Diego Cheja Presents CloverLife at LSI Europe '23

Transcription

Diego Cheja  0:05  
Hola. Hi everyone. My name is Diego. I'm a physician. I'm from Argentina currently living in Madrid. And together with a partner, we are focused in transforming the heart valve. As some of you may know, the structural valve environment is a very important environment for startups and it's getting a lot of attention. As we heard this morning, in a in a panel, I'm going to be speaking about the status quo, our product, the business thesis, and some other issues today. As some of you may know, currently, there are two main valves that are implanted in people who have to be who need to have their valves replaced, you have the biological valves, and the mechanical valves. Unfortunately, there's no ideal valve. Each of these valves has advantages and disadvantages. The biological valves as you know, have the advantage of not needing anticoagulation. However, they have a short lifespan, and they are implanted surgically in patients that are older, whereas the mechanical valves lasts forever. However, the patient needs to be on anticoagulant drugs, which are expensive, which are dangerous, which may need a change in the lifestyle of the patients, they need to go to the laboratory to check how thin their blood is. So there's no idea about up to now. The size of the market is huge here we had Manny Villafana, before who spoke about the market around a billion dollars we have the same figure. So the market for surgical heart valves is large. We propose a vial that is biocompatible, that is durable, that does not attract platelets to the area so it's non thermogenic and has a low transvalvular pressure gradient. So, we have here a new valve that is has the benefits of the mechanical valve that means it will last forever, but will not need anticoagulation therapy. This valve has been presented in multiple meetings or cardiovascular meetings and doctors in general have been incredibly positive about it. So, so, it is there are two reasons for it being the way it is the one it is the first tri leaflet valve. So no try leaflet valves in the market as of now and that generates a very nice smooth and central flow that does not generate generate turbulence. And the other reason is that current valves are made of paralytic carbon. This is a titanium vial coated with titanium oxide. We got two patents. The first patent was granted to us for the US in 2019. And we got a patent for the EU late last year. We are now in the first stage in vitro or in vitro validation. We are doing the tests for structure durability and fatigue. And we anticipate doing the animal studies next year after that the clinical feasibility study and continuing with a with a first in humans. So the I mentioned already two benefits won't need anticoagulation and it won't need reoperation as it happens today with with the biological valves the go to market strategy we've been approached by a couple of companies but our our our idea what we're talking with with my partner is like we would like to go do everything for ourselves, although this is has to be finished yet. And the team is Osvaldo and myself. He's a cardiovascular surgeon, I am specialist in telemedicine and I've experienced in medical devices for over 20 years. I have here a prototype that has just been finished by our manufacturing in Barcelona, so happy to show it to anyone who would like to ask me some questions. Thank you very much.