Steven Mickelsen, Field Medical - PFA Solution for Cardiac Arrhythmia | LSI USA '24

Steven Mickelsen  0:00  
Steven, Hi, my name is Steven Mickelsen. I am the CEO of field medical I'm board certified cardiac electrophysiologist, and I want to tell you a little bit about ventricular tachycardia and why we need new technology to address this very important unmet need. Field Medical is focused on treating ventricular arrhythmias, which are potentially deadly things like ventricular tachycardia and premature ventricular contractions that lead to clinical morbidity. Turns out, it's a relatively large market between the United States and Europe. There are over 6 million people that currently meet criteria for a procedure called catheter ablation. This is based on the US and the European guidelines. It's a large addressable market, but it is highly under penetrated. In fact, there may be only about 100,000 ventricular arrhythmia cases done every year. And this is true despite knowing that ventricular catheter ablation is by far the most effective therapy, in fact, sometimes curative, and so there are big barriers to treating more patients, largely because of the difficulty of doing catheter ablation today, there are only two catheters that have actually gone through regulatory approval for treating ventricular arrhythmias. This is the tactiflex by Abbott and the SmartTouch at biosense Webster. These are RF catheters with contact force and magnetically enabled sensors that are really the cutting edge of what RF catheters can do, but they were really designed to work well in the atrium, not necessarily in the ventricle, and the ventricle poses some additional problems. There's been a recent paradigm shift from doing atrial ablation with radio frequency and thermal technologies to a new energy source called Pulse field ablation, and with this paradigm shift in the field of electrophysiology, moving it is and the limitations of radiofrequency, it's just really a matter of time before we bring it into the ventricle. And this is important, because this is probably the more important application for this new energy source. The ventricle itself is a very complex structure, whereas the atria is smooth and very thin by comparison, and doesn't really move a lot, compared to the ventricle that moves centimeters and has deep rugation. That means that if you bring a RF catheter, you can ablate in the compact LV very easily, but you have a hard time getting the fingers of tissue that can lead to arrhythmia and abnormal and reaching the abnormal tissue because it's so thick, it's very hard for catheters like radio frequency that require long term stability in order to deliver energy. So we know the barriers talking to physicians. You know it takes a high level of technical, skilled use catheters that really designed for the atria in the ventricle, and this leads to long procedures, but also procedures that have a huge amount of variance. So it's hard to schedule a single procedure, not knowing whether it's going to be three hours or seven hours. And so because of that, generally VT ablation is only done at referral centers, and most patients are under treated using medical therapy, we think we can address the barriers that keep us from making this a first line therapy by building a catheter that's built for purpose, contact, force, magnetically enabled, and it's basically the same as the tools you use today, but with some very important differences. The energy source itself is electric field, pulse field, ablation, an area I'm an expert in, and it has some radical design changes that allow us to take the tip of the catheter and change the shape of the electric field around it and manipulate it in a way that allows a huge range of ablation, from very small focal And tolerable footprint when you need discrete, very precise spots all the way up to a very large ablation zone that can be three centimeters in diameter. You know, the field force generator we're building it. This is the future. We're going together. The system itself, which has been optimized for ventricular use, is capable of making fully transmural LV lesions from a single position. And here's one of the animal studies where you have this beautiful, round lesion which is predicted by the finite element modeling, and you see the transmural lesion itself. This is another application of the system where we're able to get fully transmural septal lesions, a very difficult place for electrophysiologists to reach. We've done some prospective animal studies that are controlled in animals that have had infarcts and large scar area in their heart, and we took half of them after 90 days, did an EP study, and we induced VT in all of them. And then we ablated using the standard of care versus and half of them we did the field force ablation catheter, and this taught us some very important things. First, standard of care took a long time, over 30 applications, whereas with the field force catheter, we only had to apply three to six applications, and these took seconds, not minutes. That means that sub one hour. Vt ablation is possible having a much more predictable procedure time, we may also have some improvement in efficacy and safety, just because now you don't have people under anesthesia for seven hours needing hospitalization for recovery. We're moving on to our first in human studies. We have two protocols, and we'll have human data by the summer. V cast one and V cast two are focused on purely ventricular applications, but we also have an atrial protocol that will have data on to show that it can be used in those areas of the heart as well. This is all in preparation for the Veritas trial, which is a prospective randomized trial that we hope to start in 2006 it's a pivotal trial for approval in the United States and Europe. And right now, in our timeline, we're right here. We've already raised $14 million with, you know, 30% of the money coming from two strategics, unnamed strategics, that have already invested in the company. And we're raising money to be able to cover our commercial product development and and initiate the pivotal trial after that. So we hope to be able to submit, you know, finish the Veritas trial by the end of 2026 and submit for PMA sometime in 2027 or so. Thank you very much. If you have any questions, please reach out Bye, bye.