Patient in renal conditions and presenting for SeaStar Holding Corporation is their CEO, Eric Schlorff. Eric. Thank you, Matt, and thank you, Biotech Showcase, for having us here today. So with SeaStar Medical, we're traded on the Nasdaq under the ticker symbol ICU, or like Intensive Care Unit, which you'll understand that is actually where the initial therapy is being delivered today. Obviously, there's forward-looking statements. I'd like you to refer to those as appropriate. What is our mission? Our mission is actually quite simple. It is to stop organ failure and to save lives. We've been able to show that through many of our clinical studies that are ongoing, as well as one of our commercial products, which we'll talk about here today. Also, the goal is to expand indications. We currently have six Breakthrough Device designations with the FDA. We're actually probably the first and only company to actually achieve that on the single same device. We're maximizing our market penetration, which I'll talk through the commercial strategy, and we're driving shareholder and stakeholder value really through the amazing profit margins or gross profit of about 90%. So it really is a pharmaceutical-style product. The markets that we're addressing today, the initial market is in children in the United States. So there's about 4,000 children that experience acute kidney injury requiring continuous renal replacement therapy. Continuous renal replacement therapy is like continual dialysis is the best way to put that. That projects to about a $100 million market today. We did launch that in Q3 of 2024. Obviously, the big market is in adults, which is 50 times that size. So we're looking at a revenue potential between $4-$5 million annually once that study is completed with a successful readout and FDA approval. So what is the problem that we're actually addressing? The problem is inflammation that's out of control or hyperinflammation, as many call it. We, through COVID-19, actually refer to it as the cytokine storm. That's how everybody really kind of got to know it. The cytokine storm or hyperinflammation really can be initiated by surgery, trauma, viruses, bacteria. There's a lot of ways that it can actually be initiated, and one of the things the first responders of that are activated neutrophils and monocytes. These are the first molecules in the immune system to actually go and address the problem. They actually then expel these things called cytokines, which everybody is very well aware of, things like IL-6 and TNF-α. Those are mediators that actually are signaling that there is a problem. When hyperinflammation is out of control, it can cause, as it says here, significant organ damage, as well as organ failure and potentially loss of life. How do we actually deliver the therapy today? What you see here is a depiction of kind of the standard CRRT circuit. So blood comes out of the body into the hemofilter. We use an anticoagulant called regional citrate anticoagulation, which actually lowers calcium levels. That plays a key role in the mechanism. It goes through a hemofilter and then comes back into the body. In our case, we actually add the SCD, or what we call the Selective Cytopheretic Device. It's called QUELIMMUNE in children. The way that actually the mechanism works is that whole blood comes into the SCD. So the most highly activated neutrophils and monocytes, which actually have a lot of proteins, a high density of proteins that are on the outside of these two molecules, actually stick like Velcro to the inside of the fibers. In a low-calcium environment, they're driven into apoptosis or cell death. They then shed these proteins that were the Velcro, and the deactivated neutrophil and monocyte goes back into the body, into the spleen and the bone marrow to tell the body that the storm is over. This is a very unique approach to being able to solve inflammation, one that has challenged the pharmaceutical industry, and we'll kind of talk through why that is. We are overseen as Biologics, so we're actually overseen by the Biologics division of the FDA as a medical device. The reason for that is that they actually believe and perceive this as autologous cell therapy. So this is how the cytokine storm or any kind of inflammation starts. We can see these two here, which are the neutrophils and monocytes. They also then create the cytokine storm. This is where pharmaceutical companies and the biopharma are all targeting. So this is where it's all protein-based, right? So you're looking at monoclonal antibodies, trying to look at how do we take out IL-6 or TNF-α. The challenge that you've had, at least the industry has had as a general whole, is that while it is a very logical approach, there's a lot of redundancies built into the immune system for obvious reasons for our own survival. And so when we get into ICU studies and critical care therapies, these kind of targets and these clinical studies tend to fail at phase three. So when we talk about our pipeline, the lead product that we have is approved by the FDA. It's called QUELIMMUNE. So this is for pediatric patients under 22 years old that have acute kidney injury requiring continuous renal replacement therapy. And also, they have to have sepsis or septic conditions, so we are one of the first and probably only companies out there to have sepsis on our label to be able to address this critical nature of this population. And we will talk about that, but that's not where we end, so we also have a pipeline, and this pipeline is really a platform. These here, NEUTRALIZE-AKI, is for adults with acute kidney injury requiring CRRT. NEUTRALIZE-CRS or cardiorenal syndrome. That's a bridge to LVAD. That actually is being sponsored and paid for by NIH through one of our partners. We also have end-stage renal or chronic dialysis, hepatorenal, and then also cardiac surgery for both adults as well as children, so all six of these that you see here below in this pipeline are all Breakthrough Device designation. And what that really does yield us is the ability to have conversations much more timely with the FDA throughout the kind of the process of not only the clinical study, but also the regulatory approval process. So let's talk a little bit about QUELIMMUNE and what it is addressing in the intensive care unit for these children. So about 25% of the children that come into the ICU have acute kidney injury. They stay in that ICU twice as long. Unfortunately, it's a coin flip whether that child's going to live or die. And when we talk about when the coin flip is not weeks and not months, it's usually hours or days that they have because their kidneys, as well as their heart and lung, are usually failing. And those that are lucky enough to survive, about a quarter of those patients will be on long-term dialysis. Obviously, that's not the way we want any of our children to be living the rest of their lives. Let's talk a little bit about the registration data. When we applied and got the approval for HDE, or Humanitarian Device Exemption, with the FDA, this was the basis of that, which was on 22 patients. What you can see here is the standard of care. As I said earlier, it's a coin flip whether that child's going to live or die. We were able to actually increase survival by 50%-77%. As I said also, long-term consequences is that those that do survive, in this case, 10%-30%, will be dialysis dependent for the rest of their life. In our clinical data, we showed zero. Their kidneys literally heal themselves. They produce urine, and they do not require any additional therapy after we actually conduct this therapy. We also do not see any immunosuppression or any serious adverse events or anything of the like. So it's always nice to have clinical data that actually shows, "Hey, you guys have shown this. What about in the real world?" Well, we do have a registry that's a post-market surveillance study that's required under an HDE by the FDA. The first 21 patients have now read out, which we presented in late September of this last year. And what you can see is, of those patients, we essentially got the same data that we saw in the clinical study. I will note that many of these patients that actually are in this data are actually sicker than what we had actually studied in our clinical study. Many of these patients are actually hem-onc as well as kidney transplant patients. Some of these patients have already had one or two kidney transplants, and we've become reliant on that sole kidney. When it comes to kind of a safety profile, you can see here, clearly this is the previous studies that we've done. We've had zero device-related serious adverse events and zero related infections, so it has a very clean profile, and obviously this will play very important into the platform as we move from one indication to the next. This is something that will be leveraged, so how are we going to market? Well, there's about 220 children's hospitals throughout the United States. We're targeting the top 50 children's hospitals, which will be about 50% of the AKI patients within that 4,000-patient market. Really, the goal was initially to go after the top kind of early adopters, which is the top 20% of those, which is about 10. That's where we ended our year in 2025 with 10 active customers. We started 2025 with two. You could kind of see the progression that we've done. We have kind of shared with investors that our target for the end of this next year or 2026 will be between 20 and 25 customers. This does require a registry, which I had mentioned. We have just recently, in early December, announced that we were able to successfully negotiate with the FDA to reduce the number of patients from 300 down to 50 to be able to potentially reduce and eliminate the need for that registry. The reason that the registry has kind of slowed a little bit of the commercial adoption is because we have to get IRB or institutional review boards to actually bring this product on. So you're bringing it on not only for the HDE or humanitarian device, but you're also now bringing it on for the registry. And in the minds of many of these institutions, they look at it like a clinical trial because we have a clinical trial agreement. Obviously, without a registry and that whole burden, we believe that there's the potential to have some quicker uptake within that. So there's not a lot of products that you can say that really are disease-modifying and really change the course of a patient in the sense of we reduce mortality rates. And not only that, we actually save hospitals money. And actually, they make money by using our product. And so if you look at the cost of a patient with acute kidney injury with sepsis, it's about $400,000. That is what it's going to cost the institution. What we've been able to show through our own healthcare economics is that we can reduce ICU time by about three days as well as reducing mortality. What that translates to is after even using the product of the SCD or QUELIMMUNE for six days, the hospital is actually pocketing between $39,000 and $46,000. So we're actually bringing money back into their own pockets to be able to do this. And they have much better outcomes. This is obviously very important to our commercial strategy. And when we think about, "Okay, what about adults?" So we've talked a little bit about kids and the survival rates of the studies that we've done to date. In adults, we've seen the same kind of survival in using the SCD in previous studies as well as from a dialysis dependency, which takes me to this, which is our current study, which is a pivotal or registration study. We have to do one study under CBER as a device. This is a 339-patient study. This is for adult acute kidney injury requiring CRRT. This is a randomized control versus the standard of care. The endpoint is 90 days. So it's a composite endpoint of all-cause mortality or dialysis dependency. This is very, and I call these hard endpoints in the sense that it's not biomarkers. It's either is the patient alive or dead, or are they on dialysis or not? So it becomes something that is truly clinically meaningful, not that many of the biomarkers are not, but this is truly a black and white. Now, one thing to note, there are some subset populations that we're looking at. One is sepsis. So about 70% of these patients, and even the patients, the clinical data I've showed before, about 50% of those patients were septic. So in this study, there's probably about 70% of these patients will be septic, and about 40% or so will have acute respiratory distress syndrome. These are two of the key subsets that we're also looking at. So where are we at on the study? We had disclosed back in early December that we're about 40%-50% of the way through. We have about 17 medical institutions. You probably are questioning or looking at this going, "How does a small company like this get Stanford, Mayo, Cleveland Clinic, University of Michigan, as well as many others?" This really speaks to the potential promise that this therapy has and the passion that these investigators have as well. The other really important thing to note here is the mix of institutions. So not only do we have many of the top institutions in not just the U.S., but the world, academically, we also chose to put in community hospitals like Methodist or Good Samaritan out of Oregon, as well as DOD site. This was very intentional because AKI or acute kidney injury doesn't just happen in the top institutions throughout the country. It actually happens throughout all institutions. If we're able to, and when we're able to, and show that not only does it that we're able to do this in all of these types of institutions, it really does speak to the broad nature of all institutions being able to actually implement this. We also have CMS reimbursement for patients that are on Medicare and Medicaid. The idea here is that by the end of this year, 2026, we will have the study fully enrolled, at which time we'll wait 90 days for that last follow-up endpoint, and then it's about 45-60 days to get the top-line data. We're not stopping there. This is actually the cardiorenal syndrome bridging to LVAD or left ventricular assist device. This is a really important study from multiple, actually, avenues. It's a small study. It's only 20 patients. It'll be five different sites. We have activated one site already. But this is a study that is going to be for six hours for up to six days. So NEUTRALIZE-AKI, the previous study, is continuous. So it's actually 24 hours and changing it out every day for up to 10 days. This is important because what this actually does is now it broadens us into potentially doing things in more of an outpatient setting. Right? That's one of the things. And you can think about even end-stage renal, which is dialysis. What if you're able to do it for four hours or six hours once a week? That really does broaden the market presence that we potentially have. The second thing it does is it takes us into the cardiac space. So obviously, chronic heart failure is a major problem throughout the United States. With a successful study, we can also apply for another humanitarian device with even the small kind of clinical study of 20 patients. And so that's another way of us being able to get to the market much quicker. And the reason that cardiorenal syndrome bridging to LVAD is also really critical is that these patients that are trying to be put onto an LVAD or even a heart transplant, one of the reasons that they're not able to do it is they have too much inflammation. They actually are highly inflamed. And so if we're able to change that profile of that patient and bridge them to LVAD or even to a heart transplant, that's where the win is for the patient as well as the hospital system. We use medical affairs as a key pillar of our kind of strategy. We've been investing in this for the last four or five years. And the reason that this is really critical is that we're not just an AKI company. We're actually organ agnostic. Neutrophils and monocytes actually work across the gamut. Right? They're not sitting in just the kidneys and saying, "I'm staying in the kidneys." They actually go across all organs of our body. And so this is really important to be able to start to educate. And obviously, education takes time. It's not something you just show up on a Tuesday and say, "Okay, we're here." It does take a lot of investment and a lot of time to be able to get that. We do that through presentations, case reports, different types of presentations at scientific meetings, lots of publications in the space, as well as we have a world-class scientific advisory board that's comprised of not only nephrologists in critical care, but also on adults as well as pediatrics. The team, which is comprised of six of the senior leaders of the team, but we also have about 17 people in total that are actually going and embarking on this journey. So that actually does translate into capital-efficient resourcing. But one of the things that you'll notice is that the backgrounds of the majority of our employees are actually pharmaceutical-based. Right? We believe that we actually have something more like a pharmaceutical or a therapeutic than a medical device. We're not a mechanical process. It really is very intentional of where we've been heading. So this is one, obviously. Balance sheets are really important to our investors as well as to ourselves. If you go back to when we went public through a de-SPAC in late 2022, our cash position has dramatically increased. That is not a misprint. We did have $47,000 of cash as of in 2022. You can see that we've now ended 9/30 with just over $13 million of cash, shareholders' equity of $11 million-plus, and our payables have been coming down. The company has zero long-term debt. And so it really is from a capital standpoint and a balance sheet. Think about it from a health. This is a very healthy business. So this gives you a little bit of sense of the market cap. So now I'm telling you that the market cap is $9 million, or I think it actually rose a little bit today, but we're trading really at or below cash value. We have disclosed that we anticipate finishing 2025 with about one million of sales within the QUELIMMUNE product, which is what we had just launched. So it's about. You could also look at that metric and say, "Well, they're trading at about one times trailing sales, 10 times trailing sales." So milestones for 2026 are pretty clear. It is about doubling the QUELIMMUNE customer base. That's one of the key drivers, as well as completing the NEUTRALIZE-AKI, which is our pivotal or registration study in acute kidney injuries in adults, advancing the CRS study, which is sponsored by NIH and paid for through one of our partners, and then applying for different types of FDA pathways to be able to accelerate the regulatory as well as the commercial presence of the company. So with that, I will open it up to any questions. Yes. Yeah. So the question, just to repeat it, so what is the milestones or what does the study need to look like to get FDA approval? So in adults for acute kidney injury, that is NEUTRALIZE-AKI. That is what's required. It's a 339-patient study that will be required, and the endpoints are all-cause mortality and/or dialysis dependency. And so that is one of the criteria that will be needed to be able to go to the FDA for basically approval through a PMA. And that's one that was a breakthrough. For CRS or cardiorenal, that's the one that was sponsored by NIH. That one we believe is a 20-person study, and the endpoints for there will be more around mortality rates and bridging that to LVAD and the success that we have. That actually should be enough to support a humanitarian device exemption and be commercial in the United States. [audio distortion] The costs are not a requirement. No, not to get FDA approval. No. I mean, the cost will come out just like I had presented on this slide for children. So it costs the hospital systems $400,000 to treat these patients. So our job is to lower that cost, doing that through reducing the time in the intensive care unit as well as reducing mortality rates. That translates into cost savings for the hospital as well as the healthcare system. We will lower the cost. Thank you for your question. Yeah. Another great question. So the question, just to repeat, is how did we go through the process of reimbursement for children and that? We actually do not have reimbursement for children. We've gone through the exercise. It didn't actually make economical sense. This is actually purely driven. The economics are actually in the benefit of the hospital system, which is what's really driving it. So we don't require a reimbursement code for this. We will have a code and reimbursement through NTAP and all of the like for CMS for adults, which are a different patient population. But for children, that was not required. Great questions. Okay. If there's no further questions, thank you again for your time.