Iwan van Vijfeijken, Pulsify Medical - Ultrasound Monitoring Patch | LSI Europe '22

Transcription

Iwan van Vijfeijken  0:10  

Good morning. Thank you for joining this. This talk. I'm the CEO of Pulsify Medical and Pulsify Medical is developing the ultimate ultrasound patch. And with that patch, we will have the first the world's first continuous monitoring of the cardiac output in a non invasive way, in a safe way, and an accurate way. So what are we talking about here, we're talking about a patch that will be worn continuously on the chest, that measures monitors the cardiac performance, this is the cardiac output, ejection fraction, stroke volume. And we do that with his wearable connected ultrasound patch. And so what is key here is that we measure monitor continuously and accurately and of course, safely, this cardiac output. And we do that in first instance, in ICU where there is a huge unmet medical need, because they're in the ICU for both acute patients, but also for the more chronic patients, the doctors at the moment, they don't have good solutions to accurately read out and understand how the Cardiac output is evolving over time. So he has some elements of the key proposition that we can bring. First of all, we can address a huge market potential only for the ICU, the cardiac applications, we're talking about a global market of roughly 9 billion euros, sorry, dollars. So indeed, the key thing here is that we're non evasive for easy to use, we also take the expert dependency out of the whole equation, which in a hospital setting, as you probably know, is very key for today. And what we will aim for is better clinical outcomes, but also less time in the ICU, less hospitalization, fewer hospitalization days, and healthier patients. Of course, along with cost savings, we think we can save over 25% of the cost of care. A market access strategy in the US is also straightforward, because we have confirmation that the 510 K route is available to us. And of course, we have a very experienced team in place. And I'll show you that later. Our shareholders were VC funded. But also our two parents are the IMEC research organization in Belgium in Leuven, which is where we're based, as long as well as the local university. We've raised over 10 million euros to date in series A including non diluted funding, and we're seeking 25 million for the next round Series B. So let's now focus in zoom in on the first application, which is that of cardiogenic shock in the ICU. If you just look at the Europe and the US about 10 million patients entering the ICU every year, roughly 30% of those have symptoms of shock. And so that equates to about 3 million patients. And when you have a patient and shock, you want to know very quickly is this due to cardiogenic insufficiency, or for example vasodilation. And this patch, when you put it on, it will very quickly tell you whether or not we're talking here about a cardiogenic shock patient or not. And this is very key, because that immediately drives subsequent therapeutic actions. And I will show that the current solutions are suboptimal, they're inaccurate in terms of data, expensive and cumbersome. And aequorea require some very skilled physicians to be on hand. So what does that look like we start with a wired version in the ICU. And that's okay, because the patient obviously is stationary, when we quickly move to a wireless patch for hospital ward patient monitoring. And then as a third step for home monitoring, the patch will be large to have enough coverage to get the accurate reading. And we'll have to be flexible, of course, accommodate for the curvature. And it will be smart in that it automatically corrects for that curvature, it automatically finds the intercostal spaces and starts that's extract from the left ventricle, the cardiac output within a few heartbeats. Accuracy is the first key criterion. And we think with our patch, we can really achieve much better accuracy and current solution scan reliability and already mentioned the operator independency which will be very key you put on the patch on the chest and it will quickly start to monitor and of course, non invasiveness. So let's look at what is currently out there in terms of competition. And we depicted that here in this chart. On the horizontal axis, you have a measure of patient comfort, going from highly invasive to non evasive, and on the vertical axis, the ability to do the longer term monitoring in a safe safe way because it's really the trend line. That is very key for doctors to understand, because that drives subsequent interventions. So we have the catheters, the swollen gums, and some others well known. They've been around for decades, but they have intrinsic drawbacks because they are bases are expensive to cumbersome, they have always a risk of complications. That's one. And then you have on the bottom right, you have the handheld ultrasound probes, you know them, it's very hard actually, to get good accurate reading, you need to be very well trained, how you manipulate how you handle the probe. And even then it's hard to get data. And you can never get longitudinal data trend data, which is really what the doctors are after. And then the third class of competition or the CardioMEMS. It's an implantable device. And that, of course, brings with it cost and complex procedures. What is nice about CardioMEMS, they actually proven that having longitudinal data, because it is implantable, right, having that longitudinal data actually does lead to better clinical outcomes, which is also what's underpinning the proposition behind our patch. So we think we will be uniquely positioned with our wearable patch. So we have recently achieved a major technological breakthrough, because underlying this patch is some real deep technology with excellent sensor performance. And the output actually, we benchmark ourselves against a commercially available off the shelf probe. And we have three times better output. What is also important is a strategic partnership we have with the company in Japan, because this new sensor needs to be manufactured not in a regular fab. But in a display fab and the right partner, we have found actually in Japan, and we have a strategic partnership with them. So that is for supply chain for the future, also a key success. Here you have some images, as we move on the handheld probe to the wearable patch, we have proven that we have a working sensor with good performance. And also we have whole software platform because along with this large two dimensional array of sensors, you also need to of course, manage all the information, all the data, the pulses, and the echoes in an efficient way. So we have both now, and we are about to do our first in human clinical trial. So we started in 2019. And as I just mentioned, next month, we're planning to do a proof of concept first human clinical trial. And that has been the stepping stone to Series B funding. And as I said, we're raising 25 million. Our launch strategy is a dual US European strategy. And as I mentioned 510 K is available for us. So this story so far is really focusing on the cardiac application shock in the in the ICU, and also heart failure, but as much more. So we have the chronic heart failure monitoring in the ward. And also of course at home, we have a cardiotoxic patients, we also can use this for non cardiac applications, lung fluid, urology, and also muscle wastage. So there's a lot of upside potential there with a very experienced team 10 people in total, and round about 20 years of experience, on average. Also a board, of course, very experienced representing our shareholders, and led by our independent chairperson, Mr. Japp. And also very important, we have a very well respected medical advisory board with four key opinion leaders from from Europe to from the US and one from Australia. So to sum up, we think this is an excellent investment opportunity for combining tried and trusted ultrasound with a really revolutionary patch that, as I hope you see by now, is really driven by this deep technology. And that's why we have the Japanese partnership. And with that we can do continuous monitoring of internal organs. The heart is the first application. But there are also other applications and in total, we're really talking about a huge unmet medical need. And finally, we this will be safe, ultrasound is safe, right? It will be cost effective, and we will improve health outcomes and indeed save patients patients lives. So thank you very much. If you have questions, please come and find me.