Video Transcription
David Neale 00:02
It's a pleasure to be here again at LSI providing an update. I'm David Neale. I'm the CEO and co-founder of Arga Medtech, a company developing technology in cardiac ablation. We are a Swiss company established in Switzerland, headquartered with labs as well in San Diego. We're very fortunate right now to have closed a big round a few months ago. So this will work more as a, let's say, it's never too late to start raising the next round. So I want to provide an update to all here. We are a team of very experienced executives and startups in big companies. Most recently, Steve McQuillan joined us as we now shift into the clinical phase where we'll be running our IDE study in early next year. We have a very, very experienced R&D team that enabled us, from our first round of financing back in January 2021, to go to first in human in just under 20 months, right? And we've continued that journey. We've now treated over 75 patients very successfully. That gives us the confidence now to go into the pivotal study in the coming months. We are initially focused on atrial fibrillation, which is the largest arrhythmia diagnosed. It is the second leading cause of stroke, but most importantly, patients experience a very diminished quality of life. So we're there to provide that treatment for them. It's a very established market, with key players exceeding 5 billion in catheters alone in the US. These numbers, depending on whether you source them, go up to 12 or 13 billion already, depending on what they sell. The challenge for the current treatments, the standards of care today, is that many procedures have to be done to achieve success. The two gold standards today, radiofrequency and cryo, are thermal in nature. Being thermal, it does not discriminate between neighboring tissue and can lead to collateral damage. Because of having to take extra caution when delivering therapy, you could end up with gaps as well. That's one of the leads to the need for redo procedures. PFA is a solution. Several companies are out there in this race. A couple of them are already available in the US, a few more in Europe. The principle is we apply electrical fields. These electrical fields will generate changes to the membrane of the cardiomyocytes that will lead to apoptosis and natural death. The scarring of this tissue then is very differentiated from the normal or thermal, providing some elasticity. Now, the beauty of PFA, as well as due to cardiomyocytes having a lower threshold sensitivity for these electrical fields, is that it also becomes very selective. We have a wide band there for safety, considering 400 volts, for instance, for cardiomyocytes and 1700 we can manage that very, very elegantly and provide for a selectivity of that tissue not harming collateral. Here are some examples of what's out there in the market, commercially or in development. We can see that they don't look alike, right? But you can see that they all look complex, very complex in their design. We at Arga Medtech, when we took the approach of developing our technology, wanted to strive for simplicity and efficiency. We got to a point in medical technology where we also have to think of bringing more benefits and lower costs to the system. So we developed a system. We developed a new generator that gives us more flexibility based on a sine wave, but we developed a catheter that's very simple in the sense that it's out of the box in a circular configuration that will enable us to do a certain number of lesions, and then we can morph it into a linear catheter, multi-electrode that can do lines, delivering a whole line at once, rather than, but then dotted, right? The impact that that has on hospitals changes their workflow, and it allows them to save money as well, because one catheter can do the whole procedure, rather than depending on the anatomical part of the heart you're doing, having to bring a second catheter in, right? So here you have all the targets, different targets that EPs like to do. We have different configurations that can tailor it. And here you see our catheter changing configuration. Obviously, this is usually done within the sheath, not outside, but for visualization here, you can see how effective it can work. Our sine wave is a big differentiator for us, in the sense that it allows us to titrate for depth better than any other system out there. We can operate at lower voltages and amplify the Roche moment of delivery, but most importantly is the net result. I can provide lesions from two to three millimeters deep to so far as two centimeters deep that we've done already. Why do we need that when we're doing it in the atrium? You don't really need that flexibility. If you think of the ventricle, but click a tissue beating heart, you may go more. So this is our catheter in motion. With five applications, we isolate the veins by overlapping these semicircles. Once we've done those, the physician, if it's a persistent patient, may want to do other lines. We can do lines, or we can do dots as well, so it offers a lot of flexibility to deliver, and the fact that it's one catheter also then will provide significant savings to players. Catheter in use in our first human experience, for those that like fluoro shots, I mean, it's all in different configurations, being used first in human. We've done, as I said, 75 here. I have reported 54 of these patients. I call your attention to some of the procedural times we're doing ablations in less than 29 minutes. We've now experienced less than 20 minutes for PVI isolation. What this means is hospitals can also do more procedures. So right today, we're remapping patients in Croatia. I've got a team there where we did 16 patients in three days, which is quite surprising, the net result of our study. So a cohort of small numbers still, right? But for paroxysmal patients, we have freedom of 12 months, freedom of AF at 100%. In the persistent population, we're at 70%. Very encouraging numbers that take us then to our main studies, which we intend to start in Europe and the US early next year, enrolling 300 patients, 150 persistent, 150 under the paroxysmal arm, with a year follow-up, and then putting us in a position to start commercial sometime in late 2027. Okay. Now, as I said, our platform offers flexibility. We're now investigating VT as well. We've got some tailored lesion sets already developed, most importantly to speed up the progress and ensure that we had contact. We did test it recently in a robotic magnetic navigation system with great results. This is still in the early conception, but we achieved lesions there of 1550 millimeters with operators in Austin and Vienna, operating a system that was installed in St. Louis. So very attractive flexibility for future applications as well. That said, we now continue our journey. As I said, we start our first IDE early next year, and we will continue to develop VT CE mark to come sometime in 2027, where we should then go into commercialization. So I appreciate your time and update, and if anyone's interested, you got my contact and I'm happy to share more. Thank you. Applause.
