Video Transcription
Steve Sandweg 00:02
It's a great honor to have the opportunity to provide you all with an update on Valcare Medical, tell you a little bit about who we are, what we're doing, and more importantly, why we are doing it. What I've tried to figure out is, how do I get 30 minutes of really good, exciting developments crammed into nine minutes? So I'll do my very best. So in any event, Valcare Medical is a leading innovator of transcatheter-based mitral valve solutions. The Amend annuloplasty ring was designed to treat patients suffering from severe mitral regurgitation who are not considered surgical candidates. So what do we know? For those of you unfamiliar with mitral regurgitation, referred to as MR, it is a disorder in which the mitral valve on the left side of the heart does not close properly. It allows blood to leak backward. So what happens is, basically, if these are the leaflets in your valve, right, and you've got unnecessary stress, what happens is the ventricle, the muscle weakens. The ventricle expands as a result. Your God-given ring, your annulus dilates as well. What does that do? It pulls the leaflets apart. What does that propagate? It propagates regurgitation. Why is that a problem? It leads to heart failure. So mitral regurgitation is the most common type of heart valve disease, affecting 2% or 140 million patients globally. Now, within that, four to 5% are considered severe. That's 6.5 million patients. So why is that number important? It's important because if left untreated, 50% of those patients are going to die in five years. So how do physicians go about treating these very sick patients? Well, one, there's obviously a surgical repair solution, right? The surgical mitral valve repair is the gold standard. Why is it the gold standard? This is really good; the results, the safety, the efficacy, the longitudinal results are incredibly impressive, but 50% of the patients that suffer from severe MR are not eligible for surgery, right? So what are their options? Well, there's a transcatheter-based solution called edge-to-edge repair. It's abbreviated TEER, right? There are two commercial devices available today. One is Abbott's MitraClip. The other is Edwards' Pascal. And basically, what a physician does, instead of a surgeon, is an interventional cardiologist, using wires and catheters, they go down and with the left ventricle, they will literally clip the leaflets, right? And the data is good. The data is encouraging, right? It's a very safe procedure, and you're always going to get a reasonably good acute result. So that being said, there are two challenges with regard to this particular therapy. Well, let me back up and just mention also it's a billion-dollar space. 200,000 patients have been treated to date. So big space, right? The problem is that both therapies, both Abbott and Edwards' therapy are what they call not forward compatible. Meaning, once the leaflets are clipped, that's it. Good luck. Hope you have a good result. If you don't, well, there's really not much of an alternative; the only meaningful alternative is surgery. And as I mentioned, these were non-surgical candidates to begin with. So despite all of that, we continue to have an incredibly large unmet clinical need. That billion-dollar space I referred to realistically should be $2 billion. Why? It's driven because 20% of these non-surgical patients are also not eligible for TEER based on anatomical restrictions, and an additional 20% are considered off-label. Those would be patients with preserved ejection fractions of 50% or greater. And then lastly, the landmark study that I made reference to earlier, Abbott's COAPT study, their own data shows that at one year, a third of the patients still have an MR score of moderate or greater. So I've often said it's a simple procedure; it's safe. You're not going to do any harm. And today's interventional cardiologists see it as a hammer, and every patient is a nail, right? They don't have any alternative. So what does that mean as it relates to the investment opportunity? I'll talk a little bit on an upcoming slide, as it relates to our current restructure recap and what have you, but structural heart, as most of you know, is a massive space estimated to be north of $6 billion within the next three to four years, half of that coming from transcatheter-based mitral repair and replacement solutions like Amend. So let me introduce you to Amend, right? This is based on the surgical predicate. It is a D-shaped closed ring designed to, as I indicated, be the predicate on surgery and provide what they call anterior-posterior reduction. So what a surgeon does is basically, when they put a ring in, the ring is put in there to stabilize and provide structure. And what it'll do is it'll pull that dilated annulus back, and as a result, you start to bring those leaflets back and they coapt. Okay, I'm going to run a quick video. So what I've done, in addition to an animation, I think it's always important to show the procedure. Everyone's animation is award-winning, but this has got a split screen that shows the device that's going to be delivered both fluoroscopically and with echocardiography as well. It's a typical transseptal procedure, just like the Pascal and the MitraClip. It's a slotted nitinol tube, right? Nitinol is a memory metal. Once it's delivered through the sheath, it's going to take its form in the atrium, right? Once it's in position, the ring will be locked, right? And then the device will be navigated and oriented across the mitral plane. Once that happens, those two yellow wires, those are track anchors. They're temporary anchors. They're basically designed to stabilize where you're positioning, and you're going to anchor the device at the annulus. They'll be buried in the trigons, which is the strongest structure within the annulus, and then, in order to achieve anterior-posterior reduction, the tracks will push to maintain and achieve a posterior position. The anchors will be deployed in a two-step process, button one, button two, P1, P3, and then the device will be pulled to literally cinch everything down. And the same process will happen on the anterior side. These rings are a big differentiator from previous technologies. There were all sorts of issues as it relates to how long it took, issues with regards to dehiscence, which is detachment. We'll talk a little bit more about that, and then we've got some imaging, both 3D transesophageal echo as well as fluoroscopic images. So at the end of the day, this is about getting not only a good acute result, right? So here's some color Doppler to show you. This is a baseline pre-procedure that showed severe MR, and then post-procedure, you see really good acute results, similar to MitraClip. But what does it mean beyond that, even at 30 days? And keep in mind this patient I'm showing you is our second patient; the 30-day follow-up looks fantastic. So we have now treated 17 patients successfully in our first-in-man study with outstanding results: no death, no stroke, no MI, and all of these 13 patients that have been tracked out to six months not only show a reduction from severe down to milder trace, but it's maintained over those six months, which is incredibly important. In addition to those 17, we're leveraging that, right? We're building a whole clinical story, a portfolio around this; we need to deliver the data and provide the proof. We've initiated an EU pilot study. We did that in the first quarter of this year. We're going to treat up to 20 patients in five sites. We've now treated four. We've got a patient we're going to be treating in Italy on Monday of this coming week, and another patient, our sixth patient, will be treated on the 30th of this month. Following that, that'll take place this year. Following that, in 2025, we'll initiate our US early feasibility study. The FDA attitude is, "Listen, you're gonna need to demonstrate that you can go it alone, right? That somehow you're not gonna be dependent on some sort of MitraClip." Because the surgeons, oftentimes, will not only put a ring in, they'll do leaflet repair, resection, chordal repair, and that sort of thing. So we'll initiate that in Q1 with 15 patients across five sites.
Steve Sandweg 08:42
So before I jump into the milestones and what we're looking to do, I think it's important to provide just a quick snapshot of the company's history. It's very important. So the company was founded in 2012, right? It's been around a while, right? It was founded in Irvine, and then within a year, it was moved to Israel. It's usually the other way around, but in this instance, it's now in Israel. We're a US-based company, but we do have our R&D manufacturing in Israel. The company raised $70 million and did a really nice job. They had very broad ambitions as it relates to, "Hey, we can increase value in the eyes of strategics by developing not only a mitral repair but a mitral replacement and a tricuspid." And although that's noble, they struggled to achieve any meaningful milestones, and as a result, they ran out of money. So what happened is, at the end of last year, Tech Wald, who was a minority shareholder out of Milan at about 5%, came in and did an asset purchase, a complete recap, right? And then they dropped in $10 million. That $10 million is being spent this year to enroll the EU pilot study I just made reference to. Where we are today is we're looking for one or two more partners to raise the incremental $15 to $20 million to get us through the early feasibility study in the United States. At that point, we will have more data than any prior annuloplasty ring that's ever come on the market, and it will be an appropriate time to shop the company. Right? I've had an opportunity to sit with all of the strategics. They love the fact that you guys are finally focused. You're looking at this through the lens of how we look at it, right? But there's a little bit of muddied waters just based on a couple of therapies you may or may not be aware of, called Millipede. Boston Scientific acquired them for $400 million. And CardioBand, which is originally Baltics, Edwards acquired them for $700 million. Neither one are available. I say there's two bloody bodies on the side of the road. So the bar is a little bit higher for us, and we take that obligation very, very seriously, and we are going to deliver the data and provide the proof. So we don't have a big team. We have a very small team, but we have a very effective team. I'm incredibly proud to lead this group of individuals. Nada Yan is our general manager, Dr. David Mirkin, who is our chief medical officer, and Anahita Naderi. They're fantastic. Their commitment to excellence in everything we do is, quite frankly, inspiring, and it is a complete delight. With regards to our Scientific Advisory Board, I can say the same thing. I often refer to these guys as the Valcare Medical SEAL Team Five. Right? They do a remarkable job as we're charting our clinical strategy. They tap our rudder. They keep us on track. They make sure they're interfacing with the strategics, making sure they're providing intelligence, and then also making sure that we stay out of harm's way. And then I just want to take a quick moment with regards to IP. This is a differentiator for us. This is a differentiator for us in terms of we've got 84 patents, and we're very, very well protected. So that said, thank you all. I appreciate the opportunity, and I look forward to entertaining any discussions with any investors that would be interested in learning more about Valcare Medical. Thank you. Applause.
