Medsider: Learn from MedTech and HealthTech Experts

Managing a Clinical Trial with a Small Team and Lessons Learned Raising Money for an Early Stage Medtech Startup: Interview with Dr. Marie Johnson, Founder of AUM Cardiovascular

January 31, 2017 Scott Nelson
Medsider: Learn from MedTech and HealthTech Experts
Managing a Clinical Trial with a Small Team and Lessons Learned Raising Money for an Early Stage Medtech Startup: Interview with Dr. Marie Johnson, Founder of AUM Cardiovascular
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Medsider: Learn from MedTech and HealthTech Experts
Managing a Clinical Trial with a Small Team and Lessons Learned Raising Money for an Early Stage Medtech Startup: Interview with Dr. Marie Johnson, Founder of AUM Cardiovascular
Jan 31, 2017
Scott Nelson

More than a decade ago, AUM Cardiovascular founder Dr. Marie Johnson was a doctoral student when tragedy struck her and her family. Her husband, Rob, passed away suddenly at the age of 41. He had blockages in his coronary arteries including a ruptured plaque in the left anterior descending artery supplying a large part of...[read more]

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Show Notes Transcript

More than a decade ago, AUM Cardiovascular founder Dr. Marie Johnson was a doctoral student when tragedy struck her and her family. Her husband, Rob, passed away suddenly at the age of 41. He had blockages in his coronary arteries including a ruptured plaque in the left anterior descending artery supplying a large part of...[read more]

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Scott Nelson:   0:08
Welcome to Med Cider, where you can learn from experienced medical device and med tech experts through uncut and unedited interviews. Now here's your host, Scott Nelson. Hey there, ladies and gents, welcome to another edition of Met Cider Radio brought you from the W. C. G studios here in Minneapolis. If you're new to the program meant side of radios, where we learn from med tech and other health care thought leaders through uncut and unedited interviews. Just a few quick messages before we get started. First, I sent out a free email newsletter about once per month, highlighting my favorite med tech and or health care related stories, the one that I personally get a lot of value from. I don't send the newsletter out very often, but when I do, I really try to make sure it's valuable. So if you're interested, head on over to met cider dot com and enter your email address as a bonus, I'll send you a free e book on the strategies I personally used to make connections at conferences. I think you'll find the book pretty useful. And while you're online, head on over to iTunes and radar show a five star rating would really help us out. Second, for those of you that subscribe to the email newsletter, you're probably aware of this. But I recently joined the MedTech practice of W. C. G, a fully integrated marketing agency. So if you're looking for some marketing help, there's a few reasons you should consider our firm first were entirely focused on Med tech. Second, our wheelhouse is analytics, which drives all of our recommendations. And third, we're fully integrated, which means you don't have to source capabilities from another shop. So if you have a project in mind that you'd like to discuss, hit me up at Scott at med cider dot com again that Scott at med cider dot com. And lastly, speaking of marketing to generate more awareness for some of these interviews, I've recently started using a pretty unique system called pan optic stacking from the team over. Reach Fire digital. I know Pan optics stacking. It sounds sophisticated, right? Well, to be honest, it sort of is. But let me try and explain. First, they validated some of my messaging in real time and developed an automated customer pathway based on my audience here. Met cider, then utilizing something called eco marketing. They're using behavioral targeting to move that same audience through a customized online journey. After executing my personalized pan optics back, I'm already seeing a really nice impact, and I'll share some of those results in future episodes. So if you're interested in learning more about the system, the team over Reach fire. Digital has agreed to build a custom pan optic stacking blueprint for the 1st 15 men. Cider listeners that respond to this message normally charge 2500 bucks to build one blueprint. But because they're big fans of med cider, they're giving it to our 1st 15 listeners for free. So go to reach fire. Digital dot com Ford slash med cider again US. Reach fire digital dot com Ford Flash Med cider Grab that blueprint okay onto the episode. Within a decade ago, Home Cardiovascular founder Dr Marie Johnson was a doctoral student when tragedy struck her and her family, her husband, raw, passed away. Suddenly, at the age of 41 he had blockages in his coronary arteries, including a ruptured plaque in the left anterior descending artery supplying a large part of the heart muscle at that time, Dr Johnson had been working on a prototype device to listen to heart sounds as part of her doctoral degree. Her husband's coronary artery disease have been present but silent and undetected. Inspired and motivated by her loss, Dr Johnson decided to apply the principles of frequency analysis to create an acoustic device to identify obstructive coronary artery disease, which is now called the Cadence System. Murray has a PhD in biomedical engineering and is the founder of Own Cardiovascular. She successfully raised over $10 million an angel investment from individual investors, small funds and physicians. Before becoming CEO of Ohm Cardiovascular, Dr Johnson designed and launched the University of Minnesota Medical Devices Innovation Fellowship Program. Here's a few things we're gonna learn in this interview with her. The time when Dr Johnson realized he had a winner on her hands with a cane system. The origin story for the device itself, how Dr Johnson went from initial idea to prototype to eventual production what she's learned. Raising money from a wide variety of investors in an era of consumer centric wearables. How Dr Johnson landed on a business model for the cadence system. Her approach to managing clinical trials with a small team. Dr Johnson's favorite business book, this CEO that most inspires her and the advice she'd give to her 25 year old self. Of course, there's a lot more than we're gonna cover in this interview, but without further ado, let's dig in. Dr. Johnson, welcome to the program. I appreciate you coming on.

Dr. Marie Johnson:   4:12
Thanks, Scott.

Scott Nelson:   4:13
All right, let's dive in. Let's start with some of the accolades that you and your team at home have won over the past several years on a list. Um, but I want to ask you a couple questions about these. So you've won, you know, as I mentioned, several wars, you know, for the invention of your device. More specifically, the Top Cardiovascular Innovation Award in 2015 you've been named a top 10 Met Tech innovator, I think, in 14 2001 of the top 100 creative people in business, you know, the list goes on and on. So if we keep that in mind and sort of rewind the clock just a little bit, was there a point in time when you, you know, you look at the ohm story when you think? Wow, This device. I think we've got it here. It's not perfect, but I think we've got something that can really make an impact.

Dr. Marie Johnson:   4:52
Thanks for asking that question. And I'm really embarrassed. And I just humbled that you would have looked up these things about the company and about me. I am embarrassed, but so, yes, I think that once we got the product into the handheld device and we were deploying to clinical trial centers, we knew that we have something commercialize Herbal. We knew the technology was gonna work from the beginning, but just reducing that into a form factor that would be easy for clinicians to use, I think was a pretty important part off the product development

Scott Nelson:   5:24
process. I got it. Okay, so it was really at that clinical trial standpoint. We really sort of being really begin to resonate for you and your team. That that's great. I certainly want to dig into that more because, you know, the word disruptive gets thrown around a lot. But your technology is truly disruptive, and I want to kind of go back further in time to learn a little bit more about how you went from initial idea to eventual commercialization. But let's sort of level said everything for the audience that's listening. Can you provide a high level overview of your technology? Cadence, I think, is how you pronounce it. So what it does you know who it treats. And then there's a couple of follow up questions I want to ask you about clinical data and no corresponding regulatory approvals as well.

Dr. Marie Johnson:   6:00
Sure, absolutely So. Cadence is a noninvasive handheld nonintrusive half way to rule out coronary artery obstruction in patients with chest pain and two or more risk factors

Scott Nelson:   6:14
about it. Okay, And so what is it? Is it displacing a current sort of treatment algorithm for healthcare providers? Now?

Dr. Marie Johnson:   6:20
It sure is. So we have just finished a 1000 patient clinical study proving that we're not inferior to a nuclear stress test in terms of ruling out obstructive disease. What's important about that comparison is that a nuclear stress test can take between three and five hours up to two days, where cadence requires only eight minutes. The data and the results are returned back within 12 minutes. It takes basically the patient has to lie on their back breathe normally, room has to be quiet, but that's all it takes to perform the cave ins exam. Where is with a nuclear stress test, it requires between 1/4 and 1/2

Scott Nelson:   6:57
of

Dr. Marie Johnson:   6:57
one's lifetime. Exposure to radiation requires exercise or pharmaceutical inducing agent. It requires technicians. Special facility. Kate is is very easy to use. We provide a system where it can be performed anywhere. A cell phone tower could be access to where there's a room where nuclear stress test on a lot of places around the country and around the world don't even have access to that kind of technology.

Scott Nelson:   7:22
Sure, and I think for most people that are listening, they've been inside a hospital with sort of that nuclear nuclear testing department, if you will. Maybe I'm not describing accurately, but I've certainly was really walking by a fair number myself. And so this technology is this device, the cadence system. That sort of displaces that situation where the patient would have to go to the nuclear testing department to get that sort of I don't want to call an invasive that certainly more investment needed on the patient's behalf, right? Not just patient. I guess, but the entire health care system, really? And so you sort of bypass all that you're testing, can get the same thing basically accomplished in eight minutes, sort of paraphrasing. But is that sort of true? From a high level perspective,

Dr. Marie Johnson:   7:57
it is minutes, eight minutes to collect the data and then another 12 minutes to get the results back. Yeah, that's exactly what we're doing. And that's in terms of ruling out disease. So just consider going to the emergency department. What chest pain. You're gonna spend at least six hours there and a lot of time. So even keep you overnight. And with cadence, they can release you within a couple of hours. In primary care. Doctors, family practice, doctor practices, same things. A lot of times they will perform a lot of tests on a patient to determine what's causing the chest pain. Maybe they're not in the acute kind of setting, but cadence communities really quickly to little out coronary disease. And you already know this. Most people that are in the United States would know this, but her disease is really the number one killer among Americans. One of three people will suffer from some type of heart disease.

Scott Nelson:   8:48
Yeah, that's very cool. And you mentioned that you just finished in ruling was 1000. You're just finished up that 1000 patient clinical trials? Well,

Dr. Marie Johnson:   8:55
we have. So we have tested a total of 1350 patients today. It in five clinical studies. We just recently finished about 1000 patients study comparing ourselves to a nuclear stress test in patients that were indicated for nuclear stress. Test of this is important because it's actually in the patient population where Cadence will use, and we proved that we were not inferior to the nuclear stress test. We don't want to scoop our clinical partners, but essentially what we can say and I can't say publicly, is that nine out of 10 times if the patient is normal, we can tell the doctor that that patient is normal.

Scott Nelson:   9:32
Well, that's impressive. And you have regulatory approval, I guess. Where do you stand from a regulatory approval standpoint?

Dr. Marie Johnson:   9:38
Yeah, great questions. So we have our CD mark, and we are able to sell and any in place in the world where see, Marcus, except we do have to have registration in those countries, of course, but we also have approval in Canada, Australia, the Philippines and are cleared to fell in a number of other European countries. Right now we are being used commercially in Germany and another limp

Scott Nelson:   9:59
right, and I presume the FDA clearances on the horizon at some point. Is there a anticipated date for that?

Dr. Marie Johnson:   10:05
So there is. We think, that we will have our first clearance in Q two of 2017 and then our second clearance at two for 2017. Got this the first time I've ever said this publicly, but we have added e c g to our cave system.

Scott Nelson:   10:22
Well, e g yeah, way. Well, thank

Dr. Marie Johnson:   10:26
you so much. Yeah, it really agree addition to the product because it doesn't require leaves or electrodes, and we can provide equivalent of a six Leedy CG wirelessly,

Scott Nelson:   10:37
and it's awesome.

Dr. Marie Johnson:   10:38
Punishing takes the data, and then they return. The day that we return that within 12 minutes to a minute not only provides that new CG information to the clinician, but then it also allows us to be even more accurate in terms of our assessment

Scott Nelson:   10:51
of

Dr. Marie Johnson:   10:52
turbulence in coronary vessels, because we can't split out justly from Di Asta Lee, and it's that Love Dub loved up so we

Scott Nelson:   10:59
can

Dr. Marie Johnson:   10:59
separate the inspections of the cardiac cycle, and it just is really terrific because it allows us even more powerful assessment of that data.

Scott Nelson:   11:07
Nice, Nice. I know med cider for those listening that are familiar with, You know, with the interviews or the program, I should say it's not typically, don't break news here. We were usually dive deep, you know, stories behind, you know, medical devices and founders and how you know how these technologies came to fruition. But nonetheless, congratulations on that addition, that is very cool news. And so you're currently see Mark Clearances on the horizon. That's great news. Let's use that as an opportunity to really dive into how this technology came about and how you got to where you are today with film. So if we had the chance to rewind the clock even further, can you? I think most people that are familiar with your background of maybe heard the story before. But can you provide a no overview of how the cane system came to be the idea of the concept for

Dr. Marie Johnson:   11:49
sure, Absolutely. 14 years ago, I was working with the three AM Lippman company, was a fellow in the problem and I was doing some research work at the University of Minnesota, computerizing and electronic stethoscope, and we were. Our goal was to automatically detect part valves pathology, and I am not a clinician. I'm an engineer. And so I used my husband as a test subject. I collected lots of data from him, and he was 41 years old, six foot 2 £180. An excellent condition. Swam three days a week and nine months after I started, my PhD died from a sudden cardiac event. He had a vulnerable plaque rupture in a widow maker. Coronary artery. That's the left interior descending coronary artery. It was a complete surprise. I had a four year old and a six week old baby at the time, and I always say this. I'll say it again, that you could have listed a 1,000,000 things that would have happened to me next in my life, and that was not one of them. At that time, I decided this is not by accident, and so I decided to dedicate my life to taking attack out of heart attack. So I started the project and then I moved my kids to Italy, ended some work on more science. Human dynamic sent arterial elasticity of blood flow to the vessels. Discovered a lot of literature about times and places where the similar phenomena have been described. In that phenomena is using acoustic to detect corner disease. There was a guy back in 1967. His name was Dr D. O C. K. And he described a case study of a guy who had come into a Brooklyn d A and was suffering from severe hypertension. They did a physical examine him and discovered he had a really unusual loud sounds and they didn't quite know what was from he came in. The same patient came in two weeks later and unfortunately died at the hospital and they did an autopsy and discovered that he had a widowmaker. Wonderful plaque rupture in the l. A. D vessel. And when I really dug in and I found that there were darker that have described this a lot and engineers to and ultimately the clinicians came to the conclusion that they didn't hear the sound all of the time, and so they couldn't trust it clinically. In addition to that, that sounds really quiet. And so it's just really not. You can't pick it

Scott Nelson:   14:13
out, that

Dr. Marie Johnson:   14:14
is. And then I went to Italy, and then I was out of Stanford for a while. There's some pretty successful entrepreneurs and innovators and learned a lot about how to translate an idea into

Scott Nelson:   14:27
it makes a lot of sense, but if I go back to that time period, I mean your husband passes away on completely unexpectedly. You got two young Children and you moved to Italy. So what was kind of going through your head at the time? If you don't mind me asking, what will certainly move on to kind of how you brought this technology, you know, into life, you know, through the kind of prototyping, stage and whatnot. But I'm just curious. I've always been intrigued by by MedTech founders and, you know, sort of where they know what drives their passion. And clearly there's a personal story here. But I got to think that a lot of people wouldn't have made those types of efforts, you know, with two young kids and moved to Italy. Study the girl really, really deep in terms of technology. So what do you think that comes from that drive? That passion.

Dr. Marie Johnson:   15:06
Oh, my 100% agree with you that well, I people thought I lost my mind. So they did. I mean, because why would a widow take two little kids to Italy being Mr Big Italian? But I felt that God was calling me to solve this problem. And that's why I threw the hard time. Easy to keep moving forward. When you feel that you've got something ordained on your life,

Scott Nelson:   15:29
I wouldn't have expected you to answer in that fashion. But this Certainly I can completely appreciate that. And so how, uh, how long were you over in Italy then? Before you came back to the States?

Dr. Marie Johnson:   15:38
Yeah. I was there for half a year

Scott Nelson:   15:39
after year. Okay,

Dr. Marie Johnson:   15:41
I

Scott Nelson:   15:41
got it. This may be a little bit more of a personal question, but your kids now are are the teenagers. Now, if I kind of do the math correctly in my head,

Dr. Marie Johnson:   15:47
Yes. My daughter is 18 and

Scott Nelson:   15:49
my son

Dr. Marie Johnson:   15:50
is 14 and their whole lives, basically they've been a part of this this whole

Scott Nelson:   15:55
quest

Dr. Marie Johnson:   15:56
and have grown up around it and they're human beings.

Scott Nelson:   16:01
They're saying, you know, entrepreneurism lived out right before them. So I imagine those skill sets full will come in handy for sure down the road so that you could start. I would encourage everyone to know that if they wanna hear Dr Johnson, you know, touch on a little more detail in regards to the background. You know, there's a great Ted talk that she gave while back. There's a couple other stories that are on the website which willing to in the show notes for this particular interview, but definitely that Ted talk is one to watch for sure. So its transition to talk a little bit more about him and how you kind of went from studying the technology over in Italy, moving to the West Coast and learning, you know, I think you were part of the Stanford bio design program. Correct?

Dr. Marie Johnson:   16:33
Yes,

Scott Nelson:   16:34
yes, great. So you've got this technology. But yet, you know, now it's a very sleek device based on sort of the images in the videos that I've seen online. So first, how do you go about raising money when you don't have deep connections with venture capitalists. So can you talk a little bit about that part of the ohm story?

Dr. Marie Johnson:   16:50
Yeah, absolutely. But can I step back just a little

Scott Nelson:   16:53
bit? Because you're

Dr. Marie Johnson:   16:53
I was at the University of Minnesota when I came up with this idea and disclosed it Thio the university. They filed patents on it, and they put it on their website to try to entice entrepreneurs to take the product commercial. And, you know, it was kind of funny. I could never understand why, over years, nobody stole the potential of the device. And you know what, Scott? It was because it was math.

Scott Nelson:   17:17
Interesting e

Dr. Marie Johnson:   17:21
obvious. Well, I went to the Stanford buyer design program not even expecting to do anything with my invention. It didn't even occur to me. I went to This is a post doc. I thought it would be a really terrific program. Well, I was at Stanford and in the bio design program. I contact the University of Minnesota and asked them to waive the technology back to me. And so that just means I could take it forward and start a company. And I came back and Here's where I started. I don't know if you remember years ago there were some stimulus grand available. They called them the qualifying therapeutic delivery project grants and basically they were grant or tax breaks. I think I took the grant. I don't know what the deal was on the other

Scott Nelson:   17:59
side, but

Dr. Marie Johnson:   18:00
they were $250,000 it didn't require much work. I was at the University of Minnesota. They had recruited me to come and develop and lead a program similar to that in front of the one. I had just the bio design program anyway applied for this grand. We applied for the money in July, and then they awarded the money in October. And then we had to spend it by December. They're here. Itwas I won the grant and I had all of this money and I thought, Well, I won't be able to carefully take care of this money. And so I ended up leaving the university to start the company. And so I remember I went to the bank and I had to open a bank account, actually receive this money from the government, and the banker asked me if I wanted to get checks. Credit card

Scott Nelson:   18:45
e looked at him

Dr. Marie Johnson:   18:46
and I thought

Scott Nelson:   18:47
E

Dr. Marie Johnson:   18:50
when I got the credit card mail, I thought, Well, I have a business.

Scott Nelson:   18:53
I really

Dr. Marie Johnson:   18:54
you have the vehicle money. So anyway, that's why I started the company. And after that, I started to raise money, and I reached out to angel groups, and I should also

Scott Nelson:   19:05
just

Dr. Marie Johnson:   19:05
what? You know, that steam for bio design. They do a great job in networking the fellows. And so I had been introduced to a number of venture capitalist groups. They train you on how to put together strong pitches. They teach you a variety of topics that intersect with translating a technology. So insurance reimbursement after a regulatory or O. U S regulatory things, business model putting teams together. So

Scott Nelson:   19:30
you have

Dr. Marie Johnson:   19:30
this background and I have learned from these just incredible entrepreneurs and innovators. So that's what I did. I started putting together my overview and cold called

Scott Nelson:   19:41
group

Dr. Marie Johnson:   19:41
got on some angel groups. I got onto their radar making presentations, and then I always say that the first I got $200,000 was hardest.

Scott Nelson:   19:51
Everything else

Dr. Marie Johnson:   19:51
was pretty easy after that. but it's just getting someone to listen to you so that you can describe exactly what you're thinking. And I'll tell you, I worked with this woman who had been a Medtronic and shield me put my business plan together, and that was pretty pivotal to because I have it in my head. But writing it down on paper, I think, was really the next stop. And once

Scott Nelson:   20:10
you're skidded into

Dr. Marie Johnson:   20:11
that format, it's easier to start working from that and massaging it and get it into this PowerPoint format so that you can

Scott Nelson:   20:18
start pitching

Dr. Marie Johnson:   20:18
your ideas.

Scott Nelson:   20:19
Sure, yeah, and I could completely understand where you're coming from. I mean, there's this notion, I think, in Silicon Valley right now, at least in the tech vertical, that business plans any more relevant. It's all about Iterating every you know, 8 to 12 weeks. But the reality is that writing Ah Amore formal plan and getting those into slides and telling that story with data. I mean, that helps to sort of, like, really fosters this kind of this foundation for the company moving forward. So I think that that's great. So those first few months after that ran thin once you got, you know, the credit card and the check writing ability. You spent most of that time at least early on trying to raise additional financing. Is that correct?

Dr. Marie Johnson:   20:53
I did. And the first thing I did with my cash waas I and this sounds kind of crazy. I knew that. Getting into a form, you know, like the handout and kind of taking the math and putting it into the actual device would be pretty straight board once had enough money.

Scott Nelson:   21:07
But

Dr. Marie Johnson:   21:08
what I knew sort of intuitively up front is that we needed to lay out a plan for how we would prove it clinically. So I hired someone who had a lot of stats, background and did clinical research and looked hard on putting that plan together. And once we had an idea of how we were gonna prove it, then raising money was pretty straightforward. So I just started cold

Scott Nelson:   21:30
college appointments. Yeah, but a lot of people think that, like, you know, that's, you know, that's the world of raising money is there's, like, a mystique about it, I guess maybe for lack of a better description, reality, it's like it's cold calling it's kind of cells. You're you're selling someone on on your story and you know what you're trying to build. I can appreciate that. I remember a presentation here locally in Minneapolis that Stacy Insing saying gave on raising money because she's now with Light Stone Ventures and is a really good presentation. I'm hoping to have her on the program, you know, soon weaken gonna, you know, go into that a little bit more detail, but yeah, I mean, one of avenues that she recommended for early stage founders was it was grant money, friends and family foundation money, and it was really good. What it sounds like to me is that you spend your time trying to figure out who were some low hanging fruit, that I could raise them additional funds?

Dr. Marie Johnson:   22:14
Definitely. And I think in part, the entrepreneur isn't passionate or really that sort out. Whatever idea they're pitching, it's easy to pick up on it. But my passion has never waned. And one more thing I should tell you, Scott,

Scott Nelson:   22:26
when

Dr. Marie Johnson:   22:27
I spend money, I be my investors faces before me. We are so careful with the way that we've been money were very considerate. with respect our stewardship of that money. So think over the years we've proved ourselves really trustworthy. So we've raised three rounds. We've raised $10.3 million from individual investors. I don't have any institutional investors in my pool.

Scott Nelson:   22:50
And so on that note, I want to kind of move on eventually here to sort of the business model for ohm and in the clinical trials. And how you went about that, because, I mean, you know, 1300 some odd patients. That's no small feat by no means. But on that note regarding financing, I interviewed the founder, Saffron. Gosh, this was probably five or six months ago now, something like that. And they didn't raise me. They didn't have a traditional, you know, a venture capital firm lead any of their rounds. It was all through, you know, angels and individual investors. So, looking back is that something that you recommend to other med tech entrepreneurs? Or would you do it differently the next time around?

Dr. Marie Johnson:   23:20
No. When I would 100% do it the same way when you're interacting with high net worth individuals, they've been festival, so they all bring additional knowledge and you grow. Every time you speak to one of these folks, I would do it exactly the same way.

Scott Nelson:   23:34
Well, that's good to know. That's great. So you raised three rounds and are you currently raising money again or you follow the philosophy? If, like you're always sort of, you know, passively raising money, what's your push to that?

Dr. Marie Johnson:   23:45
So I don't I don't always passively read money because so concentrating on the business. But we are raising a convertible round right now.

Scott Nelson:   23:53
Very good. And if someone was listening and was interested in possibly investing is the best way to just to reach out to you directly.

Dr. Marie Johnson:   23:59
Yeah, definitely,

Scott Nelson:   24:00
very good. Okay, let's move on. Let's talk a little bit about the business model and then a little bit more about your clinical trial to I think, as I mentioned before, I mean, it's not like you just did a small little trial. I mean, it was it was a significant number of patients, but in regards to the business model, you know, it seems like your device could potentially, you know, kind of play within this consumer world of like Fitbit and tumbling off it. But I guess just acquired Pebble. But you know, I watch in that pool like consumer centric Rome. But obviously you went down a different path. So explained us kind of like your take on maybe those two different directions and why you pursued the one that unit up running down

Dr. Marie Johnson:   24:34
100%. Happy to talk about that. So the American Heart Association, American College of Cardiology guidelines in the cave that testing asymptomatic patients is not a good idea, and my ultimate goal is to test every person over the age of 40. And that's ultimately getting to the point where we're eliminating that kind of heart attack in sudden cardiac death. But at this point, the medical system is not ready for that type of testing because it can increase costs downstream. And also it's higher wrist a patient if you have them undergo additional testing. And so I think it will definitely be a great fit in the consumer market. Its point of care could be performed anywhere. At this point, though, we are concentrating on patients with chest pain into a murderous factors. Do you think it's the best saying that we can do for the patient for the public

Scott Nelson:   25:24
got it. Okay. So long term, in order to meet those goals and have everyone, you know tested below the age of 40 Yeah, it would sort of require a little bit more proactive effort, you know, on the consumers behalf. But I can completely understand, I mean, that I don't think the health care system, nor most people in general are ready to, you know, to go down that path or that are active. Unless you're talking to a very specific audience. You know, it's sort of that bio hacking audience that know her. You probably know that audience that I'm speaking about. Yeah, I mean that they probably love to get their hands on your technology and test themselves, but that makes sense. So you've gone down this path that's a little bit more traditional. Sort of meant tak where you're eventually sort of want to get societal support, and so would this eventually. You know, once you have FDA clearance here in the in the US, you'll eventually. This is something that you hope insurance companies will cover and then reimbursed for

Dr. Marie Johnson:   26:09
Yeah, 100%. We hope that they see the word, and we think we can take a tremendous amount of cost out of the system.

Scott Nelson:   26:16
Yeah, absolutely. It would seem like that on that note, that might be the biggest East to tackle its coverage. Remembers when I recently interviewed Bill Facto, Who's the CEO of Ireland's? And he was the CEO of the Clarence Letter clearance through the acquisition by J and J. And we went deep into this whole concept of, you know, coverage and reimbursement and you know, the lessons he's learned along the way, so that will go live. By the time I guess our interview goes live, that will probably be up. But I encourage anyone that's interested in learning a little bit more about Bill's thoughts to check that one out. So very good. Let's talk a little bit more about your clinical trial. So if I understood you correctly before you have, do you have two trials in place? One that's around 1300 soap, 1300 ish patients, and then another one. That's 1000 patients, Is that correct?

Dr. Marie Johnson:   26:54
No. We've tested a total of 1350 patients. 1000 of them were in al Big Turbulence study and then we had a few smaller either post market registry studies or actual in US perspective blinded studies.

Scott Nelson:   27:10
Okay, that

Dr. Marie Johnson:   27:10
are FDA study. Is the turbulence trial

Scott Nelson:   27:13
okay? And so when you went about sort of designing and developing what you wanted this clinical trial to look like, How did you look at that from the beginning? And how did that sort of come to life?

Dr. Marie Johnson:   27:21
Yeah. So originally we wanted to dio a pre angiogram study because that would have allowed us to collect patient data and then automatically have kind of the answer, right, the gold standard associated with our test. So we would pretty easily be able to match up those two things, right? Our test results and then the angiogram test results. Proving that the technology work, we went to FDA and suggested this study and they required us to debt back, collect the patient data at the point of stress testing. And so that was pre nuclear stress. Test is what we decided was kind of the best place for the company. When we originally started this study, we thought that we would have to collect about 368 pieces of data to be able to calculate our performance standpoint. What we discovered was in the middle of this process was that what we thought was happening in clinical medicine and what was published wasn't really what we found in practice. So originally we thought there would be about maybe a 40 60 split in terms of diseased in normal patients. But what we discovered was that about 15% of all patients who undergo nuclear stress tester positive. And so that made our study it just about this three times, almost four times as big as we thought it would originally be. Just put those numbers out to you. There are about 10 million nuclear stress tests performed every year, and about 10% of those patients actually have some disease. And so nuclear stress tests are vastly over prescribed for normal patient. And that's an $11 billion industry.

Scott Nelson:   28:57
Wow. Wow, Those are some, uh, there's some big numbers. I wouldn't have expected that. Were those numbers specific to the U. S. One? There's that worldwide

Dr. Marie Johnson:   29:04
so specific to the U. S. Alone.

Scott Nelson:   29:06
Got it. Okay. And on that note, your clinical trial did you enroll patients just here in the U. S. Or did you enroll patients in Europe as well?

Dr. Marie Johnson:   29:12
So for our large clinical study, they were only one clinical trial centers around the United States. We have done post market registry studies in another Linds, and also in Germany. I

Scott Nelson:   29:23
got it. Okay. Very good. With respect to managing the clinical study itself. Did you do that internally, or did you work with a sorrow?

Dr. Marie Johnson:   29:31
So we did it internally. We did look at a rose in the beginning that they're really expensive to do. A 1000 patients study it

Scott Nelson:   29:40
more

Dr. Marie Johnson:   29:40
than a $1,000,000 just to do that. And so we were very careful about understanding, learning, memorizing FDA guidelines with respect to conduct of clinical studies, monitoring requirements, data safety, ways to just ensure that you're getting good data. You're capturing good data. We ended up using electronic data capture systems, hired really good consultants to help us. But then I had on staff monitors that, you know, kept an eye on the date. And we did lots of monitoring visit all over the country. But we opted not to use a hero just because it's so expensive.

Scott Nelson:   30:14
Sure, Dr Johnson, there's got to be a story there because it's because of the laughter at the beginning. It seems like a beast. I mean, to tackle especially, you know, managing internally with the company at your size. But obviously your able to do it successfully. What are some of the best practices, I guess, or challenges that you encountered. And how did you sort of have a ton of time to go very deep in this? But I mean anything that you can offer up to other people that are kind of in the same boat or considering, you know, starting a clinical trial and don't know whether the energon internally or her to work with a c r O

Dr. Marie Johnson:   30:41
100%. And I'm

Scott Nelson:   30:42
having to

Dr. Marie Johnson:   30:42
share this knowledge. And I

Scott Nelson:   30:43
think you're

Dr. Marie Johnson:   30:44
awfully smart about it within the company. So first of all, let me say my staff was really small. I had any time about 12 people, and any one of us can train users on home to collect cadence data. I think that's very important. In addition to that, all of us control shoot the systems. And so if we had groups that needed to

Scott Nelson:   31:04
be trained,

Dr. Marie Johnson:   31:05
it

Scott Nelson:   31:05
was

Dr. Marie Johnson:   31:06
not just

Scott Nelson:   31:06
a

Dr. Marie Johnson:   31:07
single clinical person. It could be a clinical person who was reviewing regulations. And then I could have an engineer that would travel along with them to train them on how to use the device. And so we were careful about Resource is. And then we learned an awful lot about risk based monitoring. And so I had, and actually we still work with Susan. Alpert, who was one of the senior VP, is at Medtronic over regulatory. She was also chief at CDR. Each of FDA and I

Scott Nelson:   31:33
talked to

Dr. Marie Johnson:   31:33
her at length about monitoring requirements because I think that's really the most difficult aspect of running. Her clinical study is just going into the centers and checking the data. I had talked to her at length about this. I read the FDA regulations probably more than 10 times and realized that I don't think it was ever really don't think that they the way that we interpret those regulations, is really what they meant. And this was everything really reiterated by Susan to me, just that doing this 100% monitoring and just the amount of time and money that people spend on this I

Scott Nelson:   32:09
just don't think

Dr. Marie Johnson:   32:10
that that's exactly what they meant right

Scott Nelson:   32:12
by.

Dr. Marie Johnson:   32:13
I just want to be careful about how I'm saying this because we did not cut corners, we used statistical methods. We did 72 monitoring visits, and it's really let me tell you something, Scott. That is very eye opening. To me, clinical monitoring just basically means that you go to the center. You take a look at the data they written down. So they write this down on a piece of paper that the research coordinators do. And then the monitor will go in and just check to make sure the data correct. Right? So the look at box a box A is no age 25 then we'll go into the patient's record is aged 25 they're just matching up this data, right?

Scott Nelson:   32:50
Sure,

Dr. Marie Johnson:   32:51
a lot of these monitors are making 150 up to $300 an hour, and it's a check data. That's

Scott Nelson:   32:58
well,

Dr. Marie Johnson:   32:58
that's really all there doing, and that is not met with any level of district back. But I had monitors who came to me and said, I make $300,000 a year and nothing to check data.

Scott Nelson:   33:08
Wow, I've never actually, for the first time, I don't usually go too deep into this world, but that's really fascinating to know. Wow, there's a lot of money going somewhere there. It's

Dr. Marie Johnson:   33:19
incredible. And so that's what happened. And I think it's really hard to me and into these kind of studies just because you're people out all over the country and they're interact with the cardiologists with the nursing staff of what the coordinators, you know at the hospitals. But that's where the bulk of the money, I think. Oh, this is

Scott Nelson:   33:35
just going

Dr. Marie Johnson:   33:35
to monitoring the data.

Scott Nelson:   33:37
Yeah, in a conversation I had with Duke Row Lien Hughes acquisition, Fox Hollow then sold Stevie Ingenuity to covet in etcetera. Etcetera is now with spy rocks. When they were doing their clinical trial at Fox Hollow that they or it wasn't Stevie ingenuity. I can't remember which company maybe, but they specifically wanted to manage it internally because of that relationship issue in the field. They really wanted to get to know everyone at their trial science not only just physicians, but you know, all of the health care providers, and I think that really helped, you know, increase enrollment in an era where a lot of times clinical trial enrollments pretty difficult, huh? Yeah, I agree. I agree.

Dr. Marie Johnson:   34:08
And we have great relationships there and coming up with ideas to get patients to join clinical studies. I mean, I think you're 100% on for all of those things, this kind of small nuances relationships and getting people excited and motivated to collect data. I think it's a lot of work for the folks of the sites to do a good job and actually get patients that fit within criteria and within really our patient population and the goals for our, you know, sort of commercial launch.

Scott Nelson:   34:37
Absolutely so that we don't have a ton of time left. But on that, No, There's a few other questions that we probably won't be able to get into, unfortunately, But it does seem, you know, just just hearing sort of your story. You know, over the past 45 minutes or so, it seems like you've been able to recruit and build out a team of really solid people, right? I mean, it started with the lady that you got to know that Medtronic even just taking on this clinical trial thing. I mean, you were able to obviously build out an internal team to help you manage this. So are there certain things you've learned along the way or how you've been able to track those people and keep them motivated internally toe, You know, when they're probably not times, you know, pretty overworked, considering you're at a start up or you're building out of startup. But can you talk to us a little bit more about that?

Dr. Marie Johnson:   35:14
Sure. So I think the clinical need and the drive to solve this problem is the reason why people stay with the company. I don't just like you mentioned. It's a lot of work. It's overwork. It's really We study a lot of the regulations, we know the product, we know the clinical field and cited out, and I just think you have to be sold out to the patient and dedicated to the patient. In addition to that, I think that they really like to work together. I mean, we have a certain DNA within the company, and once you develop this team, you bring people in letter, have consular DNA, they want to work together, and it's easier to retain that talent.

Scott Nelson:   35:54
Sure, it sounds like you've got a pretty good culture there, a lot of lot of smart people that are willing to hustle.

Dr. Marie Johnson:   35:58
Well, we do. And one more thing I would say toe other people that would be listening to your show is that needs change. And so I had a lot of clinical people on staff for a while, and I only have one person who does any clinical work, and it's just a very small amount. And so it's really keeping people when you need them and letting

Scott Nelson:   36:16
them go

Dr. Marie Johnson:   36:17
when you don't need them. Yeah, to be flexible. You mentioned earlier on that a business plan should change every 12 to 16 weeks. And I would say that the business does change every 12 to 16 weeks and you have to be agile and the team has

Scott Nelson:   36:29
to

Dr. Marie Johnson:   36:29
be come to board that kinda quick change.

Scott Nelson:   36:31
Got it. And before we get to kind of the last three rapid fire questions, you know what's next for, you know, for a home. And you know, if if you could highlight maybe, you know, we've talked a little bit about this, but, you know, looking back over the last, you know, 13 14 years or so, You know, I'd just be curious, you know it. Would you do anything differently, or is there something that you think if we could have just done it this way, I think we would have gotten there a lot faster?

Dr. Marie Johnson:   36:52
Sure. Oh, yes, absolutely. The answer is that so probably I would have not only for myself, but for my longer term team members just kept in mind that it's a marathon and it's

Scott Nelson:   37:04
not

Dr. Marie Johnson:   37:04
a sprint because we were non stop for three years. And then you get to the point where you start getting really tired. So, you know, I think that for me personally, that has never really been an issue because I'm so just so motivated. But I think for some of the other folks have been old traffic. It's really exhausting. So that's one thing I would have. I would have let people were until one in the

Scott Nelson:   37:26
morning.

Dr. Marie Johnson:   37:27
You go home to

Scott Nelson:   37:28
your

Dr. Marie Johnson:   37:28
vacation, please have a balanced life, and I think I'm really good at that now. In truth of being a leader, make sure that people take time off. And then maybe the second thing that I would add on is, I mean, maybe raise a little bit more money up front, just all at once since of piecemeal ing it all together. I may have done a little differently that way because I think you can move a little bit faster. If you have more money. That's certainly second thing. And then our

Scott Nelson:   37:53
next step is that

Dr. Marie Johnson:   37:54
I'm currently looking for a chief commercial officer off like a VP failed in marketing that wants to join our team and help us ramp up commercially. We're ready. We've got a commercial product ready January 1, and I want to hire someone that strong commercialization, background and who has a lot of energy and wants to take on a disruptive product.

Scott Nelson:   38:15
That's great. Eso anyone listening that their ears just perked up. If you want to just email me directly, I'm sure I could. It could pass along your information to Dr Johnson here. So with the last few minutes here, I'll just ask you quick, rapid fire questions, their rapid fire, you know, in terms of the nature of the questions, but not necessarily you know, rapid fire. You don't provide rapid fire answers, but I don't. And I don't blame you if I'm putting you on the spot here for this first question because you're running a fast moving startup. But is there a favorite business book that comes to mind or one that you recall has kind of made an impact over your career?

Dr. Marie Johnson:   38:42
Yes, and

Scott Nelson:   38:43
my son

Dr. Marie Johnson:   38:43
makes fun of me. It's Dale Carnegie, but how to make friends and

Scott Nelson:   38:46
influence. I

Dr. Marie Johnson:   38:48
swear to you,

Scott Nelson:   38:48
my son

Dr. Marie Johnson:   38:49
a basic hysterical,

Scott Nelson:   38:51
But yeah, it's

Dr. Marie Johnson:   38:52
been very helpful.

Scott Nelson:   38:53
I love that answer. In fact, it comes up actually quite a bit that it's still a book that lot of people remember us as one that's been the most impactful over their career. So is there a CEO or business leader that you're either kind of following right now or one that's inspired you over the last five years or so?

Dr. Marie Johnson:   39:07
100%? Yeah, sorry to Dennis. War is one. Think he's an incredible leader, and then also Bob Poulsen. He's just a terrific motivator and has a great business mind. I

Scott Nelson:   39:18
got it, I think

Dr. Marie Johnson:   39:19
not med tack, but

Scott Nelson:   39:20
I

Dr. Marie Johnson:   39:20
think Stan Hubbard is pretty remarkable. Too

Scott Nelson:   39:22
cool of those answers. And then lastly, you know, we've really rebound the clock quite a bit in this interview. But, you know, if we had the chance to do it again and we, you know, go back to your you're 25 year old self. Is there something that you tell her?

Dr. Marie Johnson:   39:35
Well, you know, I was working at General Motors at the time, but I was looking out of Sandusky, Ohio, and

Scott Nelson:   39:41
I really

Dr. Marie Johnson:   39:42
never thought that I would do anything but be an engineer in the car industry. And so I would just say, Take more chances.

Scott Nelson:   39:51
You've certainly taken that advice. I guess maybe it would be. There's there's gonna be opportunities. Don't take your chances or take your chances. This you say Don't turn him down. So very good. I know you've got to get going. I can't thank you enough for coming on the program. Such a great story will link to your website. There in the show notes. Is that probably where you direct the audience for those that I want to learn a little bit more about you. You're always Google. Dr. Marie Johnson and Ohm spelled a U M but willing to that in the show notes as well. But thanks, Dr Johnson, for coming on. I'll have you hold on the line here, but for everyone listening to the show Thanks for your attention. And to tell the next episode of Med Cider. Everyone take care. Thanks again, ladies and gents, for listening. This episode has been brought to you from the W C. G studios here in Minneapolis. And don't forget to grab your pan out. Extracting blueprint by visiting reach fire digital dot com for slash met cider Again that's reached fire digital dot com forward slash met side. Okay, bye for now.