Mihalis Boutaris Presents IntraCross Catheter at LSI Europe '23

Transcription

Mihalis Boutaris  0:05  
I'm going to present you $100 million opportunity that could massively improve the outcomes of half a million patients worldwide per year, and also boost annual sales of all endovascular devices. So until we are waiting for the presentation to go on, yep, I will tell you that the opportunity is really about creating a new category of catheters, their catheters with balloons, stationary balloons are casted without balloons. And now, thanks to my co founders invention, they will be catheters with mobile balloons. And when I heard this, about three years ago, I got so excited, I got motivated even though we were in Greece. I said, I'm going to build this venture. And I'd say Greece is not the most obvious place for medtech innovation. However, we won last year, first prize among 100 startups that were competing in the inner Source Awards in European Union competition. What's the problem? The problem is that even most skilled surgeons can be limited in treating patients with chronic total occlusion. So it's one of those pervasive problems that go a bit unnoticed until you see an amputated limb. So it's cramping, fatigue, pain, poor quality of life. And the problem is that you don't cross the guidewire, which is the main challenge for CTO. revascularisation How do most catheters work in the market there hundreds of them, still one out of three fail, longer surgeries, more complications, higher costs, and failed endovascular procedures means open or no surgery at all. The current approach clinically speaking is you try with a simple support catheter, you may cross if it's an easy occlusion, you may end up going sub intimal. So if I go a bit too clean, too technical here, so so minimize go through the the walls of the vessels, right, so it's very risky. And you might succeed, then you will need a reentry device or not. And then you'll try retrograde going from the distal cap under the knee, you may fail again, and they do fail. So our device intercross catheter will offer a last resort before you abandon and you either leave the patient for an open surgery, staying intraluminal Is the goal. So going the center of the vessel, because that's the most lasting therapeutic effect. Now, key to success is centerline crossing. We have patented a two in one design in the market, we either have products that Anchor very well, or they do telescoping none of them actually do books. So we go from either or to end end, and this is how it works. We have an outer shaft, a balloon, an inner shaft, and through it the guide wire. So as we park the device against the CTO cap, we inflate the balloon to anchor and then we move with the you know shaft extension to gain support and avoid kinking and buckling, and then the guidewire can cross. And here you can see our current prototype in action. It went really well just say you're in our in vivo trials in Israel. You can see how it has done in our in vitro trials. This is a demo with silicone so that you can see how the brown part is the inner shaft. The black part is the guide wire the balloon can deflate then you can be reinflated and gain better support to cross so we will create a new standard for intraluminal success. The gold standard today's we consider to be the Bentley BBack impressive performance ADA success rate. But most of it is I've been to more since I've been demoed more expensive, more risky, and it requires a lot of skill that you can't find everywhere. So, our benchtop studies have shown that we can be 100% into aluminum, we avoid the vessels and therefore we end up being a lot faster. So different surgeons have tried with heart occlusions simulated for the actual CTO lesion. We use the BD Seeker state of the art catheter. Two out of four times it didn't work, didn't didn't cross and even in those two that across We were 10 times faster. Now in the soft occlusion the seeker was when fine, but we were, again 10 times faster. We have a patent family that we've built over the last eight years. So the original invention with a mobile balloon, and then some additional work with continuations and other indications and different engineering approaches. And we're hoping that with this pattern, we open up a new market. So I mentioned at the beginning about the $1 billion opportunity, let me explain a little bit how that works. So there are about a million underserved patients, no. Chronic critical limb ischemia is a debilitating disease, there are about 25 million people in the world, about 6 million procedures are done every year. Now out of these one or four are not done endovascularly, right. And we assume that half of them so that means about 703,000, patients could get a device for option if there was a device that could cross the guidewire. And these would open up about a billion dollar opportunity for all other devices that are therapeutic used after you can get the guidewire across, we assume that our products could address about 250,000 patients out of them, meaning the EU, US and EU where we have IP protection, and that will be our beachhead market, we assume that we could be selling at about $400 per unit. So right there a little bit more expensive than a standard catheter. So that's where our opportunity is for our own venture. We're a small team based in Greece, but we are helped by active advisors around the world. So Marquis is a renowned vascular surgeon based both in the US and Greece and helps us with clinical access, as well as David with preclinical and clinical work in Israel. Alexander, who has been part of the Endosense team that was bought out by St. Jude and Abbott is driving our product design is based in Switzerland, but spent some time in Romania and Greece. And Christmas and Michael are based in Boston, and they're helping us with corporate development, IP strategy and overall support. Also, our suppliers currently are based in Israel, Switzerland, where SD Medical helps us a lot with manufacturing. We're still at an early stage, but at least we've proven that the product can be manufactured. And it's robust and it can work. Original proof of concept work was done in the US merge medical, and were backed by one of the leading VCs in Greece. Big pie, supported by the European investment fund a key milestone ahead is the feedback from the FDA we're expecting, we might be able to get pre preclinical approval for 510K without clinical trials. But of course, our next goal is to enter clinical trials next year. So we are raising more funds, we've raised 300k to date. And we are focusing on the peripheral above the knee today, but we have coronary tomorrow and below the knee. So we see two futures. One is acquisition for a significant competitive advantage and two is licensing to raise broadly the state of the art. So what role will you play in treating more patients stay in touch and stay intraluminal. For safer procedures, easier to use faster crossing at a low cost to manufacture. Thank you very much for your attention, and I'll be around until Thursday to meet up. Thank you