Wouter Markus Presents Haermonics at LSI Europe '23

Transcription

Wouter Markus  0:05  
Today I will tell you the story of Dave Kohlberg. In Dutch, we said Kohlbeck, and he's a very experienced and well respected cardiac surgeon. Back in his resonant time, 25 years ago, Dave had to go back to surgery after a successful open heart surgery. And we all know open heart surgery is, let's say invasive, another little, little thing. But after the successful surgery, once out of 20 times he go back to surgery up till today. Because something as simple as a drain that is failing. Today, I'm going to tell you that it is not necessary. First of all, what is happening here, excuse me, for all the bloody pictures. After successful open heart surgery, patients are at risk to end up because the drain is not able to evacuate the blood around the heart. And the accumulation of blood and clots actually reverse the coagulation cascade. So you start to bleed harder, and the problem gets worse and worse. And six of percent of all cases, this leads to all kinds of complications, the worst thing being, you have to reopen the chest, sometimes at the ICU because it's a tamponade. And you need to act now, because the heart no longer beats. Total burden of healthcare is 14 billion euros. So it's a massive problem. Now, the current standard of care does not provide clinicians with the information whether this is at all happening or not. You see on the left a drainage pot, and that is standing under the bed and it shows no trend on blood loss, whether the pressure is actually increasing around the heart, whether it's happening. 95% of all surgeons recognize the problem. And more than two thirds is actively looking for a solution. But honestly, there is no solution so far into interesting thing is that the solution is actually very close at hands. If they do a re-operation. Here shown on the left, they open up the chest again, remove all the clots in the blood. And then the magic comes, they flush the space around the heart with warm saline. This removes the blood reestablishes the coagulation cascade. And that's a trick but this is of course a very invasive method. So we're going to prevent it. We have developed a device and a disposable belonging to that, that flushes the space around the heart preventively, all patients. Now what you see here is a sneak preview of the device that we're going to unveil next week. So no pictures, please. We've built a device to be CE applicant to be applying for CE next year q1. And this device will move with the patient from the OR up until the ICU until this patient stops bleeding. I also have explained that clinicians have no good sight. What we've built is a roadway a pathway to the heart. So we can measure blood loss, we can measure trends. And we report on the trends also under pressure and other important parameters. So now clinicians have tools to decide what to do. And there's a preventive device. So this gives doctors peace of mind, and they can sleep again. The beauty of it, it's clinically proven. Other than other ventures that you'll see is you first have to build a product and then build the proof. We have manually flushed over 340 patients and proven that there were zero reoperations zero with any of the flush patients so half of the group. And other complications were also reduced as you can see here. After this first proof, we've done build an investigational device. Of course, it was a complicated device, not nicely to use, but we've used it four clinics, and that is our pivotal trial. We're now evaluating the figures of that. Of course, I cannot reveal anything of it. I also don't know anything of it. But that will provide the data for CEE mark application in q1 next year. The interesting part is that the FDA has said to us, we will give you a breakthrough designation, meaning that we have a faster track to FDA approval and a good communication with them. And they say okay, go and there's also a guideline, the arrows guideline, also US initiated guideline that says you have to actively keep the drain open. Doctors, but how? Well use us. Now what is our next stage with the money with this of the series a last year, we have actually good at the trials I was talking about with the investigational device, we've built the final device. And we will apply for CE in next year, the introduction of the product to the market in Europe and thereafter quickly thereafter in the US, is planned with a series B. Now we'll talk about a little later. Now, all these accomplishments so far, of course, I can show you data of market and business models, but I only have two minutes, excuse me for that. So we excelled with all these accomplishments. So far, we've proven to deliver, as promised, with our strong team and board. And I don't want to get out any of them. But all I can say is we have over four exits in the team. And we have massive commercial and technical experience. We've done it before. So in short, we will enter the market in the US in Europe first, then us perform an international clinical trial with the money that we're raising. And we're building the next version of the device in which AI will further improve this invention. And we start flushing with medicine. So there's a pathway to growth. And we're looking for a series B investment of 15 million. Haermonics is offering you an investment opportunity that is already de risk. There's clinical proof, the device is built. And now it's a matter of application of see and getting it and growing. It's in a growing 1.5 billion market. And the investment is also supported by current investors who will do a follow up investment. Long story short, and after that I'll answer two minutes your questions because I see them a little bit too early here. Haermonics is offering a proven solution. I'm most important of all, it saves lives of patients. It provides peace of mind to doctors. And it's economically beneficial for hospitals and payers. So do you guys any investor I didn't see any but maybe somebody can have the heart or TED talk about is to further discuss this with me and our team