Eric Schlorff, CEO of SeaStar Medical Holding Corp. ICU, was recently a guest on Benzinga's All-Access.
SeaStar Medical seeks to bring organ-saving and life-saving solutions to critically ill patients who are suffering from hyperinflammation. The company’s first therapy, QUELIMMUNE, which was approved by the U.S. Food and Drug Administration last year, is designed to treat pediatric patients with acute kidney injury (AKI) due to sepsis or a septic condition.
SeaStar is also engaged in a trial evaluating the safety and efficacy of its second proprietary Selective Cytopheretic Device (SCD) therapeutic in adults with AKI. That trial already has half of the adults enrolled and represents a market opportunity Schlorff says is worth about $4.5 billion a year. SeaStar, which has received several Breakthrough Device Status designations from the FDA, is betting its therapy can be broadly applied to many serious, life-threatening conditions.
SeaStar Medical seeks to bring organ-saving and life-saving solutions to critically ill patients who are suffering from hyperinflammation. The company’s first therapy, QUELIMMUNE, which was approved by the U.S. Food and Drug Administration last year, is designed to treat pediatric patients with acute kidney injury (AKI) due to sepsis or a septic condition.
SeaStar is also engaged in a trial evaluating the safety and efficacy of its second proprietary Selective Cytopheretic Device (SCD) therapeutic in adults with AKI. That trial already has half of the adults enrolled and represents a market opportunity Schlorff says is worth about $4.5 billion a year. SeaStar, which has received several Breakthrough Device Status designations from the FDA, is betting its therapy can be broadly applied to many serious, life-threatening conditions.
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NewsTranscript
00:00And it is my distinct pleasure to welcome in the CEO of Seastar Medical, Eric Schlorff.
00:09It's great to be with you today.
00:11Hey, thanks, Dan.
00:12And I'm sorry to disappoint, but I was not a backup dancer for MC Hammer.
00:16That's all right.
00:17As long as you watch me in the background, that's all that matters.
00:20Eric, looking forward to getting into Seastar Medical with you.
00:23Let's talk about giving an overview if you want to start off here.
00:26Yeah, so thank you so much for the opportunity to provide an overview of Seastar Medical to your Benzinga All Access viewers.
00:33We're really excited about the opportunities and believe we are nearing some several important milestones I'll talk about today.
00:41Before I begin, though, I do want to remind investors that I'll be making forward-looking statements, so please review our SEC filings for further information about our company.
00:49Now, let me provide a quick overview of Seastar Medical.
00:51We are bringing organ-saving and life-saving solutions to critically ill patients that are really under attack by destructive hyperinflammation, so inflammation out of control.
01:02Our patented and proprietary selective cytopheretic device, also known as SCD therapy, is the first and only therapy to selectively target the most highly activated neutrophils and monocytes responsible for this hyperactive immune response.
01:18Coelumine is our first commercial product, and this is for pediatric patients that are in the intensive care unit with acute kidney injury.
01:27This is a small but very important market.
01:3050% mortality rate.
01:32Most of the time, these patients have days to live, okay?
01:35We're not talking years.
01:36We're talking days.
01:37And those that are fortunate to survive are usually on long-term dialysis.
01:42And I'm happy to report that we're also hearing amazing stories from a lot of the children's hospitals around the country that have adopted Coelumine.
01:50We also have a registration trial underway for acute kidney injury in adults.
01:54That's nearly 50% enrolled.
01:56We're excited about this opportunity that we estimate to be around $4.5 billion market opportunity in the United States alone annually.
02:05And not only that, we don't stop just there.
02:08This really does work across multiple indications, so an even larger market opportunity as we develop the therapy with more indications.
02:16Such important, amazing work you're doing, Eric.
02:18And I know C-STAR is also focused on treatments for critically ill patients facing organ failure and potential loss of life.
02:25Let's talk about the current problem of that and why the treatments available today are simply falling short.
02:31Yeah, that's right.
02:31I mean, today our focus is on patients that are in the ICU facing critical and, in many cases, irreparable damage to organs, resulting in organ failure and even loss of life.
02:41Their immune systems have overreacted, producing destructive hyperinflammation that is damaging cells and tissues.
02:48Unfortunately, you can't eliminate the immune response, but you need to balance the immune system to get rid of the destruction, but also maintain healthy immune function.
02:58Our SCD therapy does what no other therapy can do.
03:02It neutralizes the primary immune cells that are overreacting and returns them to the body in a deactivated form.
03:08This process leads to fewer destructive cells and a more balanced immune system.
03:13That's awesome.
03:14I mean, I know you talked, Eric, about Quillimmune, and it was approved by the FDA in 2024 to treat acute kidney injury or otherwise known as AKI.
03:23How does this treatment work and what has been the impact since it's been in the market?
03:27Yeah, so Quillimmune is really a smaller version of the adult's SCD therapy.
03:32You know, Quillimmune today fits right into the existing continuous renal replacement therapy system.
03:39So think of all the infrastructure and the equipment is already in the ICUs today, so the hospitals don't need to buy it, which is a huge bonus because, you know, we can sell into a disposable market, which is how we actually sell our product on a daily basis.
03:53And, you know, and I can't overemphasize enough the impact this has had on patients' lives.
03:58And we're hearing amazing stories from some of our customers already.
04:01There was actually one at the University of Michigan.
04:04This was a patient that had a kidney transplant.
04:09They were immunosuppressed.
04:10They then developed lymphoma or cancer.
04:14They had a mortality rate of about 95% chance of dying.
04:19That patient, I can gladly say, is now home receiving normal, you know, chemotherapy once again and normal kidney function.
04:27And so, you know, those are the kinds of stories that we hear every single day that obviously make it a very easy way for us to go to work and do what we do.
04:37And you mentioned ICU.
04:38That's why a great ticker, having your ticker be ICU.
04:40It all comes together, Eric.
04:41It does.
04:42Tell us a little bit about the technology that's underpinning Quillimmune, known as Selective Cytophoratic Device, or SCD.
04:48What promises does that hold?
04:50Yeah, the technology for Quillimmune and the SCD in adults are really just the same.
04:56They're just different sizes to allow fluid differences because patients that are pediatric are different size, obviously, than adults.
05:03The therapy does what no other therapy can do.
05:06It neutralizes these destructive immune cells and returns them into the body into a deactivated state.
05:12But, you know, more importantly, though, this therapy is broadly applicable to many serious life-threatening conditions in renal, cardiorenal, cardiac surgery, certain chronic diseases, such as end-stage renal diseases.
05:24So the whole underpinning is that when the immune system is out of balance, this is where the SCD may have a real chance to be able to help that patient.
05:33Something else that's fantastic you guys have received, I know SCD has received breakthrough device designation multiple times from the FDA over the past few years.
05:44Eric, why is that so important to the company and its prospects?
05:47Yeah, you know, look, it's actually quite simple.
05:49Yes, we do have a robust pipeline of product indications, primarily based on these breakthrough device designations that were granted by the FDA.
05:57Maybe give the viewers a little context, you know.
06:00So if you think about what we're doing is if you had one drug that could address all these different various conditions without changing the formulation, we believe that's what we have is one drug with the SCD, right, that can treat adults as well as children.
06:16But more importantly, when we think about the breakthrough device designation by the FDA, there's some key criteria that are really important.
06:23So it must have to be a more effective treatment than what's already out there and that no other cleared or approved alternatives exist and that it offers a significant advantage over existing, which is exactly what the SCD and adults as well as now children through their breakthrough devices have done.
06:41More importantly, for shareholders or investors, this actually helps us speed up the review process itself with the FDA.
06:50We can actually have much more engaged and quicker discussions and don't have to wait 75 days just for a meeting.
06:57So this really does allow us to have that dialogue that, you know, all companies really working with the agency really do want to have, which is a dialogue on a very quick timeline.
07:09Yeah, and Eric, as you all know, speeding up that process with the FDA, always a positive thing.
07:14Let's talk about the market opportunity, you believe, for Qualcomm Union and C-Star's other SCD devices.
07:19What do you see that right now?
07:20Yeah, you know, Qualcomm Union in the pediatric setting is an important market because it literally is saving organs, saving lives in this very young patient population, which we, you know, the market is probably around 4,000 patients.
07:32But, you know, when we think about the adult population, you know, this adult AKI or acute kidney injury really is our near-term opportunity.
07:40With that registration trial underway, you know, we could be filing that PMA sometime in next year.
07:47You know, that's a 200,000 patient population.
07:50So it's about 50 times the size of the pediatric in the United States alone, which then translates to about $4.5 billion annually.
07:58And, you know, following that, you know, you look at all the other breakthrough device designation grants that we've received, now six, you know, we see a potential doubling of that opportunity from $4.5 to around $9 billion annual.
08:11And then, you know, it just takes time to get there.
08:13But the near-term opportunity, in our view, is significant, especially because of the given the unmet clinical needs here.
08:20Well, very exciting times for C-Star Medical.
08:23That's definitely for sure.
08:25And, Eric, it was an absolute pleasure talking with you today.
08:27Thank you so much for your time.
08:29Hey, thanks, Dan.
08:30It was great to be on here.
08:31And have a great day.
08:32And you as well.
08:33A pleasure to honor all mine.
08:34That was the CEO of C-Star Medical, Eric Schlorf.
08:37Their NASDAQ ticker is ICU.