Morning everyone, and thank you for joining the 27th Annual HC Wainwright Global Investment Conference 2025. My name is Daniel Smith, and I'm an H.C. Wainwright Equity Research Associate in Biotechnology. With that said, let me introduce our presenter for this session. I'd like to welcome Eric Schlorff, CEO of SeaStar Medical, who are developing their QUELIMMUNE Selective Cytopheretic Device for immune-related renal injuries. SeaStar Medical trades on the NASDAQ under the ticker ICU. Eric, the floor is yours.
Thanks, Daniel, and thanks to HC Wainwright for allowing us to present to the investors today. SeaStar Medical is focused, as Daniel said, on transforming treatments for critically ill patients facing organ failure and potential loss of life. We are traded under the ticker symbol ICU, like Intensive Care Unit, which is where the therapy actually takes place. I will refer you to the forward-looking statements, which you all are aware of. Please review at your leisure. As we look at the investment highlights, there really is, this is a best-in-class technology, and it's actually more of a platform than anything else, and we'll walk you through that later in this presentation. We are commercializing our first indication. This is actually FDA approved for children that have acute kidney injury with sepsis. This was actually approved under a humanitarian device exemption in 2024.
As Daniel said, the Selective Cytopheretic Device, or SCD, is also branded as QUELIMMUNE for children. We are also undergoing a pivotal study, which is a registration study needed to be able to file a PMA or premarket approval in 2026. This has multi-billion dollar potential, and you'll see both from an acute as well as from chronic indications. Interestingly, it is the same mechanism of action across all the multiple indications. When we look at the pipeline, what you'll see here is the pipeline is built off the first, which is the commercialized product in children, which you see we have launched now and begin sales. We also have several adult indications. These adult indications that we have are all under the breakthrough device designation as well. We have about six of these indications now that are through the breakthrough device.
You can see NEUTRALIZE-AKI, which is that pivotal or registration trial that I talked about, is now 90 or 60% enrolled. You'll also see we have another study in cardiorenal, which is a bridge to LVAD or left ventricular assist device. That is actually being funded through one of our partners through an NIH grant. You can also see several other indications like end-stage renal disease, AKI, chronic dialysis, hepatorenal, which means liver and kidneys, as well as systemic inflammatory response in cardiac surgery patients. That's also for both adults as well as children. Those are all under the breakthrough device designation. Interestingly, as well, investors should also note that it is the same device that's used in all these adult indications. The pediatric device is a little bit different just because it's smaller because children are smaller.
You can really think about it from a really kind of a leverage play. It really does drive a really nice economics. Let's start a little bit with the market opportunity in adult AKI, which is the near-term milestone and near-term market potential. As I've said, the pediatric AKI market or acute kidney market is about $100 million. There's about 4,000 patients in the U.S. The adult population really is where the real market potential is for SeaStar Medical and for our investor base. You can see that that is actually about 50 times larger, over 200,000 patients in the U.S. each and every year. What you start to also see here is that market potential is around $4.5 billion annually. What is actually the problem that we're addressing?
As you guys all know, there's always things in the intensive care unit where maybe somebody has infection, trauma, surgery, and this could be bacteria, viruses. The immune system kicks off an immune response called the innate immune response, and this actually involves things that are called activated neutrophils and activated monocytes. Think of these as the angry immune cells that are actually driving more cytokine production. Hyperinflammation is also known as the cytokine storm, which is more commonly referred to. If you look at all of these little kind of triangles and dots, these are all the different types of cytokines that really go out into the body to signal that the storm is underway. This is really important because what you'll see on the next slide is we actually quell this immune system at the source, which are the neutrophils and monocytes.
Many of the drug companies are actually going after each one of these different little points or cytokines, which obviously there's a lot of redundancies built into the immune system, which is why some of the clinical results that you see in many of these critically ill patients have been very varied. At the end, what you also do see is that end-organ damage and even death is one of the outcomes that you'll see. You'll see from our own clinical data how we've been able to actually demonstrate the efficacy of the Selective Cytopheretic Device. When you think about the cytokine storm and how it works, there's an insult or injury that happens at the epithelial cells. The neutrophils or monocytes or immune cells get angry. That's where we target. You have this cascade that happens. This really is the whole heart of it.
What we've been able to show is that we can neutralize these monocytes and neutrophils into homeostasis and actually put them from a more pro-inflammatory state more into a reparative. This gives the audience and the investors a little bit more detail that it's actually doing things at a very selective basis. You'll see on the next slide how the actual device works. We essentially are binding many of these neutrophils and monocytes in these various ratios. Under a low calcium environment, it actually is driving a lot of this. What you really do also see is that it's real-time cell processing without immunosuppression. This is always a question we get: you must be suppressing the immune system kind of like a corticosteroid or steroids, but we do not.
We've actually been able to show that even patients that are on steroids, the SC D or QUELIMMUNE works just as advertised. How does it actually work? The standard of care today is what we call a hemofilter. If you think of dialysis, CRRT is continuous renal replacement therapy, is continuous dialysis in the intensive care unit. The way it works is with using an anticoagulant, in this case, it's regional citrate anticoagulation. What you really see here is that the hemofilter, the blood goes through, goes into the SCD, or Selective Cytopheretic Device under a low calcium environment. It's actually the cells, these activated neutrophils and monocytes bind selectively to the fibers inside the SCD in a low calcium environment. They're driven into what we call apoptosis or cell death.
They then dissociate from it or detach from it and then go back into the body, signaling that the storm is over. That's actually how simply it works. It's a very elegant solution to a very complicated problem. We believe in what you'll see in the clinical results is that it is a viable solution. We've been able to show that in many different ways through our clinical studies. Let's talk a little bit about the need. You're looking at pediatric patients that have acute kidney injury. They are vulnerable to cytokines, cytokine storms, or hyperinflammation. Despite the supportive treatments, and we use the word supportive a lot because things like CRRT or continuous renal replacement are supportive. What we're actually doing is disease modifying. We're actually changing the course of disease. In the ICU, about a quarter of the patients that are admitted have acute kidney injury.
They stay in the hospital twice as long. It's a coin flip whether that child will actually live or die. On top of it, those that do survive, about 30% have long-term chronic diseases that can be associated with it. The problem still exists. What is the clinical data that we've shown? If you look at standard of care, it's about 50%, as I said, and about 10%- 30% of those patients will be dialysis dependent, which means they're on long-term dialysis for the rest of their life. Obviously, that's not the outcome that we look for and we would want. What we've been able to show in our clinical studies, this is through two different studies of around 22 patients, which was the basis of our FDA approval. We were able to improve survival, so increase survival by 50 some % to around 77%.
No patient was on dialysis, meaning after 60 days, the patient is free and clear of dialysis with no other need for it. There were no serious adverse events, infections, or immunosuppression. While we started in children, what you do see here is that it is really the same in adults. The problem is still there. The clinical results that we've been able to show to date have shown the same outcomes that we have in children, which is significant reduction in the amount of mortality rate in that adult population, as well as no dialysis dependency at day 60. This is really obviously important that the investors understand that what we're seeing in children is very likely what we're going to see in adults as well.
This just also gives you, the investor, a little bit more insight as to the number of patients we've treated, but more specifically that we have seen no device-related serious adverse events. We've also seen no infections. Also, it's important to note that half of the patients that are even in the clinical results that we've shown were septic or had sepsis. Obviously, sepsis is one of the holy grails of medicine. It is a huge problem that has yet to be solved. This is where QUELIMMUNE comes in. QUELIMMUNE for kids is actually approved for acute kidney injury patients requiring CRRT and with sepsis or septic condition. We started shipping our product in July of 2024. We currently have eight U.S. pediatric children's hospitals.
You can see really the strategy here is to focus on the top 50 children's hospitals in the United States, where about 50% of the acute kidney injury patients are going to be. It is really looking at targeting those early adopters. This does run through investigational review boards or IRBs, which means that it does require the hospitals to approve that. One of the things that we have found is that the IRBs approve a humanitarian device exemption or that piece of it, but also, the FDA is mandated that we have a patient registry, which means we are tracking the patients that were treated. We'll talk a little bit about some of the early results there. The other things we're doing is we're deploying our nursing team and other experts to ensure that smooth transition across it.
We've also, we are in full control of our sales and distribution model and reducing any middleman fees so that we can really have the best experience for our hospitals and for our customers. What do health economics say about the SCD or QUELIMMUNE in children? What you see here is that with the median length of stay with the SCD in children was around 28 days versus a database or registry that was around 31 days. We saved about three days of the hospital stay. You can see the savings cost. When a hospital uses the SCD in six days of therapy, they actually make money because of the way the economics are set up. We believe that this really sets us up for commercial success as we continue to roll out the adoption. What are some of the early results? This was the first 20 patients.
This was actually 28-day survival. This was the SAVE registry, SAVE surveillance registry, which is assessing how the therapy is doing. This was collected. Just recently, a few weeks ago, we had a press release out that we showed that we saw the same reduction in mortality rates or the same survival rate of around 75% in this very, very sick patient population. Further information and data will be presented later in September at a conference where we'll be sharing more details about dialysis dependency, day 60, day 90 data, as well as some of the further demographic data as well. In adults, as we've kind of walked through the adults or the pediatric side, what you see here is that in the U.S., there's about 200,000 adults that have acute kidney injury. Again, there's a severe mortality issue of around 50%.
Those that do have severe AKI episodes have about eight times more likelihood that they're going to progress into end-stage renal disease. As our audience knows, the cost of dialysis on a yearly basis is about $100,000. There was a Newsweek article that for the investor they can click on, but they cited AKI as a post-operative risk in cardiac surgery. If you think back to one of the opening slides where we walked through the pipeline, obviously cardiac surgery is one of the areas where we'll be focusing in the future. What does the clinical study look like that we're undergoing today? This is a pivotal study. It's a randomized controlled study using the standard of care, which is CRRT or continuous renal replacement therapy with the SCD on the treatment arm. This is a 200-person study. We are around 125 patients now enrolled.
The post-treatment is around five days. This is up to 10 treatment days. That's a 90-day primary endpoint of all-cause mortality or dialysis dependency. This is very important because this is really looking at hard endpoints. We're not looking at biomarkers or anything of those to get the approval. It really is around, is the patient alive or are they dead and are they on dialysis or not dialysis? We also have a one-year follow-up, which is really important for the audience to understand because what we are showing is that at day 90, if that patient is not on dialysis, that means that they don't have chronic kidney disease by definition. We're going to show through this that it is a durable solution, which is what we've been able to show at day 90.
Unless that patient undergoes another episode of acute kidney injury through a different insult like infection, surgery, trauma, we do not anticipate any changes in the outcome there. It's also important, as I've said, that the target was around half the patients will be septic, which is one of those key populations that are undergoing or underneath this, as well as acute respiratory distress syndrome. As Kevin mentioned, Dr. Kevin Chung on our earnings call here recently, we are selecting out the patients that have high inflammation, which is actually through the C-reactive protein. We're making sure that those patients that are being treated with the SCD in adults have a high level of inflammation, which then bodes well to the potential outcomes. Where are we at?
We have 16 activated sites, and you can see from here on the right, we have some of the sites, and not to mention all of them, but folks like Stanford, Cleveland Clinic, Mayo, University of Michigan, etc. This is really a mix of academic, military, and community hospitals. The reason we've designed this way is we really want to show the broad nature of the therapy across all different types of hospital systems. We do have CMS reimbursement for the trial itself.
We have an interim data review or interim analysis that will be the first 100 patients, sometime still this quarter in Q3, where the Data Safety Monitoring Board will provide us with a recommendation of continuing the study or the various different types of outcomes, which could be stopping early, stopping early because it's successful, stopping early because it's futile, or maybe even a resizing of the patient population, the study population. The final analysis, once we're done finally enrolling the study, it is a 90-day endpoint. It is a very short endpoint in the grand scheme of things where we'll present the, obviously, the results of that. The plan right now is to have the PMA filing in the second half of 2026.
When you think about medical education and medical affairs, we really want to show that the platform here is really where the additional value is in SeaStar Medical. That's what we do through things like case study reports, publish different manuscripts, scientific meetings. We have a world-class scientific advisory board, research grants, that non-dilutive funding, all of those types of activities are really known to really drive the science, to really show the breadth and the depth of the potential use of the Selective Cytopheretic Device in future indications. Our capital structure is very clean. As I've said, we are traded under the ticker symbol ICU. The price as of 8/12 was $0.73. We had just under about 28 million shares outstanding. You can see our market cap as well as the warrants outstanding. It is really critical to note that we have no interest-bearing debt.
We also had raised around $8.6 million additional capital in the July timeframe. Many of the catalysts you can see here as we kind of march down in 2025, we're really continuing to focus on launching up to that 20 hospital systems for the QUELIMMUNE pediatric opportunity, as well as completing enrollment of the pivotal study in adult AKI. In 2026, it really will be top line for the adult study, as well as that submission, as well as that we believe that we'll have some top line data for severe cardiorenal, as well as additional breakthrough device designations. The team that's been together here consists of myself, Dr. Kevin Chung, our Chief Medical Officer, Dr. Sai Iyer , who leads our Medical Affairs effort, as well as Tom Mullen, our SVP of Manufacturing and Product Development, and then Tim Verichek, the Senior Vice President of Commercial Operations.
You can see that they've had great experience also in many of the pharmaceutical companies. If I kind of conclude the whole presentation, this really is a best-in-class technology. We are commercializing our first product, our first indication in children. You see where we're at on the progress on the adult pivotal study, and it's a multi-billion dollar market opportunity. With that, thank you for listening today.