Steven Mickelsen Presents Field Medical at LSI Europe '23

Transcription

Steven Mickelsen  0:05  
So I'm Steven Mickelsen talk to you about my new company Field Medical. I spent the last 10 years of my life becoming a expert on cardiac pulsed field ablation. It's a new energy source started the company about a decade ago, that ended up being acquired by Boston Scientific. And the new energy source, which is quickly replacing radiofrequency in Europe will soon be doing so in the United States is an electric field mediated tissue injury that has some great properties that improve safety. And so there's been a lot of interest in this area for that first generation as it kind of comes out. The goal of this company, though, is focused in a different area, because almost all the technologies are focused on atrial fibrillation. Our goal is really to become the industry leader in this type of energy delivery. But more importantly, we want to build the tools that the doctors need, and the patients truly deserve. The second generation of pulsed electric field, expand the market. The problem is that for the last 37 years, the technology of pull of catheter ablation relies on a tiny catheter identify inside the heart the source of an arrhythmia that's causing trouble and cauterize or or destroy that little area of tissue that is causing the problem. The difficulty that we have with the physics of heat transfer, is it makes it difficult for us to control in certain environments. And in the heart, we still have problems this by 37 years of iteration and improvement, where we can lead to a runaway problem called a steam pump, which is visualized here, or other problems such as collateral injury to things like the esophagus, the phrenic nerve, and other areas of the heart. And this is why there is so much interest in pulse electric field ablation. In fact, there's so much interest that right now the analysts are starting to predict that more than 50% of the entire world ablations will be done using this new energy source by 2030. And that is truly a paradigm shift. And that market is mostly an interest is driven in this AFib market. It's massive, it's growing at 14%, continuous annual growth, everyone's excited about funding stuff that address this area. And a lot of people are sort of ignoring some of the other areas of arrhythmia management. And certainly the ones that are most dangerous to patients like the ventricular arrhythmias are a well recognized unmet need. And this is because for 37 years, we've been building tools that work really well in the atria. But we haven't been making the tools that work really well in the ventricle yet. And so the way I see that piece of the market, even though it's only 6 million people in the addressable market, that is still six times bigger than all the ablations that are done on earth today. That's about a million procedures per year. And that's driving a very large segment of growth for a number of these big medtech companies. We see this as a blue ocean opportunity because the there just aren't a lot of companies focus on bringing new technology to treat this area. And so Field Medical, of course, is trying to replace the workhorse tool that every doctor knows how to use to treat every arrhythmia the focal ablation catheter that uses radiofrequency, we want to replace it with something that that they are going to want to use because it is going to be better and have a value proposition. But before we can get to that value proposition, it has to at least meet the criteria that doctors want. And they need to be cost efficient contact force, which is a way of knowing how much pressure is on the tip of the catheter as you move it around in the very tender parts of the heart, it has to have the type of magnetic navigation that allows us to move in the ventricle and not have to use too much X rays. And the handling mechanics has to do what they're used to using already with market leaders. We know what that's like. And in order to get adoption and what we're really focused on is what is the value proposition we're bringing to doctors and pulse electric field in particular in the atrium has already shown a value proposition. But to bring it into this market, this untapped market of ventricular arrhythmias, we know that pulsed field is a uniquely qualified to be able to deliver the range of treatments, lesion sizes, making it faster taking procedures that currently take four to seven hours to do and there's a huge barrier to entry and so now a lot of patients are being treated, we can move those into sub one hour procedures and increase procedural workflow for cath labs worldwide. We, in order to do this have been developing one of the world's most advanced pulse generators and I can go into some key details on the technical stuff at any time. If anyone finds me here or elsewhere, I'd love to talk about it, but the way the company started was with the electric field itself. Since this is an electric field mediated technology. We started by modeling with finite element modeling a idealized electric field for a focal catheter and the range of penetration that we wanted and the feature so that when you use the strong electric fields, the there isn't a lot of Far Field stimulation of other parts of the body like a defibrillator. When it goes off, you go clear, and the chest jumps, that's not comfortable, and it's hard to do that in awake patient. And so to address tolerability, most companies that are doing PFA have moved towards waveform development to address those problems. And unfortunately, that makes the PFA a little more thermal a little less effective. And so in order to preserve all the benefits of this new energy source, we have worked with the field initially and reverse engineered, what type of catheter would it take to do this. And this is what we ended up with was a new electrode design is radically different than than what's out there doesn't do radiofrequency, you can't toggle between the it's been optimized to do pulsed field, it has an internalized electrode, it's very different than what's out there. And there's fluid that moves through the center lumen that acts as a conductor, it doesn't work to cool the catheter, it actually conducts electricity from the inside electrode bends around the obstacle on the outside, which is made out of ceramic and lands on the electrode on the outside. And this means that the electric field gets condensed, and it falls off very rapidly. So it's potentially tolerable. We did a series of early animal studies, a whole bunch of safety studies and bench studies to look at whether our finite element modeling translated into something that we had predicted. And this is what I mean, when I talked about tolerability if you take an animal and you deliver the pulses in the chest in the unit polar configuration, like many of the companies like a Farah, like by Biosense Webster and the Medtronic new, that's the Farah but the and then Galaxy, which is available in Europe, you can see on the left side that unipolar with a standard traditional pulsed field wave form causes a big jump for the animal. The same wave form delivered through this new electrode geometry causes hardly any jump at all, and is seven and a half times more tolerable than what what is the standard without having to play with the waveform too much. So we can have very effective waveforms. The waveform works very well to make good atrial lesions, they look like PFA lesions, they heal very fast two weeks instead of six with thermal ablation, the blood vessels are preserved, the nerve fibers are preserved. And the myocytes are homogeneously. Selectively ablated, which is ideal. And we can bring that technology to the ventricle and we can turn it up full blast and give doctors what they need, which is the ability to reach all the way through the thick muscle of the ventricle. Here's the ventricle in a swine, there's an area of little kind of brightness in the bottom that actually represents everything here. And it works very well to make a transmitter lesion. And currently you can't do that we got a great board of scientists and physicians working with us towards a clinical trial that we plan to start in 2026. Right now, we're getting ready for our first in man human trial with a great team of people. And our timeline is really fast. But this isn't my first rodeo. We've done this before. And so now we're working on getting ready human trials, q1 of 2024. And moving very quickly into readiness for a pivotal trial in about 18 to 24 months, we just closed a seed round for $14 million, which will convert into the Series A, we have a radical approach to our financing, which is let's just do a single series ABC, but it's really in Series A single financing round that we're gonna raise, and hopefully close that in the new year. And that's why we came to LSI to kind of talk about the excitement about addressing a really big unmet need and going forward with this cool, very effective technology. Thank you very much