Steven Mickelsen, Field Medical - Next-Gen Pulsed Electric Field Ablation | LSI Europe '24

Steven Mickelsen  0:04  
All right, so, Field Medical is a company that's two years old. My name's Steven Michaelson, sort of a company called fairpulse, which was bought by Boston Scientific I was working on this at the University of Iowa 12 years ago. I'm a cardiac electrophysiologist, but I've really dedicated my life to understanding pulse field and advancing therapies in the cardiovascular space. The what EP doctors do is that they take very sophisticated mapping system, minimally invasively determine where you have an abnormal heart rhythm problem, either a focal area or or a reentry structure. We navigate catheters to that place using very sophisticated equipment, and then we deliver energy to ablate the tissue that is causing the trouble. And what everyone's been focused on, fairpulse was a company that was really focused on atrial fibrillation. This is a well defined market, growing market, driving a lot of the innovation in the space of electrical physiology, but everyone has been kind of ignoring the ventricle for years and years. And these problems aren't nuisance problems like atrial fibrillation, even though atrial fibrillation affects maybe 14 million people, VT, a lot of people, is a harder problem to solve. These are deadly arrhythmias, ventricular ectopi, or premature ventricular contractions, can lead to heart failure. So these are high morbidity problems, which for years, we didn't really go after as cardiologists. Maybe 10% of the actual market today is ventricular arrhythmias. And the reason is, the tools are really designed to work in the atria really well, and they're paying the ass to use in the ventricle the ventricular arrhythmia market is ubiquitous, much like AFib is, but symptomatic ventricular arrhythmias are quite large, but the ones that are refractory to medical management, that is still 7 million people in the United States and Europe. And so when you look at the global ablation market, we think about atrial fibrillation a lot, but there really are only two catheters that are used for the ventricle. The most popular catheter on Earth is biosense, Webster, Smart Touch. It's a radio frequency contact force magnetically enabled irrigated catheter, and its biggest competitor is TAC deflex, which is right here. These are the only two catheters with an IFU in the United States for doing ventricular arrhythmias. And they have 99% of the market, but 10% of the market of the global but 90% is this. Every doctor knows how to use these catheters. What they don't know how to do with these catheters is reached the ventricle very well. The atria is thin, so getting a transmitter lesion is easy. The atria doesn't move very much with every contraction. The atria is smooth, so it's easy to get stability and move around. The ventricle is complex. The ventral moving centimeters with every contraction. The ventricle is thick. So how do you get a fully transmitter lesion here with heating and you have your trabeculated area that's floating around in the blood pool. How do you get deep transmitter lesions? And PFA is a solution pulse field allows us to have a proximity ablation in the ventricle. And if we optimize a second generation of pulse field, we can do it. This is our solution. It's a focal catheter. It's contact force. It's magnetically enabled. It does everything that doctors already want. We're not taking away anything from them. We're just expanding the capabilities of the catheter to reach places it's never been able to reach before. It has an internalized electrode and externalized electrode, because when we started Field Medical. We started by drawing the electric field, the ideal electric field at the tip of a catheter, and we reverse engineered it. We ended up with a really weird electrode. We curve the current path around that electrode, and that's what field bending is. And then we switch it really fast between multiple electrodes in a nanosecond speed. And that allows us to actually have the first contact force built for purpose ventricular ablation tool today. It's an ugly box. We got four of these, two of them in Europe, two of them in the United States, and we just started doing human clinical trials. First one is VCAs. This is two arms. We have arm one, which is ventricular tachycardia. Look at all their arrhythmia events in the preceding 90 days. Do an ablation, look at it 90 days later, and see how they do ventricular ectopy. Same thing. Halter monitor, 90 days. Halter monitor 90 days post. And 15 patients have been enrolled in that protocol in the United States because we presented some data at hrs. This year, there's been this overwhelming interest in doctors asking us for for compassionate use in the United States, and this, this tells me one thing, this is an unmet need, and we, we didn't even budget for this, so we're just trying to figure out how we can answer the call, because we want to treat these patients. Here's an example of a patient that. Did in Prague a few months ago. This is the epicardium, the heart, the outside. Normally you'd have to blade inside and outside. But here you can see that the outside of the heart, the purple area, is relatively normal voltages and but underneath that normal voltage is the big scar that's causing a patient deadly arrhythmias, ventricular tachycardia. He ablates. He does seven little treatment zones only, endocardial. He goes back to the epicardium and remaps it. The red area, it shows you it's fully transmural. And then we wait a while, we do it again. It's durable, which is really great. The learning curve is really fast. At first, he was taking his time, but now we're getting down into this is a 12 minute ablation. 12 minutes for VT ablation tells me one thing, instead of a four to seven hour procedure, it is possible that we're going to be able to offer patients an outpatient, elective, one hour procedure, reliably for scar related VTS. We went from these patients having 12.5 deadly events that needed therapy down to zero in the following 90 days afterwards, it's an end of two, but we're going to get another group of four coming up soon, so we're going to start filling out that data. We also did an AFib trial. I'm not that interested in afib, but everyone else is. Of course, you can ablate the atria. If you can ablate the ventricle. It's sad and how hard. It's a very versatile tool. But we decided to do a small series of patients just to show the versatility of the catheter the platform. And so we've enrolled five patients at this point, and acutely, all of them had first pass isolation. But probably the coolest thing about this is, you know, you know, as the founder of farrapulse, and I'm and I still practice a little bit. You know, when I use Ferro pulse, it is like, I feel like I'm using something that's really old. The average Ferro pulse case is 24 minutes of ablation time. And so with this focal catheter that has all this versatility, we did in nine minutes. So it's faster than Ferro pulse, and it can do something nobody else can do in the ventricle. This is our timeline. So we're two years old right now. We got our seed funding. We had about 19 million in on a convertible note. We're about ready to raise our Series A it's $40 million to get us from this early R and D system into a full commercial build, ready for our pivotal trial, the IFU, The Veritas trial. And the Veritas trial is going to be it requires to get through this next phase. We're going to do all this great stuff and submit to the IDE 40 million gets us through the beginning of the IDE trial. Probably enroll in about 10 to 20 patients, but we're planning on doing 600 This is a prospective randomized trial that'll get us to the finish line. We're not shooting for approval, we're shooting for adoption. And we want really powerful data to show the patients, the doctors, that they don't have to be afraid to go to the ventricle anymore. We've built a tool that they want. All right, let's Field Medical if you're interested in talking to me, please reach out. You.