Video Transcription
Olivier Decuypere 00:02
Olivier, thank you and good afternoon. So my name is Olivier Decuypere. I am the CEO of CorQuest MedTech, and it's my pleasure to present my transcatheter mitral repair technology. The disease that we are tackling is known by many of you as mitral regurgitation. This disease is big, complex, and severe. It's big because it's affecting, roughly speaking, 2% of the population. If we take the US and Europe only, it's about 20 million people presenting with MR. Out of those, 4 million people are in urgent need of treatment. But only 150,000 to 200,000 procedures are done every year. So it's big, but it's really underserved. It's complex because the root causes are diverse. You can have a structural issue with rupture of the chordae, elongation of the chordae leading to prolapse, but you may also have dilatation of the annulus leading to functional MR. And it's severe because it's leading to respiratory and cardiac symptoms, potentially to death. It's a disease that is severe for patients that present it. So typically, a patient today goes to the hospital, and the current practice would be to propose an open-heart surgery. You all know that it's very invasive, it's traumatic, and many of those patients are frail. They are old, they are not eligible, and they don't get the treatment. So today we have one more option: the transcatheter edge-to-edge repair with two products commercially available, MitraClip and Pascal. And it does work; it’s an effective treatment for many of those patients, but many of those patients present residual MR. Is this something that we want? And there are very specific anatomic limitations to the clip. Are those patients clip-able? If they are not clip-able, the only remaining options today are potentially to enroll in a transcatheter mitral valve replacement. Several products and projects are underway; hopefully, some will enter the market in 2025. But the conclusion is this is not enough. Not enough options for many patients suffering from MR. So at CorQuest, we thought about a great, disruptive, and pretty innovative approach. With a transseptal transcatheter approach, we will deploy a mitral grid in the left atrium. We will position the grid supra-annular, on top of the mitral annulus, and anchor posteriorly and anteriorly the grid on the annulus. This idea is protected with patents; we have PCT submitted and freedom to operate. And the question is, fine, well, how does the grid do the job? Or what job does it do? The grid solution is made of three components: the grid itself, which is a nitinol polished grid; we have designed specifically electric screws that will anchor the grid at each distal tip of the branches; and of course, we need the delivery catheter that is there to bring all that to the left atrium. The job is done in two ways. First, it will prevent the leaflet from prolapsing above their coaptation plane. So any prolapse, multiple prolapses, will be blocked by the grid. The leaflet will stay in an effective coaptation position. And secondly, it will connect the anterior side and posterior side of the valve, preventing dilatation of the annulus. We cannot really claim that it will reduce an existing dilatation, but we've seen in sheep that it stabilizes the annulus and prevents further dilatation. So far, we are still an early-stage startup, so we are still in that design phase. We've done ex vivo studies and in vivo studies on 10 sheep, implanted with our grid, initially via surgical access, and we've been following those sheep for 90 days, with the last experiment ending this Monday. I'm still waiting for the data and the report, but it's an exciting time: 90 days follow-up with an implanted nitinol grid, and the results so far have been the following. We've seen efficacy in reducing or eliminating DMR, the regurgitation coming from a P2 prolapse that we've created ourselves by cutting the chordae. We've seen a good anatomical fit between the grid and the sheep ovarian model, and we've seen no tissue damage. So, you know, big questions we had were, what if those leaflets enter into contact with the grid 10, 100,000 times a day for a long period of time? And the good news is we have no damage on the leaflets, and we have no thrombus infections or other complications. So we are very satisfied with the progress so far with the grid. Of course, the grid has to come with the anchors. As I've said, we've done extensive research and still believe that the electric screw is the most effective anchoring approach and design for the mitral annulus. We've tested that ex vivo and in vivo. So the 90-day sheep we've been following had a grid anchored with our own screws. The catheter came as a third work stream. So we are a bit less advanced on the catheter, but we will be implanting, sorry, implanting a first mitral matrix grid transcatheter at the end of this year, October, November 2024, so progress is being made, and so far, things are going very well. So it's a boiling space with many different options and many different techniques. Cardiologists and engineers have been very creative in the mitral field over the last decade, of course. So why MitraGrid and what makes MitraGrid different from others? Here are a few techniques: edge-to-edge has its limitations, anatomic limitations, and potentially risk of stenosis. So it can work for some patients, but not all of them. Annuloplasty, transcatheter, so far has been seen as very complicated, and we all know projects that have been stopped because of lengthy and complex procedures. Chordal repair is seen as fairly complex, but potentially new projects will come and make me wrong, and we see MitraGrid as a solution treating both structural MR and preventing functional MR. So it’s pretty versatile, tackling different pathologies. And of course, we are building it to be simple, safe, and fast. A question that we still have to work on is the redo: what if we have to go back? We have a grid there in the mitral annulus. This is something to manage if we have to go back for a redo procedure. The team is still small; we are five in the team. The team is built around Professor Didier De Kanter, a cardiac surgeon with experience in Europe and in the US. He’s been an entrepreneur, having created a company in the past and sold it to St. Jude, so he is used to this entrepreneurial spirit in the med tech field. I joined them two years ago with 18 years of experience at J&J MedTech and am now experiencing the startup life. I brought on board another cardiologist, or let's say clinician, a little bit, maybe from Switzerland, and we also have a medical engineer. The rest is outsourced with very excellent partners. And of course, we set up a nice advisory board with a mix of cardiologists and surgeons because they bring very different values to the table. As a cardiologist, we have, for example, Ollie De Backer, working in Denmark and seeing roughly half of the mitral valve disease in Denmark. So plenty of experience and guiding us in terms of adjusting the project. This is the roadmap. So today we're looking for 6 million euros, but to do what? The next big milestone will be to deliver the full functional prototype by early to mid-2025, which means great anchors and catheter working nicely together with implantations and good results. From there, we will be working on preparing the first in man that we are planning for early 2027, and as you all know, we have a lot of steps after that clinically to potentially get to market. So we are looking for 6 million euros to get ready for the first in man, and we hope to close that by the first half of 2025. So MitraGrid? Why MitraGrid? Because there is a big unmet need. The disease is big, complex, severe, and underserved. Repair is better than replacement. We've seen that from surgery; the patients that are repaired do better in terms of survival rate than those who undergo replacement. TEER is a good option, but it's not the only option, and we need more solutions for many more patients. So happy to chat later on with you, and thanks a lot for coming this afternoon. Thank you. Applause.
