Myles Greenburg, Alucent Biomedical - Natural Vascular Scaffolding (NVS) | LSI USA '24

Myles Greenburg  0:04  
My name is Myles Greenberg. I'm the CEO of Alucent biomedical. I started my career actually as a physician back about 25 years ago, taking care of patients. And have spent the last bit of time, last 24 years in the startup world, in biotech and medical devices and healthcare services, and the startups that always got me really excited were ones that treated patients that had a huge unmet need in a very common condition. So I want to tell you about elucidant biomedical today, because we're treating just such a condition, and that is kidney failure and kidney replacement therapy. So this is a very common problem. Patients lose function of their kidneys. Medicare actually spends $50 billion a year on the care of these patients. There's over 750,000 patients in the US suffering from kidney failure. And these patients are tough to deal with. They're they've got lot of problems. They spend a lot of time dealing with the access that they need for hemodialysis. Hemodialysis therapy being the main treatment for kidney failure, they need high flow access in order to be attached to a dialysis machine, and this high flow access is difficult to create and to maintain, so much so that you see, there's over a million procedures per year in the United States that occur for both the creation and the repair of dialysis access, and this is a billion dollars of expenditure per year. Medicare, being the primary payer in the US, is very interested in trying to reduce the complication rates and the amount of suffering that their patients go through for that kind of dialysis access. So let's talk a little bit about dialysis access, because that's what we're focused on at elucid. There's basically three ways of obtaining that arteriovenous fistula, which is a connection between the artery and the vein and the arm, and that's the preferred method of doing it, and then catheter or graft access, aVF is the preferred methodology, and it's preferred because you're not sticking a foreign body in the patient that can then get infected, get clotted, cause complications. But every patient doesn't get AVF because of the existing Achilles heel with AV fistulas, and that is that those fistulas can take a long time to mature and often don't mature. When I say mature, what I mean is that the fistula gets big enough and wide enough a big pipe for you to be able to get high flow bloodstream, high flow access through this is the unmet need that we're looking to treat at elusive it is surgical AV fistula creation that allows for three times a week, dialysis access in the patient. And the main takeaway from this slide is that up to 60% of the time, that's a huge number. 60% of the time these fistulas fail to mature, and in addition to that, oftentimes, to get them to mature, you need to do repeated maturation procedures one after another. And you can imagine what this is like for the patient and also for the payer who's paying for it. This simple schematic will give you an idea of what I'm talking about. You take a normal vein that's designed for low pressure, you hook it up to a high flow artery. And what you want to have happen is you want to get this successful AVF maturation, where you get a nice, big pipe. What often happens, however, is that you end up with an injury response, and that pipe kind of grows inward and you end up with a straw instead of a pipe, which can't really be used for dialysis. So along comes a Lucent and our proprietary technology that we call Lucent NVS. What that is is a it is comprised of three components, a novel, photoactivatable small molecule, a light fiber that activates the molecule at the proper wavelength, and a balloon catheter that both delivers the drug and dilates the vein. And what we're trying to do is to create what we call a natural vascular scaffold, which essentially is a reinforcement and dilation of the venous side of the fistula just before attaching it to the artery. These three components are integrated into a very simple to use device you can see here in this picture. So this is a balloon catheter with our yellow, orange colored drug coated on the balloon and an integrated light fiber then attached to a small outside light source. It's a two minute procedure that the physician, the vascular surgeon, in this case, can apply during the course of AVF surgery doesn't really interrupt their workflow, cause them a lot of time, and it's very intuitive, because they're used to using products like this. I promise. I'll go light on the science here, but here's how the 10. Technology actually works. This drug is introduced off the balloon into the vein, is then activated with 450 nanometer blue light. When that happens, it is a catalyst to create direct linkages between the structural proteins in the vessel wall, namely collagen and elastin. And by doing that in the presence of an open balloon, we create a natural vascular scaffold and a reinforcement and an ability for that vein to properly mature. This slide is from our very first animal study that we did in ABF so you don't have to be a histologist, of which, by the way, I am not, in order to appreciate the difference between these two sides of the slide. So this is an animal that had animals that had AV fistulas created on the left hand side of the slide you can see a nice, wide open pipe. What I'm talking about. On the right hand side of the slide you can see an untreated animal that develops a straw instead of a pipe. I just hit the tip of the iceberg, of course, and all of the science and animal work that we've done over the years to get ready for human studies, we are now just about finished with our first human study that we call activate aVF. We've enrolled 27 patients in what will be a 30 patient study of patients undergoing surgical AVF formation. This is the design of the study. I'm not going to go through this, but suffice to say, what we are doing is taking those patients, looking at their fistulas and then determining whether they're mature or not mature. To give you an idea of how to interpret this data, it's important that you know what the current standard is this study, the HFM study is about a 600 patient study. It's the largest cohort of AV fistulas that was ever looked at to determine the success rate. And the takeaway from this slide is that less than 30% less than 30% of these patients at three months have a mature, wide open fistula, and many of these patients undergo multiple complications and multiple repeat procedures in order to get mature. So with that said, let's take a quick look at our interim data. First of all, the therapy is extremely safe. We've only had one patient of the 27 that has had an early complication, much lower than the rate in AB fistula surgery, so we have a safe technology. The two endpoints that we're looking at are measures of maturation. So like the general population, our study is looking at patients both who are already on dialysis, who require a fistula, as well as patients who the doctor anticipates dialysis is going to be necessary in the coming months. So in order to measure maturation, we do it both physiologically, using ultrasound to look and see how much flow is going through that pipe and how big it is, as well as the patients that are already on dialysis. The acid test. Can the fistula be cannulated? Can you actually complete dialysis through it, and this is the data that we've generated to date, which I'm very excited about. What this says is that we are doubling the rate of maturation at three months compared to the numbers I just showed you before. And not only we doubling it with the hard end point, but several of the subjects that are, quote, in the failure bucket today are actually proceeding towards maturation, so we're looking at a very high success rate here with very high flows and vein diameter. Maybe even more exciting is that of the six patients that have actually required dialysis in our core cohort, all six of them have been able to be dialyzed through the fistulas treated with elucid NVS, so 100% success rate to date. And just as importantly, it's only taken 43 days on average to get from the surgery to maturation, which is much faster than is typically seen during surgery without our technology. I'm quite proud of the achievements that we've accomplished as a company since spinning out from the research institute where we started. We are finishing up, as I mentioned, the activate AVS study, and our goal is to get into a pivotal study starting early next year, with the aim of FDA approval. I'm also very proud of the team that we've put together in order to run a drug device combination therapy company, you have to have people with a lot of expertise, and my senior team has an average of over 20 years of experience in either the pharmaceutical industry, the device industry, or both. Likewise, when you have an exciting technology, you try to use that to attract a great scientific and clinical advisory board, and we've been really lucky at bringing some of the leading lights and dialysis access into this company as scientific and clinical advisors. Those of you who are in the field will recognize some of these names. They've been the leading PIs in many studies in the field.

Speaker 1  9:57  
It would also be remiss of me as a CEO of a company. Any that has an exciting technology. Not to talk to you about some of the other indications that we could possibly pursue with this technology, and on the basis of the success that we're having here, these are a number of the areas, both in dialysis access, as well as in vascular more broadly, that we might consider pursuing in the future. Why am I here today? Well, like everybody else, I'm raising money, and we're just initiating a Series C financing effort. The effort is intended to finance the pivotal study, the 350 patient randomized clinical study that we would like to run for FDA approval and run the company over the course of the next 36 months to get to that data and to PMA submission. We believe this is a compelling opportunity. We have a large unmet need with really no competition in the field. We have early, promising clinical data that suggests we can be successful in a pivotal study, we have a tremendous cost savings opportunity for CMS and hospital systems broadly, a simple and intuitive, easy to use product for the physician, a pivotal study that has clear and near term endpoints and also success in this indication, we believe, can be added onto with other fields where we can create value. Thank you very much for your attention, and I'd be happy to talk with any of you interested afterwards. You.