Exploring the Future of Cardiovascular Medicine with Dr. Udo Hoffmann, CSO at Cleerly Health

[00:00:02] Hey everybody, welcome back to the Outcomes Rocket. So excited to be reporting to you live from ACC24 in Atlanta, Georgia Today I have the privilege of having the outstanding Udo, Dr. Udo Hoffman with us. He is the chief scientific officer at Clearly Health

[00:00:18] Dr. Hoffman, thanks for joining me today. It's a pleasure It's a pleasure to have you here and look we're gonna cover a lot of the work that you guys are doing in AI And really across a lot of different areas, but in particular

[00:00:30] I wanted to learn more about you and also about Clearly. Yeah, by training I'm a radiologist and I spent 20 years at Mass General and Harvard Medical School and built there the cardiovascular imaging program clinically and research

[00:00:46] And during that time I did a lot of clinical trials and really I was fascinated by CT technology or imaging technology in general and And my goal was always to bring the best to the patients.

[00:00:58] And that is also what I think led me to Clearly. So I joined about a year and a half ago as the chief scientific officer, as you said

[00:01:05] And one of the reasons is because we are, we're one, I would say what's unique about us is that as a medtech company We are investing very heavily in clinical trials and evidence generation

[00:01:19] That you typically see only at a level in the pharmaceutical industry, but not in medtech We're gonna talk about some of these. That was very fascinating to me And of course Clearly as a whole, as a company

[00:01:32] we think we can contribute of cutting down the number one cause of death in the United States, which is death from cardiovascular disease and heart attacks and stroke, etc. Clearly has developed a very good technology to capture coronary artery disease.

[00:01:50] And we do this with the help of AI and we have published many studies that show that we're pretty accurate compared to gold standard. We're ready to roll. We're still a young company

[00:02:00] But we are growing and we're seeing at this meeting a very great reception as well. So yeah, I'm happy to be at this year's meeting Yeah, for sure. And it's so great to hear your passion and feel your passion about this area.

[00:02:16] Coronary artery disease is a big thing. As you said, number one killer of people in the US and probably top five in the world. One of the things that I really like to learn, right?

[00:02:27] We're here to share the things and advancements that we've made and we're gonna touch on those But tell us one insight that you've come upon here at the conference. It's a good question

[00:02:37] I've been coming to the ACC for the last 25 years. I go to other conferences, AHA, RSNA But I think this year I would say I feel there's an energy about the meeting that I feel is better than or is one of the best meetings and

[00:02:54] what I've really realized this year is that there are so many innovations out there like there's so many innovations that are presented here whether it's devices, whether it's drug, whether it's other interventions and So we don't lack innovations

[00:03:09] But I can see our main issue is to implement these innovations into and get them to patients You know, they all sound great as an idea and as a concept they work in a certain environment

[00:03:21] But how do we bring this to the patients and how do we know whether it works with a patient? There's the growing insight I feel that we have to really differentiate between efficiency, efficacy trials and then implementation science

[00:03:35] Often that gets put together in pragmatic trials and at the end you don't really know Why you saw the result that you saw and it's not very satisfying So I think if I can promote something in the way we look at devices and how efficient they are

[00:03:48] I would say let's start with proof of principle and then do implementation science separately and later I don't know if that resonates with you, but it does it definitely does and it's good to have a balance between

[00:04:01] Advancing the science, the technology, but is it reaching patients and ultimately that's the measurement of success Yeah Yeah I love that and look top of mind at this conference and really Across the world is this topic of AI and Gen AI in healthcare

[00:04:18] Talk to us about what Clearly is doing and in particular I'd love for you to highlight a little bit more on the transform trial and the recent FDA approvals that you guys have gotten That's obviously a great softball from me

[00:04:30] I'm gonna take that. When I in the early years of CT or even when I was at Mass General It took us about five to six hours To analyze a cardiac CT for quantitative data. Now you can imagine that is not practical

[00:04:45] That's not you can do that in a research setting also, but not in a clinical practice setting So Clearly has cut this time down to one and a half minutes Amazing to AI and of course, they are still quality management, etc

[00:04:58] So it's a little bit more than one and a half minutes But that's just something if you're doing 80 CTs a day You can't hire 15 fellows or faculty to look come up with these numbers

[00:05:10] But you can use an AI based software to give you these results right away. So I think there's a there's an immediate very palpable benefit for that it's just fascinating and We thought about okay, so what can we do? Maybe I dare

[00:05:27] CT although it's there and it's accepted It's still a not very much used technology Like the stress testing is 80% of the testing is done. So we thought about what can we do? What's the trial that we can do to really convince patients providers? That doing a CT

[00:05:49] Analyzing coronary disease is the right thing to do, you know, and I'm saying this Let the results speak for themselves. So what is the trial? And so we came up with a transform trial, which I think so exciting because we are looking here at high-risk asymptomatic patients

[00:06:04] And there's a randomized trial and randomized patients to be managed based on risk factor based care hypertension LDL levels Diabetes versus clearly based care with which is a coronary artery disease Based care and for that one

[00:06:21] We put an algorithm together that you can see here that uses all the information That you can extract from coronary arteriosclerosis and puts it in a simple staging system And where we got this from we got this from cancer that cancer you have stages and based

[00:06:38] Yeah, and based on the stages there is different treatments That's the principle of the transform trial We stage coronary disease and then we treat based on stage the higher the stage the more aggressive the therapy and the more aggressive the therapy goals and

[00:06:53] We randomized we plan to randomize seven thousand five hundred patients at hundred US sites And we'll follow them for a median of three and a half years And then we our end point is events health cardiovascular events. Am I

[00:07:08] Cardiovascular death stroke, etc major heart events we call it heart events And of course the hypothesis is that if you treat based on coronary disease Your baseline assessment of cardiovascular risk is much more precise than as compared to risk factors

[00:07:23] And so that will result really in saving lives and reducing the number of heart attacks Significant. Yeah, that is a couple clarifying questions on that So that with this trial is the primary mechanism of detection CT. Yeah

[00:07:39] Okay, got it. Got it. And and and and the stages that you mentioned is that something that is new you guys came up with? Yeah, tell me more about that. Yeah, that's something that's new It's a device under investigation. So it's of course not FDA approved yet

[00:07:54] But the trial will actually serve at the end of the trial We aim to get FDA approval for that device so at the trial It's almost like we're running this more like a pharmaceutical trial. Sure

[00:08:05] As I said, that's one of the main reasons I joined feel is that excitement to really do the right thing Even though it's a big investment I love it and once the results come through if

[00:08:16] They are what we think it's gonna be there's possibly an opportunity for people out there to take more proactive care Of themselves. Yeah, something like I had mentioned mammography or colonoscopy that type of idea, right? Yeah, absolutely

[00:08:32] We know that when patients can see the coronary disease it motivates them to change their lifestyles to adhere to medications And we know that is lacking if you don't have it

[00:08:42] So just to give you an example based on how you treat LDL with statin water a little bit lowering therapy A year after initiation of treatment only 50% of patients actually still taking the drug and after five years It's only 10% right so patients need to be motivated

[00:08:59] It turns out that if a patient knows they have heart disease and they can look at it This is my heart and this is I can show you this is the coronary disease It motivates them. Of course, we have to strike the balance

[00:09:09] Patient also get anxious about these things. That's normal. That's part of the motivation actually to adhere to medical therapy I want to just say one thing which I forgot going back to the you mentioned FDA We feel very privileged that we got accepted in this device CID staging

[00:09:26] Was accepted as a breakthrough. I got a breakthrough device designation. This is reserved for products or devices That A have no predicate. So there's nothing comparable at the market and B They are expected to really make a big difference in people's lives

[00:09:44] So through that we got accepted into the the TAP program, which is the total product pilot program Yeah a pilot program and there we are the FDA together with us is Thinking about the right way to bring this product to the market

[00:10:00] We're very thrilled to work with the FDA on that and for a company that is of course a big deal for us Yeah, amazing and folks. That's the thrill of where we're at in medicine today with doctors like dr

[00:10:11] Hoffman a company is like clearly health you're looking at the digitization of health and it's just incredible when you go from five hours to a couple seconds of reading a CT and then having this opportunity to have

[00:10:25] Proactive care for these types of diseases that didn't exist anymore is really exciting Thank you for helping us understand the context all that I know that our listeners and viewers likely are gonna have more questions and they're gonna want to know more

[00:10:38] So, where can they find out more about this and what call to action would you leave everybody listening and viewing us? Thank you again And please if you're interested so you want to be part of the transform trial you want to know more about clearly

[00:10:51] There's a couple of ways you can reach us one is we have a website transform trial org And then of course clearly health you can find on the web very easily

[00:11:01] And please let us know whether you have questions or if you're interested in joining one of our endeavors. Thank you. Dr Hoffman and for everybody watching and listening us today in the show notes You're gonna find links to all of the references that dr

[00:11:15] Hoffman referenced in addition to that the team at clearly are doing a webinar series Where you could educate yourself on the progress of this trial on the progress of AI within cardiac medicine and beyond

[00:11:26] So make sure you check that out all in the show notes. Thank you everybody for tuning in and dr. Hoffman Thanks for being with us today. Thank you pleasure