Stéphane Piat Presents Carmat at LSI USA ‘23

Transcription

Stéphane Piat  0:04  

Thank you. Good afternoon to everybody. So, comment, I think it's really the next revolution in cardiology. And that's what I call the fifth revolution. After defibrillator, the TAVR. mitral clip, I had the chance to be responsible for the development, and as well drug eluting stent I worked actively on. So Carmat, well, our mission is pretty simple. So we want to become the primary alternative to a transplant. Very quickly, I think we all know that MCS, mechanical security support is a very difficult space. In 40 years only one technology made it for tech acquired by Abbott, with LVAD. So it's a very difficult field, but very is a real need. And as you can see, the company has been created in 2008. And we've been pretty fast at developing the company in terms of manufacturing studies, we got to see Mark in 2020. And we got commercial launched in 2021. We had to suspend, because we had some quality issues as it very often happens. And we are restarting as we speak. And we are in discussion right now with the FDA to restart called B of the early feasibility study. What is striking is that we have been outperforming all competitive projects in the world the only company starting 2008 commercial and in US studies. Our teammate goal obviously it's to be destination therapy. Today we are approved for bridge to transplant. So I think you don't need to be good at math, the equation is very easy. You have a need around 250,000 transplant between Europe and the US only a year on you have only 5500 donors so only or less than 3% of people will be treated all the rest will die within a year. And this number unfortunately is growing exponentially as you know. In the last 10 years, our failure became the first cause of death in front of cancer, as you all know, and there is a very interesting publication that has been published a few months ago showing that dying from heart failure is much worse than dying from cancer. Well, so as of today doctors would do they do VIP day we have Jags CRT technologies, and LVADs but varies a real need for a total martial arts such as our product called Eason the device isn't is probably and for sure the most sophisticated medical device developed so far. So we are using electronic boards for me sales who are using pumps from helicopters much smaller obviously. And we are using sensors and ways to make sure that we can mimic the work of a human art. So our our founder was an account J That's why we are called Calmette car from caught on to Metro Metro defense Airbus Group. And an Karpati wanted to have an art which works like a human art on it work pretty well, as you will see. So the way it works on vets a unique approach everybody is using types because we all know how to build a plant based on the LVAD work, the issue of perhaps you have a lot of clinical complications because you have metal or plastic in contact with blood. So what Karpati wanted, it's to avoid the blood to be in contact with metal or plastic. So that's why we use hydraulic system. as well. We are the only company to have a second rhythm. So we adapt the blood flow real time. So we change the flow every two milliseconds. So basically what we do is what we measure the needs. So if I were quicker, every millisecond I know how much blood I need. And every two milliseconds we adapt the blood flow. Obviously the caveat today for all these technologies is all the batteries are outside. It will change. I mean you so over technology cerebral use will work on induction. But nowadays we have external batteries. Our product is very different from all the others on it's really a game changer. So we are Elimar compatible. We have no email disease. So we're the only device. We believe we won't need any antibiotic therapy. We'll publish it very soon. It's baby aspirin, but we think we don't need that. And on top of this, we think we don't need anticoagulation either. Unlike the others, we have no Coumadin, but low molecular Perrin, and we know we can make without it. It's silent, its physiological fluids, Belser dial and it varies all the time, real time. What is striking if you read the literature, I won't ask you to read the literature. I didn't read myself the literature but my team told me that you need four requirements to avoid complications you need to have by ventricular support pulsatility email compatibility autoregulation and we are the only device today to be able to gather this and it translates directly into clinic out of 60 years of cumulative support vary for patient. We never experienced stroke never experienced bleeding, never experience infection. So it's by design on it's been proven to work as we wanted. So as of now and we are commercial we are back and we expect this year to be the full first commercial year. So we treated so far 34 patients even patient had been transplanted the longer support in the study, it was both breech your transplant and destination was 25 months. The patient died from cancer, we extracted the product and was working still very well. In terms of short term goals, so we will concentrate to the German region, which is the larger region in medtech in Europe, so we won't spread thin. Our goal is to be in 30 hospitals by the end of the year, secure reimbursement in key geographies, which worked already pretty well in Germany with many regions reimbursing the device 240k per device, and scaling up the organization for market expansion. In parallel, we're working on a study to really support the value proposition as we grow. That's a 52 study in health economics, which started last quarter in France. And the goal is to be finished with the study in 2025. Obviously, we started as well, I fought in us probably some of you read the case report on the first patient treated two years ago in Duke it's pretty impressive. What we managed to do at was a rescue guys, cardiac arrest. And so we had to call out one a free patient and now we need to go to court to have seven patient we are still in discussion with the with the FDA to work on the restart. So it's a huge business the time is more than 10 Billions. We have a unique technology we have no constraints unlike structure our businesses where you have a limited number of doctors have labs, I mean you have capacity for surgery, and we will invest especially in manufacturing, we are burning roughly 5 million euros amounts and we have runway until July of this year. Our shareholders our lead investor is the CO leader is the co founder is our best we have 12% We have deeper cats family offices, and we are working to attract now institutions as we are getting commercial. So very quickly the goals for vizier it's a full commercial year to enroll in the French study complete the early feasibility study doubled manufacturing capacity from 250 to 500 per annum at 30 centers active and the outlook for the year is at least 10 million euros for the first year and midterm objectives 1000 devices by 2027 get reimbursement reduce cost of goods and get breakeven by 2027. So, in a few words, a big time significant unmet need is the only device with a potential to replace our transplant no competition on the proven leadership. So thank you very much for your time.