SeaStar Medical (ICU) Q2 2026 Earnings Call Transcript

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DATE

Wednesday, Aug. 12, 2026 at 4:30 p.m. ET

CALL PARTICIPANTS

• Chief Executive Officer - Eric Schlorff
• Senior Vice President of Commercial and Business Operations - Tim Varacek
• Chief Medical Officer - Kevin Chung
• Chief Financial Officer - Michael Messinger

TAKEAWAYS

• Net Revenue -- $615,000 for SeaStar Medical Holding Corporation (NASDAQ:ICU), representing an 82% increase year over year driven by expanded adoption of QUELIMMUNE therapy.
• Six-Month Net Revenue -- $1.1 million, reflecting consistent momentum toward the full-year target of $2 million.
• Gross Profit Margin -- 91%, remaining consistent with the prior four quarters and reflecting pharmaceutical-like margins for the selective cytopheretic device technology.
• Research and Development Expenses -- $2.5 million, representing an increase from $1.0 million due to additional clinical sites and higher patient enrollment in the NEUTRALIZE-AKI study.
• General and Administrative Expenses -- $1.8 million, reflecting increased compensation costs, legal fees, and professional fees.
• Net Loss -- $3.7 million, or $0.91 per share, compared to a net loss of $2.0 million in the prior-year period.
• Cash and Cash Equivalents -- $7.0 million as of June 30, 2026, compared to $12.0 million at the end of 2025.
• Hospital Customer Base -- 20 hospitals, including top-rated children's medical centers, which represents a doubling of the customer base since the beginning of 2026.
• 2026 Hospital Adoption Goal -- 25 hospitals, representing the company's year-end target for establishing QUELIMMUNE in the pediatric critical care market.
• NEUTRALIZE-AKI Enrollment -- 223 patients enrolled out of a total target of 339, with completion anticipated between the fourth quarter of 2026 and the first quarter of 2027.
• Monthly Patient Enrollment -- 8 to 12 patients per month, though management expects this rate to increase to 15 to 20 patients as new sites are activated.
• Adult Market Scale -- 50-fold larger than the pediatric market, representing the potential growth opportunity if the selective cytopheretic device is approved for adult use.
• ICD-10-PCS Code Implementation -- Oct. 1, 2026, which is expected to simplify hospital billing and remove administrative barriers to therapy adoption.
• Clinical Trial Site Expansion -- two new clinical sites onboarded recently, with four additional sites expected to begin screening patients shortly and eight more committed to participating.
• PMA Submission Timeline -- late 2027, remains the target for submitting the final clinical module of the modular Premarket Approval application to the FDA.
• C-Reactive Protein (CRP) Enrichment -- 3.5 mg/dL threshold used as enrollment criteria to ensure trial participants have sufficient inflammatory levels to demonstrate therapeutic effect.
• Inventory -- $77,000, representing a slight increase from $66,000 at the end of the previous fiscal year.
• Accounts Receivable -- $208,000, compared to $237,000 as of Dec. 31, 2025.
• Current Liabilities -- $4.4 million, including $3.5 million in accrued expenses and $750,000 in accounts payable.
• SAVE Registry Progress -- 50 patients completed in the safety registry required by the FDA to evaluate QUELIMMUNE safety in real-world pediatric settings.
• Primary Endpoint -- 90-day composite of mortality or dialysis dependence, established as the main metric for the NEUTRALIZE-AKI pivotal trial.
• Cost of Goods Sold -- $54,000 for the quarter, compared to $27,000 in the second quarter of 2025.
• Notes Payable -- $134,000, net of deferred financing costs, as of June 30, 2026.
• Weighted Average Shares Outstanding -- 4.1 million shares, compared to 1.1 million shares in the prior-year period.

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RISKS

• Chief Medical Officer Chung stated that monthly enrollment has averaged 8 to 12 patients, which he characterized as "slower than what I would like," though he noted that site expansion and reinforcements are expected to increase the pace to 15 to 20 subjects per month.

SUMMARY

Management reported significant progress in commercializing QUELIMMUNE within the pediatric acute kidney injury market while advancing the NEUTRALIZE-AKI pivotal trial for adult patients. The company stated that a modular PMA submission strategy is being used with the FDA to expedite the regulatory process by allowing for the review of technical and manufacturing modules before clinical data is finalized. Administrative milestones include the implementation of new ICD-10-PCS codes on Oct. 1, 2026, which management expects will simplify hospital billing and foster adoption. Strategic focus remains on activating additional clinical sites to meet enrollment targets and conducting educational outreach to solidify the therapy as a standard of care in critical care environments.

• CEO Schlorff highlighted the economic potential of the adult market, stating, "We believe our continued QUELIMMUNE revenue growth bodes well for our future potential opportunity in the adult AKI market that is 50 times larger than the current pediatric market in the U.S."
• Chief Medical Officer Chung emphasized the importance of trial integrity over speed, noting that "enrolling the right patients takes precedence over enrolling quickly" to avoid the failures observed in previous sepsis and acute kidney injury trials.
• The company reported that 20 of the 50 premier children's hospitals in the U.S. have now purchased and used the QUELIMMUNE therapy, doubling the customer base since the beginning of 2026.
• Management stated that the SCD technology holds breakthrough device designation for six therapeutic indications, which may support an expedited regulatory pathway and more favorable reimbursement dynamics at launch.
• A recent educational webinar titled "Rethinking Pediatric Sepsis-Associated AKI" drew high attendance, providing practicing clinicians with case reviews and guidance on navigating the adoption of QUELIMMUNE within hospitals.
• Chief Medical Officer Chung noted that mature clinical sites are shifting their use of the therapy from a last-resort rescue treatment toward earlier intervention, stating, "clinicians are scanning their ICU to see who may benefit from the therapy" based on positive earlier outcomes.

INDUSTRY GLOSSARY

• Acute Kidney Injury (AKI): A sudden and temporary loss of kidney function, often caused by severe infections, trauma, or organ failure.
• Selective Cytopheretic Device (SCD): A medical device that targets and neutralizes hyperactive immune cells to stop the cytokine storm responsible for organ failure.
• QUELIMMUNE: The proprietary brand name for SeaStar Medical's SCD therapy approved for pediatric patients.
• Continuous Renal Replacement Therapy (CRRT): A form of dialysis used in critically ill patients to provide continuous blood purification over a 24-hour period.
• Premarket Approval (PMA): The FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices.
• Humanitarian Device Exemption (HDE): An FDA approval for a device intended to benefit patients with rare diseases or conditions affecting fewer than 8,000 individuals in the U.S. per year.
• C-Reactive Protein (CRP): A protein made by the liver that increases when there is inflammation in the body.
• Sepsis: A life-threatening emergency that happens when the body's response to an infection damages its own tissues.
• Cytokine Storm: A severe immune reaction in which the body releases too many cytokines into the blood too quickly, which can cause multi-organ failure.

Full Conference Call Transcript

Operator: Good day, and thank you for standing by. Welcome to the SeaStar Medical Reports second quarter 26 Financial Results. At this time, all participants are in a listen-only mode. Please be advised that today's conference is being recorded. After the speakers' presentation, there will be a question-and-answer session. To ask a question, please press 11 on your telephone, and wait for your name to be announced. To withdraw your question, please press 11 again. I would now like to hand the conference over to your speaker today, Jackie Cossmon.

Jackie Cossmon: Thank you, Josh. Good afternoon, and thank you for joining the SeaStar Medical second quarter 26 financial results conference call. I am Jackie Cossmon with Wheelhouse Life Science Advisors. Joining me from SeaStar Medical today are Eric Schlorff, chief executive officer Tim Varacek, senior vice president of commercial and business operations doctor Kevin Chung, chief medical officer, and Michael Messinger, chief financial officer. I would like to remind listeners that comments made during this call by management will include forward-looking statements within the meaning of federal securities laws These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from any anticipated results.

For a list and description of these risks and uncertainties, please review SeaStar Medical's filings with the Securities and Exchange Commission. Furthermore, the content of this conference call contains information that is accurate only as of the date of the live broadcast. 08/12/2026. SeaStar Medical undertakes no obligation to revise or update any statements to reflect events or circumstances except as required by law. And now I would like to turn the call over to Eric. Eric?

Eric Schlorff: Thank you, Jackie. And thank you all for joining us today. We are very pleased with our progress this quarter. Our pediatric AKI market penetration and continued strong QUELIMMUNE revenue growth bodes well for our future potential opportunity in the adult AKI market, that is 50x larger than the pediatric market in The United States. Successful treatment of pediatric AKI with QUELIMMUNE therapy by patient care teams is driving greater clinical confidence from the tight knit critical care pediatric community, which we believe will only strengthen the future potential launch of this therapy in the adult AKI market.

Tim will speak further on our plans for our continued of QUELIMMUNE in the pediatric AKI market, and also discuss how we are strategically planning for a potential launch of this therapy in the adult market. And Kevin will describe our progress in our NEUTRALIZE-AKI pivotal clinical trial and our regulatory strategy for the adult AKI indication Before I turn the call over to Tim, if you are new to SeaStar Medical's story, I would like to clarify that the same foundational therapy in Quellimmune known as the selective cytopheretic device or SCD, is the same therapeutic device that we are evaluating in our pivotal study for the adult AKI indication.

The adult version is simply a larger device to accommodate larger blood volumes. Also, like to emphasize that our SCD therapy is first-in-class. It is the only immunomodulatory therapy that targets and neutralizes hyper active leukocytes and monocytes and immune cells the immune cells primarily responsible for causing the cytokine storm. Shuts down organs and takes the lives of far too many patients with AKI requiring renal replacement therapy. Given the unique mechanism of our STD therapy, and the significant value of finding a potential solution to this continuing unmet need, I would note that we anticipate our current pharmacologic, pharmaceutical-like gross margins to continue for QUELIMMUNE and to extend to our adult therapies if approved.

Furthermore, we believe that the FDA understands the importance of bringing innovative treatments advancements to critically ill patients with AKI. The FDA approved Quellimmune for pediatric AKI under humanitarian device exemption and also awarded us breakthrough device designation for the SCD for adult patients with AKI on continuous renal replacement therapy which should support a more collaborative and rapid approval process. We also have received breakthrough device designations for our other pipeline indications, including systemic inflammation from cardiac surgery, and chronic inflammation in end-stage renal disease among others. I provide this context today to reiterate our strong belief that our opportunity is significant.

We remain keenly focused on achieving our near term goals understand the importance of driving new customer adoption for Quellimmune. Enrolling patients in our NEUTRALIZE-AKI trial. By the same token, we are not losing sight of our long-term opportunities and what SeaStar Medical can achieve for all our stakeholders. With that, I will turn it over to Tim. Tim?

Tim Varacek: Thanks, Eric, and thanks, everyone, for joining us today. We are making great progress in our efforts to establish Quellimmune as an important therapy in the critical care of pediatric patients with AKI and sepsis. Currently, 20 of the 50 premier children's hospitals in The US have purchased and used our QUELIMMUNE therapy. Recall that our goal for 2026 is to increase the number of hospitals to 25 by the end of the year from 10 at the beginning. So we have already doubled our customer base this year, and we are well on our way to achieving that goal. And as Eric indicated, the use of QUELIMMUNE therapy is broadly resonating in the pediatric critical care community.

Let me describe how. We discussed in our first-quarter call the considerable interest in Quellimmune at the AKI and CRRT meeting in San Diego. Adding to the buzz we observed there, we sponsored and participated in this year's KDP Summit a few weeks ago. The summit occurs annually and brings together a highly specialized interdisciplinary team, including nurses, advanced practice providers, nephrologists, and critical care physicians from across the country. Its core importance stems from tackling the exact systemic failures that leave pediatric kidney failure under-recognized. And just yesterday, we assembled leading experts in the treatment of pediatric AKI to speak at a SEASTAR medical educational webinar. webinar was entitled Rethinking Pediatric Sepsis-Associated AKI: What Clinicians Should Know About QUELIMMUNE?

We brought together practicing pediatric nephrologists, critical care physicians, advanced practice providers, and nurses to learn more about pediatric sepsis associated AKI the use of QUELIMMUNE therapy through case reviews, and how to navigate QUELIMMUNE adoption within hospitals. Both events were very well attended and provided an opportunity for the pediatric community to get answers to key operational questions, gain exposure to the rich content from cutting edge scientific and clinical data, in sepsis associated pediatric AKI, and how to apply that knowledge to employ our QUELIMMUNE therapy the hospitals in which they practice. As previously stated, this is an ultra rare population with a very high unmet need.

And as the first and only therapy available to treat children with AKI and sepsis QUELIMMUNE is helping to drive new thinking in the pediatric AKI community. Now turning to our revenue targets and future opportunities in this ultra rare pediatric market. We reported QUELIMMUNE net revenues of $615 thousand in the second quarter. A strong 82% increase over last year's second quarter. And with 6-month net revenue at 1.1 million Momentum remained strong as we advance toward our 2026 net revenue target of $2 million. In short, we are very encouraged by the current rate of QUELIMMUNE adoption and we continue to focus on adding new customers as quickly as possible.

We have great expectations, of helping more patients by bringing our QUELIMMUNE therapy to more pediatric hospitals. And as we look to 2027 and beyond, we believe we can expand our overall market opportunity beyond the top 50 pediatric medical centers. We announced in June that the Centers for Medicare and Medicaid Services also known as CMS, assigned ICD 10 PCS codes for our SCD therapy. Allowing hospitals to efficiently bill qualimmune therapy when used in treating sepsis associated pediatric AKI. And we believe all future potential indications for from our SCD therapy will use the same PCS code. The implementation of the new ICD 10 PCS code initiates on October 1 of this year.

This is an important administrative development as it removes another potential barrier to QUELIMMUNE adoption. In addition, we have completed the 50 patient SAVE Registry that was required by the FDA to further evaluate the safety of our QUELIMMUNE therapy. Our preliminary report was submitted. And we are now preparing the final report for FDA review. Our results from the first 21 patients were reported in the prestigious peer reviewed journal pediatric nephrology. And that alone has driven continued interest in adopting Quellimmune. So in summary, the future for our QUELIMMUNE therapy looks bright.

As we continue to expand into the pediatric market and work in parallel on pre-commercialization efforts focused on the adult AKI population which is estimated to be 50x larger than the sepsis associated pediatric AKI population in The US. Thank you for your attention. And with that, I will turn the presentation over to our chief medical officer, Kevin Chung. Kevin?

Colonel Kevin Chung FACP: Thanks, Tim. And thank you to everyone for listening to our call. I want to echo Tim's enthusiasm about our growing presence in the pediatric critical care community. It is rewarding to hear how these nephrology and critical care teams are adopting the QUELIMMUNE therapy and understanding that it is truly the first of its kind. These kids have days, if not hours, to live, and we have heard many stories about first-time use of Quellimmune with life saving outcomes. These stories are truly remarkable. And they continue to validate and reinforce why getting this therapy to a broader patient population is so important.

And to be clear, we believe that Quellimmune for pediatric AKI indication is just the first of a broad range of indications for SCD therapy. To our knowledge, no other pharmaceutical therapy or medical device on the market today is able to identify, target, and neutralize the specific immune cells that cause hyperinflammation. That means the SCD's unique immunomodulatory mechanism positions us to potentially reshape treatment paradigms across a range of serious inflammatory conditions. Not only for AKI, but cardio renal syndrome, systemic inflammation from cardiac surgery, chronic inflammation in end-stage renal disease, and other states of pathologic immune activation where dysregulated cytokine release drives organ failure and death.

Which brings me to the discussion highlighting our efforts to bring our SCD therapy to critically ill adult patients with AKI requiring CRT. We are currently conducting the NEUTRALIZE-AKI trial and have plans to file a modular premarket approval or PMA. With the FDA to potentially speed the overall approval process for this important indication. The modular PMA enables the FDA to review and comment on portions of our application prior to submitting all modules. The last of which would be the submission of the NEUTRALIZE-AKI clinical trial results. I would also note that we have been awarded breakthrough device designation for this indication. Which should support expedited regulatory review.

As a reminder, our NEUTRALIZE-AKI pivotal trial is a randomized controlled trial designed to assess the SCD therapy in critically ill adult patients with AKI requiring CRT. The primary endpoint is a composite of mortality, or dialysis dependence at 90 days. We now have enrolled 2 hundred and 23 of our total anticipated 3 hundred and 39 patients in the trial, and have stepped up our site recruitment to accelerate pace of enrollment as we move forward. We recently onboarded 2 additional clinical sites who have already recruited patients. We have 4 additional sites that we anticipate will be screening patients shortly. In at least 8 more sites, that have committed to participating in the trial.

Our sites are extremely motivated and are continuously screening patients. When they identify potentially eligible patients, our sites are typically able to successfully consent and enroll those patients into our trial. This reflects highly on the site investigators and incredibly professional research staff who are tactfully approaching family members during a patient's most desperate hour in the ICU. Must emphasize that we continue to be focused on enrolling the right type of patients. This careful selection of patients is essential to demonstrating therapeutic effect and avoiding the limitations that have confounded prior AKI and sepsis trials. 1 of our enrichment criteria is a c reactive protein or CRP level greater than 3.5 mg/dL.

Patients who do not have a CRP greater than 3.5 are excluded. Why? CRP is a very sensitive marker of inflammation in those patients with a low CRP are unlikely to benefit from our therapeutic device. In past interventional sepsis or AKI trials directed at inflammation, many of these types of patients were included and those trials ultimately failed. Beyond CRP, we are also we are also applying our carefully considered exclusion criteria to remove patients whose pre-existing conditions could obscure the true treatment effect. Patients who might not survive regardless of whether the SCD works.

This is the same disciplined approach we took in our pediatric trials and it is the right way to design a study that can demonstrate therapeutic benefit. It is worth emphasizing that clinical trial populations are by design more narrowly defined than real world practice. We are seeing in the commercial setting physicians who are already applying QUELIMMUNE to a much broader, unlabeled population of pediatric patients than those enrolled in our trials. Including patients with complex comorbidities who would not have met trial eligibility criteria. That broader real world use reflects clinical confidence in the therapy and suggests the addressable patient population is larger than what our trial enrollment numbers alone might imply.

We are making meaningful progress in NEUTRALIZE-AKI. And our confidence in the trial design in site execution, has never been higher. As we discussed, enrolling the right patients takes precedence over enrolling quickly. And our sites are delivering on that standard. While we expect to complete enrollment around year end, or in the first quarter of 27, our PMA submission timeline in late 27 remains unchanged. The breakthrough device designation we hold for this indication means that when we submit the FDA is positioned to move quickly. A PMA approval of the SCD therapy for adult patients with AKI on CRT would enable commercialization with ICD 10 PCS codes in place. Significantly simplifying hospital adoption.

Also, given the foundation we are establishing, in the pediatric critical care community, with Quellimmune we believe it would support more rapid adoption among nephrology and critical care experts in the adult AKI community. We are passionate about our ability to improve and potentially save lives of these critically ill patients and look forward to reporting our progress. And with that, I will hand it over to our CFO, Michael Messinger. Mike?

Michael Messinger: Thank you, Kevin, and thanks everyone for joining our call today. I will provide a brief overview of our financial results for the second quarter of 2026. Please note that our Form 10 Q will be filed with the SEC within the next 24 hours and it will include a lengthier discussion of the company's financial results for the 3 months ended June 30, 2026. You will find the 10 q at sec.gov. Or through our website at seastarmedical.com. We recorded net revenue for the second quarter of $615 thousand reflecting increased demand for QUELIMMUNE. This represents an 82% increase compared to net revenue. Of approximately $338 thousand for the second quarter of 2025.

And this is an increase in the rate of growth from the 69% growth we had in the first quarter. And we continue to maintain our gross profit percentage of over 90% in the second quarter of 2026. Consistent with the prior 4 quarters. Turning now to our operating expenses. In the second quarter of 2026, we reported $4.4 million in operating expenses compared to $2.1 million in the second quarter of 2025. Our research and development expenses increased primarily to the additional clinical sites and increased patient enrollment compared to the same period in 2025.

Our general and administrative expenses increased compared to the second quarter of 2025 primarily to an increase in compensation costs legal and professional fees, and certain SEC related expenses. As we indicated in our first quarter call, we expected our sequential quarterly research and development costs to increase based on adding additional clinical sites and our focused recruitment efforts. We did see a roughly mid single digit increase over our first quarter, and we continue to expect the same for the rest of 2026, as we anticipate meeting our enrollment goals. Net loss for the second quarter of 2026 was approximately $3.7 million or $0.91 per share based on weighted average shares outstanding of approximately 4.1 million shares.

This compares with a net loss of approximately $2 million or $1.77 per share for the second quarter of 25 based on approximately 1.1 million weighted average shares outstanding. We had approximately $7 million of cash on our balance sheet at 06/30/2026 compared to $12 million at December 31, 2025. And with that, I will turn it back to Eric.

Eric Schlorff: Thanks, Mike. And our goal today was to share with you our second quarter achievements, but also express how keenly focused we are on the key value drivers both short- and long-term for our stakeholders. We have a small but passionate team at SeaStar Medical, yet we believe we are reshaping the possibility for kids and in the future, potentially adults that often face organ failure or death without new therapies to modulate cytokine storm in acute kidney injury. Our goal is to set a higher standard for the treatment of all patients that face the trauma of AKI.

We believe that the opportunities that lie ahead for us for SeaStar Medical are significant, and we look forward to reporting our future progress. With that, I will ask the operator to open the call for questions. Operator?

Operator: Thank you. As a reminder, to ask a question, please press 11 on your telephone and wait for your name to be announced. To withdraw your question, please press 11 again. 1 moment for questions. Our first question comes from David Bautz with Zacks Small Cap Research. You may proceed.

David Bautz: Hey. Good afternoon, everyone. I appreciate you taking the questions. First off, I was wondering if you could comment on what the current monthly enrollment rate is for the NEUTRALIZE-AKI study. And if you are seeing any type of acceleration of enrollment at the newer high volume sites. And then lastly, can you quantify your confidence for hitting that 39 patients either by year end or the first quarter of 2027?

Eric Schlorff: Yes. So thanks for the question. So, let me tackle the second 1. What we basically kind of guided the market as is really our time line is around year end or into Q1. Obviously, it is gonna depend on, you know, Kevin and his team bringing on additional sites, etcetera, from an enrollment standpoint. But I am really proud of what Kevin and his team are doing on bringing those on pace. But, you know, if I think about this, David, before, he kind of talks about maybe enrollment, we still believe that we are really on track at the end of the day to have end up 2027 submission for the final PMA module.

Which, you know, obviously, really not impacting the timeline. But Kevin, you could talk a little bit about, enrollment of various sites.

Colonel Kevin Chung FACP: Right. Thank you, Eric. So on average, over the last few months, we have averaged somewhere around 8 to 10 to 12 patients in each of those months. And that is relatively slower than what I would like. However, I have to emphasize we have to get the right patients. And by right patients, I mean those with modifiable disease. what is the point in getting finished with enrollment if we enroll a bunch of patients out of haste to try to just get our number and we are not enrolling the right patients. That is-- that would be a flawed strategy.

For me, the focus is on getting the right patients enrolled so that we optimize our chance for success. that is number 1. Number 2, as, we discussed in the report, in our update, we are very busy right now activating in the process of activating numerous sites. As I said, there are 4 that are so close. To getting activated Just some residual signatures and etcetera, those kinds of things, and we are ready to activate them. And so, we are gonna be very soon be seeing some reinforcements come in with an additional 4 sites ready to go. Already trained. SIB's already performed site initiation So we are ready to go with those sites.

There are additional 8 sites half of whom contacted us. Because they wanted in on the trial. And so they have committed. Now whether or not we are gonna be able to activate all 8 sites is still debatable. But we are gonna try. To get as many sites activated as possible because that is gonna get us to 15 to 20 subjects per month, which is more at the pace that I would like. Again, though, focused on the right patients. We have to get the right patients. We have to get that right to have a chance for a positive trial.

David Bautz: Okay. Great. So with the enrollment expected by the end of this year, early 2027 and the PMA submission target for the end of 27. Was wondering if you could just walk through what are the major activities for the PMA that need to happen, say, after enrollment or after database lock before you can, you know, fully submit it.

Colonel Kevin Chung FACP: Yeah. So your question is what are some of the well, once we once we lock the database, obviously, then we will give out top line results. You know, once it is locked, we can analyze, etcetera. And then, really, it is just submitting the clinical section. it is really essentially because all the other previous sections will have been submitted by that time. And that is really what the goal is so that when the FDA then has their time, you know, they can then focus just merely on the clinical sections and not have to go through things like device and description, etcetera. So that is really what the strategy is.

David Bautz: Okay. Sounds good. And then, last 1, talking about the increase in revenue. I was wondering if you could quantify the contribution from existing customers versus the new customers that you added during the quarter.

Eric Schlorff: Yes. Thanks. Tim, you want to tackle that 1?

Tim Varacek: Sure. Yeah. So it is a combination of new hospital systems as well as existing systems that delivered that revenue, And, you know, we have a very high repurchase rate with the existing sites, and then, obviously, the new sites that come on board they wanna stock the product as soon as they can. So that they are ready to treat patients. So it was a group effort. By all of the customers that were out there.

David Bautz: Okay. Great. Appreciate you taking the questions.

Eric Schlorff: Thanks, David. Thanks.

Operator: Thank you. Our next question comes from Anthony Vendetti with Maxim Group. You may proceed.

Anthony Vendetti: Yes. Hi. Thanks. Can you talk about the milestones between completing enrollment and then the final PMA submission?

Eric Schlorff: I think you mentioned you submitted the preliminary. Right? Or you submitted We are submitting preliminary reports. So we are submitting no. Well, so you are talking about the PMA, right, for adults? Yeah. Yeah. Yeah. Yeah. Yeah. So, yeah, for that, I mean, obviously, you know, what we are doing right now is a modular PMA. So there is various sections where you talk about the device. You talk about, you know, sterilization. You talk about all sorts of you know, kind of the technical things that go into it.

But then you get into, you know, that what the goal really is, Anthony, is to have those sections already submitted to the FDA already have had the discussions with the FDA on those sections. And so really, what you are waiting for at the end is once you have data lock and then you can show top line and, you know, do the analysis, you are really just submitting the clinical section of it. Okay. And you so you have submitted already the certain sections, and No. We are in the process. So yeah. We are in the-- yeah. We are in the process of doing that. Yeah. Got it. Got it. Okay.

Tim Varacek: And then you have right now about 20 pediatric hospitals. Right? Correct. So is there is there a process or what do you have to do to make sure they are not just sort of like, okay. They are they are a hospital that uses this, but how do you get them to be a more meaningful recurring customers or are just, hey, you just need the patients to come in and they are they are already on board, and there is nothing really left to do with those particular hospitals. Yeah. Maybe, Tim, you could kind of address it, and then, Kevin, if you would like to add any additional comments on top of it.

It is really a multidisciplinary approach that we take to these hospital systems. Okay. Yeah. It absolutely is. Just to give you insight. So let's say a hospital just came into the fold today. They have adopted QUELIMMUNE formally. There was a whole process that took place in terms of IRB approval. Becoming a qualified vendor, all the associated things you have to do to basically be a customer to the hospital system. Then, a patient actually shows up in the emergency room, gets moved to the ICU, and QUELIMMUNE becomes, you know, something that is top of mind. We have, then the clinical team that will come over.

They will actually help the setup of that first to ensure everything goes smoothly. Now in terms of what happens after that, there is a lot of work to do. Because these every hospital system is large. They have a lot of different staff. They have different shifts. And so there really needs to be an educational approach to that hospital system that never ends. Because there is turnover like in any other business.

And our goal is to continually increase the not just the breadth, but the depth that we get to within all of our customer base and the new ones that we will add so that QUELIMMUNE is something that is top of mind for the patient care teams. Because we believe that while QUELIMMUNE is a super effective therapy, if you do not know about it and a patient comes in and there is not 1 of your advocates there, they may not realize that they could use QUELIMMUNE to treat that patient.

So it is a continual effort from a commercial standpoint and from a clinical standpoint to ensure that we really ingrain, the brand into these hospital systems, and they understand the clinical value of it, so that they recognize patients when they come in. And they can choose to use qualimmune therapy as an option when it is when it is there and it is available. Okay. So just to understand. So, obviously, getting into the hospital is just the first step and trying to make sure all the trained health care professionals that could use it, a, know the benefit, know how to use it, and you stay engaged.

Because like you said, if there is new doctors, nurses, or so forth that are coming in, you wanna make sure that they are aware of the treatment and of the application of the QUELIMMUNE. Correct? 100%. Yep.

Colonel Kevin Chung FACP: Okay. If I may add some color to the clinical perspective, So yesterday, we conducted a webinar that we will make available very soon so that those of you who missed the webinar or had technical difficulties are able to dial in. During that discussion, it became-- it was-- it is-- this has been clear, but it became more clear to me that there is a big difference between new sites that have device and mature sites that have device. New sites anytime there is a new technology, even if it is lifesaving, because of the natural skepticism that is very prevalent within the medical community, they have to see it work.

And so, you know, generally, it is used as a rescue therapy. And what I mean by that is it is used for the new sites as a last resort. Oftentimes, with a bunch of other experimental therapies that are not even approved being applied prior to SCD. So that is new sites. that is the approach that they take. And that is been true for almost every site that have been activated because whenever a therapy is new, that is what is gonna happen.

And I have to say and have to emphasize that even with those types of patients, that have failed other therapies, we are talking about a 70% survival in that population which I have to emphasize that is remarkable. But yesterday, we are starting to sort of notice the shift, with the mature centers. With the mature sites that have been doing this now for over a year. These sites everybody's already educated. Everybody is already has seen what I call the index case. The moment, the case that converted them and in their mind, made them think, oh my gosh. We need to do this.

And this is occurring, and adoption clinical adoption mentally is occurring pretty universally across our mature sites. And so right now, as we speak, those clinicians are scanning their ICU to see who may benefit from the therapy. And so it is no longer now a rescue therapy. They are not waiting until the bitter end. They are starting these patients early, and we are seeing even better outcomes. Which is just, really remarkable. So that was my takeaway from the webinar. Again, we will make this available very soon. And, hopefully, you will be able to watch it and verify my statement.

Anthony Vendetti: No, that is helpful, Kevin. Yeah. So I mean, you know, we know the focus as it should be is on you know, the pediatric market and now the adult AKI. You know, with this trial enrollment, and you are at 223 up to 339. And we know it is adult AKI is 50x larger than the pediatric market. But there is other markets that you know, that your, you know, device can of your device can treat. Whether that be acute respiratory distress, hepatorenal syndrome, cardiorenal syndrome, and, of course, sepsis.

So I know you want to stay focused as like I said, you should, but you know, behind the scenes, you know, can you give us some insight into what kind of work is being done on these other indications?

Eric Schlorff: Yeah. Yeah. So I can tackle that 1. Yeah. So I mean, yeah. So, you know, we do obviously evaluate all the other applications that we believe that, obviously, from our perspective, the there is a pretty long laundry list of things that really would be on our wish list. But obviously, you know, we, as a company, have to be focused on, you know, certain things, and that is really been on Quellimmune for pediatric AKI and adult AKI and neutralized AKI. Obviously, we have got the neutralized CRS study that is actually been funded by NIH.

And, you know, we I would say, you know, we have various discussions with various parties looking at, you know, everything from nondilutive to strategic discussions, you know, business development, on all these types of things. To be able to really advance the other indications that we believe we have in our pipeline. But obviously, you know, it will just take time for some of those things to mature and we will just have to see how they pan out.

Colonel Kevin Chung FACP: If I may just add really quickly, I should remind everyone that for neutralize AKI, a priority we identify patients with ARDS at the time of enrollment and sepsis at the time of enrollment. And we randomized via this technique called block randomization. What that does is it allows equal distribution of subjects to be assigned in the ARDS bucket in the sepsis bucket, in the combined sepsis and ARDS bucket. We will be able to for sure, make a statement about those specific populations who have concomitant AKI, of course.

Anthony Vendetti: No. Yeah. that is that is very that is very helpful. Thank you. Thanks, Eric, Kevin, everyone. Okay. I will hop back in the queue. Thanks.

Operator: Thank you. I would now like to turn the call back over to Jackie Cossmon for any closing remarks. Thank you, Josh, and thank you all for joining us today for the SeaStar Medical Second Quarter Financial Results Conference Call. If you have questions, please contact us at seastarmedical.com, or visit our website at www.seastarmedical.com. Thank you. And goodbye. Thank you. This concludes the conference. Thank you for your participation. You may now disconnect.

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