Medsider: Learn from Medtech and Healthtech Founders and CEOs - How to Align Goals in an Interconnected Healthcare Ecosystem: Interview with Dr. Meesha Dogan, CEO and Co-Founder of Cardio Diagnostics

Episode Date: March 15, 2023

In this episode of Medsider Radio, we sat down with Dr. Meesha Dogan, co-founder and CEO of Cardio Diagnostics.Meesha is a well-respected leader in the epigenetic space. After completing her Ph.D. in biomedical engineering, she co-founded Cardio Diagnostics and co-invented its patent-pending cardiac technologies, which seek to improve the early detection, diagnosis, and prevention of heart disease through objective risk assessment testing. In this interview, Meesha shares how her company was founded on the grounds of compelling scientific research. She also talks about the different methods to improve the clinical adoption of a device and explains the possible benefits of going public. Before we jump into the conversation, I wanted to mention a few things:If you’re into learning from proven medtech and healthtech leaders, and want to know when new content and interviews go live, head over to Medsider.com and sign up for our free newsletter. You’ll get access to gated articles, and lots of other interesting healthcare content.Second, if you want even more inside info from proven experts, think about a Medsider premium membership. We talk to experienced life science leaders about the nuts and bolts of running a business and bringing products to market.This is your place for valuable knowledge on specific topics like seed funding, prototyping, insurance reimbursement, and positioning a medtech startup for an exit.In addition to the entire back catalog of Medsider interviews over the past decade, premium members get a copy of every volume of Medsider Mentors at no additional cost. If you’re interested, go to medsider.com/subscribe to learn more.Lastly, here's a link to the full interview with Meesha if you'd rather read the summary instead.

No one person or no one organization is going to fix or change healthcare. So if you think that building a company and you alone are going to change the way healthcare is done, you're going to be very disappointed. So learn to play in a village. Welcome to MedSider Radio, where you can learn from proven med tech and healthcare thought leaders through uncut and unedited interviews. Now, here's your host, Scott Nelson. Hey everyone, it's Scott in this episode of Medsider, I sat down with Dr. Misha Dogen,

CEO and co-founder of Cardio Diagnostics. She's a well-respected leader in the epigenetic space, and after completing her Ph.D.D.D.E.M.E.M.E.E.D.? She co-founded Cardiagnostics and co-invented its patent-pending cardiac technologies, which seek to improve the early detection, diagnosis, and prevention of heart disease through objective risk assessment testing. Here for you the key things that we discussed in this conversation. First, reverse engineering, a solution to an existing

need in health care isn't the only way to build a viable product. Another approach involves transforming compelling scientific breakthroughs into a marketable product designed to fulfill an unmet clinical need. Second, accessibility plays a vital role in determining the fluidity of your product's transition from lab to market. Getting your product into the hands of consumers is just as important as getting it in front of health care providers, organizations, employer groups, and other key stakeholders. Third, the best approach to raising capital might look different from one company to another. But whether your company chooses to go public or raise funds from angel investors and venture capitalists onboarding the right people during the process can make all the

difference in the world. Before we jump into this episode, I wanted to let you know that we recently released the second volume of Medsider mentors, which summarizes the key learnings from the most popular Medsider interviews over the last six months or so. Look, it's tough to listen or read every single Medsider interview that comes out, even the best ones. But there are so many valuable lessons you can glean from the founders and CEOs that join our program. So that's why we decided to create Medsider Mentors. It's the easiest way for you to learn from the world's best medical device and health technology entrepreneurs in one central place. If you're interested in learning more, head over to MedsiderRadio.com forward slash mentors. Premium members get free

access to all past and future volumes. If you're not a premium member yet, you should definitely consider signing up. In addition to every volume of Medsider mentors, you'll get full access to the entire library of interviews dating back to 2010. This includes conversations with experts like Erica Rogers, CEO of Silk Road Medical, Dr. David Albert, founder of a live core, and so many others. In addition, as a premium member, you'll get to join live interviews with these incredible med tech and health tech entrepreneurs. Learn more by visiting medsiderradio.com forward slash mentors. Again, that's medsider radio.com forward slash mentors. All right, Dr. Misha Dogen. Thanks for joining Medsider. Appreciate you coming on.

Thank you for having me. I'm thrilled to be here. All right. And you've got an impressive pedigree. And so for the sake of the conversation, I'll refer to you as Misha. Is that okay? That's perfect. All right. Sounds good. Well, I recorded kind of a brief bio at the outset of this interview. But let's start there. Can you give us an idea of kind of your educational and professional background leading up to starting cardio diagnostics? Yeah, so I grew up in Malaysia, a country north of Singapore, as trying to figure out what I wanted to do as far as education. And I knew U.S. was one of the options I had to come to the U.S. and get my undergrad degree.

Frankly, I put my love of chemistry and wanting to be the first female engineer in my family together and said chemical engineering. But when I got to Iowa, I learned quickly when my mom said, I think you need to go get a job to start paying your bills. I thought to myself, and I'd learn a lot about research. I had an uncle who was doing research when I was a kid learned a lot of it from him. So I said, I'm going to go get a job in research. And so that's where I started in epigenetics. And that was about 15 years ago when epigenetics was barely known. Everyone was still doing a lot of work in genetics before there was a way for us to measure epigenetics,

scale. So got to really understand the science behind epigenetics, truly the value that we're able to derive from it. Went on to get my master's, again, did a lot of work in epigenetics, but at that time, we started to have the ability to measure epigenetics in scale and pivoted a little more to the machine learning and AI world to now make sense of all the data that we had. And then I went on and did my PhD in biomedical engineering. Essentially, my project for my PhD was bridging genetics, epigenetics, specifically DNA methylation and artificial intelligence. And little did I know that it would work so well that we would end up patenting the work and spinning off cardio diagnostics in 2017. Got it. That's an awesome. That's an awesome overview. And so for people that are hearing the word epigenetics

for the first time, right? We had a short conversation before we hit the record. button about how this topic is arguably maybe more well understood within the biohacking, you know, community and amongst longevity enthusiasts. But for those that have never heard of this or loosely familiar with it, can you give us like sort of a high level overview of epigenetics in general before we kind of dig into kind of the core product that you're working on at cardio diagnostics? Yeah. So I think one of the best way to understand epigenetics is to contrast it to genetics, right? Because we've all heard of genetics. We have all at this point 23 and is a household name. We've come across it, but I think there are a few key elements worth highlighting.

The first is we're all born with our genetics. It doesn't change throughout our lifetime, essentially. And genetics, when we're thinking about complex diseases, only accounts for heart disease, for instance, only 20% of our risk for heart disease. So one, we're born with it, two, we can't change it. Three, it's important, but not sufficient. And one way to think about genetics as sort of a DNA hardware, right? Because it's there. It's what you inherit it. Now, when we contrast that to epigenetics, I would contrast it and said epigenetics is a DNA software. So it's a software that's affected by our lifestyle and environment. So what we do in our day-to-day lives, it turns around and affects the cellular function, how our cells react and adopt.

And one of the ways is by turning genes on and off through something called DNA methylation, which is an epigenetic biomarker. So if we're thinking of genetics as DNA hardware that we can't change, I would think of epigenetics as DNA software that is dynamic, meaning when we change our lifestyle and we change our habits, it does influence our DNA methylation, our epigenetics. So it brings about the ability to not just understand what we're doing that's good or bad, but also what's influencing our risk for disease. But at the same time, what we can change, and I think that is very important, and it truly contributes to the larger aspect of risk for complex diseases like heart disease.

Yeah, that's a great overview. Thanks for that. And this topic of epigenetics, it still feels very, very new, right? And I think that's probably a safe way to describe it. Right now, within the U.S. or maybe even globally, are there certain kind of, you know, of sort of pockets where, you know, this is being researched more heavily, right? You went to the University of Iowa, go Hawks, right? But, you know, is, you know, is Iowa City? Is it one of those pockets? Or are there others kind of throughout throughout the U.S. or even globally that kind of

have a better understanding of this landscape in general? Yeah, I would say it's definitely pockets. Like, especially when I started in epigenetics some 15 years ago, I mean, barely anyone, even at University of Iowa, no one else is doing epigenetics, right? It was really new. Mostly we've seen the field of epigenetics grow and people understand it in cancer, predominantly when we're thinking about like how are we understanding epigenetics relative to disease? And to your point, in the biohacking community, thinking about longevity, how can we reverse some of the aging that's happening from what we're doing our day-to-day lives. So I think the pocket is no longer as isolated as it was some, you know, 10, 15 years ago

and more people are understanding it because we're frankly exhausted being able to leverage and understand genetics, even from a perspective of things like drug development. So now knowing that we're able to leverage epigenetics, we're able to understand it well, measure it at scale, know what's happening when we change our behavior. I think those aspects, are becoming highly valuable when we're thinking about how do we advance health care. Right, right. And for those listening, this topic of epigenetics, like, watch out for it. I mean, I personally think it's going to be a super, super hot space moving forward. I actually first heard about it through my involvement with Juve and kind of the engagement that

we had across sort of the, you know, with health and medical influencers in the longevity space. So people like, you know, Ben Greenfield, Dr. Mark Hyman at the, at the Cleveland, clinic, like a lot of these folks I know have been, have been, I think, talking about it for the better part of, you know, five plus years now. And obviously, Misha, you've been involved a lot longer than that, right? 15, 15 years. So this should be a fun conversation and interested in learning a little bit more about what you're building, as well as kind of what you've learned, you know, since starting the company back in 2017. So let's start with kind of your current product, which is the, is it the epigen-ch-d test? Is that how you?

Epi-plus gen C-HD, yeah. Epi-plus gen C-D test. without getting too deep, give us like an overview of kind of what the product is and kind of, you know, how it's used. And then we'll kind of go back in time a little bit. So Epiplus Gen CHD is focused on primary prevention of heart disease. So it's a clinical test, meaning it needs to be prescribed by a clinician. Now, when we think about heart disease today, one of the areas we sort of lack is the visibility, good visibility when making clinical decisions, meaning we still have blind spots with the tools that we use today and understanding who amongst this. are at risk of having a heart attack, which is essentially what coronary heart disease leads to. It's the major cause of heart attacks.

And so what EpiPlus Gen. CHD does is it more sensitively points out to providers, which of their patients are likely to have a heart attack in the next three years. And the underlying technology of it is what we essentially talked about, epigenetics. We do couple it with genetics as well, and we couple it to artificial intelligence. got it got okay and so this this is a this is can you can help us walk us through sort of like the patient pathway so as an example say i'm with my primary care physician and um you know getting a blood pressure reading is pretty normal right it's been sort of standard standard protocol

let's say i have elevated blood pressure as an example is this something that then the physician would prescribe and and how much more accurate or like what is this what kind of picture does this paint uh to me as a as a you know as a as a patient in terms of you know helping to prevent you know, future heart attack? Yeah. So the good news is with the test is presented in a way where we've made it more accessible. What I mean by that is there's an opportunity to go into your healthcare provider and get the test prescribed and get your blood drawn at the end of the date is a blood test.

The other option is whether you go through telemedicine with your provider or our own provider that we have integrated with, you can do an at-home Lancet kit to collect your blood at home. so 100% remote to get tested, you don't have to leave your home. Now, to your point, who's eligible for this test? It's a primary prevention test. So the American Heart Association says, once you hit 20 years old, you should start thinking about preventing heart disease, right? It is the number one killer for both men and women.

So regardless of risk factors, but especially if you have risk factors, whether it's blood pressure, cholesterol, diabetes, family history, you start getting tested. So this test would be something your provider would be. prescribed. You have to be at least 35 years old, not diagnosed with coronary heart disease. There are eligibility criteria for the test. But once the blood is drawn, it's sent to the lab and it's profile, and the provider gets the results to talk to you about it. Now, one of the things that was pretty eye-opening when we were working on this technology, and frankly, I mean, my co-founder is an MD-B-B-T-B-HD by training. He's an MD-P-HD by training. And he was surprised, and so was I.

What we found was that, and we did the study with Interimount Health Care, peer reviewed, published, on average, if you're looking at current risk calculator for cardiovascular disease, which use traditional risk factors that we just talked about, lipids, blood pressure, so on, for every hundred men who are likely to have a heart attack within three years, on average, we're identifying 44 of them correctly. And for women, 32 out of 100, on average. if we're looking at the Epiplus Gen-CHD test, we're identifying 78 out of 100 women correctly

and 76 out of 100 men correctly, meaning a 2.4-4-times sensitivity increase for women and 1.7 times for men, which to me, first and foremost, the part that we have to address is we're making clinical decisions based on the tools that we're deploying. And if those tools are giving us not so great information, we're relying on not so great information to make clinical decisions.

Got it. Well, that's really impressive. The fact that you're sort of like, at least in summary, sort of two-xing the accuracy of whether, you know, a patient male or female is going to be subject to a potential, you know, heart condition within a relatively short amount of time, right? Three years. I mean, that's a pretty near-term window. So that's really cool.

So in terms of kind of where the company's at, and again, we'll kind of go back in time here over the next, you know, 20 minutes or so. but where the company's at today, you're actively commercializing this, correct? This test? This test is already on the market. So this is already being used by providers today. Okay, okay, very cool. And if I'm, in most of our audience, right, is in the med tech or health tech space and

they're like, you know, obviously more business inclined. But I think for the most part, we're all, you know, we're all sort of interested in health care in general, right? So like I can go, what's the best place to like, you know, get access to this technology if my provider is unaware? Just go to the website, cardio diagnostics. And kind of cardio diagnostics in.com. And there's a link to the telemedicine provider elicity.com. There's also an opportunity to request the test or a requisition form if you want your own provider to order the test.

Okay. Okay. Cool. And so if you're listening and don't make it to the show notes for this interview, which will include, you know, a long form summary of the kind of the key insights from Misha. But it's Cardio Diagnostics, Inc.com. So Cardio Diagnostics. Inc.com. So Cardio Diagnostics. InsticsinC.com is the website. And of course, we'll link to it in the summary for this particular interview on Medsider.com. So I think that helps set the stage for kind of the next segment of this conversation, which is really kind of, you know, rooted in what you've learned, right, since starting the company back in 2017.

So let's start kind of with the earliest versions of the technology, you know, your alpha and beta versions. When you think about those, right, and kind of that iterative, that very iterative process versus is what you're commercializing now. What are some of the key lessons that you've learned, you know, develop, you know, through that development process? Yeah. I think for us, where we started was very important.

And that was with the science, right? A lot of times there's, in my mind, there are somewhat two ways. It's not always the same. But there are two ways to go about it. One, we're looking at a need and we're kind of working backwards to find a solution. The second is, you know, something is so compelling. You're turning it to meet a huge unmet need. So for us, it was that way, right?

Like, when I think about the early days of cardio, it was rooted very heavily on the science and the technology. And then I would say the next iteration of that was to say, this works just too well. Like, is this really what it is, right? And I think that is something that we're all afraid as we're building companies to ask, because what if it's not? And so in our case, I think we did that next step right

in working with Intermount Healthcare to say, let's go validate it externally to make sure that it's showing us what we saw in the proof of concept. And then I would say the next iteration of the company was to say, how do we now take something that works so well on the bench and turn it into something that works in the commercial real world? So translating that into building commercial partnerships, building those steps, being able to go out and talk about it, educating physicians. Those, I would say, are some iterative steps that we took, getting from the science all the way to what providers use today. Got it, got it. Your first answer around kind of framing up the approach that most of us have

kind of in the, you know, that are working on a life science startup is most of us are inclined to like, you know, look for the big need, right, or the big challenge that we're trying to solve for and then reverse engineer a solution to your point. But I really like that it doesn't always have to be that way, right? I mean, you obviously saw something super compelling from a scientific standpoint, a really a true breakthrough. And we're like, this is to, like, we'll figure out, like, how to, like, the pains, right, that this is going to solve. But this is, like, too compelling of a technology not to work on. And it reminds me of, like, you know, the way Elon, like, Elon Musk approaches, like, his approach, like, SpaceX and Tesla is, like, there wasn't necessarily, like,

look at, look at SpaceX as an example, right? Like, he was going to go down that path. But as, as, like, a byproduct, there's a business model around Starlink, right, as an example, right? It's like, I'm going to do this. This needs to be done. It's too compelling not to work on. And we'll figure out like the business model, like a little bit later. And it kind of reminds me of that. It doesn't, we don't always have to focus on, you know, on this existing, you know, pain. Not that, not that you shouldn't, but if you're, if you're on the kind of the verge of a compelling, you know, scientific kind of breakthrough technology, right? I mean, yeah, I mean, I mean, I always It would have been a crime for us not to take something after the data being so compelling

over and over again, to not translate it to, frankly, two things that come together that's very synergistic. One, being able to improve patient lives and improve quality of life for all of us in general. And two, as a company, increased shareholder value. I think those things can happen simultaneously. but for us, it's part of our core principle that we never wanted to put something out that didn't first and foremost, we could stand behind from a scientific clinical technology perspective. Got it, got it. And the second part of your answer as it relates to kind of, you know, sort of validating this technology on the bench, right? And it seems like an extremely smart

plate, right, partner with a well-known organization Intermountain Healthcare to sort of validate it in the real world. But when you think about it, kind of that those translation those translational efforts right taking something that appears to be working extremely well but it's not maybe not maybe far enough along right to commercialize yet like working through that process you know where there's some key kind of big big wins along the way or maybe some some you know some things that you tripped over and you know learned a lot from to walk us through that process of kind of that that work kind of getting it ready for for eventual commercialization I would say one of the key challenges we ran into very early on is trying to find the right kind of partner who has exactly what you need.

And that's not always easy to come by, right? Like, especially if you think in our case, we were looking at three-year risks for coronary heart disease. So we needed people with a biobank of samples that we can use to go out and profile the molecular markers, but also followed these people for at least three years. And that's something really specific. Right? Got it. And so the initial challenge we ran into was we had to call up people in our network and be like,

hey, do you know anyone who has kind of around this realm of things that we need? And I think not taking any shortcuts in finding that partner, again, a reliable partner, a well-known partner, someone who is truly in it, again, for their patience, for the science, I think that was very critical. The second thing is always everything in healthcare is so expensive. Building a life science company, MetTech, healthcare, anything in our area that we do, it's always very expensive. So thinking through what are some ways we can either allocate funds.

Is there a way for us to get more interns involved when it comes to areas, of course not the core area where you're like developing the product? But just being creative in the process in the use of funds. Because I think a lot of people would resonate with the whole circular problem we face in building deep tech, life science, healthcare companies in that you need to show results to get money, but you need money to show results, right? So for us, I would say those were some key challenges, is making sure that the resources we had were allocated appropriately.

And the second thing is finding the right kind of partners. And we actually launched EpiPlus Gen PhD tests with less than half a million dollars. Wow, that's impressive. So you were definitely able to kind of be creative and efficient, right? With that with that sort of budget. Yeah, that's impressive. Regardless of kind of the vertical that you're working in, right? Especially kind of life science. But you raise a good point. I mean, it's one of the, it's one of the reasons I always sort of have a different level of respect for people who are building companies in, you know, whether it's device or biotech or whatever. It's like you're not only dealing with significant regulatory, you know, challenge. And typically like very high development or technical, you know, hurdles to cross. But it's always, I mean, it's so expensive, right? So you've always got to do more with less always, you know, versus maybe something else in, you know, traditional software tech or something like that. So then that, I don't mean that to demean, you know, other other kind of, you know,

categories or whatnot. But like building in med tech, biotech, except life sciences in general is just, it's hard. It's hard. It is. I mean, all the pieces have to come together to your point. you know, all the studies that you have to do, all the regulatory aspects, the right types of commercial partners and the cash. I mean, all of that has to come together to be able to, you know, get remotely close to bringing a product to market. Got it, got it. And your point about

finding the right partners, I mean, that's something I can't, like, just even in my own personal experience. That's so crucial. And I just think if you're working on a startup, in an early stage, you know, expect to go wide, right? Almost, it's almost like kind of like dialing for dollars to a certain extent where it's like you're going wide in your networks, you know, just to eventually hopefully narrow in on a few key partners that maybe have are a good fit. But like, you know, if you have the expectation that you're going to find that partner with, you know, within, you know, after one or two conversations, that's usually not going to, usually not realistic, you know, especially now, you know, with kind of the larger kind of

sort of macroeconomic conditions in general. It's just harder. You know, supply chain challenges, etc., etc., you know. I would say options are never a bad thing, right? Like, you might get a better data set than you thought. You might get a better price point than you thought. You might get a more well-known name than you thought. It's always nice to shop around and have those options, but also at some point there's diminishing returns. So it's a fine balance. Got it, got it. I want to circle back around to a comment you made earlier about education, right? Educating the broader community about what epigenetics is, the importance of it, why they should maybe use a test like the epi plus gen, CHD diagnostic. But just to make sure, just to kind of close the

loop on kind of this kind of early stage development work, what does the regulatory path work for a test like this? Is it a, is it a class two device then? Is that what you're looking at? Actually, it's a laboratory developed test. So an LDD, so it doesn't require at the stage FDA a premarket authorization. It's more so in the realm of CLEA regulations. So being able to go through and do the analytical validity testing, in our case doing the clinical validation. So it requires rigorous studies, but it's under the purview of CLEA more than it is the FDA. Got it, got it. Okay. And so with a diagnostic test like this, is it almost, like, is clinical data almost always required then as part of that pathway or that process?

How do I put this? Not everyone goes through the process of getting rigorous clinical data, but is that something everyone should be doing? Absolutely. Right. For us, that was non-negotiable. I mean, people point to us all the times of, you know, some other tasks that may not be as rigorously validated.

People ask us all the time, hey, is yours rigorously validated, right? Because there isn't really a, ABCD. It's not like a pharmaceutical where it's phase one, phase two, phase three, or anything like that. So that's not always the case, but it should be. Got it, got it. So that's almost like it sounds like it was an intentional choice, right, by your team to run those, those powered clinical studies to help validate the technology. Yes.

And for us, you know, being an LDT is a start, going through the FDA pathway is something that we may choose to do. do over time, just again, to go through and have sort of the FDA seal, if you will, and other things that come with going through the FDA pathway. But one of the key things being able to launch as an LDT is to get market feedback, to go out in the market, start educating people, tweaking the way we present the data, the results, the report, and then sort of, you know, keeping it in an optimal position before we, let's say, decide to go through the FDA process. So starting off there, but I can't say that that would be kind of the final destination. Got it.

Got it. Okay. That makes sense. That makes sense. Let's talk a little bit more about kind of this educational process, right? Because we already touched on this idea that epigenetics is this new kind of like sexy space for lack of a better description. But there's still like kind of a general lack of awareness. And even for those that have heard of it, they don't really understand how it works.

And it kind of complex, right? Or it can be kind of complex when you start to kind of peel back the layers of the onion. So walk us through kind of your approach at cardiac diagnostics, considering this is a test that is prescribed, you know, by primary care physicians. But at the same time, you know, a consumer like myself could go straight to your website and, you know, connect through through telemedicine. So walk us through kind of that approach. And are there a few maybe key things, like one or two key things that have worked, have worked well for you kind of in these early days of commercialization. Hey there, it's Scott. And thanks for listening in so far. The rest of this conversation is only available via our private. private podcast for MedSider Premium members. If you're not a premium member yet, you should definitely consider signing up. You'll get full access to the entire library

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