Iwan van Vijfeijken Presents Pulsify Medical at LSI USA ‘23

Transcription

Iwan van Vijfeijken  0:05  

My name is Iwan van Vijfeijken, CEO of Pulsify Medical at Pulsify Medical, our mission is to transform management of heart failure patients, the world over there, a lot of people, it's growing population with heart failure. And it's very hard to treat. And one of the fundamental reasons is that physicians actually have a lack of accurate data on the performance of the patient's heart over time, that is to say, the cardiac output, ejection fraction stroke for you. And so at Pulsify, we have a solution for that. And that is a revolutionary wearable ultrasound patch. So a large patch of flexible patch attached to the chest and it will continuously monitor the end diastolic and systolic volume of the left ventricle, and from that, of course, directly derive the cardiac output. And this is in contrast to other devices such as ECG, and other impedance devices, for example, that measure electrical function, and then try and derive the pump function and mechanical performance of the heart. But in making those steps to introduce errors, we directly measure with our ultrasound patch, that mechanical performance, and that gives the basis for the accuracy. And of course, the wearable patch will provide the continuous data that the physicians so desperately need, both in an acute setting in the ICU thing, cardiogenic shock, as well as for chronic heart failure management monitoring, at home. And we have some excellent first new clinical results, which I will show you in a second. We're a Belgian based company with some very renowned founders, such as the IMEC Research Institute, based in Leuven in Belgium, near Brussels, as well as the local university, which has a very renowned expert center in Medical Imaging Research. And we're also VC funded. So underlying this patch is some deep tech innovation. If this was easy, it would have been done by the big guys like Siemens, GE and Philips a long time ago, there's a huge market opportunity. And our proposition is that we can indeed improve health outcomes with a non invasive and highly accurate and continuous measurement device, we will also be able to save costs. And we already have confirmation from the FDA that the 510 K route is available, sort of as a predicate device. And we have some very experienced teams and I will show you some details later, we raised 10 million euros in the first series A series. And we're now in the midst of a 25 million euro Series B round. So this is what the patch will look like we start on the left with a wired device for the ICU. But of course, then we move as quickly as possible to a wireless device, because then the proposition becomes the strongest both in in the hospital ward, but certainly then also towards home monitoring, the patch will be flexible and smart, flexible to attach to accommodate the curvature of the skin smartly will correct for that curvature, it will automatically identify the intercostal spaces and the left ventricle wall and start to monitor within a few heartbeats to cardiac output. What is also important that in introducing this patch, we take away a lot of operator dependency, which as I will show you is in other existing solutions, a key inhibitor. So underlying this move from a handheld ultrasound probe to a wearable patch. There's hardware innovation, there's a totally novel way of making same ultrasound sensor, but in a way that allows us to make that sensor essentially two orders of magnitude cheaper than all the existing ultrasound transducers can today. But there's also software innovation because as you can imagine, there's a lot of software needed to efficiently manage the large amount of data in terms of the ultrasound pulses going out and the echoes coming back. So here's how we did our approach our first in human clinical trial. You see at the bottom left, you see the different positions of the sensor on the thorax, we take a two dimensional sweep, the software identifies the perimeter of the left ventricle and starts to automatically track that. And then these two dimensional sweeps are reconstituted into 3d volumes and diastolic and systolic volumes. And we compared our measurement with our sensor and software to that of a reference device, a high end G probe that is used in a hospital in Louisville. You see at the left hand chart, you see on the horizontal axis, our measurement of the cardiac output and liters per minute as compared on the vertical axis with the GE the system measurement that you see excellent correlation. We also did the so called blank opened plot to demonstrate a need that we have a very high level of agreement between the reference device and our own new system. So that is actually very encouraging first clinical result and of course we're building on that. So how do we see yourself against competition? We already talked about the handheld probe. You can never do longitudinal measurement. One and two is you need to be very well trained. How you To handle the probe in order to get decent, decent data. And then there are of course, the invasive device into catheters, they're quite inaccurate. They're invasive, too expensive. And they're only usable, of course in the ICU, and not in hospital ward, let alone in home situations. And then there are implantable devices, such as CardioMEMS, which are quite cumbersome, expensive, only for the most of your patients. So we think with our wearable patch, we have a strong position visa vie the competition. In terms of the patient indications, there's a lot of them. It's a lot of cardiovascular disease indications, of course, you see them here, heart failure is one of them. But also think cardiotoxic patients and indeed post operative, instant hemodynamically unstable patients. So as a result of market opportunities, big these are numbers in millions of patient procedures, patients that would benefit from having to patch and you see already just for the ICU application. For the main geographies worldwide, you're talking about something like 10 million patient procedures per year, but the hospital ward market is four or five times bigger. And over time as confidence in experience grows with a patch, the whole market will be the most dominant market. So our clinical plan is we are starting the Series V route for 25 million, it will culminate in a demonstrator trial. And then in 2025, we will have a pivotal trial with two arms, European and American to reflect the fact that we have a dual US and European market entry strategy. We have a very experienced team. This is the leadership team average over 18 years of experience. We are very well supported by our board of directors. In fact, there has to hear at the conference. And also very important we have a medical advisory board with physicians key opinion leaders from Europe, but also to from us, Dr. Scott Solomon from Harvard, and Dr. Daniel birkoff, from Columbia. So what is also important to realize this as a platform technology, we as a startup company, we're focused on the first application cardiogenic shock Heartfilia in the ICU. But there's more. There's chronic heart failure, monitoring cardiotoxic patients, as I mentioned, post operative, but going beyond cardiac, there's lung fluid monitoring, bladder monitoring, muscle wastage. And indeed, you could also think about high end athletic performance monitoring, or indeed animals. So to sum up, what this patch does is combine two things. One is ultrasound, which is a technology that doctors know and trust, and combine it with a revolutionary new form factor, which is this patch. And in order to make the patch, there's some deep technological innovation needed. We have the unique IP for that. And of course, we are patenting that and building our opinion, our IP portfolio, we have excellent first in human clinical results to prove the concept. We're focusing on the cardiac application. That's where the biggest unmet medical need is, but as I already alluded, there's a lot of upside in monitoring of other human and indeed animal organs. And ultimately, it's always all about patients saving lives, and improving health outcomes. And we think that's our patch. definitely has that promise. Thank you very much.