We are rich in events. We started the commercial launch of our product called Aeson in seven patients. We started the first cohort of the US early feasibility study, which we completed in August with three patients. We continue to enroll in our PIVOTAL study to reach the number of 17 implants to date. We ramped up the manufacturing to four procedures a week in December. Following the transplant, we had some quality issues, and we come back to this, and we voluntarily suspended our implants due to these quality issues. An update on the quality hold that we had in December of last year. The situation. We have to report three serious adverse events, of which two were related to device malfunction. Following the first SAE, we decided to suspend as quickly as we could the implant on December 2nd. That was the day before an implant program, and we had many other implant programs the following weeks. Following that suspension, we started to work actively on the identification of quality defects, which we saw on two different components. One coming from the electronic part of our device, and the second coming from the mechanical part of the artificial heart, the tank. We worked on the identification of the root cause of the defect. We've been able, in the three cases, which we think are isolated, to identify the root causes and to reproduce the root causes. As soon as we managed to identify the root causes, we started to work on the definition of corrective actions, and we are now in course of implementing these corrective actions. We took quick and responsible action to go through the whole process. What are the next steps? First, obviously, we still have four patients on Aeson as we speak today. We put in place the action necessary to make sure that we can mitigate the risk. As I said, we do believe following our analysis that these cases were isolated. We are monitoring closely these four patients, of which three are on the waiting list for transplant. One of them is a destination therapy patient. In terms of supply, we've been working the last two months to understand if we were able, yes or no, to use the products on the shelf. As of today, we are not able to say if the products on the shelf are safe enough to be used on patients. That's the reason why we decided for the time being to work on new products to be manufactured with corrective action. These products should be available in October this year. Obviously, once we review the manufacturing with new products, we will have to deal with notified bodies and competent authorities to get the green light to restart implants, both commercially or clinically. We have ongoing dialogue with DEKRA, which is our notified body in Europe for commercial implants, and the ANSM, which is a competent authority in France for the French study called EFICAS, and the FDA to potentially restart the Cohort B of our EFS study. The current expectation is to resume all implants in October 2022, pending the authorization of DEKRA, ANSM and the FDA. Now, obviously, we are working actively on resuming the full manufacturing and obviously to get the authorization of the competent authorities, and we are working very actively as well to project the company into the future. Now we'll speak about strategy and outlook. Our vision remains the same, and we firmly believe in the fact that Aeson will become the primary alternative to our transplant, not only in terms of device, but as well in front of our transplant. We'll speak to it later on, but we believe that if we're able to have a device which does what Aeson does today, which is durable and comfortable for patients, it could become the first line treatment for transplant. What are the learnings from clinical commercial experience? First, out of more than 30 patients, the product design minimizes strokes, GI bleeding, and driveline infection, unlike other mechanical circulatory support technologies. The service provided by Carmat in terms of implantation and patient follow-up is highly appreciated by physicians. Now that we are offering a new therapeutic solution, the patient flow is starting to build up. As of today, the demand for Aeson is very high, and that's the reason why we are working very hard to resume implants. We get every week many requests to restart. There are lots of patients waiting for treatment. In Europe as well, our competitor, SynCardia, is on hold as well. I will hand over to our Chief Medical Officer, Piet Jansen, to speak about the voice of the customer. Please. Yes. Thank you, Stéphane. As you may have heard, the Aeson device has three distinctive features that bring it very close to physiological heart replacement therapy. First of all, we have the biological blood-compatible surfaces and the blood flow through the device, which is brought into motion by a hybrid membrane. Together, this provides for a blood-friendly system that minimizes shear stress. Because of that, there is a very low need for anticoagulation treatment. Secondly, the Aeson device is heart configured, provides full pulsatile flow, and it's electronically actuated, which means it is silent operation with physiological flow. Last but not least, the Aeson is the only device in the industry that possesses the ability to self-regulate blood flow based on the patient's needs. Now, if you look at the comparison with the existing devices and the competitive approaches or system, and in this table, you can see the devices that are currently on the market, the pneumatic-driven artificial hearts, the bar vests used, the LVADs with temporary RVADs and the LVADs alone. If you look at the essential features to provide physiological flow, it's clear that the Aeson device has the potential to stand out in this case. Although most of the devices can provide quite partial support, it's only the existing artificial hearts and the Aeson device that provide true pulsatility. The autoregulation and hemocompatibility are two distinguished features from the Aeson device that are not occurring in any of the other existing systems. Now, if you look at the data that is published that the six months support can compare that to our experience on 15 patients, it is clear that the device stands out again. In the early experience, we did have some intervention for surgical bleeding, which is normal in this type of surgical procedures. If we look at the safety profile, it's the Aeson device stands out thanks to its biocompatible surfaces and performance. In our experience, so far in 15 patients, we've had no strokes, no gastrointestinal bleedings, which are readily observed with LVAD systems, and we have also had no driveline exit site infections so far. All these features attest to the biocompatible profile of the Aeson device. Now, if we summarize this, and if you look, what's important for Aeson, as Stéphane mentioned, to become the first-line treatment for end-stage heart failure, has potential and alternative to heart transplant. It's not only safety and effectiveness, but it's also to provide a reliable, durable system with a gentle solution that still mimics the function of the natural heart without the negative side effects on our organ systems, and mostly without any impact on the immune and defense system that is seen with the use of donor organs. If we then look at the features of our device such as hemocompatibility, we use minimal anticoagulation requirements, which in clinical practice means that there's a lower risk for stroke and gastrointestinal lesions. The physiological flow, which is pulsatile and autoregulated, allows for the patient to have a quick recovery after the procedure. Also when the patient mobilizes and is discharged home with the device, there's an automatic response to the needs of the patient when he exercises or he takes rest. We've already alluded to the biocompatible surfaces of the device. Simply said, it means that there is no rejection of the system, and there's also no need for immunosuppression, which means the risk for infections is limited. The detrimental effects of the use of long-term immunosuppression do not occur with the mechanical support system as the Aeson is. In terms of long-term reliability and durability, this has to be established with extensive clinical experience, and that will be done during those studies as well as our commercial use. However, in our limited experience, we already have proven that the device has a support duration well over two years in a patient that received the device as a destination therapy, but he ultimately died because of medical reasons. Last but not least, if you ask the clinicians, they all want to have a fully implantable device. The Aeson device currently needs power supply from the outside, but that's the only thing that we need from the outside. Everything else, like the brain of the system and the sensors, et cetera, they're all embedded in the device itself. The only thing it needs from outside is a power supply. We're confident that within the future developments of battery and energy providers, we will be able to to make these devices fully implantable at some point. Now, I would like to hand over the microphone to Dr. Carmelo Milano, who will share with us the experience with the Aeson device. Carmelo. Yes. Thank you, Piet. I'm one of the cardiothoracic surgeons here at Duke. I'm actually the chief of the section of adult cardiac surgery. I've worked here for more than 20 years and have been very involved in heart transplantation and in mechanical circulatory support. Duke has an extensive experience in mechanical circulatory support, all types. Perhaps our most common support device is the implantable LVAD. This is predominantly used in our patient population as a destination therapy. We have been a leader with regards to a variety of different trials of newer devices, particularly the HeartMate 3 device. We have seen improving survival outcomes where on average, patients are living about six years as a destination therapy with implantable LVAD, and we have some patients out to 13 years. However, there are many limitations to univentricular support. You know, we encounter these on a daily basis. First of all, of course, in practice, what commonly is an important fraction of patients have very limiting biventricular function. The echo image illustrates a classic situation where the left ventricle is decompressed with the LVAD at the interventricular septum is pulled to the left side. The right ventricle remains fully loaded or overloaded, and there's insufficiency of the tricuspid valve, and these patients continue to suffer with heart failure symptoms. Sometimes they're able to be discharged, but a lot of times they may need continuous inotropes for the right side and higher doses of diuretics just to continue to treat the right-side heart failure. In addition to this scenario, we have patients who have restrictive cardiomyopathy where the conventional LVAD cannulation is not feasible because the ventricular chambers are very thickened, very small. We have an important subset of patients who may be anatomically suitable for LVAD, but do not have stable heart rhythm. They may have recurrent ventricular tachycardia or ventricular fibrillation. Again, they do not maintain good right-sided function when they're in these ventricular arrhythmias. Finally, there's a growing population of patients with congenital heart conditions. These patients commonly have cycled through different types of corrective procedures but have still gone on to experience progression in heart failure. Frequently they will require biventricular support or need biventricular mechanical support because of a variety of issues on the right-side circulation. LVAD has progressed, and we support many patients with LVAD. Close to 100 patients a year in our institution are maintained on LVADs. We also have an important subset of patients that it is clear that the LVAD is inadequate support, and these patients are in need of durable biventricular replacement. Dr. DeVries actually was a resident here at Duke before he went to Utah, where he treated Barney Clark with the first total artificial heart implant, the Jarvik-7. Unfortunately, you know, this was in the 1980s, and here we are many decades later, and the current approved total artificial heart technology has a variety of limitations. Durability is questioned. You know, thromboembolism and biocompatibility are huge issues, and we hope that the Carmat device, you know, is able to address all these deficiencies of the current total artificial heart strategies. Dumping the circulation is very important. When we do biventricular mechanical replacements, overcirculation of the lungs and abnormal pressures in the lung circulation have commonly created situations of lung injury, sometimes devastating lung injury. Lastly, we need systems that are exercise responsive so that the patient can increase their output when they become more active. There have been a variety of different total artificial heart strategies, but those strategies have a variety of limitations that they currently exist. What that's forced us to do is forced us to actually utilize LVADs probably more than we would want to. We continue to put LVADs in patients who have biventricular failure, some patients who have ventricular tachycardia, etcetera, because the current total artificial heart replacements have their own set of limitations. Again, we hope that the Carmat represents an advance, and we were very pleased with our first U.S. implant. The patient was a 39-year-old male patient from South Carolina, one state below us. This patient had known ischemic heart disease despite being very young, and suffered a heart attack with associated heart failure and was transferred here. After arriving at our facility, he destabilized further with another cardiac arrest and actually required support with VA-ECMO as well as Impella. This is a very, very ill patient. I would say from a state of being on temporary support with VA-ECMO or Impella, you know, your survival is, you know, probably 10% or 20% at one or two months. This patient was in dire straits, requiring temporary support, and being a very large patient, really was not suitable for immediate transplant options. In addition, the patient had incurred ventricular tachycardia, so it was a combination of poor biventricular function as well as ventricular tachycardia that really warranted biventricular replacement. The sizing of the Carmat device is very important. You can see axial and sagittal CT imaging with overlay of the device size. We were very careful, and the Carmat team was very careful in making certain that we had an adequate anteroposterior dimension in this patient as well as an adequate dimension in terms of the pulmonary artery to diaphragm. After careful, you know, sizing using this computer modeling, we felt that the device would fit suitably, and we proceeded with the implant, transitioning the patient from Impella support to BiVAD. This shown here is the operative scheme. Dr. Schroder and myself were the surgeons, but we were heavily supported by Carmat and an experienced European surgeon that had done implants. This was a reoperation in the sense that the patient had prior sternotomy for central VA cannulation. It was a reoperation which was somewhat more involved. In general, the implant went smoothly, and really there was some coagulopathy which we addressed initially, but there was no real immediate complications, including very minimal issue with bleeding. This slide is to remind me that while we commonly will approach patients like this with LVAD support, we end up with suboptimal hemodynamics. This was very much not the case following the Carmat device implant. You can see that we have substantial cardiac output with right and left-sided flow rates exceeding six liters, 6.4, 6.6 L of flow per minute recorded there. We have pulsatile circulation as shown on the right panel. Very normal flow rates, very normal central venous pressure and pulsatility. In essence, we really have recapitulated the normal characteristics of this patient's circulation, which I would argue would not have been achieved with LVAD support alone. We have treated patients like this with LVAD, but typically we end up with, you know, four or five liters per minute of blood flow. We're oftentimes limited by the right side that is not supported. We have high central venous pressure and obviously, we don't have pulsatile flow with modern LVAD devices. The Carmat really restored normal hemodynamics for this patient. Shown here is the patient after discharge with his family. Fortunately, he not only was able to be discharged into the community, he did well and a donor organ became available, and we were able to safely explant and transplant him. He now has been discharged after his transplant. He was supported for four and a half months. One thing that I have not asked him, but it's an important question, is when I see patients who've been supported on an LVAD and undergo a transplant, they will invariably report feeling better with the transplant than they did with the LVAD. I think that's largely because we don't achieve normalization of hemodynamics with the LVAD. This patient really had a greater cardiac output with the Aeson device compared to what he probably is getting now with a transplanted heart. He may actually be experiencing hemodynamics that are a little bit less optimal compared to what he had when he was on total artificial heart product. Now, I'm sure that he's happy to be without the battery pack, but on the other hand, his resting hemodynamics and even his response to exercise, those hemodynamics probably are no better with the transplant than what he was achieving with the Carmat device. We were very pleased with this initial case and in all aspects. There was very little manipulation or alarms that we had to respond to, and the device really supported this large patient very well. We are anxiously looking forward to being able to work further with the device as we continue to meet patients who have a variety of issues that make them non-ideal for LVAD support alone. I think that's the last slide, Piet. Thank you. Yeah. Thank Carmat for this exquisite presentation. I hand the microphone over to Stéphane here. Thank you very much. Obviously now we come back to 2022. What are the key objectives now? There are four buckets. First, manufacturing. We're working right now on implementing corrective actions. Unfortunately, well, [inaudible] are really inherent to the medical device industry when you ramp up. We are in the phase of ramping up, and it's very hard to anticipate. Now we are working very quickly on corrective actions. Obviously we keep on working on continuous improvement on processes, which will never stop. We are working well to make sure we can do inventory for restart. Second thing is, obviously we are keeping on training new centers. The demand is very high and many centers were planned to start, and they decided to carry on with training despite the fact that we are suspended right now. This is to prepare for a strong restart and hopefully to resume implants such in the commercial setting itself in October. Second as well is that we are hopeful we can restart the EFS study with Cohort B as quick as we can as well in the US. Start probably the EFICAS study on total artificial heart with EFICAS in France, which will be a very large study of 60 patients, which will help us to understand better in terms of health economic impact of such a therapy. Last but not least, so obviously we took a big hit because of missed sales, so we have been working on many steps while in effort to maintain the cash runway until July 2022 and to prepare for the next financing for the company. I think it's important anyway to take a look at where we are and all the achievements. Early Carmat started in 2008. In 2008, four other projects started as well. Two of them now are stopped. A German project and a U.S. project, and there are still two ongoing. A Swedish project and a U.S. project as well. One is still on animals and one is still on bench test. Just to show how fast we've been getting to commercial and humans compared to other projects. What is notable as well is that obviously our project, our product has features that no other projects under development have. As Piet said, and Carmelo explained, we are able to re-establish hemocompatibility of the patient, which is very important. The hemodynamics is back to normal or sometimes even better, as we just explained. As you have a durable machine and if the machine works, it has what you require the machine to do. I do believe it. In a device is durable and without any batteries, as Carmelo demonstrated, it could become potentially years from now a first line treatment for transplant. Things have been accelerating in the last five years. We started the Tumors study. We have a new manufacturing site dedicated to Carmat. We got CE Mark last year and, we start commercial ESS next year. Our vision is, remains the same. We want to become the first biventricular device to get a destination therapy indication. Our vision really is to become a, the first line treatment. We believe that if technology evolves and if we make it better, it could even become a first line treatment for this patient, which despite a new heart, don't manage to get the blood flow that they need. That's really about the update we wanted to give. As I used to say to many of you, who've been following the company for many years, when I joined five years ago from Abbott. Well, first, I said that manufacturing was probably the most important change we had to face, which is the case. We are ending it the right way, I believe. We are confident given the nature of the problems we had that they are probably we are at the end of a tunnel of quality issues. We are preparing for restart for good, and we are hopeful that we can come back in October to treat all the patients we could not treat in December and January. But unfortunately, we won't be able to treat some of them. Hopefully we'll get access to our transplant and we are putting all the effort necessary just to be back on track as soon as we can. I wanted to thank you very much for your time today. We have some questions and answers. I have only one, which is, does a patient with Aeson need a long-term anticoagulation? I think that's a very interesting question. Obviously, there are still a lot of unknowns, but in respect to heart transplant, maybe first, we don't have any rejection. That's a very important point. That's the first thing. Second thing, even if today we didn't want to push too much the envelope in the studies, but the anticoagulation in Carmat over mechanical circulatory support devices is very much different, much lower. We have 25 mgs of aspirin today, so the aspirin and low molecular weight heparin. Some centers had to stop the anticoagulation, right, for many days, and we never had any clot issues. As well, some patients could not stand heparin, and they got different type of anticoagulation even lighter. We believe, I mean, what we will do in the coming studies, especially the French one, we will try to lower as well, even if it's very low compared to the other devices today, we could go even lower. I will maybe hand over for that question to Piet our CMO who will give more color to what I just said. Yes. We've been asked the questions by our physicians as well, because as Philippe mentioned, we've had several patients who spent a long period of time and days to weeks without any anticoagulation. We do have patients that are using aspirin only for medical reasons, and patients who use it for effect because of low molecular weight heparin. What's also important to realize is that because we use biocompatible surfaces in our device, we have seen new endothelialization inside the device over time. We're pretty confident that as long as we have long-term support over months, that we should be able to further reduce the anticoagulation. Since we're now doing safety studies, we don't want to take that risk at this point in time. We know that there are a long, large group of clinicians who are anxious to initiate a study looking at further reduction of anticoagulation. Thank you, Pete. Other question: Will you have to write down current inventory? As of today, we are still running analyses and we are not comfortable with using the product on the shelf. It's not final, but it's improbable that we'll be able to use current inventory. How many defective units do you have in inventory? Now, that's a question. We strongly believe that what we experienced are isolated cases and we would think that this product could be potentially good. As I said, we are not able to be sure 100% and we do prefer not to use them for the time being. Potentially, further analyses will allow us to use these units, but it's unclear today. That's the reason why we didn't take that solution into consideration in our resumption plan. Are you going to develop a pediatric scenario, too? We need to first stabilize our technology, and once we do, we'll see, but it's not today part of our plan. Can you give more details in the timing? Why October for the restart of sales? Are there any important milestones before October? Well, I think it's really depending on the time it takes to assemble the Carmat heart. As I said now, regarding the two components that are concerned, we're working on corrective actions, and we do intend to use inventory manufactured with these corrective actions. As of today. The time cycle is pretty long. We should get the components back on track with corrective actions around the month of May, and the time that we integrate these components and we do the testing, so we have the bench test at the end of the cycle. Because each products are different from each other, and we have the conformance at the end of the cycle testing product we send through sterilization. That's unfortunately the timing required when we start the manufacturing at a certain point where we usually start. Do you still believe the demand accumulated in the first three quarters of 2022 could be satisfied in Q4 2022 once implementation is resumed? Probably no, because obviously we have a lot of patients that should have been treated in the last eight weeks, and it will be pretty hard or even impossible that we can recover in Q4 only. Why don't you use driveline infection in your device? Why don't you see, sorry, driveline infection in your device? What makes your device different from LVAD driveline? I will start. Yeah. That's again a very good question. Remember that the difference of LVAD use, as Carmelo also mentioned, is that with the pacing device you provide full pulsatile valvular physiological blood flow on the left side and on the right side, so we ensure that there is adequate perfusion delivery also in the tissues and subcutaneous area. By not having congestion that we see with the LVAD patients that do not have an adequate right ventricle support, we also make sure that there is no fluid retention in the subcutaneous tissues. We ensure that we have a good environment everywhere in the body to ensure good healing. A longer-term support so far 25 months that patient doesn't have an infection on his driveline. We're very concerned despite the fact that the driveline may be a little clearer than with the LVAD patients, but that's the main distinguishing factor. Thank you, Piet. Could you share some more details on what went wrong with the three recently implanted that slide 16 includes the three cases that were stopped in production? If not, what would slide 16 look like should we include these cases? I'm not sure what slide 16 is. I'm just checking right now in live. No. This slide is contemplating the results in the study. It was a study which was not the expense is not contemplated in that study. Well, by the way, no, you're right. One case was in the study, but not contemplated in there. No, the three cases are not included in the slide 16. Around the details, the reason why we believe first, we are almost hopefully, you know, when you start to develop a technology, you have many problems and you try to debug the device as long as you go. Obviously, when you start, the problems are very easy to identify and anticipate. These problems would have been very difficult, and we did not manage to see with bench test or whatever. Really we are about quality issues, really. It's really about manual steps. It's really about human error more than anything else. Like it happens very often in med tech. We will add more quality controls on things that we were not thinking of controlling. The details, you know, I think Carmat is one of the few companies, at least I work with, which were able to identify root cause and reproduce root cause. It's pretty difficult usually, but in our case we managed to do it. We understand well what happened. I think that will take a long time. I don't know Filippo if you're a scientist or no, but it's a very complex thing. It's not something, you know, we could see during our testing getting out of the line, only it did not happen the first week of use. It's something that developed after a certain period of time. This is really about evolution of small quality issues that became a problem for the functioning of the product. That, in some cases, led to the stop of the pump. But it's really electronics and mechanics. It's really about the manufacturing itself doing manual steps. Obviously we won't limit ourselves to adding additional controls, but we will as well take advantage of all the science we put behind our investigation to as well decide preventive actions to make even stronger the two components we spoke about. The electronics and the mechanics. There are no additional questions. With this, I will thank the two other speakers that supported me today in that call. Carmelo Milano for his precious time. I guess he has a very long day in front of him. As well, our Chief Medical Officer, Piet Jansen. Thank you very much for your time. See you soon. Thank you.