Saravana Kumar, 4C Medical - Supra-Annular TMVR System | LSI USA '24

Saravana Kumar  0:04  
Thank you everyone for having me here at LSI. It's a exciting meeting to be part of. Once again at Dana Point, I want to start off introducing, foresee linking it one of my favorite quotes from Albert Einstein, creativity is seeing what others see and thinking what no one else has ever thought. That is especially true of our technology at foresee medical that we are developing, which is essentially an out of the box idea in order to treat mitral regurgitation, not often in one's careers, you get to work on a technology that's creative, that's unique, that can help patients, and frankly, as entrepreneurs in this room, can help prove a lot of people wrong. That's exactly what our technology is. So if you look at what the problem is? What is mitral regurgitation? What are we treating? It's a very, very simple mechanical problem that you see on the left side of the heart. A mitral valve should help close off when your blood is being pumped from the left ventricle to the rest of the body. In many patients, especially as we age, valve can deteriorate for a number of reasons, either due to the disease of the valve itself, in which case it's called primary Mr or it can happen because you have heart failure and issues related to the ventricle, which is your main engine of the heart that's pumping blood to all over your body. And this case, it's called secondary MR It's extremely well established that once this disease progresses to severe stage, if it's not treated, more than 50% of these patients pass away, and hence require intervention to help give them a better quality of life, and ultimately life itself to help these patients. So in this context, if I simply put numbers to where the market is today, just looking at the three largest geographies that I can think of, China, US and Japan as large medical device markets, it's estimated that more than 25 million people have Mr ongoing today. And if you look at reimbursement pathway and where these devices would be reimbursed, you're looking at the reimbursement of 40 or 50k per device for treatment. So overall, this market opportunity is in the billions of dollars, 20 to $30 billion estimated right now, and is only expected to grow. So in this context, it's not surprising that a number of companies are developing technologies, replacement technologies, to not only access the market and help the patient, but also grow their revenue over a longer period of time. So it's if you look at 2015 to 2017 acquisitions in the field, ranging more than $2 billion with very few human experiences happened, and these technologies are still in clinical trials right now, if you look at it. So one question that always gets asked is, what's taking it so long? If these were acquired in 2016 and 2017 why haven't we commercialized any of these technologies? Yet? The simple answer to that is to a study I'll point out at the far right corner of the slide, the scalability of these technologies and when applying to these patients is being is in question. And there's a study that came out in 2022 that clearly showed maybe 30% of these patients are treatable with these technologies, 70% of these patients are not and that limits scalability of these technologies. So if you look at it from that context, what we came up with was an extremely creative and an extremely different solution. Our approach was, why do what everyone else has done in accessing the mitral valve or the left ventricle to keep the device in place? Why not go above the mitral valve into the left atrium and use that to treat the MR in these patients, by design, by construction is extremely simple. It's a stent. We use stents all over the body. It has a valve inside it. Again, there's nothing novel about the valve that's used all over the body, and you have a fabric that goes at the bottom of the implant to prevent any leak from going around. So from a con. Construction. It's a very simple technology. The biggest difference is how we apply it. By going atrial we're doing what no one else attempted to do. So when we came out with this design, when we came out with this technology, six years ago, I still vividly remember the first two reactions I got from nearly everybody I talked to. 99% of the people said, this is highly innovative, highly creative. The remaining 1% said, Why didn't I think about it? And the second question was always, does it work? Do we introduce any new clinical issues that others are not thinking about? And that's a question I will answer today with enough human clinical data to show that it works and helps patients. The key to the technology by simplicity of its design, we eliminate right off the bat issues that other technologies in this field are seeing right now. The second most important part is, I can have a great implant. It is a creative implant. The onus is on us as a company to show if it works in patients or not. But the second most important thing is, how do we deliver the technology? It has to be simple. It has to be easy to use. It has to be easy to learn for physicians, and it has to be proven out in clinical situations that you can do it predictably. We have a transeptile delivery system. What it means is, you go through the growing of patients. You access the heart by going through all the way to the heart, deploy the implant, come out. Most of these patients, because you're going through the groin and going through the leg, can go home the next day. That's the beauty of the technology. We have one of the smallest sized delivery system in clinical trials. It's a 29 French system with proven clinical experiences as well. So I'll start our clinical journey and to share with you what we have done so far by illustrating what are the different types of patients and anatomies. We have treated the etiology of the disease does not matter to us. We have treated patients who are considered primary. Mr, we have treated patients who are considered secondary Mr a number of patients, as I said, are evaluated and rejected by other technologies. We have treated a huge volume of those patients as part of our clinical experiences to demonstrate what other technologies cannot treat. We can treat those patients. We have treated patients with calcium. We have treated patients with prior implants. None of those have been a constraint to us. Our clinical experience are glowing on a week to week basis. We are right now, more than 70 patients treated, and I'll walk you through two important pieces of data. One is we have run and finished a phase one clinical trial, the early feasibility trial in US and Europe and we have done with the transeptal system, including all compassionate use patients. We have treated more than 30 patients with this current system that we have so talked about transeptal delivery system. I talked about our implant. I'll show you how it works. I'll give you a specific example of the complexity of the disease and why and how we are able to do more cases than other technologies can. Here's an example of a patient we treated about eight months, nine months ago, in Minneapolis. This patient, at that time, was 85 years old. He he was evaluated by three other technologies, and all three technologies said no to treating the patients because of two reasons. Patient had a lot of calcium. And number two, the patient had a small left ventricle, which means if they implant their technology, they could cut off the blood flow to the rest of the body, potentially. Here's how the procedure went. You can see the huge chunk of calcium. Here's our system coming in. This is taken from the procedure. We're steering our system down to the calcium. Open up our valve. In this case, we engage with the anatomy. You have calcium here, you engage with it. Open up the rest of the implant, evaluate its position, assess its function, and you confirm everything is good before you release the implant from the delivery system. There's one another feature I want to highlight, if for any reason, the physician does not feel the position or function is good, you can recapture that implant back into the catheter and take it out if it's necessary. That is again unique to our system. So. How long did the procedure take? 35 minutes. And that's an example of a complex anatomy. Physician doing the first case without technology. Never had experience with it before. Yet they're able to finish the procedure in a very short duration of time. So if I put the entirety of our transeptile experiences, including all compassionate use patients, again, for those of you who are not aware of what a compassionate use patients are, these are end stage of life patients. They don't have any other options in life. 30 plus patients we have treated 90 plus percent technical success. That's our ability to deploy the implant and successfully treat Mr if you look at the clinical outcomes at 30 days and six months, 11% mortality rate, it's especially in this patient population. That's something that I'm extremely proud of, and as a team that we have helped these patients. If you look at how the device is doing, 80% of these patients, you completely remove mitral regurgitation by immediately implanting the device, their quality of life improves immensely just because you're able to remove that leakage from those valves. As I highlighted, our procedure times are less than an hour. Last week, we did our fastest procedure at 18 minutes. And again, that shows you an example of the ability of our device to help these patients, as well as to make the lives of physicians simpler as they're implanting the device. So what is our value proposition? I think I've told this only, like 18 times during this presentation, we can treat more patients than other technologies can, and that's by design, and that's by the unique features of our design right now, if you look at the publication for a comparison, 30% of patients are treatable by other technologies. In our case, 70% of patients are treatable. Can others catch up? Yes, potentially, if they do a major redesign of their technologies, they may be able to start capturing into the patients that we can do, but it's going to take time and effort, and we are well ahead in that race. So what are the next steps for us? We have finished our early feasibility trial, as I mentioned, we have discussed with FDA on our next steps to start the pivotal trial. We are planning to run the pivotal trial on patients who are considered as high risk, a prohibitive risk for surgery. There's two arms to the trial. It's a single arm trial design for patients with no calcium. We'll be doing 350 patients, for patients with calcium, 100 patients. Our goal is to start this trial in June, July of this year in Europe first. And we are well on track to do that. And we are planning to start the trial in the US around September, timeframe that'll put us in a position to commercialize the device in Europe, anticipated in 2026 and in 2027 we anticipate that in the US as well. So of course, like everyone else, we are fundraising to support the pivotal trial. We are in our series D fundraising. We have raised 100 million in US dollars thus far, and we are targeting a raise of 50 million, which will put us at the doorstep of European commercialization. We do have a term sheet in place. We have signed it with it's being co led by a strategic investor and a VC. If any of you would like to have a conversation and learn more about us, I would welcome the opportunity to summarize, we talk about creative devices. We talk about innovative platforms. We have one of those with proven clinical experiences. We have a transeptile delivery system with clinical data to substantiate our ability to help patients. We are uniquely positioned to be one of the better players and the market leaders in the future in the mitral valve replacement, and we are in the process of fundraising for those who may be interested for our conversation. Thank you so much for your time today. Thank.