, right and those lesions have to be transmural in order to block that electric signal. However, when we think of current technologies, the most frequent ones the standard of care today is radiofrequency followed by cryoballoon these are thermal energies and as thermal heat does not discriminate between health and targeted tissue and neighboring structures. So in applying the technology, so in today's world, people have to be very careful as to not to damage neighboring structures and, and tissue. So for instance, here in cardiac ablation, the main concern is damaging the esophagus. And cryo, the main concern is affecting the phrenic nerve. And as I said, all because of the thermal nature. So what that ends up doing is that patients end up coming back two or three times for procedures to be effective and treat their AF. So here you have a compilation of different studies, you'll see that after two procedures, you may have a 90% success rate over time, it's decreasing. And it decreases because of natural evolution of the disease. But because as well, many are most of the times these lesions that were created were incomplete, they heal and the problem is back. So then pause field ablation came up. So what is that? We actually with Passfield ablation, apply an electric field to the to the cells that was going to open pores and the easiest way to think of it is if those pores are open long enough, you create an imbalance and you lead the cell to death by apoptosis natural depth. Okay, it is also very sensitive cardiomyocytes are very sensitive to it. So at 400 volts per centimeter and these numbers are debatable. You have a threshold that is way lower than neighboring tissue. So it also makes this therapy selective. So now we can apply more energy. Okay, we can create those transmural lesions, we can avoid the reconnections and have a better outcome. So what we've developed is, with simplicity in mind, we've developed a catheter that's able to do all the Legion sets that we have in the heart that were expressed before, as well as a generator, that's pretty unique in how we generate the electric policies. Most companies use off the shelf OEM manufacturers to generate those we've, we've gone out of the box, and we use a coherent sine wave in order to do so the main advantages, we can titrate for that, and in doing so we can open not only the market for AF, but we can also do the ventricle market, ventricular tachycardias. Okay, I have three pictures here of catheters, that's in reality, one catheter that morphs into the different configurations. So making one catheter able to do all of those. Here just a quick illustration of the sine wave that we use, and you see the two representations at the bottom, and current technologies under development, the field is kept very close to the catheter with our technology, we're able to titrate that depth and get for the same parameters, a deeper field. We presented this at hrs very successfully last year, the concept with a lot of interest, and then we moved on to doing our first in human. Okay, here, quick picture of competition, what competition is developing or what's out there. And the one thing you can see here is their devices have nothing in common. Okay, everybody's searching for something different. We have gone from simplicity, we have gone to develop a catheter that can easily integrate to the day to day of the existing existing practice, they have no additional learning to it, and delivering this energy to the scope. So we like to think of our catheter, the one on the upper left there. The simplicity and effectiveness of a single shot device that is used for lesions in a with the flexibility of the focal devices that can then deliver all the lesions in B and C. Our team successfully conducted the first in humans, just 20 months after funding team at the hospital couldn't not be here if they hadn't done this wonderful job. And today, our first in human data is indicating success rate of 94% compared to recent publications and literature, that are way beyond way below those numbers right now. So it's obviously first in human it needs to be extended to a first to our pivot tables. And that's what we seek then for funds. Here, very quickly representation of our catheter in use, we were challenged that we were not able to probably develop this catheter for the complexity of all them, different shapes that needs to came. But here's the proof, it was an action. And in all of its configurations, our timeline, we look for raising $40 million to support closely the perfection of this device, but mostly the clinical studies. Okay, and take our AF and VT indication to approval. Why invest in us? I think there's unit one you unmet need here over 33 Some numbers some people say over 40 million people with AF in need of this treatment that are heavy impact that has to the healthcare system and costs. from a company perspective highly efficient capital. Spending, right I mean, we were able to get first inhuman, very, very little funding seemingly integrates to the procedures so no, no special learning and a portfolio of products that can really make a difference in this rate to technology and develop Horsfield ablation to diversion. The market has no doubt the pulsed field ablation will substitute the RF technology today. Question is how do we get it even better to what it has already demonstrated recently. That's it for now. I appreciate the time and happy to take questions outside of anyone has any Thank you