00:00Hey, Zingers, it's Dan Leach, and I have two wonderful guests for you today, Dr. Kevin
00:05Chung, Chief Medical Officer of C-STAR, and Dr. Stuart Goldstein of Cincinnati Children's
00:10Hospital. It's so great to be with you both. Thank you very much. Thanks, Dan. Dr. Chung
00:15and Dr. Goldstein, can you please tell us a little bit about yourself and your connection
00:19to C-STAR? And let's start with Dr. Chung. Thank you, Dan. So, Kevin Chung, I'm the Chief
00:24Medical Officer of C-STAR Medical. I'm a practicing adult critical care physician and have been
00:31with the company for three years. Great, and thanks, Dan. I'm Stuart Goldstein,
00:36a pediatric nephrologist at Cincinnati Children's Hospital, and I was the principal investigator
00:42for the two studies funded by C-STAR that led to FDA clearance of the selective cytopheric
00:49device now called Quellamute. Very excited to have you both. And Dr. Chung, let me start
00:54with you. Let's talk about the current landscape of pediatric patients with acute kidney injury,
01:00also known as AKI, due to sepsis or a septic condition. Yeah, thanks, Dan. Currently, on a
01:07year-to-year basis, there are approximately 4,000 cases of AKI in children in the country,
01:15and among those that need renal replacement therapy and have concomitant sepsis, these patients have
01:24a high mortality. About 50% of those patients die, unfortunately. Now, it's very, very sad. And
01:30Dr. Chung, let's talk about Quellamune and how does it work to treat these patients and save their lives?
01:36Yeah, so thanks, Dan. So, Quellamune is really designed to target the innate immune response.
01:43And so, when patients get very sick, it becomes very dysregulated and cells really go haywire and
01:51really trigger something called the cytokine storm. The Quellamune device is designed specifically to
01:58target the cytokine storm at the source of the storm. And it is associated with really good outcomes,
02:07especially in the pediatric population, where mortality was cut by half from 50% to 25%.
02:16Oh, it's just incredible numbers, and it's so great to hear. Let me start with you, Dr. Goldstein,
02:21on this one. Can you tell us a little bit about the patient experiences you've seen so far?
02:26Yeah, it's been really quite traumatic, Dan. And as Dr. Chung said, over the last 20 to 25 years that I've been
02:37practicing, even though there has been a lot of improvement, medical advancement in caring for patients
02:45with acute kidney injury, dialytic therapies, even treatment for sepsis with different antibiotics and
02:52targeted medications, the intersection of patients with acute kidney injury that's so severe that they
03:00require continuous dialysis and are massively inflamed from sepsis or a sepsis-like condition
03:06had not improved in my medical career. And what we saw as we started the initial SCDP-01 trial
03:17is kids that had a 50% chance of mortality, not only did that go in half, but we saw dramatic
03:26improvements almost within 24 to 48 hours, which was just quite shocking to us, frankly. And of the
03:36patients who survived, all of them are off dialysis 60 to 90 days later, which is also another amazing
03:44finding where 10 to 30% of kids who survive an acute kidney injury episode like that are still requiring
03:52chronic dialysis. So it's a dramatic improvement that you see almost within the first one to two days
03:59that is nothing like I'd seen before in clinical medicine for the last quarter century.
04:05Let me go back to you, Dr. Chung. Is there a therapy specific to pediatric patients,
04:08or does it have broader application in AKI or other areas?
04:13Yeah, thanks, Dan. It clearly has applications elsewhere. For example, right now we're commercialized
04:21in the pediatric AKI space. However, we have an adult study that is ongoing and we're way over 100
04:29patients thus far shooting for 200 total. And that study is being conducted to try to bring
04:37call immune to the adult market through a PMA approval. So that is ongoing right now.
04:46And also the therapy itself is organ and disease agnostic, which means that it can treat any
04:51condition that whereby the innate immune system is disturbed. And so we have, as you may know,
04:58six breakthrough device designations that we were able to receive from the FDA. And so other disease
05:06states are definitely going to be next.
05:08Just incredible stuff. Dr. Kevin Chung, Chief Medical Officer of C-Star and Dr. Stuart Goldstein of
05:13Cincinnati Children's Hospital. That was an absolutely fascinating conversation. Thanks so much for
05:18what you're both doing. And thanks so much for joining me today.
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