Hi. Good morning everyone, the H.C. Wainwright 28th Annual Global Investment Conference. My name is Ananda Ghosh, a Senior Research Analyst at H.C. Wainwright. H.C. Wainwright is a full service investment bank dedicated to providing corporate finance, strategic advisory, and related services to public and private companies across multiple sectors and regions.
From a logistics standpoint, please make sure to reference your virtual conference online portal that provides you individual links to our meetings and all presentations. Please join us for corporate presentations and panels that will be available live and streaming from September 14 -September 16. With that said, have a very productive and enjoyable day. I would like to introduce our first presenter, I'd like to welcome Eric Schlorff, who's the CEO of SeaStar Medical. Welcome, Eric.
Thank you, Ananda, and thank you H.C. Wainwright for allowing us to present to the community here at HCW. Maybe I can start with telling everybody a little bit about SeaStar Medical and what it is that we do. It is a company that really is focused on transforming treatments for the critically ill patients. These patients really do face organ failure and potential loss of life, and I'll walk the audience through what that really means and what the solution is that we provide for the market.
Obviously, there's forward-looking statements that you'll be able to refer to at the SEC. Our mission is quite simple, as I've said, it really is to stop organ failure and save lives. This is actually from the destructive hyperinflammation that's actually leading to this organ failure and loss of life. We've actually been able to show that and demonstrate this through clinical studies and now through a commercial product, which we'll talk about, that we can actually preserve that organ function and save lives.
This is not a one trick kind of indication that we're going after. Obviously, the lead indication is acute kidney injury, but we have actually six Breakthrough Device Designations with the FDA, all for the same device. We actually see this as this therapy being agnostic, which we call the SCD or Selective Cytopheretic Device. It is the first and only therapy that we know of to neutralize destructive hyperinflammation, and it has high gross profit margins, much like a pharmaceutical. As I've said, our lead indication is in the acute kidney injury space. Pediatrics is where we actually have the first approval, which we'll talk through in a bit.
That's about 4,000 patients a year annually in the United States. We did launch that in about Q3 of 2024. That market is about $100 million. But really the real value inflection point here for the company is in the adult side, because that is where the patient population is 50 times larger or about 200,000, and we estimate that to be about a $4.5 billion annual market in the United States alone.
We are conducting a pivotal trial as we speak. Just as a kind of a brief update, we did announce a couple of weeks ago that CMS has assigned an ICD-10-PCS code, which will be effective as of October 1st of 2026. This will enable standardized inpatient billing and support a more rapid adoption in reimbursement. What is the problem that we're actually trying to solve here? Well, it does come down to hyperinflammation.
Everybody's heard about the cytokine storm, that's actually this tornado that you see here. What's interesting is that it really can, the cytokine storm can be initiated by things like viruses, bacteria, surgery, trauma. All of these things will start a cytokine storm and what then the first responders are our innate immune system, are the monocytes and activated neutrophils.
These are the ones that go to the They're the first kind of responders. They get to the site and then they release more cytokines, to telling the body that there's a disruption and that healing needs to happen. Unfortunately, if this gets out of control, that's where it really does lead to permanent organ damage and as well as potentially as death. As we look at this, all the pharmaceutical companies are looking and trying to target all these proteins.
You think of like a IL-6 or TNF-alpha. One of the things that you do see is that many of these clinical studies, we've seen them even recently, is that they end up failing when they target only one cytokine. It really is because the high redundancy that's built into the system or in our immune systems. I call it almost like a game of Whac-A-Mole.
When you put one down, another one's just going to pop up to make sure that the body is in that homeostasis. What we do is really target the source. If you can actually think of turning the volume down of the production of these cytokines, that's essentially what we're doing by targeting the most activated neutrophils and monocytes. How do we deliver our therapy?
Well, we use really a standard CRRT or continuous renal replacement therapy kind of line where you think of dialysis. It literally takes about 15 minutes for the hospital staff to add the Selective Cytopheretic Device or QUELIMMUNE for children. The way it works is that the whole blood comes into the Selective Cytopheretic Device or SCD. The most activated neutrophils and monocytes actually present proteins and actually act like Velcro. The most activated ones actually stick to the inside with the fibers of our SCD. In a low calcium environment, they're driven into apoptosis or cell death. They then dissociate and go back into the body in a deactivated state.
Actually in real time, what we're doing is telling the body that this cytokine storm is over and it's really like a recalibration or kind of a reset of the immune system to be able to go back into a reparative mode and out of the destructive mode. Our pipeline, as I've talked about, our lead product is QUELIMMUNE, which is a pediatric acute injury that is under a Humanitarian Device Exemption.
We have two clinical studies that are undergoing, as we speak, NEUTRALIZE-AKI, which is now over 65% enrolled. Then you have NEUTRALIZE-CRS, which is a cardiorenal. Again, I'll talk a little bit about the importance of why both of these studies are very important for the pathway going forward. We do have, again, six different Breakthrough Device Designations, all actually presented here.
The reason these whole Breakthrough Device Designations are important is really it has the potential to speed up the development, the approval assessment by the FDA. QUELIMMUNE addresses a high unmet need in pediatric AKI. If you think about it, a quarter of the patients in the ICUs actually have acute kidney injury. They stay in there twice as long.
It is a coin flip whether they live or die, and those that are fortunate to survive, about 30% will be on long-term dialysis. When we looked at the actual registration data, what you see here is that the standard of care, it is, as I said, a coin flip, and dialysis dependency at day 60 was 10%-30%. What we were able to show through this registration study was an improvement of about 50% or 77% survival. More kids are going home.
No child was on dialysis in these studies, and we had no device-related immunosuppression, serious adverse events, or infections. This was, again, based on about 22 patients. One can say, well, this was a controlled study, or this was a clinical study. We actually in September of 2025, published what we call the SAVE Registry, so the first 21 patients.
As part of our approval for Humanitarian Device, the FDA mandated a post-approval surveillance registry. What we were able to show is that the first 21 patients that we saw in a commercial setting had essentially the same survival rate, 77 versus 76. This obviously is very encouraging for the physicians, the families, et cetera, that really do not have any options going forward. Safety profile. As you can see, this is actually now six different completed studies.
We have had no device-related serious adverse events or infections. The commercial strategy for QUELIMMUNE, this is targeting the top 50 children's hospitals. There is about 220 children's hospitals. We estimate about the top 50 really treated probably 50% of the acute kidney injury patients. Our strategy really was to focus initially on the top academic sites and then get up after about 20% of the first, that top 50.
We are definitely there. Actually, we are at about 40% of the top 50 children's hospitals today. We have talked about this registry, which we are looking to decouple as an optional as we work through it with the FDA. This is a general list of the sites that we actually have, and you can see here these are many of the top children's hospitals in not only the country but in the world.
We are also asked a lot about reimbursement. This is not currently a reimbursed product for children. The reason that it is because actually the healthcare economics which we have published actually suggest and drive the hospitals to actually use it. If you look at the DRG, it is about $400,000. When you compare and look at the DRG compared to what it would save the hospital system, if they use this for six days of therapy for about $3,750 a day, the hospital actually makes or earns about $46,000 worth of profit. That is done by reducing things like length of stay as well as reducing mortality rates. As we move from pediatrics into adults, you can see here is our historical pediatric studies, here is our historical adult studies. These were smaller adult studies.
But what we did see in all the studies was that we had an improvement over the historical control, and then there was no dialysis dependency in these two patient populations that we had studied previously. Look, these were smaller studies, which is why we're conducting a pivotal study. So NEUTRALIZE-AKI is a 339-patient ICU study. It's a randomized controlled study, and you can see here what we look at is the primary endpoint, which is 90-day survival or all-cause mortality or dialysis dependency.
This is important because what we're evaluating here is continuous. So every 24 hours, it's changed. It's a disposable model. Through this disposable model, they can be using this. The study actually is up to 10 days. That's going to become important as we talk about NEUTRALIZE-CRS as a different study and a different mechanism to go after.
So NEUTRALIZE-AKI, here's the list of the actual sites that we have. We have about 20 medical sites to date. One thing that Kevin, our Chief Medical Officer, and his team have really done a great job of is actually getting a mix of sites. As you can see, we have some of the top sites in not only the U.S. again, but in the world. You think of Stanford, Cleveland Clinic, Mayo Clinic, as well as University of Michigan as some of the top key sites really in the country. But we also took community hospitals as well as military hospitals because we know AKI is not just happening at the high-end institutional academic sites, but it's actually happening at all the sites.
That's obviously why Kevin and the team have shown that, because we look at this from a commercial standpoint, that showing that you can use it in all sorts and types of sites actually lends itself to that commercial strategy and that commercial ramp-up. We do have CMS reimbursement for those Medicare/Medicaid patients. We anticipate filing a PMA based on a successful study sometime in 2027.
We have begun the Modular PMA. What that also does is potentially speeds up the approval process because you can do chunks at a time. You can do that. Really, you get it to a place where, when the study now is fully enrolled, we've read out the data, all then we're submitting to the FDA is just the clinical section. I mentioned that NEUTRALIZE-AKI was really based on basically, what?
Up to 10 days for 24 hours each day, and so it's a disposable model. This one is different. This is important because this is a smaller study. This is actually funded by NIH through one of our partners. It is only 20 patients, but it's looking at more of a six hours for six days. Now, this really does have a lot of importance to it.
The first one is, it's really one of the first studies we're doing outside of renal, so this is in the cardiac. This is really looking at how do we enable an LVAD, or left ventricular assist device, implantation or heart transplant. These patients, these CRS patients, usually have so much inflammation that it actually prevents them from getting either an LVAD or a heart transplant, which is what the hypothesis that we have is.
But the other thing is that it really does then start to prove out a concept of intermittent therapy. What if you don't have to be in the ICU, but you can be more of an outpatient setting? This then starts to open up a broad range of chronic hyperinflammatory diseases. You could even think of chronic dialysis. With a successful study here, we believe there may be a pathway to do a Humanitarian Device Exemption as well.
We're evaluating that as well. One of the other big drivers that we've been investing in for the last several years is around medical affairs. Medical affairs is obviously something that you have to set up the groundwork and the foundation, and that's what the team has done. You can see, really, the list of publications that this team has been able to drive.
This obviously is the basis for the scientific and the medical community to understand how the device works. Really to have it be peer-reviewed is really the goal here, which is what we've done. You really want to show how it works and that it is something that is rigorous science, which is what we stand behind. Here's a list of pictures of the leadership team.
One of the things that you'll really notice here is that the backgrounds here are much in the pharmaceutical space. It's really important to note because we actually don't see this as a mechanical medical device because we're not really removing stuff. It's actually much more like a pharmaceutical, and we're actually having a bigger impact on the body. From a capital structure and finance, like I said, the ticker symbol is ICU, like intensive care unit.
Market cap's about $15 million, 4 million shares outstanding. As of June 30th, we had reported about $6 million, $7 million of cash, and we have zero long-term debt. When we look at the catalyst to drive value, we've talked about 20 total customers as of the last earnings release. The goal really is to have around 25 by the end of the year, completing enrollment around year-end for NEUTRALIZE-AKI or into Q1 2027, and then advancing the clinical development on things like the cardiac heart failure or CRS, and then looking at different approval pathways that really will now enable us to get to the market quicker.
As I've said, the mission is quite simple. It is to stop organ failure and save lives. We've expanded into different indications, and we'll continue to do so. It is really the first and foremost. It's the only therapy we know to neutralize destructive hyperinflammation. With the high gross margins, it does make it a very attractive investment for our investors. With that, I will end the presentation. Thank you very much.
Thanks very much, Eric. Appreciate it.