Martin Herman, Powerful Medical - AI-Powered ECG Interpretation | LSI Europe '24

Martin Herman 00:02
Martin, so good morning. My name is Martin Herman, and I'm the co-founder and CEO of Powerful Medical. I came here today to talk about PM Cardio, our AI-powered cardiovascular diagnostics platform. So PM Cardio is AI that reads ECGs, and it has been trained on several million historical outcomes. In Europe, we're already certified as a Class IIb medical device to diagnose 39 different indications from a standard 12-lead ECG, and we're also certified to recommend treatment in accordance with the latest clinical practice guidelines. Now, while the technology is quite complex on its own, we managed to package it into a very easy-to-use product in the form of a mobile application for iOS and Android. So all you have to do is just take a picture of any ECG recording from any ECG device. We're able to digitize it within seconds, and you're now able to diagnose up to 39 different conditions with the performance of a cardiologist who has been doing it for the last 30 years. And on top of that, you're also able to decide what to do next with the patient.

Now, since launching this last year, we now already have over 45,000 healthcare professionals onboarded onto the platform, and in the last 18 months, they've already screened about half a million patients. Now we have users and healthcare professionals using it across the whole health system, really, in every corner. We have GPs and nurses using it in primary care. We have paramedics using it in emergency care, as well as cardiologists and other physicians within hospitals, PCI sites, and cardio centers. And for this reason, at the beginning of this year, we decided to connect all of these stakeholders within the health system into one comprehensive ECG diagnostics platform to really streamline patient care, and we call that PM Cardio for Organizations. So on top of the diagnostic functionality, PM Cardio for Organizations also comes with a lot of care coordination features, such as notifications. It also comes with a web app that integrates seamlessly with any EHR and is embeddable deeply within clinical workflows. And it is also meeting all industry standard requirements for compliance, such as ISO 27001, SOC 2, HIPAA, and GDPR.

Now, at the moment, the number one use case for PM Cardio is heart attack diagnostics, and the reason is quite simple. While heart attacks are the number one cause of death worldwide, still up to 50% of them get initially misdiagnosed, leading to delays in treatment. And as my cardiologist friends like to say, time is muscle. The sooner you're able to treat a heart attack patient, the better his outcome will be. And unfortunately, due to this misdiagnosis and initial delays in diagnosis, one in three American women and one in four American men don't make it past the first five years of getting a heart attack. Really, this is down to the delays in diagnosis, and therefore the treatment, and PM Cardio has a solution to this. We call it the PM Cardio AI-powered chest pain pathway, and we've trained an AI on angiographic outcomes to detect heart attacks with double the sensitivity of the current standard of care. And our AIs are also able to see them about three hours sooner than a human would on the ECG.

Now these are some impressive results, but we published our validation in the European Heart Journal last November, and to date, this has been the most read study for nine consecutive months. Let me show you how it works in practice, and let me show you how our product for individual healthcare professionals really allows us to onboard full health systems as paying customers onto PM Cardio for Organizations. A great example of this is the health system in Alst, Belgium, where, before last summer, we've noticed we already have quite significant usage. We had users in emergency care. We have users in their PCI site as well as users within the emergency rooms, and we decided to onboard them onto PM Cardio for Organizations at the end of last year. We've also connected emergency care and the spoke sites and emergency rooms to the PCI sites through our AI-powered chest pain pathway, and now, anytime someone either records an ECG or takes a picture of an ECG with a heart attack, the correct interventional team immediately gets notified, and this further decreases the time to treatment for chest pain patients.

Now, after nine months of this being prospectively implemented in Alst, we've seen significant increases in outcomes, or better outcomes, for over 3,000 chest pain patients. We've managed to reduce the door-to-balloon time in STEMI equivalent patients, so the complicated heart attack cohort, from 16 hours to three hours. We were able to also decrease the false positive cath lab activation rate by about 70%. It's quite expensive, as well as causes a lot of physician burnout. And various Alst initially missed about 35% of their heart attack patients. After PM Cardio implementation, they missed exactly zero.

Now our ultimate vision is to make the PM Cardio AI-powered chest pain pathway the standard of care. After all, it's twice as sensitive as the current standard of care in diagnosing heart attacks and can detect them up to three hours sooner than a human would. And in order to do something like that, you obviously need a lot of clinical evidence, and therefore, we're now running 42 pilots, all run as clinical studies independently that will get eventually published in health systems around the world. To date, we've already enrolled over 100,000 patients within these trials, and we've also received a massive research grant from the European Commission to run Europe's sixth-ever clinic randomized control trial for an AI-powered medical device.

Now all of these results, obviously, will get published in peer-reviewed journals, but we'll also get case studies out of them that will allow us to then convert some of the costs of all the health systems into paying customers. And we've already converted some of them in Europe, where we're certified, and we have a few health systems already paying for PM Cardio in Europe. Now we already also have some of the results of the validations, and they're really consistent across the board. Mount Sinai, for example, will present the results at the AHA in November of this year, as well as the State University of Washington, who has also already finished their clinical evaluation.

In order to make something the standard of care, you also need a world-class advisory board, and for this reason, I'm proud to announce Professor Emmanuelle Barbato, the former president of EAPCI, so the society that writes the heart attack guidelines in Europe, and as well as his US counterpart, Tim Henry, on our advisory board. We also have Professor Stephen Smith, who runs the largest ECG blog in the world, with about 4 million unique visitors, as well. As recently, we signed Suzanne Baron, who, on top of being a top-notch interventional cardiologist, also has a health economics degree from Harvard. She will help us to quantify the value PM Cardio is able to provide.

Now our sales pitch to providers is really simple. We're able to save about $170,000 on decreasing the length of stay. We're able to save about $150,000 on reducing false positive cath lab activations, and we're able to increase their STEMI bills by about $110,000. On top of that, we decrease physician burnout. And all of this is worth about $400,000 profit increase on an average PCI site. We'll price the PM Cardio chest pain pathway at about $75,000 per year for a PCI hub in the US, and about $25,000 for smaller spoke hospitals with an emergency room in Europe. This is already fully certified, and in the US, we've been in the de novo FDA process for the last 16 months, and we hope to get it within the very foreseeable future. We're also working on reimbursement with our partner, NAMSA, who has previously helped other AI companies get reimbursement for similar products in radiology. We are positioning PM Cardio to be the definitive solution for AI cardiology, connecting all stakeholders within a health system. And we don't need to do it alone. We can do it through partnerships.

So for example, with the chest pain pathway, we managed to connect emergency care to PM Cardio by integrating with Sol pre-hospital ECGs. Moving on, we will move into heart failure, where we already have an algorithm detecting left ventricular systolic dysfunction with a very high sensitivity and specificity. And then we will also connect patients through an arrhythmia pathway to PM Cardio by integrating with wearables and patches. And last but not least, we will venture into structural heart disease. We started Powerful Medical with my brother, who is a medical doctor, and a group of world-class cardiologists. And by now, it's about 50 people in the company, split across locations in Belgium, Slovakia, and the United States. We're currently raising a $25 million Series A, which will allow us to enter the US market and start commercialization there, and still, quite a big part of the money will be allocated towards further clinical testing, as we believe that this is key to getting to $100 million in annual recurring sales. For any medical device, you need to become the standard of care, and therefore you need to provide the evidence. The rest of the money will be spent on commercialization, further product development, and finalizing our heart failure pathway.

Thank you very much. I'm Martin Herman, this was Powerful Medical, and see you at the conference.