Wouter Markus, Haermonics - Flush Therapy for Cardiac Surgery | LSI Europe '24

Wouter Markus 00:00
Val, good afternoon. We're here to talk about open heart surgery. My name is Wouter Markus. I'm the CEO of Haermonics, and I would like to talk to you about something seemingly simple that goes wrong every day. And now this is new for me, because we have a little movie here; the problem and the solution are going to be explained here. Open heart surgeries are complex and life-saving. And post-surgery, bleeding has critical consequences. I want to

Wouter Markus 00:33
talk to you about it a little bit better. After surgery,

Wouter Markus 00:38
the patient bleeds. That's obvious, but this bleeding actually needs to be removed by the drain, which you see here, and they need to be kept open and clear. If not, then the blood and the clot accumulate around the heart. This will actually lead to excessive bleeding. That's how it's counterintuitive. That's the way it is. So you start to bleed more, and then a reoperation is needed during the night very often, and it happens during the night because you operate during the day. This all leads to the effect that you now see longer hospital stays, but the staff stress is also tremendous. Now, what does the surgeon do at night? He reoperates, removes the blood and clots, and then he flushes the space with warm saline, and as if by magic, the bleeding stops. So this is actually treating the patient, but then you have a reoperation, of which we think it's unnecessary. Now, Dr. Kohlberg and our inventor said, "Why do we not do this preventively?" It's as simple as that. So we flush the space around the heart preventively. That's the solution. So how does it work? We not only insert the tube, but we have an extra, let's say, inflow line, and with that, we prevent all these complications proven. I think that's the part that I wanted to show. Talk about proven; we have so far included 744 patients in five different trials in various hospitals, and what we've proven is that we reduce blood loss by 35% and we reduce reinterventions by 40% overall. The latest trial results are just recently known, and again, they're confirming what we do. Professor Claude will be presenting here in Lisbon next month the overall results at the EACTS, which is next month here in Lisbon. This, of course, will also contribute to our CE mark, which we intend to apply for at the end of this year. Now, how does the product work? What you see here on the left side is a console, and the console is an automated, fully automated solution machine. It has disposables for everything that is in contact with blood. But what you see on the top is also very important. On the top, you see a monitoring device. And our solution is not only a treatment device; the monitoring part is half of the solution because the doctors do not know whether this problem is occurring inside of your chest, so that part what we measure there now is blood loss and pressure around the heart, and with that, we can see a tamponade coming up. We have aims, and that's the beauty about it. Now we've created a pathway inside with which we, in the future, can measure more. So then we're going to the market. Now let's first talk about the competitive landscape. There's one party in the market, ClearFlow, and they have a solution which is very manual. It solves the problem, but it's not accepted in the market because it's too manual, and nurses need too much time. There are two companies in this; these are Medela. They have a solution that is not a solution for the problem, but it measures the problem. It measures blood loss only, and it has already traction in the market. This shows how much the problem actually needs to be solved. What makes us unique is that we are the only ones who prevent the problem and monitor. I think that's where we stand now, looking at our go-to-market. At the end of this year, we apply for CE. That means next year, somewhere in the course of the second half of next year, we will have the CE. We first go to market in the Netherlands. Now why? If we have an FDA breakthrough in America? Because the clinics that we work with want our product now, and we cannot say, "No, no, we'll first go to America." You invented the stuff; that's not possible. We will go to market with one price for the whole treatment, 750 euros in Europe and $1,500 in the United States. I'm going to talk to you a little bit more about the market size: 1.8 million patients worldwide get cardiac surgery times the price is a 2 billion market; that's an obvious one. Now we flush fully automated. What we're going to do in the future is make this more intelligent, and the value for the patient there is that we actually can treat better, and treating better means adaptive. We have the patient outcome. We're measuring it with our device, and we know whether an increase of treatment, decreases treatment, or less patient time is a good idea or not, and we also aim to improve the sensor technique and measure more. For example, the current measurement, we can already measure hemoglobin. We're not reporting it yet, the temperature inside. We can also measure whether an infection is coming up or not. Those kinds of things, long-term future. Every doctor who hears us asks, "Hey, I understand your idea. Can we flush medicine with this? Because I want to solve atrial fibrillation locally, or I want to treat endocarditis with your system?" Well, you can. That's lower-term future. So that's the upside market, where our market will further grow. Where do we stand as a company? What you see on the left-hand side is what we have already done. Let's not talk about it too long because I think I have explained that the product is there. We're applying for CE this year; next year, we aim for the first half of the year, and we have the MDC approval already pending a small 60-patient study to show what this device is using, whether the usability is as good as we think it is. CE application. Then we commercialize slowly in the EU, and we do a larger study. Now, why is this larger study in Europe? You need to do a post-market surveillance, and we combine that with the US market, half of the patient, and there is a submission study. Now, of course, for that, we're going to need more money. We're going to talk a bit about a little more. But the commercialization and the go-to-market in the US is very important for that. We do not only have an FDA breakthrough; we also have just recently been granted a HART-X program, which is an accelerator. It gives an investment, which is nice. But the nice thing is it gives us two hospitals which say we want to do it, and we want to do it for free, not the $10,000 to $50,000 per patient that they usually treat. So there's a good result there as well. I've seen a couple of pitches, and I'm going to tell you what everybody's telling here: great people, and I couldn't do without it. But I think the main message, and it's really true, if you look at the management, but also most of the engineers, we've done it before. This is my fifth company. Luke has done it also before, with two other companies after you and away from Philips. And I can go all like this; we've done it. I think the other part is we deliver up to promises, and that's what our track history has shown. Okay, we're here to talk about money. In the end, what we're aiming for is a 15 million Series B to be closed in the course of next year. It is a 100 million revenue company. That's our aim to be in 2031, and we're going to use that money for market access. And that's the commercialization part. It's the biggest chunk of that. You need to scale up. You need to build your materials. But we also know we're going to learn from what we're seeing in the market, and we need some further product development. And then the last one is, of course, this larger trial that I spoke about. My invitation to all the investors, all of the investors in the room, is to be a part of this and improve patient care. That's why we do it. And also provide the clinicians, the doctors, and the nurses peace of mind because you give them peace of mind and night rest. And after all, it's a system healthcare cost that will be lower with this, so the economics works. I would like to thank you for your attention. I'm actually I can talk half a minute more, I think, but let's not do that. I'm going to invite you to look at this a little bit because this is what doctors think about our system. And I think that the picture is Dave Goldberg, and he's the inventor, but he is really sick and tired of this. We had a board meeting last week, and in the middle of the board meeting, he gets called away because he got a template going on. That's what it's about. Thank you very much.