ERX_Erik Kulstad: Audio automatically transcribed by Sonix

ERX_Erik Kulstad: this mp3 audio file was automatically transcribed by Sonix with the best speech-to-text algorithms. This transcript may contain errors.

John Shufeldt:
Hello, everybody, and welcome to another edition of Entrepreneur Rx, where we help health care professionals own their future.

John Shufeldt:
Hello again, everybody, and welcome to Entrepreneur Rx, I've got the great pleasure of introducing Erik Kulstad, who was a few years behind me in residency and was one of the Christ hospital EM rockstars that came out of that program, of which I'm not included on the rockstar piece of it, but I've been hearing about Erik for years, so this was really cool that we had to chat. Erik, how are you?

Erik Kulstad:
Great, John, thanks. Honored to be here and a pleasure to be interviewed.

John Shufeldt:
All right, so I always make this joke, I've never met a dumb chemical engineer. Like, if you wanted, I was a sociology major, if you wanted to kill yourself in college, chemical engineering or electrical engineering was the way to do it. Like what the hell? What possessed you to do that?

Erik Kulstad:
You know, it was a kind of a fluke. I had started off not doing well in high school and maybe having a little too much fun in high school, not academically, and ended up leaving to go become an auto mechanic and thinking that was the easier life, you know, than going to college. And it's a tough job and you're not paid enough for the frustrations that you, that you endure. And that was the trigger for me to think about going to higher education and initially thinking that mechanical engineering was the logical choice since, you know, auto mechanics kind of led that way. And somehow chemical engineering seemed more interesting once I started getting into the chemistry parts of program for mechanical engineering, and that's how I ended up there, so not intentional in any way.

John Shufeldt:
We uh, it's funny I had a similar experience working on a factory. It was like, you know, 12 hours a day, six days a week. And I looked at all these poor guys, were 5, 10, 30 years older and I'm like, they're working awfully hard, there's got to be a better way to do this. But how long were you an auto mechanic for between high school and college?

Erik Kulstad:
A little under two years. I mean, I did a couple things in that time frame that led to the auto mechanic position, and within, within two years I'd made the decision that auto mechanics was, you got paid insufficiently for things that, or trying to fix things that're always broke.

John Shufeldt:
Wow. But that's, that's interesting. Ok? So you did MD college, why emergency medicine? I was like asking this question, see why other people found their way to the same specialty I did.

Erik Kulstad:
When I, you know, after, after being a chemical engineer for a while, going to grad school, getting a masters, and then getting recruited out to do biomedical engineering, it was more biochemical engineering at the time. And, you know, back in the nineties, this is when there were a lot of, you know, biotech startups and most of them not doing well, a few stellar successes that drove everybody to that, to that area. But when I decided that medicine looked maybe more appealing and more stable than the startup life of engineering and bioeng in the 90s, the first thing I did was take EMT classes. As no one in my family had gone to medical school, I didn't know any physicians personally, and it was a little bit of a foreign concept for me, so, so I thought, well, let me at least dip my toe in the water, see if I liked doing things with patients. And so by, by taking the EMT classes, and one of the first things you do in these classes is go shadow or ride along with the real clinicians and EMTs and paramedics. And you know, my first day doing that, I thought, this is so cool I would do this for free.

John Shufeldt:
I said, .., Most days I do for free, some days you're going to pay me enough to do it.

Erik Kulstad:
Right.

John Shufeldt:
Very cool.

Erik Kulstad:
Back in the early days, yeah, I hadn't yet seen that, the frustration so.

John Shufeldt:
Yeah, ... Price was such a good place to train because it's such a knife and gun club.

Erik Kulstad:
Yeah.

John Shufeldt:
So when did you get the idea to do that? I mean, you have, you have this kind of entrepreneurial background in the sense with your engineering degrees, and when did you get the sense to do this? Tell us about your company, this temperature monitoring.

Erik Kulstad:
It was, so, early in the days of cooling people for cardiac arrest, when we started adopting that approach, this is sort of 2005-ish era when AHA put up the guideline recommendation for post-arrest cooling, we were using whatever was available at the time, and a lot of it was, was technically difficult to use, somewhat complex to set up and rather expensive. And so my first thought was that, hey, this and we published some of our outcomes data after adopting cooling. And it looked pretty good notwithstanding some of the recent trials that have questioned the benefits. But at the time, you know, the difference before and after it was large, and it just struck me that if this is a fairly simple technology or simple idea to cool people after cardiac arrest, yet it's hard for us, is that tertiary care, level one trauma center to get the treatment implemented, how bad is that for typical communities, small hospitals, and where all the opportunity to save lives is going to be lost? So I thought, I was old enough to have been a med student, when we did, we did gastric lavage for GI bleeding.

John Shufeldt:
Yeah.

Erik Kulstad:
So I remembered seeing people get really cold as we were doing that and thought there must be something available to leverage that concept, use the heat transfer environment of the GI tract for therapeutic purposes and initially thought somebody might already have that product on the market, somebody else must have designed this, produced it, it's a device available somewhere. And the, first, the more I looked, the less I could see that anything had been done in this realm. And so that was the sort of the, the germ of the idea, that this is something that makes sense clinically, it's not that much different than what we used to do for a different purpose with gastric lavage for GI bleeding. And yet there's nothing available and, and so, so that that started the whole process.

John Shufeldt:
Wow. And then so OK, so you have the idea, you research it and think, you know, before someone else had to think of this, no one thinks about it, then did you go through this like, oh my god, do I really want to do this sort of phase? Or should I just tell somebody else about it?

Erik Kulstad:
Yeah. I was really incremental, and so in a sense, accidental because I had a friend in the neighborhood who was an IP attorney, at the time I didn't even know the difference between a litigator and a prosecutor, but I just knew he was an IP attorney and, and so, and as all good IP attorneys, he would probably have to triage 90 percent of the folks that came to him with these great ideas.

John Shufeldt:
Yeah.

Erik Kulstad:
So, so he did the same with me. I think the first time I asked him that, hey, Rick, I got this great idea. He said, well, you know, go back and look for prior art. And this is when, when Google patents had recently come out, you know, fairly widespread and available and cataloged pretty much everything that USPTO had listed, so it wasn't as hard to do a search as it would have been going to the library and microfilming and so forth. But, but, what I did was then was take his advice and went and look to see what else was out there, what, what had been done, what had been patented, knowing that nothing had been commercialized at that point. And as I went back to him sort of iteratively with what I'd find, he realized, OK, you actually do have something here, this is worth pursuing. I think at the time, the thought was you file some IP and license it out and go back to your regular day job. And we always operated with that sort of idea that, hey, we just sort of file something, get something issued, and then you can license it. And they thought, oh, a couple of years will be, will be done. And that was, you know, in 2009. So obviously it's taken longer and we took a different path and, you know, just, just exiting via a licensing deal.

John Shufeldt:
Wow. So, OK, so was that, did you not go out and shop it to be licensed or did you just say I'm going to build this myself and sell it myself?

Erik Kulstad:
We, we actually did. We had some, we had acquirers that were interested and at one point got close to even talk in terms sheet structure. And at each point that something looked real when, when the, when the numbers came out and we saw what the potential could be and what we thought we could be capable of, of pursuing and completing in milestones, it never made sense to take the early option.

John Shufeldt:
Interesting. So the device was, go on and explain the device, and I've obviously researched this, but go on and explain the device.

Erik Kulstad:
It's basically it's a, it's a multi-chamber medical grade silicone tube that looks like an oral gastric tube, but with multiple chambers that have connectors to connect to an external heat exchanger. And so instead of placing the standard NG tube or OG tube that most patients would get after they're intubated for, you know, pulsed resuscitation and so forth, the, our device maintains the functionality of the gastric tube, so it has a central lumen for gastric suctioning and decompression, but then it has these additional channels that allow circulation of water in a closed-loop circuit, so no water actually leaves the device, right? By changing the temperature of the water, you affect the heat transfer between the device and the patient, and so you can cool or warm patients as needed for the various therapeutic indications that you would want to pursue a temperature change of a patient.

John Shufeldt:
How quickly does it work? So, for example, your post-resuscitation, you want to cool a person down to thirty-two?

Erik Kulstad:
Yeah, it used to be thirty-three, as the target and a lot of the rate of change depends on patient habitats and other environmental factors. But you know, you can get to cold temperature within a few hours, typically so on par with any other approach out there in terms of surface devices, intravascular devices and so forth. And so the interesting thing is that, that was the original focus, that was my interest. You know, clinically, the unmet need was was for inducing hypothermia in patients, maybe secondarily warming patients after accidental hypothermia. But it was all about body temperature management and what really happened now just in the last few years is that electrophysiologists started using our device independently, a handful of them across the globe, in the UK and Germany, and Illinois started using the device in the EP Lab for protection of the esophagus. In other words, they were actually intentionally cooling the esophagus to prevent the thermal injury that occurs fairly frequently with left atrial ablation for the treatment of atrial fibrillation. And it's funny that ablation for AFib when when I started med school in 97, that was when the first paper came out proposing that it could be done. The conventional wisdom was that you couldn't oblate AFib because it was too chaotic a pattern, there weren't individual tracks that you could identify, like Wolf-Parkinson White and so forth, that you could oblate and cure the arrhythmia. And so in the late 90s, that, all that changed, and now here we are in 2022 and it's a procedure, the procedure now that's done something like 300,000 times a year in the U.S. and another couple of hundred thousand times or more in the EU and growing it, you know, 10 to 15 percent a year because of the rates of AFib that are, that are just continually increasing. And, and so the procedure itself has a decent efficacy, but the risk of the procedure, the biggest risk, the most life threatening risk is something called atrial esophageal fistula, where a thermal injury from burning on the posterior wall of the left atrium goes through the left atrium into the esophagus. That thermal injury then progresses over weeks, anywhere from 2 to 12 weeks for the fistula to actually develop, and once that fistula forms, the mortality rate is on the order of 80 percent. So there aren't any great ways to prevent this condition. People do things like adjusting the power as a blade on the posterior wall, they'll use temperature sensor to monitor when temperature rises, but of course, that's a lagging indicator that tells you when you've already caused thermal insult across the esophagus.

John Shufeldt:
Yeah!

Erik Kulstad:
And so cooling, a lot of folks thought a cooling might, it might be an interesting way to address this risk. And with our device being out available on the market already, FDA cleared for temperature, for patient temperature management, with the physicians in electrophysiology starting to use it. As soon as we heard about it, we of course, went in and started asking questions. And as we, as we learn more and did some studies on this effect, it turned out to be vastly more effective than anything else available on the market.

John Shufeldt:
Wow. It seems like.

Erik Kulstad:
That's changed everything.

John Shufeldt:
Yeah, it was, it seems like it should be the standard of care. I mean, if you have this device, why wouldn't you use it?

Erik Kulstad:
Yeah, it's becoming, I mean, medicine is changing a little slowly sometimes, so.

John Shufeldt:
Yeah.

Erik Kulstad:
We've got a few things happening simultaneously. We're pursuing specific indications for esophageal protection to expand the current indications that are broadly just temperature management, we have a lot of viral spread, word of mouth use and that's, you know, that's causing us to have to sort of address these and and, you know, learn everything that we can and collect all the data that's available to quantify what sort of effects we're having, not just on the safety of the procedure, but also on the procedure itself, because now, now that we've had a few years worth of use, we've been able to go back and look at things like procedure duration, long-term efficacy, and we're finding some really interesting things from, from a large number of sites now, you know, over a thousand patients looked at just with long term follow up or efficacy of the procedure. Now, we're getting close to ten thousand uses to get all together in electrophysiology and, and still without a fistula, at least yet known to anyone that's been using the device. So with that, puts us in a realm of safety benefit far better than we could have expected based on the, the typical rates of fistula formation. And we're seeing shorter procedure times, and on top of that, we're seeing better efficacy in the procedure at one year follow up and the tracks actually for from three months onwards. And all that is presumed to be due to the fact that with active cooling, you can oblate in a much more effective pattern and you can just keep the lesion spots consistent and contiguous without having to go back and forth and resulting in partially transneural lesions, you can you can just consistently go through. And so we're seeing on the order of double digit improvements in long term efficacy at one year so, so combined, that's better than we could have ever expected.

John Shufeldt:
That's amazing. What advice do you have for entrepreneurs that want to go down the device road, because the device road is hard, you have FDA clearance, you have all sorts of testing, it probably took a few years off your life, what advice do you have for them?

Erik Kulstad:
You know, I think one of the first things to do is get connected to your local incubator organization. Most cities of decent size have one, and if you don't have one in your city, it's probably one nearby. In Chicago, we had a group called Propel, and their whole focus was to take clinicians for the most part with ideas, walk them through the process. Now they weren't, they weren't holding their hand, I mean, they were really sort of saying, hey, here's what you need to do, here are the people to connect with here are the things you need to do next, here are the typical milestones you need to meet. So with that, I mean that, that provided the education that I needed that was would have otherwise never been clear to my, I mean, medical education really doesn't offer anything in this in this realm. You know, you might, I have an idea that it's difficult, but, but no one actually says, hey, here's how you do it specifically. And so there's an awful lot of reliance on other's expertise, but there are a lot of folks that are actively engaged in trying to foster the entrepreneurial knowledge and mindset of clinicians, knowing that most clinicians have ideas. I mean, it's really how, there's no clinician of it has said at some point, hey, it would be interesting if we did this instead of that, or why hasn't someone done this approach instead of?

John Shufeldt:
Yeah, I just set up a venture capital firm with, to help physicians bring these ideas to bear because as you said, we all have, all of us have them. Some of them are great, some of them, like most of mine, are, were ridiculous, but we all have different ways to try to improve the quality of delivery of health, the health care, and you certainly have achieved it, that's excellent, congratulations. That's really cool!

Erik Kulstad:
Yeah, no thanks. I mean, it's like I said it's been, I think anybody could do it if you're willing to sacrifice the time commitment. That's the biggest thing, it's time commitment.

John Shufeldt:
Did you? Now, you're still practicing emergency medicine, correct?

Erik Kulstad:
Yes. Yes.

John Shufeldt:
Wow. Interesting. Well, you've you've done the dual path. Let me ask you a question about burnout as we talk about moral injury and burnout, and you know, for me, my premise has always been because I try to do these different things, I've been pretty unsusceptible to burnout and I don't work a ton of shifts anymore, maybe 8 or 10 a month, but I've never really felt burned out. But I think it's because of this entrepreneurial stuff. How about you?

Erik Kulstad:
Yeah, I think having the different areas of interest helps protect against burnout. If you said you're doing 8 to 10 shifts a month.

John Shufeldt:
Yeah, probably, probably eight right now.

Erik Kulstad:
Oh, that's a lot. I mean, I, right, because I'm part time clinically, so I'm, I'm probably doing half that, which is almost perfect for me. I think, it, just in terms of protection against burnout, I see colleagues that are doing full time and plus and having to pay extra car payments, mortgage payments or college tuitions and, and actually doing more shifts and to make the extra money and they, you can do that for a little while, but it, it's hard, I think in this environment, you know, with notwithstanding all the, all the additional stressors over the last couple of years, it's you know, I think for me, the secret is having the different interests and the different focuses. And, you know, going into a shift is almost like a relief to me that now I can sort of focus on patients and not have the distraction of everything else. And then, you know, a couple of rough overnights, and I'm sort of happy to look forward to having, having a conversation with a potential end user looking at data, writing a manuscript, I mean, it's just, it's all nice to have that balance.

John Shufeldt:
Yeah, the diversity of it and you're right, I look, you know, I, in a point I look forward and I go in and see patients because it's, it is a different thing that I usually do, so I'm excited to do it still, hm, that's cool, this has been awesome, Erik! Congratulations. Where can people find out more about you or contact you?

Erik Kulstad:
You know all the usual mechanisms, I think Twitter, LinkedIn, the company is Attune medical, so just a search on Attune Medical, will put our site up fairly quickly, the actual HTML web page is Attune-Medical.com, but there's also because the name of the device is ensoETM and so spelled with an s, so E N S O and then ETM, E T M being esophageal temperature management, enso up being a name that one of our marketing folks came up with that fits sort of the bill of what apparently was a good marketing name should be, and so ensoETM.com also will pop up that, the website.

Erik Kulstad:
That's very cool. Well, congratulations. We'll have all this in our show notes, ways to contact you and also links to the device. Erik, thank you very much, good to finally reconnect after all these years!

Erik Kulstad:
It's been an honor. Thanks, John, appreciate it, and yet I'm following in your footsteps here.

John Shufeldt:
Thanks, love.

John Shufeldt:
Thanks for listening to another great edition of Entrepreneur Rx. To find out how to start a business and help secure your future, go to JohnShufeldtMD.com. Thanks for listening.

Sonix is the world’s most advanced automated transcription, translation, and subtitling platform. Fast, accurate, and affordable.

Automatically convert your mp3 files to text (txt file), Microsoft Word (docx file), and SubRip Subtitle (srt file) in minutes.

Sonix has many features that you'd love including powerful integrations and APIs, automated translation, world-class support, transcribe multiple languages, and easily transcribe your Zoom meetings. Try Sonix for free today.