Good morning, and thank you for having me today. I'm Eric Schlorff, CEO of SeaStar Medical. The ticker symbol is ICU. We're traded on Nasdaq. SeaStar Medical is a company that is focused on treating critically ill patients facing organ failure and potential loss of life. I'll walk you through our story today, and I really do appreciate you guys taking the time to listen to our story. There's forward-looking statements that you can read at your leisure. Please refer to the SEC, or Securities and Exchange Commission, as well. What is our mission? Our mission is quite simple. It is to stop organ failure and save lives. We've actually done this through our therapy called the SCD. We've demonstrated this through many clinical studies that we've done throughout the years. Our goal really is to expand indications in areas of treatment. The SCD is agnostic to the disease state.
This is actually shown through six different FDA breakthrough device designations that were awarded to us for both the ICU as well as clinical settings. This is the first and only therapy to neutralize destructive hyperinflammation. It's patent-protected and has very high gross margins that really drive the efficient commercialization strategy. Our initial indication is in kids in the United States. The pediatric AKI market is about $100 million. This is about 4,000 children in the United States annually. We launched this in Q3 of 2024. While it is an important market to really show from a risk standpoint that we can de-risk it in terms of regulatory, the real market potential here is in adults, which is 50 times the size or 200,000 or about a $4.5 billion market potential. That clinical study is underway.
Just recently, we also announced that we received from CMS an ICD-10-PCS code that basically will be effective October 1st, 2026. This is important because this will enable inpatient billing as well as support rapid adoption and reimbursement. What is the problem that we're actually addressing? Hyperinflammation is something that does lead to multi-organ damage as well as death. How has it started? This can be either from bacterial infection, viral, surgery, trauma. The first responders are the activated neutrophils and monocytes. These are the molecules or immune cells that first go to the site of injury. From there, these monocytes and neutrophils then excrete cytokines, which we've all heard about that. Once it becomes out of control, that's what's called the cytokine storm. That cytokine storm, when left uncontrolled, can cause permanent organ damage as well as death.
The setup and how we deliver the therapy is actually quite simple. If you think about a dialysis circuit, this is one that's done continuously. We are a simple add-on. It takes about 15 minutes for the hospital staff to add our SCD on in a controlled environment. We're able to let the most highly activated immune cells actually stick to the fibers. They then stick like Velcro in a low-calcium environment. They are driven into apoptosis or cell death. They then dissociate and go back into the body in real-time, telling the body that the storm is over. It is really a real-time kind of cell therapy. What's also very interesting is if you look at the cascade, we look at targeting the source.
Most of your pharma companies are actually looking at each of these proteins, like IL-6 or any of the proteins that are out there that are going after inflammation. That's what they're going after. We actually go at the source of it. If you can turn the source volume down, you actually can lead and drive that body back into homeostasis, into that reparative nature. The pipeline itself continues to build and is very robust. As I said, we have an approved product in children. That's through a humanitarian device exemption. We are currently enrolling a pivotal study, which we'll talk about later, which is about 60%, which is called NEUTRALIZE-AKI. We also have another study called NEUTRALIZE-CRS, which is cardiorenal syndrome. That study is actually funded by NIH through one of our partners. It's a much smaller study, but we'll talk about the relative importance of that.
Breakthrough device designations in end-stage renal disease, call it chronic dialysis, hepatorenal, as well as cardiac surgery for both adults as well as children. What is it that we address in the pediatric market? It's quite alarming that of all the admissions in the ICU that come in, about 25% of those patients, those children actually have acute kidney injury. They stay in the ICU twice as long. Unfortunately, it's a coin flip whether they live or die, and when I say live or die, meaning within hours or even days because the cytokine storm moves very swiftly. Those that are lucky enough to survive, about up to 30% will have chronic kidney disease. This was data from our registration study. The standard of care, like I said, a coin flip whether the patient's going to live or die.
Dialysis dependency, meaning they're on long-term dialysis 10%-30% of the time. Again, when we look at our own data, what we saw was increase of survival by 50% and no patients on dialysis, and no patient had any device-related immunosuppression, serious adverse events, or infections. Obviously, this was from a registration study that we had done. This was the basis of our approval. Let's talk about real-world. In September of 2025, we presented this and shared this with the market, but this was actually data from our SAVE Registry, which is a post-approval study mandated by the FDA. This was the first 21 patients. What we saw was pretty much a mirror of exactly the same survival. Before in the registration study, 77%, 76% here in this real-world evidence.
What's actually also important to note is that these patients actually, I would argue, are more sick than what we did in the registration study. Many of these have active cancer as well as several of these patients actually had multiple kidney transplants that we actually were able to. The therapy still works on. From a safety standpoint, the profile is very clean. There are no device-related serious adverse events or infections. This was all the completed studies to date. The commercial strategy is quite simple. It really is. There's only about 220 children's hospitals in the United States. Our target really is the top 50, and that's where 50% of these acute kidney injury patients are going to be. We already have around 17 patients, which we announced at the earnings in March. Really this is just continuing to march down the path here.
It is to focus on those top academic sites initially, which we've done. We're starting to get the early adopters to start to come in, which we're now working through. We do have a registry, which we have talked with the FDA about. Initially it was a 300-patient registry. It is now, we announced in December that that was reduced to 50. In March, we announced that registry, we've actually enrolled the 50th patient, and we've submitted that data now to the FDA for their review. This is a general list of some of those hospitals, those top-rated hospitals. Obviously, these are some of the top hospitals in the United States for children's, the treatment of acute kidney injury. We're asked all the time, hey, what about reimbursement? Well, this is not a reimbursed product as of yet.
We have gone through the exercise, and it did not make sense at the time. This actually, the DRG for this product is around $400,000. This was actually a healthcare economics study that was published, and what it showed was that if by using six days of the SCD therapy at $3,750, the hospital actually saves almost $46,000. How do they do that? Well, they do it through reduced length of stay in the hospital as well as reduced mortality. The nice thing about this is that, yes, the hospital does have savings, but it does allow us to actually, over time, increase the price as well and to be able to share some of those savings with the hospital. Turning a little bit out of children and into adults.
What showed you a lot of the data on the pediatric AKI, we saw in some of the historical data very similar results in terms of mortality as well as dialysis dependency. These are smaller studies that were conducted previously, that is why we are actually conducting a pivotal study in adults. This is a 339-patient study. It is a controlled study with a controlled arm of citrate. The primary endpoint is a 90-day composite of all-cause mortality or dialysis dependency. This is important because it means that we don't have to wait after the last patient is enrolled and treated. We have to wait 90 days and see if the patient is alive, and then if they're on dialysis or not. We do have other endpoints. There's some subpopulations that we're looking at as well.
These are pre-specified things around sepsis as well as acute respiratory distress syndrome or ARDS. We do have a one-year exploratory endpoint, which is really looking at the durability. It's one of the questions we're getting all the time, which is: Is it durable? Well, one of the definitions, interestingly, of day 90, if a patient's on dialysis at day 90, then they have what they call chronic kidney disease. If they're not on dialysis, then they are basically what we would consider healed. That's kind of the way that we look at this. If there is another incident for that patient to have acute kidney injury, it would have been a new insult that would have occurred. As I've said, this is about 60%, 19 medical sites activated. We did choose a mix of academic, military, and community hospitals.
We did that for very much a clear reason. One of the things is AKI actually happens at all sorts of institutions across the country. It doesn't just happen to the hospitals that we have listed as the top academic hospitals, but it also is community hospitals as well as military hospitals. I'm really proud of the team that we've assembled here that's really been able to drive and get hospital systems like Stanford, Cleveland Clinic, Mayo on board, but also Methodist and Good Samaritan, more of your community hospitals, as well as Brooke Army Medical, which is one of the military hospitals. It's really important to note that AKI happens at all of these institutions, not just the high-end academic institutions.
We do have CMS reimbursement for these patients as well, this has the potential to reduce some of the trial costs, et cetera. We're looking to really publish and get this data out sometime on the top line, sometime probably second half, early second half of 2027. I did talk a little bit about the NEUTRALIZE-CRS or cardiorenal. If I go back to NEUTRALIZE-AKI, that is 24 hours for up to 10 days. It's continuous. This is different because this is six hours for six days. It's a smaller study, but what's really important here is, one, w e're going into cardiac or heart. We're going into a new indication or a new organ system. That's the first thing. The second thing is that this actually would start to then prove out the idea of intermittent therapy.
What if you only had to do for a shorter period of time, for six days? Now you could start to think about treating things like chronic kidney disease or dialysis. There's other things that are here around potential approval, around the FDA and humanitarian device exemptions because of the smaller market, and this obviously depends on the positive study outcome as well as getting an approval. Again, expanding into different indications, expanding into the different routes of treatment, all things about really expanding the base here for SeaStar Medical. Medical affairs has been a very important driver of the company.
We've been investing in medical affairs now for the last several years, and it really is important because you need to be able to show, through really peer reviews, et cetera, you need to start to kind of make sure you prove out and through peer-reviewed literature how it works, what are the use cases, et cetera. We've done this through many of different ways, through publications. We've done it through presentations to scientific meetings, case studies, compassionate use cases, research grants. We have a top-notch, basically world-class advisory board. It is something that takes time, but it is definitely one of the investments that needed to be made because that will also help with commercialization.
I believe that we're starting to see that on the pediatric indication and uptake today is that this investment that we've made several years ago is now starting to show some of the fruits. The team that we have put together, myself, but we also have several others. Michael Messinger is our CFO, Dr. Kevin Chung, Chief Medical Officer, Dr. Sai Iyer, he's our Medical Affairs and Clinical Development, Tom Mullen, Senior Vice President of Manufacturing and Product Development, and Tim Varacek, Senior Vice President of Commercial and Business Operations. What's important here is that you notice the backgrounds of most of the folks here are around pharmaceuticals. This is actually really, really important because we actually believe that this is more of a therapeutic medical device than it is a mechanical medical device.
The way we do everything from Medical Affairs to actually going out and selling and positioning is much more like a pharmaceutical, because that really is the therapeutic nature of what the SCD or the Selective Cytopheretic Device is doing today. Our cap structure is very clean. The market cap is around $17 million. Obviously it fluctuates day to day. We have about 4 million shares outstanding, 2.7 million warrants outstanding. We had about $9.3 million of cash as of the last earnings report as of Q1, and we have zero long-term debt, so it's a very clean balance sheet. The warrants are clean, everything is clean within our balance sheet. We start thinking about 2026, what are the key milestones? The first is adding more sites to QUELIMMUNE. At the end of 2025, we had 10 commercial customers.
At the end of 2026, our goal is to have 25 new customers or 25 total customers, which I had said that as of Q1, we had actually had around 17. Complete the enrollment of NEUTRALIZE-AKI, that pivotal study around the end of this year. Advancing the clinical development of the NEUTRALIZE-CRS, which I talked about earlier, as well as applying for various FDA approval pathways that would enable a much more rapid commercialization. As I've said, our mission is quite simple. It is really to stop organ failure, save lives. This is hyperinflammation can lead to that organ failure and loss of life. We've demonstrated that in multiple clinical studies, and now with an FDA approval in children, it has become something that we can actually see in the real world. We're going to continue to expand in indications and areas of treatment.
This is actually done through a lot of our FDA Breakthrough Device Designations. We really do see this as agnostic, because of the role of the neutrophils and monocytes becomes much more ubiquitous. This is something that we believe that when you look at various disease states where the neutrophils and monocytes may be out of balance, that we could actually make a significant impact. High gross margins. Just kind of, again, summarizing a few other key highlights. We do have an approved product, which we had announced, in 2025, about a million dollars of sales of QUELIMMUNE. We have guided the market to around $2 million this year in 2026. We're going to continue to march down on the top 50 pediatric hospitals. The pivotal study is around 60% done.
We now have gotten ICD-10-PCS code, which for children, but also can now be used for adults as we prepare for that launch, and these are multi billion dollar applications in both acute and chronic indications. With that, I will end the presentation and take any questions. Okay. If there are no questions, I really do appreciate everybody taking the time to listen to our story. SeaStar Medical, we are traded under Nasdaq on ticker symbol ICU. Think of intensive care unit. We really do believe that this company has significant upside. Thank you very much, and have a great day.