Pulsify Medical | Iwan van Vijfeijken, CEO

Iwan van Vijfeijken  0:01  

Okay, my name is Iwan van Vijfeijken, I'm the CEO for Pulsify Medical. We are a Belgian based medical device company started in 2019. And I would like to start with the problem statement.

What is the problem we're trying to solve here. And the beginning of that is a very simple statement. And that is that your heart is primarily a pump. And whether or not that heart that pump operates properly or not, is of course, very important question. However, this is not very easy to measure. When we talk about the heart as a pump, what do we mean, we talk about cardiac output, ejection fraction, and stroke volume, those are the key parameters. And you are probably aware that there are many devices out in the market, ECG and others that can be attached to the chest, and that monitor the heart. But what they actually do is they measure the electrical function of the heart, which is important, but it's, of course, very different from the mechanical function of the heart. Why does this matter? Well, in many cases, but I would think a key indication here is heart failure. If you have heart failure, then you are at a serious risk of gradually declining pump function of your heart. And as I will show at the moment, there are no good solutions in the hospital and beyond to accurately measure that. So there is a need for continuous safe, a non invasive device that actually monitors your pump function. And this is the Pulsify wearable ultrasound patch. So our vision is that where at the moment, patients have to go to the hospital and clinic frequently and have a measurement done either invasively, or using a handheld ultrasound probe, they can now over time go home with a patch attached to the chest that will continuously 24/7 monitor the cardiac performance. This has many benefits, obviously, for the patient in the first place for the doctor who has now a lot more information about the cardiac performance. And of course, also cost savings, which is of course, relevant for payers. So our patch will look like these devices you see here, we will start with a wired device in the ICU, and then move quickly to a wireless device for the hospital ward. And after that the home monitoring application, of course, the patch needs to be flexible. And it will have many benefits it will be safe, accurate, reliable, for continuous monitoring, etc. So what are the current solutions out there today, and there are really two classes of devices. One is different sets of catheders. And you see here some example you may be familiar with them. The swan ganz cathed er has been around for decades, really. But all these devices have very intrinsic drawbacks. One is that it's invasive, which has obvious risk of complication, it's cumbersome, it's expensive. And last but not least, they're actually very inaccurate. And this is well documented. So although they're invasive, you don't actually get a very reliable measurement. And these products are depicted in this chart on the bottom left hand side, where we show on the horizontal axis, a measure of patient comfort, and on the vertical axis, the ability to do that longer term monitoring that is essential. The second class of competition out there is your regular handheld ultrasound probe has been around for decades or so major companies who have been in this space for decades, but also some newer companies that you see here, such as butterfly and echo imaging. But they all suffer from two fundamental drawbacks. One is it's a handheld device, and that matters a great deal how you manipulate the probe. And even then it's very hard again, to get the reliable measurement data. And the second thing is that you can never get longitudinal measurements, you only have point measurements. And with our patch, we will be uniquely positioned to do the continuous monitoring in a safe and patient friendly way. So our journey started really with a totally novel ultrasound sensor transducer, because this is really the heart of the innovation because ultrasound has been around for decades, as you probably know. And the question is, why is there no patch today of such a size? And the answer has everything to do with the fundamental technology of how you actually manufacture the sensors. And we have unique IP from the IMEC Research Institute in Belgium, which by the way, is a major research institute, renowned worldwide unique IP to fabricate this new sensor in a way that makes it affordable to make it into a large patch. All the other sensors today are made in silicone and that makes it prohibitively expensive to make the patch. So this is really the heart of the innovation we are talking about. So you'll probably know that measuring the cardiac performance is an essential part of hemodynamic management. This is true in the ICU. But certainly also beyond that.

If you don't look at what are the target indications, and there is a whole series of that, I want to highlight a few. One is heart failure, I think for for those of you who know hearts really is very hard to treat is very common. And at the moment, the doctor, the physician has actually very little information to decide what is the optimal treatment. But also, and this is the more in the ICU environment, shock, there's a lot of patients with shock. And it's very important that you quickly establish what the cardiac performance is, of these of these patients. Cardio toxicity is another target area post operative, so it has a multitude of potential there. Our roadmap, we start with a wide product in the ICU, quickly followed by a wireless product for the hospital ward. And after that comes the home application, which is really the sweet spot. But in order to get that we will go through the hospital route first. There are also non cardiac applications, such as monitoring lung fluid, urology, even muscle tissue. So this is really a totally new platform an  ultrasound platform. It has many applications beyond cardiac, we as a startup company to focus. So we focus on cardiac, but there is a lot more there. To the market potential, just looking at cardiac, you see here the numbers, if you just focus on the ICU market segment, you see that worldwide, the market potential in terms of millions of patient procedures is roughly in the size of 10 million. If you translate that into dollars, you're talking about 10s of billions of dollars. And the non ICU market is four or five times bigger. And over time, as confidence and experience grows within hospital use, the home market will grow because patients will be enabled to go home faster with the patch. So we have a number of unique elements as one element I want to highlight here, which is on the bottom right, which is now this this patch will collect data and transmit data 24/7. And this data will overtime provide provide great benefit not just to one particular patient. But of course, the data set as a whole will allow us to identify risk factors for certain patients. That is simply not possible today. Our roadmap, we are on the cusp of starting our first in human clinical trial, actually next month, where we will for the first time, use our new sensor ultrasound sensor with custom software to test it on healthy volunteers. That is then followed by full product development, and clinical validation and pivotal trials. And we will launch in parallel here in the US as well as in Europe. So here you see actually a very short video of this new sensor, you see on the right hand side in blue, how this new sensor is able to actually do imaging. And this is a major breakthrough. Because this this proves that this new sensor in this new manufacturing technology that we can scale up to the size that we need is indeed functioning and we can do imaging with that. And the other side of the coin is the software. We also have validated the software so the two sides really are now ready to be tested in this first human trial which I was discussing. So to wrap up, we have a unique platform in our hands with also unique IP. We come from very heavy set of state of the art patent technology partners. We've raised 10 million in series A so far VC funded mainly we have a unique position. And with that we think we can address a major unmet medical need in cardiac as a first station. But as I mentioned also, there are many opportunities beyond that. Thank you for your time. Thank you for hanging in there. And I will be indeed in the next room. If you have any further questions or would like to discuss more things. Thank you.