SeaStar Medical Holding Corp., the commercial-stage healthcare company focused on transforming treatments for critically ill patients facing organ failure and potential loss of life, has made a lot of inroads on that front with QUELIMMUNE. A humanitarian medical device, QUELIMMUNE treats pediatric patients with acute kidney injury or AKI due to sepsis or a septic condition. The QUELIMMUNE therapy received U.S. Food and Drug Administration approval in 2024 after clinical trials showed it could cut mortality in half from 50% to 25%
00:00Hey, Zingers, it's Dan Leach, and I have some wonderful guests for you today.
00:05Dr. Kevin Chung, Chief Medical Officer of C-Star, Dr. Stuart Goldstein of Cincinnati Children's
00:10Hospital, and David, his son, Kurt, who was a patient at Dr. Goldstein's at Cincinnati
00:14Children's Hospital that had some incredible results.
00:17It is so great to be with all of you today.
00:19Dr. Chung, let's talk about Qualimmune and how does it work to treat these patients and
00:23save their lives?
00:25Yeah, so thanks, Dan.
00:26And so Qualimmune is really designed to target the innate immune response.
00:33And so when patients get very sick, it becomes very dysregulated and cells really go haywire
00:39and really trigger something called the cytokine storm.
00:44The Qualimmune device is designed specifically to target the cytokine storm at the source
00:50of the storm.
00:51And it is associated with really good outcomes, especially in the pediatric population, where
00:59mortality was cut by half from 50% to 25%.
01:04I love if you could tell us about Kurt.
01:07I know he's one of the patients that you treated with the Calimmune therapy at Cincinnati Children's
01:11Hospital and how that patient responded.
01:13Yeah, so Kurt was, as all of these patients are, very, very ill.
01:19He had underlying chronic cardiac disease from a pediatric standpoint, not like you would
01:26think of adults with heart disease.
01:29And he developed acute kidney injury and respiratory failure and was getting prepared to be put on
01:37ECMO, extracorporeal membrane oxygenation, where that's even a more advanced, more invasive therapy
01:45to support somebody who's critically ill.
01:47Kurt needed CRT as part of his standard of care and clearly was inflamed and we presumed had an
01:55infection.
01:56And I said, this, I think this device is really going to be helpful for him.
02:02Kurt just started to turn around within about 24 to 48 hours, did not require ECMO.
02:07Kurt left the ICU within probably two to three weeks and resumed his going back to high school
02:17and golfing.
02:18It was just quite dramatic.
02:20And he is just emblematic of when we see this work, which is far more often than not, patients
02:28turn around really, really quickly when you would have not expected them to.
02:33What an absolutely beautiful story.
02:35I want to go meet Kurt on the golf course right now.
02:37It's great to hear that.
02:39Now let's hear from a patient and his father and their real life experience.
02:43Dave, if I could have you also describe your experience.
02:46As Dr. Goldstein said, this was a new therapy.
02:48Here is your son very ill.
02:50How did you make the decision to allow the use of Qualmune for your son?
02:53Yeah, it was kind of like, I think it was like day 11 of Kurt being in the ICU and things
03:00weren't looking too good.
03:02And my nephew, who's a doctor, he took my wife and I down to the lunchroom to eat dinner.
03:07And I said, hey, do you mind just walking upstairs?
03:10I said, every night we think everything's decided for the night.
03:14But there's always somebody there with another question or another decision to make.
03:18And sure enough, Dr. G was there.
03:20Thank God.
03:22And Dr. Goldstein, you know, he basically asked if we would mind going on a trial therapy
03:31that he thinks would really help with inflammation.
03:33And I just turned it over to my nephew and let him listen to it all.
03:37And he said, yeah, I don't see any reason not to.
03:39I mean, you know, at that point, we were definitely looking for some answer that, you know, to
03:45help this turnaround, because it was looking pretty bleak a couple days before that, right?
03:50So the kidneys were shutting down.
03:52The heart, you know, was doing the best.
03:53And that's what he went in for was a heart surgery.
03:56And unfortunately, he went into, you know, an ARD situation, which acute respiratory distress
04:01syndrome.
04:01So he had no breathing ability, was, you know, had a trach and it was just, you know, every
04:09organ was shutting down until the ARDs got better, you know, that nothing else could recover.
04:13Everything was shutting down.
04:14His kidneys were, you know, starting to go.
04:17So they decided to put him on that morning on a continuous renal machine.
04:22So that continuous kidney therapy that morning.
04:27So we just said, you know, let's do it.
04:31If you think it will help.
04:32So we went ahead and did it.
04:35And obviously, the outcome was very, very good.
04:38Both you and Kurt are here to talk about it today.
04:40Can you even describe the feelings you had when you saw that Kurt's condition was improving?
04:45It was just amazing to see the recovery.
04:49You know, I kind of forgot all about this quillamine.
04:53But, you know, we were asked to do a testimonial for the FDA approval.
04:57And I was like, you know what?
04:59I looked back to the diary.
05:00He was only on that thing for six days.
05:02And he got immensely better after he got put on that.
05:05So it was, you know, was that the whole thing?
05:09I don't know.
05:10I'm glad we didn't have to find out what the other outcome was.
05:13So it was pretty, pretty, pretty unbelievable for, you know, my wife and I and the whole family.
05:19And just to be able to see him come out of it and obviously in a very weakened state.
05:25But, you know, nonetheless, he was out of it.
05:29Right.
05:29So and then he continued to improve every day, even after he was off that.
05:34It just improvement once he got through that was was every day.
05:38So, Kurt, first of all, it's wonderful to have you here.
05:41Congratulations on what looks like a full recovery from what could have been a pretty devastating condition.
05:46Any memories of your time in the ICU?
05:48It was a little hazy on the memories for early on.
05:52But then, yeah, definitely remember a lot later on past Christmas Day.
05:58But, yeah, just I think I woke up.
06:04My first memory was just my parents standing there and just didn't really have really understanding what was going on.
06:14Obviously, I woke up and, you know, I had a lot more things on me than I initially thought I would have.
06:22I had an NG tube.
06:24And, of course, you know, one of the first things, one of the times I woke up, I just there was nobody in the room and I had no idea what was going on.
06:32So the first things, of course, I do is like, you know, I think I lost about 20, 22 pounds or so when I finally gained consciousness.
06:42And I just couldn't move or press, you know, the nurse assistance button in the bed or, you know, move anything.
06:49So I started feeling around.
06:51I was like, well, what's like, you know, like what's a monitor that I could try?
06:56And the first thing I do is pull out my NG tube.
06:59So just to get their attention, of course, that didn't set off any alarms.
07:03But that was like one of my first memories waking up was just trying to get somebody's attention.
07:09And what about your recovery?
07:10What was your recovery like?
07:11Recovery was not easy, but it was still a struggle just because, you know, I lost all that muscle mass and it was tricky.
07:22It wasn't easy.
07:24Just a lot of help along the way, family, friends.
07:27I was able to keep pushing myself and I was able to, you know, start building that, getting my weight back and start building that muscle back to my stamina and just being able to do a lot on my own.
07:41And, you know, luckily by the end of, towards the end of February, early March, I was starting to be able to obviously play golf again and being able to just walk, walk around all day without having to go to bed at six o'clock.
07:56But, yeah, that was really the big recovery part.
08:01But, yeah.
08:02Thanks so much, David.
08:03Kurt, just so wonderful to be with you today.
08:04I appreciate you having us and letting us tell, you know, Kurt's story because, you know, it really is a life-changing situation, you know.
08:15It's a life-changing.
08:16And on a parting note, here is a clip of Kurt at his NCAA golf event just months after leaving the hospital.
08:23It's pretty clear that Kurt's drive to recover was partly inspired by his love of golf.
08:29And with a drive like that, he certainly looks like he's made a full recovery.
