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Revolutionizing Cardiac Care: Cleerly's AI-Driven Innovations in Heart Disease Management

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Speaker 1:

Hi everyone, welcome to the show. Today we're talking with Clearly about how they're transforming the way we see and treat heart disease Very important topic, jim. Welcome to the show.

Speaker 2:

Irma, thanks for having us.

Speaker 3:

Well, thanks for being here, Dr. Min.

Speaker 2:

Really intrigued by the mission you and the team are on. Maybe start with some introductions to yourself, a little bit about your biography and background, what led you to Clearly, and what are the big problems you're trying to solve in cardiac care? Thanks for the question and it's been a long time coming. I'm a cardiologist by training. I trained in the Midwest at the University of Chicago and then I moved to New York City in 2005 and took a job working at New York Presbyterian Hospital and Cornell Medical College and that's like we were sort of the quintessential physician scientists.

Speaker 2:

We did clinical trials, we saw patients and really tried to better understand heart disease utilizing a new tool that had just been introduced in 2005 called the coronary CT angiogram. You know it's a non-invasive test. It's very safe, very fast. It takes all in in a good center, probably in and out 15 minutes or so, but the data that it allows you to see non-invasively was just stuff that we had never seen before in medicine and at scale. We could do it invasively, but obviously people can't get invasive procedures.

Speaker 2:

So we leveraged this tool to do a bunch of clinical trials to really try to understand heart disease better and found some very surprising facts, like we thought that all heart disease was bad for you, like all the plaques that were building up and it turns out that's not true. There were some that were the strongest predictors of somebody who was going to have a heart attack. And then there were others who they were actually protective and stable, and so we tried to understand then how do you turn those bad plaques into good plaques? And you know, we did a study with serial imaging where we treated some folks with medicines and others without, and we found and others since then have found that like all the good things that we do for people don't make plaque go away per se, but they transform it into from a very high risk into a lower risk phenotype. And so we tried that in our clinical program.

Speaker 2:

We started a program called Heart Health. It was really made for both prevention patients as well as symptomatic patients with chest pain and shortness of breath and suspected heart disease. And then we went seven years with five cardiologists and never saw a single heart attack, using this approach to leverage sort of personalized diagnostics with imaging to really guide who should get treated, how intensively they should be treated, how they should be tracked and so on and so on that clinical success, we asked ourselves well, how are we going to scale this so that everybody can get access to this? Well, how are we going to scale this so that everybody can get access to this? And that's when we started, clearly Not really so much to be an AI company or an imaging company, but really to standardize the approach to evaluation, education, treatment and tracking of heart disease. So that's where we are today.

Speaker 1:

Wow, you basically just covered my next question. So let's see if there is anything else that differentiates Clearly's approach that you haven't mentioned yet. I mean, what you said just blows my mind, but anything else that really makes you stand out in this space.

Speaker 2:

Thank you so much for that question, irma. And then I think that, like a lot of people think of us as a prevention company, which we definitely are. Like you know, if you look at the statistics, more than half of the people who will suffer a heart attack or die from one will have no symptoms before their event. And so these are the people that we know who went for a run and never came back, or who went to sleep and never woke up, and you know that's actually the majority of people are diagnosed with heart disease by either suffering or dying from a heart attack. And we found that this plaque that's building up within the walls of the artery over many years would give us so much useful insight into the risk of that patient suffering a heart attack and then give us a very early opportunity to treat that patient with lifestyle modifications and medical therapy, without any invasive procedures and so on.

Speaker 2:

I think what others, because that message, I think, resonates so strongly and loudly with people because everybody's been affected by somebody who has had heart attacks and died from them that they often forget that we also focus on the other half of the patients who, present with symptoms of chest pain or shortness of breath demonstrated the highest diagnostic and prognostic performance to demonstrate that we can very accurately identify people who are symptomatic and determine whether or not those symptoms are arising from the disease in their heart, and that really guides decisions not only of medical therapy, but also interventional therapy, whether you need a stent procedure or a surgery or things like that and so our focus is really on prevention in everyone right, whether you have symptoms or no symptoms. This is a prime opportunity for us to really personalize your evaluation of your heart using the AI-enabled tools and to really give you the most accurate assessment out there.

Speaker 3:

Wow, amazing. I'm the resident tech geek here and I'd love to dive into a little bit on the tech side. What role does AI and some of the advanced imaging technology play in, you know, giving you a clearer view of the patient's heart health? What's on the bleeding edge these days?

Speaker 2:

Yeah, I think that's a great question. Like you know, when we started the company, it was 2017. And so, you know, deep learning was sort of the phenotypic word that you heard everybody talking about. Now it's large language models and so on.

Speaker 2:

I mean, the AI continues to improve and improve and improve, and if you look at our software platform, it's pretty much end-to-end AI. So there's AI-enabled algorithms that sit through all the images looking for image quality. There's AI algorithms that will properly segment the arteries and accurately measure things. There are AI algorithms that predict whether or not somebody has ischemia, which is the reduced blood flow in the heart that may cause symptoms, and so on. I think the future is going to be around risk prediction and really predicting somebody's heart attack risk at the personalized level. But what we always tell ourselves internally is that the AI solutions are so powerful, the technologies but the most important thing that we can do is ask the right clinical question that can really positively impact mankind. And so you know, we think that we have asked some very poignant questions that affect the lives of millions and millions of people across the country, and we have developed those tools using the suite of AI technologies so that we can deliver them accurately and at scale.

Speaker 1:

Wow, really, really great information, dr Min. So I want to go back and talk about this segment of population with no symptoms that you are working to address those treatment plans or focus on prevention, when people are not even going to the doctor. So how are you capturing that part of the population that has no symptoms, that doesn't suspect they have any kind of heart problem?

Speaker 2:

No, it's a great question. Like we presented a study earlier this year at the American College of Cardiology conference, we looked at almost 5 million patients who had suffered heart attacks across the country, across the US, and you know we asked the question how many of those people had symptoms. It turns out 51 percent of the patients had no symptoms before their catastrophic events. Then what we saw was that 20 to 25 percent of them didn't have any risk factors. They didn't have high cholesterol or diabetes or high blood pressure. And then what we found as a result of that, they don't have any symptoms, they don't have any issues. So they almost half of them had never seen a doctor in the year prior to their event and because of that, nearly three out of four of them weren't treated with a single preventive medical therapy that could have prevented these events from happening. So what to your question, which I think is the million dollar question how do you find these people? Because, as a cardiologist, if I just wait in the office, they won't come to me, they die at home. And so we said, well, if you don't have symptoms and you don't have risk factors and you don't see doctors as a result, I think the only way you can solve this problem is to go upstream into the home and screen the whole world for heart disease using imaging similar to the way we use mammograms and pap smears and lung CTs and colonoscopies. And colonoscopies like these are all like some form of advanced, non-invasive imaging that allows for personalized diagnostics right Using the image. I think we understand the vascular biology now well enough. We've got an exceptionally safe tool and I think it's time to have the conversation of whether or not we should be screening the world for heart disease. So in that vein, we obviously need clinical evidence, and from somebody who prides himself on being a physician, scientist and practicing evidence-based medicine. We have enrolled about 1,500 patients into a 7,500 patient randomized control trial. To directly answer that question In at-risk asymptomatic patients, does a clearly guided, image-based AI-enabled analysis offer improvement in patient health outcomes over the conventional standard of care, which is checking cholesterol and blood pressure and so on? So we'll have those answers, hopefully sooner than later, but we've definitely subscribed to that point of you know that we're never going to find these people unless we go into the home and then, on the flip side of that coin, for the symptomatic person that we put on medical therapy.

Speaker 2:

We talk about relative risk reduction in clinical trials. What does that mean? That means if I treat 100 people with a statin medication, I'll see a 20% relative risk reduction. So I've helped 20 people. But there's 80 people who are on that drug, in whom I've lowered the cholesterol, who don't benefit from that drug. We call that residual risk. And that residual risk is the problem, right, when four out of five people are still experiencing events, we have not succeeded. That's called failure and so we need to do better. And if you can track disease over time actual disease, not risk factors of disease then I think it gives you a very, very strong opportunity to identify who's not responding to the therapy and who needs different or more intensive therapy. So, both in the symptomatic and the asymptomatic patient, I think that our company offers best-in-class solutions that really address the patient as a person, as an individual rather than as a population.

Speaker 3:

Wow, wonderful sentiment. I mean you must have so many anecdotes and stories and data on real-world impacts that you're clearly is having you know patient diagnostics and prevention strategies. Care to share any stories.

Speaker 2:

I mean the one most recent one was from last week and a half ago. I got a text from a friend of mine. He said I'm sitting next to somebody who just got the CLEARLY analysis, and what he who just got the CLEARLY analysis and what he turns out it was Lance Armstrong. So he talked about it on a podcast, which is why I can say it openly, but the story that he relayed was that, you know, they said that his cholesterol was high and that he would need to go on a lifelong medication and he said I don't want to if I don't have disease. And so somehow he got the CLEARLY analysis and found that he really was healthy and so that if you were going to put somebody like that on a medication, that would be a medication for life, treating absolutely nothing other than a number you know, a lab test number. So what we'd really like to do is start to treat people as people rather than people as numbers, and I think the imaging of somebody's heart really allows you that very. You know upfront and direct knowledge about who should be treated, how they should be treated, how intensively they should be treated and how they should be tracked they should be treated and how they should be tracked.

Speaker 2:

We've got other stories. We have these screening programs. They're not screening programs, they're more occupational programs to perform early diagnosis and risk stratification in at-risk populations. One of those is the firefighters, right. So this is a program that we call a hero's heart. These guys are true heroes For a number of reasons. They have a much earlier onset of heart attacks than the general population, and so you can take these folks who look like Hercules on the outside, but on the inside they're very affected by heart disease, and so that kind of thing just even identifying one patient, you know you impacted their life in such a positive way, and so that's the mission of our company is really to remain purpose-driven and mission-based.

Speaker 1:

Wow, really groundbreaking approach here. So obviously with Clearlease hoping to be kind of multimodal, both used for screening of general population, then focusing on patients who already have signs of heart disease and kind of figuring out who actually of them needs to worry about those risk factors et cetera, and then also following people over time to see how disease progresses. With so many different applications of your technology, how are you navigating this very complex world of regulatory and compliance landscape in healthcare?

Speaker 2:

Yeah, it's a great question. I mean, the first thing is that this year was a couple of big milestones for the company. So you know, we introduced a commercial product called Clearly Ischemia that's specifically designed to determine whether or not somebody's symptoms may be the etiology of heart disease or not, and that comes with a CPT code that is now covered by 99 percent of commercial and Medicare payers. So that's great, so people can get that through their normal insurance. And then, as of December 8th, for the advanced plaque analysis, which is the second code, we now have national Medicare coverage and reimbursement, and so that's been great too, because it's a newer code.

Speaker 2:

We still have to work on the commercial payers in the next couple of years to demonstrate to them the robust clinical evidence that demonstrates that our products can improve patient health outcomes and reduce overall health care costs. But that is at least where in the realm of having Medicare coverage and reimbursement. So it's been great. So now people can really get these from their doctors right, it doesn't have to go to some, you know, to pay out of pocket or anything like that. I think that's been. That's a really big thing for us. We've also done a number of clinical trials to look at more legacy type technologies that have been around for 10 years and have demonstrated that the AI really is vastly superior to the. It's better diagnostic performance than some of these other legacy technologies.

Speaker 2:

So I think we're entering into this realm where we can really utilize one platform that is truly all-in-one and comprehensive, completely non-invasive, end-to-end AI driven, and really start to practice precision medicine or personalized medicine in a way that we were not able to do before. Incredible.

Speaker 3:

And I'm curious what kind of feedback are you getting from your fellow physicians and how is that shaping your product investment roadmap?

Speaker 2:

Yeah, so we do a lot of sort of market research. The market research sounds so formal. We talk to a lot of our colleagues and just get their feedback on what more they would need, what would they like, on what more they would need, what would they like. And the uniform thing is that that comes about is that they said it has to be understandable and actionable, like if it's not understandable because it's all this advanced imaging that only imagers know, then it's the data's lost on us. And then it also has to be actionable, like in five to 10 seconds I need to be able to look at this patient's analysis and know exactly what to do and how to approach the treatment of that patient and so on. And we're a support tool, right? We're not a diagnostic. We're here to support the doctors and add more data to their armamentarium, to their toolbox, so that they can better take care of their patients.

Speaker 2:

What we've done is we've done a lot of translation. So this came back from my New York Presbyterian Cornell days where you know we do all this imaging. We tell people about all these advanced imaging findings. People are like falling asleep and they're like Jim, like we're not imagers, just cut to the chase and get the brass tacks, and so what we've done is created a lot of clinical tools to help translate a lot of this information so that it's easily ingestible very rapid ingestions and comprehension, and then, most important, that it's actionable, that people know exactly how to use it.

Speaker 1:

Great, great mindset there. So, speaking of data, and you mentioned five to 10 seconds to interpret the results and have actionable insights, which seems incredible how do you ensure that this data is integrated into the clinician's existing workflow and into the EHR systems? I mean you can say 10 seconds is nothing, but for a clinician who's so busy, you know even 10 seconds added to their workflow, you know if it requires them extra steps, et cetera around it might cause an issue. So how is it integrated? Workflow, ehr.

Speaker 2:

Yeah, it's a great question. Like so we, I think you've touched upon something that I, as a doctor, didn't really think about so much. But you know, once I came out, really think about so much. But you know, once I came out, like to to delight the client, right, what does that mean? To create a user experience that is so seamless and so easy to uh, to use? I mean, if you think about the products that you love to use, most of the time I think what you'll realize is that you don't even realize you're using the product right, like the, for example, like Google search. Right, you don't think, oh, I'm going to go onto Google's website and use their search. That's just part of your life. It's part of the fabric of a product experience that is so delightful to the client.

Speaker 2:

And you know we haven't gotten there, we haven't perfected it yet, and part of the reason we haven't perfected it yet is because every you talk to a hundred doctors, you're going to get 200 opinions, and so there's going to be there's a lot of variation and what is helpful, what is efficient and so on. But we've we've made a lot of good strides there. So you know, our technology automatically generates reports for doctors to try to save them time. We have the ability to do EMR integrations. We have the ability to send it down to what's called PACS, the picture archival system, where the images are stored. So we've tried to come up with some efficiency tools to really try to make the user experience a seamless one, rather than you know to your point, 10 seconds is a lot Like.

Speaker 2:

I mean, I had a software that I used at my old hospital where I would have to type in a username and log in three different ones in order to get into the software. It was like a deterrent, like I didn't ever want to use that software because I had to spend 25 seconds like typing usernames and passwords. So that 25 seconds, you know, times the 35,000 cardiologists, times 2000 hours, like that adds up pretty fast. And so we're just trying to really listen to people, hear them what they need, what they want, and then really try to adapt the platform I think we've got. We've got certainly we've got the fastest turnaround times in the in the market, which is great. We've got the lowest rejection rates. We we can fulfill almost every study that comes comes our way and I think, from an accuracy and prognosis we've demonstrated clinical trials that, like we, are higher than the legacy technology. So you know, step-by-step we're we're just trying to continue to improve the platform.

Speaker 3:

Wonderful, amazing sentiment and you clearly make an impact today, I guess. Final closing statement, I mean why should health organizations you know big picture, who are considering new tools, add clearly to the top of their list, and not just for today, but you know you're thinking five plus years out, right? So what's your message to them?

Speaker 2:

Yeah, I mean. I think that, like we need to solve, we need to improve upon the care of symptomatic patients, our legacy tools that have been around over the last 10, 20 years. They don't work very well and we can improve the accuracy, we can improve risk stratification, we can make it easier for the patient to understand what's going on in their heart. So really focusing on that symptomatic population using our technology is called clearly ischemia, which again is covered and reimbursed by insurance, so there shouldn't be so much of a hurdle to do that. I think the long term is to really focus on that 50% of people that we've historically ignored, those people who die in the home, and for that we're committed to the evidence generation. We'll finish our clinical trial it will be a landmark trial one way or another and we believe that image-based guidance using CLEARLY will be vastly superior to the standard of care. But only the evidence and the data will actually show that to us. So more to come on that.

Speaker 3:

Awesome, well said, thank you.

Speaker 1:

Well, that's really great. Dr Min Jim, as we wrap up here, I wanted to ask you know what are your immediate plans for 2025? Are you clearly attending, participating in conferences, events like CES, for example? With ever-growing digital health and health-focused presence, where can people find you? How can they learn more? Can they ask for these technologies at their doctor's office? Just tell us how we can implement this in our own patient lives.

Speaker 2:

Yeah, absolutely so. We'll have like a conference present, mostly scientific and clinical conferences. I think our next one will be the American College of Cardiology scientific sessions and at the end of March but we'll be probably at 10 to 20 scientific conferences next year. That's where we typically go. I think if you're a patient who's interested, just you can go to clearlyhealthcom clearly spelled with two E's clearlyhealthcom, and there's info at clearlyhealthcom that they can just simply ask hey, how do I get this? And we can help white glove that patient through the experience so that they can get the kind of testing that they need.

Speaker 3:

Wonderful.

Speaker 1:

Well, thank you so much for joining us. It's been a pleasure to meet. You, learn about Clearly and you know. Thank you to everyone our audience for listening and watching and sharing. And happy holidays to everyone and thanks again for joining us, dr Mink.

Speaker 2:

Thanks so much for having us guys. Happy holidays.

Speaker 1:

Bye-bye, happy holidays.