Transcription
Ben Glenn 0:10
Say hello to my guest, Steven Mickelsen here at LSI 2023. Dr. Mickelson, thanks for coming by the studio.
Steven Mickelsen 0:19
Oh, thank you very much. My pleasure to come by
Ben Glenn 0:22
All the way from Scripps.
Steven Mickelsen 0:24
The company started down in San Diego, and it's not not too far away.
Ben Glenn 0:29
Is this your first time to come to this conference?
Steven Mickelsen 0:31
Absolutely. I was really surprised that all this is going on, and I wasn't aware of it. I'm very glad to be here.
Ben Glenn 0:39
So what brings you out to LSI this year?
Steven Mickelsen 0:41
Well, you know, I'd started a new company, Field Medical, and one of my board members informed me that we should absolutely attend that side. And here I am, Field Medical's on the seed stage at this time. We just started in August of 2022. And and very early stage company, looking probably to be on track for first in human studies next year, around this time,
Ben Glenn 1:09
What space are you operating?
Steven Mickelsen 1:11
We're cardiology arrhythmia treatment company, it's a medical device called a catheter, medical and catheter ablation is our focus using a new energy source called pulsed electric field.
Ben Glenn 1:23
And you're no stranger to that you've done some work in this field before
Steven Mickelsen 1:27
My former company, FairPulse, which started this company called IO approach, and found it in Iowa of all places, you know, is currently available in Europe and pending FDA approval, United States is anticipated to be available in United States this time next year, probably.
Ben Glenn 1:47
So what do you got in your hand there?
Steven Mickelsen 1:49
This is, uh, one of the catheters that we're working on, we're developing a new technology, although I'm familiar and very, you know, and been working in this with this new energy source for almost a decade. And not a lot of people have focused on focal catheters, which is 80% of all catheter ablation is done. Using a long tube like this with a piece of platinum and the end of it, we use it for electric cautery, inside the heart. Instead of doing a piece of platinum, we have a piece of ceramic on the end of this. And we use a new technology called Field bending, in order to control the shape of the electric field around the catheter into in a new way. And this allows us to be able to have more tolerability and a much larger range than you can achieve with traditional electric cautery.
Ben Glenn 2:37
You've got a single ceramic, but that single ceramic can then be steered or redirected.
Steven Mickelsen 2:43
Well, so the it's the shape of the electrodes, the relationship. So there's outer electrodes, and then there's an inner lumen that has is an irrigation lumen. And inside that lumen is the other electrode. So it's protected from the blood pool. But by forcing the current to go around the outside of the catheter band, that's why it's called Field bending. It creates a new type of very strong, compact electric field that falls off very quickly so that you don't have far field stimulation. It's much more tolerable than traditional unipolar bipolar. But we have found it to be seven times more tolerable than a traditional unipolar application like this.
Ben Glenn 3:27
So I'm guessing in your practice, as a cardiologists, interventional cardiologist, you've probably used the multipolar and bipolar you kind of probably grew up on those. So how did this change your workflow or your clinical experience?
Steven Mickelsen 3:40
Yes. Well, so you know, this is still very early experimental, not of this particular technology. We're anticipating our first human studies on approximately a year to 18 months from now and the and to move into clinical availability much later. But based on my experience in working in large animal studies, this is potentially transformative because now we can address areas of the heart that radiofrequency or thermal ablation just could not do a good job with and this is things like ventricular tachycardia. 7 million people a year have an ventricular arrhythmia or ventricular tachycardia, which can be life threatening and fatal. And in a number of cases, we can treat it with catheters now. But we do it very infrequently, because the procedures take so long and the efficacy is better than nothing, but it's not that great. And so having new tools to be able to expand that our ability for a safer or more effective energy source in the heart, we I'm hoping that we're going to be able to address a market that has not been addressed in the past, not just treating atrial fibrillation, but other arrhythmias like ventricular tachycardia.
Ben Glenn 4:57
So in our in your clinical work your your world revolves around arrhythmias of the heart. And so this is your finding you get to an area of this particular patient. You don't really have a tool bag.
Steven Mickelsen 5:09
Yeah we don't have a toolkit right now, we use drugs that can be very toxic, they have a lot of side effects, and we use catheter ablation. But the efficacy of catheter ablation is is challenging to say the least in the ventricle, it's well established in the atria has been the leading best therapy that we have available. And so to be able to expand from just atrial applications into the ventricle could potentially save a lot of humans. Save a lot of lives.
Ben Glenn 5:40
Yeah, and well, and also, you know, there's a there are populations of arrhythmia patients that don't have, you know, apart from pharmaceuticals. Yeah. And you know, I'm an I'm a healthcare, I mean, a health tech guy, and I love devices. And I'm always encouraged whenever you when you really do some kind of reshaping, you know, the heart is very dynamic muscle when you reshape that muscle and reteach it and it re learns and forms those new electrical pathways, you get a resiliency that you, you know, you don't find that in pharmaceuticals.
Steven Mickelsen 6:10
Yeah, no, that's very true. The body has adaptation to the medicines. And unfortunately, in cardiac arrhythmias, anti arrhythmic medicines tend to have some of the most toxic drugs outside of chemotherapy. And so really, procedural medicine is the best way to address it either through an implantable thing called a defibrillator, which doesn't stop the ventricular tachycardia, it just saves your life if you get it. Whereas this type of technology that we're developing at Field Medical could potentially stop the ventricular tachycardia.
Ben Glenn 6:45
So let's unpack it a little bit. I'm very familiar with, you know, monopole or bipolar and then you know, multiple electrodes, you know, they'll have several and that's sort of how we tailor fields and the way that a lot of stimulation is done, or maybe ablation is done. But this is very interesting to have the the second electrode is actually inside of the catheter. Yeah. So tell me more about how did you how did you uncover that?
Steven Mickelsen 7:10
Very interesting, because I, because this is the third time I've built a pulse generator and worked with this new energy source. And previously, I've always worked with designs that were previously they're really radio frequency optimized tools, you know, to do thermal ablation, the And now, when I left Acuitas Medical, I was their chief Translational Science Officer for three, almost three years, the two and a half years. But I had to work around all the patents that I've worked on in the past. And so I had an existential crisis. And I came to the conclusion that I better work really hard thought about what are the fundamental problems that we're going to have to overcome for the second generation of pulsed electric field. And I had an epiphany at that moment. And we designed it and had a whole bunch of very smart PhDs working on computational modeling, to figure out parameter parameters to optimize it. Once we figured that out, we tested brought in partners, brought in designers and very recently finished our first series of chronic animal studies that confirm that it reduces stimulation, unwanted stimulation, and has a massive range.
Ben Glenn 8:27
Yeah, that's amazing. It's like, in such a developed field, I mean, having electrodes on a catheter that's been around a long time to you know, not every kind of nobody leads with Oh, yeah, we made it out of ceramic. Always platinum is the go to Latin America. And that's what platinum, iridium. That's exactly, it's, it's great as you can use it as a marker. And you can also use an electrode. So they're very handy, a very good use to that toolkit. And now all of a sudden, you know, changing that dynamic, and then being able to, because you've got a different material, now you've got a different electric, your second electrode as a different one. It seems like you're opening up a whole new field of how you can steer the field, then the field and apply the energy.
Steven Mickelsen 9:07
Yeah, we hope so. I'm quite proud of the work that the entire team has done up to this point. And we're focused on and at the current rate, you know, we'll be in in clinical trials very quickly, usually takes a little longer to get there. But we've really assembled an amazing team of people to move very systematically towards approval in the market. But I have to credit you know, the team, you know, the the ingenuity of the partners for the company at this point. There are a couple of things I can't talk about that are also just as innovative.
Ben Glenn 9:45
Have you got early as early animal data that's that's indicative or cadaver study anything? Yeah. Share that, that talks about why you're, you're optimistic that you're on the right path.
Steven Mickelsen 9:55
Absolutely. We, we we just finished a series have large animal studies in New York of all places and, and we have histology, that show and pathology that show the range of that the therapy is capable of giving not only effective, durable, contiguous lesions in the atria, that you know, 16 days later, still durable still there, but also these very deep and very large lesions in the ventricle. So if you turn it up full blast, you can have a tiny catheter with a very tiny size, yet, you can get a huge footprint of over two centimeters around. Although we're not focused on atrial fibrillation, this catheter could easily be used to treat atrial fibrillation by putting two or three spots in each pulmonary vein, and voila, you're done there. But the real goal as a physician, watching patients who suffer from these ventricular arrhythmias and lacking the toolkit to go forward, this is where we're focused to make sure that this tool is available to physicians in the future.
Ben Glenn 11:02
I'm a big fan and have been, you know, within the Stanford Biodesign model. So you talk about the big unmet clinical need, you know, you identifying, you know, these tacky cardia is this, this untreated population of a Ruth Mia, it seems like you're you're heading right down the main line on that?
Steven Mickelsen 11:21
Oh, absolutely. That and the bio design at Stanford is is a pioneer and an archetype of what we would hope that more and more universities could kind of build. There are a couple of them out there that have done well, Arizona and Minneapolis, Minnesota has a group like that. But yeah, having physicians who are in the field who can translate or help to translate the clinical needs to the the amazing engineers, and the talent in the medtech industry is, you know, you know, they've definitely shown us one way that you can get that done.
Ben Glenn 11:57
It sounds like you've got that sort of dynamism in your team, that the engineers and you know, certainly you're you're able to translate your clinical experience into the technical needs. How did you bring all that together?
Steven Mickelsen 12:09
I decided to train as a doctor, and once when I was actually attracted to medicine, because of innovation of the idea of the frontier is there and we can make it better, but really to be taken seriously, I was willing to just jump in to become a physician, and address the needs for new technology, from the point of view of a physician. Even when I was at the NIH, as a Howard Hughes research scholar, even when I was at the Mayo Clinic, I was constantly inventing stuff and trying new things. And when I got to the University of Iowa, I, the week, the university decided to patent one of my things. And sure enough, that was worth starting a company for and we built it out. I think there are a lot of physicians like that out there, I can name a few. But, you know, I think it has made that path to innovation a little bit easier, because you can be a content expert, on on on the user need directly.
Ben Glenn 13:08
So for these other physicians out there that maybe have that same aspiration as you how would you encourage them to begin to get their toe into the water and learn more about this healthcare, this big, burly healthcare system that we all love and enjoy working in?
Steven Mickelsen 13:24
A lot of people have great ideas, but they they're afraid to become business people, they're afraid to actually decide, I'm going to actually start a business. And I'm going to develop the technology. It's easy, a lot of people have great ideas, and they hand it off to other people, they license the technology or something like that. But that's no guarantee that if it's worth doing, you need to steward that idea, from the concept to the market.
Ben Glenn 13:52
I love that stewardship of your ideas, you know, get that deepening the relationship with your own ideas, I find so many entrepreneurs get discouraged. You know, this person doesn't like my idea, they're not going to fund it. You know, it's a venture capitalist that, you know, you didn't bother to understand that all they invest in is late stage commercialization, you're at a seed round, you're talking to the wrong kind of person, but then they get all discouraged. So I think it's important for them to understand the way the industry works, and then find those people that are really committed to the early stage.
Steven Mickelsen 14:24
Absolutely. And that's a mistake I've made. You know, it's as an entrepreneur, you don't know the difference between venture capital and, you know, angel investors and really understand the difference of what stage people invest in their comfort. And so acquiring the you know, surrounding yourself with the right group of people is very important learning. Opportunity. Yeah, and so I've had the opportunity to meet so many people in this this field after a decade of working in it that you know, it's for me, it's been a little friendlier this time around.
Ben Glenn 14:58
That's terrific. Anything else you want Share with us today.
Steven Mickelsen 15:01
Well, you know, I came to LSI to learn a lot about, you know, this this organization and to meet people that I wouldn't normally meet and I was very, very happy with, with the results met a lot of great people who are going to help the company out. And I don't know what else to say. But Field Medical is transforming second generation pulsed electric field. We're gonna take focal catheters and give them to doctors so that we can treat things that we could never treat before.
Ben Glenn 15:32
Well, I can't wait to hear of your continued success. Thank you for coming by the studio. Thank you so much.
Production crew 15:38
Second sticks. Steven Michelson, take one marker. Thank you
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