Q4 2024 SeaStar Medical Holding Corp Earnings Call

Good afternoon and thank you for standing by. My name is Calvin and I will be your conference operator today. At this time, I would like to welcome everyone to the SeaStar Medical Year and 2024 Financial Results Conference call.

Operator: I would now like to turn the call over to Jackie Cosman. Please go ahead.

Jackie Cosman: Thank you, Calvin. Good afternoon, and thank you for joining the SeaStar Medical Year-End 2024 Financial Results Conference Call. I'm Jackie Cosman with Wheelhouse Life Science Advisors. Joining me from SeaStar Medical today are Eric Schlorff, Chief Executive Officer, Michael Messinger, Chief Financial Officer, Dr. Kevin Chung, Chief Medical Officer, and Tim Varacek, Senior Vice President of Commercial and Business Operations. I would like to remind listeners that comments made during this call by management will include forward-looking statements within the meaning of the 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 descriptions of risks and uncertainties, please review SeaStar Medical's filings with the Securities and Exchange Commission at sec.gov.

Speaker Change: Thank you Kelvin good afternoon, and thank you for joining the G Star Medical year end 'twenty 'twenty four financial results Conference call I'm, Jackie Kaufman with Wheelhouse Life Science Advisors, joining me for the Star Medical today are Eric Schwartz, Chief Executive Officer, David Green.

Speaker Change: Chief Financial Officer, Dr. Kevin Chang, Chief Medical Officer, and Tim Barrett check senior Vice President of commercial and business operations.

Speaker Change: I would like to remind listeners that comments made during this call by management will include forward looking statements within the meaning of the federal Securities laws.

Speaker Change: These forward looking statements involve risks and uncertainties that could cause actual results to differ materially from any anticipated results.

Speaker Change: For a list and descriptions of risks and uncertainties. Please review these star Medicals filings with the Securities and Exchange Commission at SCC got golf Fair.

Jackie Cosman: Furthermore, the content of this conference call contains information that is accurate only as of the date of the live broadcast, 27 March 2025. SeaStar Medical undertakes no obligation to revise or update any statements to reflect events or circumstances, except as required by law. Now, I'd like to turn the call over to Eric. Eric?

Furthermore, the content of this conference call contains information that is accurate only as of the date of the live broadcast March 27 2025.

Speaker Change: Eastern medical undertakes no obligation to revise or update any statements to reflect events or circumstances.

Speaker Change: Except as required by law.

Eric Schwartz: And now I'd like to turn the call over to Eric Eric.

Eric Schlorff: Yeah. Thank you, Jackie, and thank you all for joining us today. We are excited to share with you our achievements over the past year, and more importantly, our future plans and our passion for what we are doing here at SeaStar Medical. With the launch of QUELIMMUNE, which Tim will talk about shortly, we have witnessed truly amazing patient outcomes about how our SCD therapy has saved lives. One example was recently sent for publication by investigators at the University of Michigan, where the patient had a 95% predicted mortality, and after SCD therapy, they have normal kidney function, resumed chemotherapy, and are at home. We have also witnessed stopping almost certain critical organ damage and children being discharged out of ICU or intensive care units without the need for lifelong renal replacement therapy.

Eric Schwartz: Yes, Thank you Jackie and thank you all for joining US today, we are excited to share with you our achievements over the past year and more importantly, our future plans and our passion for what we are doing here at she start medical with the launch of quell immune which Tim will talk about shortly we have witnessed truly amazing patient outcomes.

Eric Schwartz: How are S C D therapy.

Speaker Change: Save lives. One example was recently sent for publication by investigators at the University of Michigan, where the patient had a 95% predicted mortality and after <unk> therapy. They have normal kidney function resumed chemotherapy and are at home.

Speaker Change: We have also witnessed stopping almost certain critical organ damage and children being discharged out of ICU or intensive care units without the need for lifelong renal replacement therapy.

Eric Schlorff: For us, these truly amazing clinical cases speak loudly of the opportunity for our SCD therapy as a potential treatment for the approximate 1 million patients that each year face the consequence of destructive hyperinflammation that can damage critical organs and take lives. In our estimation, the longer-term opportunity to treat other serious inflammatory conditions such as cardiorenal syndrome, hepatorenal syndrome, and chronic dialysis expands our opportunity well beyond the initial market that we have identified for the SCD therapy.

Speaker Change: For us these truly amazing clinical cases speak loudly or the opportunity for our S. C D therapy.

Speaker Change: Potential treatment for the approximate 1 million patients each year face the consequence of destructive hyper inflammation that can damage critical organs and take lives.

Speaker Change: In our estimation the longer term opportunity to treat other serious inflammatory conditions, such as cardio renal syndrome, hepatic renal syndrome, and chronic dialysis expands our opportunity well beyond the initial market that we have identified for the C D therapy in.

Eric Schlorff: In short, we are very excited about our opportunities and look to 2025 as a year of growth and momentum with new top-tier pediatric medical centers adopting QUELIMMUNE and the achievement of our clinical development efforts with institutions like Stanford, Cleveland Clinic, and Mayo Clinic joining the NEUTRALIZE-AKI adult pivotal study to bring our second therapeutic product to a market that is 50 times larger than the important, yet smaller market for pediatric patients with AKI. Our strong momentum coming into 2025 has been fueled by our significant accomplishments in 2024.

Speaker Change: In short we are very excited about our opportunities and look to 2025 is a year of growth and momentum with new top tier pediatric medical centers adopting quell immune and the achievement of our clinical development efforts with institutions like Stanford Cleveland Clinic, and Mayo clinic going to neutralize AK.

Speaker Change: The adult pivotal study to bring our second therapeutic product to them to a market that is 50 times larger than the important yet smaller market for pediatric patients with AK I R.

Speaker Change: Our strong momentum coming into 2025 has been fueled by our significant accomplishments in 2024.

Eric Schlorff: We not only received our first product approval for QUELIMMUNE, but we advanced our NEUTRALIZE-AKI clinical development program and also eased the cost of the trial by obtaining CMS coverage to pay for certain expenses incurred by medical centers treating patients covered by Medicare or Medicaid who are enrolled in the trial. We were also awarded our 4th breakthrough device designation for chronic dialysis, and we expanded the medical community's understanding of our SCD therapy through manuscript publications in key journals and presentations at medical conferences. In addition, we further secured our first-in-class proprietary technology through the award of key patents in the United States and Canada. We also appointed Michael Messinger, a healthcare industry veteran, as our Chief Financial Officer in January 2024.

Speaker Change: We not only received our first product approval for <unk>, but we advanced our neutralize AK <unk> clinical development program and also he's the cost of that trial by obtaining CMS coverage to pay for certain expenses incurred by medical centers treating patients covered by Medicare or Medicaid who are enrolled in the trial.

Speaker Change: We were also awarded our fourth breakthrough device designation for chronic dialysis and we expanded the medical community's understanding of our S. C. D therapy through manuscript publications in key journals and presentations at medical conferences.

Speaker Change: In addition, we further secured our first in class proprietary technology due to the award of key patents in the United States and Canada.

Speaker Change: We also appointed David Green, our healthcare industry veteran as our Chief Financial Officer in January of 2024.

Eric Schlorff: Dave has been working diligently to manage our capital structure, secure additional capital, and strengthen our control environment during this time of transition to a commercial-stage company. 2025 has started off with success. In just 3 months, we added 2 new customers, commercial customers, after transitioning the sales and distribution model in 2024. We activated 2 additional sites in our NEUTRALIZE-AKI pivotal clinical study, and the FDA approved a feasibility study for our SCD therapy as a treatment for cardiorenal syndrome as a bridge to left ventricular assist device implantation. Just last week, the National Kidney Foundation, a prominent kidney disease advocacy group, announced that SeaStar Medical has been awarded its 2025 Corporate Innovator Award. The award was established to recognize industry leaders that advance the field of nephrology by addressing an unmet clinical need or improving upon existing practice, therapeutic, or technology.

Speaker Change: Dave has been working diligently to manage our capital structure secure additional capital and strengthen our control environment. During this time of transition to a commercial stage company.

Speaker Change: 2025 has started off with success in just three months, we added two new customers commercial customers after transitioning the sales and distribution model in 2024.

Speaker Change: We activated two additional sites in our neutralize AK IDE pivotal clinical study and the FDA approved a feasibility study for our S. C D therapy as a treatment for cardio renal syndrome as a bridge to left ventricular assist device implantation.

Speaker Change: Just last week, the National Kidney Foundation, a prominent kidney disease advocacy group announced that ceased our medical has been awarded its 2025 corporate Innovator Award. The award was established to recognized industry leaders that advance the field of nephrology by addressing an unmet clinical need.

Speaker Change: Or improving upon existing practice therapeutic or technology.

Eric Schlorff: We were honored with the award this year based on our significant contribution to improve the lives of pediatric patients with AKI based on the approval and introduction of our QUELIMMUNE therapy. Previous winners have included Merck, Johnson & Johnson, and UnitedHealthcare. This is a huge honor and recognition to our team at SeaStar Medical, who continues to focus on improving clinical outcomes. Now, before I turn it over the call to Tim, I'd like to talk about our expectations for QUELIMMUNE as a commercial product. We are in the launch phase of commercialization of our first product into a small market of what we estimate to be about 4,000 pediatric patients annually in the United States. As with any launch, there is a level of unpredictability, and the time to conversion of accounts can vary widely.

Speaker Change: We were honored with the award this year based on our significant contribution to improve the lives of pediatric patients with AK I based on the approval and introduction of our quell immune therapy previous winners have included Merck Johnson, and Johnson and United Health Care. This is a huge honor and recognition to our team at <unk>.

Speaker Change: We used our medical who continues to focus on improving clinical outcomes.

Speaker Change: Now before I turn it over to the call to Tim I'd like to talk about our expectations for quality and as a commercial product.

Speaker Change: We are in the launch phase of commercialization of our first product into a small market of what we estimate to be about 4000 pediatric patients annually in the United States as.

Speaker Change: As with any launch there is a level of unpredictability and the time to conversion of accounts can vary widely. This dynamic is further compounded with quell immune, especially because our adoption process requires that we work with investigational review board or IRB to implement the patient ready.

Eric Schlorff: This dynamic is further compounded with QUELIMMUNE, especially because our adoption process requires that we work with investigational review boards, or IRBs, to implement the patient registry that is part of our commitment to the FDA under the Humanitarian Device Exemption approval. As I said earlier, we are thrilled with the feedback to date from our first commercial customers, and we now have a growing pipeline of customers working through the adoption process. Our 2024 sales have reflected the timelines required to bring customers on board and get them up to speed with incorporating QUELIMMUNE into their workflow protocols. As this process becomes more routine for them, we expect customers to expand their use of QUELIMMUNE to more patients that meet the criteria for use of the therapy.

Speaker Change: History that as part of our commitment to the FDA under the humanitarian under the human device exemption approval.

Speaker Change: As I said earlier, we are thrilled with the feedback to date from our first commercial customers and we now have a growing pipeline of customers working through the adoption process. Our 2024 sales have reflected the timelines required to bring customers on board and get them up to speed with incorporating <unk>.

Speaker Change: Into their workflow protocols.

Speaker Change: As this process becomes more routine for them, we expect customers to expand their use of quell immune to more patients that meet the criteria for use of the therapy.

Eric Schlorff: That is to say that our sales will be lumpy as we work through the launch of QUELIMMUNE and expand its use at new sites. In this early period, the more important metric to follow will be the number of institutions going through the adoption process, which ultimately will lead to product sales and growing revenue. We intend to provide updates on the number of customers working through the IRB adoption process to provide a more meaningful metric on launch. We are not providing guidance due to uncertainties that are inherent in launching a product, but we will say that we are pleased with our progress and believe we are on track to meet our internal revenue targets for 2025. With that, I'd like to turn the call over to Tim.

Speaker Change: That is to say that our sales will be lumpy as we work through the launch of quell immune and expand its use at new sites. In this early period. The more important metric to follow will be the number of institutions going through the adoption process, which ultimately will lead to product sales and growing revenue we intend to.

Speaker Change: To provide updates on the number of customers working through the IRB adoption process to provide a more meaningful metric on lot launch we are not providing guidance due to uncertainties that are inherent in launching a product, but we will say that we are pleased with our progress and believe we are on track to meet our internal revenue targets for 2025 with that.

Tim: I'd like to turn the call over to Tim.

Tim Varacek: Thanks, Eric, and thanks everyone for joining us today on the SeaStar Medical call. I'd like to start by highlighting a couple of points about our QUELIMMUNE therapy. First, this therapy truly represents new hope for critically ill children, their families, and the medical community. The kids that are being treated with QUELIMMUNE have a very poor prognosis, and their mortality rate is greater than 50% when receiving the current best standard of care treatment of continuous renal replacement therapy, also known as CRRT, plus antibiotics. Prior to the introduction of QUELIMMUNE, there was no approved therapy or drug to stop the cytokine storm that poses a great risk of multiple organ failure and loss of life for these young patients.

Speaker Change: Thanks, Eric and thanks, everyone for joining us today on the <unk> start medical call.

Tim: I'd like to start by highlighting a couple of points about our call immune therapy.

Tim: First this therapy truly represents new hope for critically ill children and their families and the medical community.

Tim: The kids that are being treated with quell immune have a very poor prognosis and the mortality rate is greater than 50% when receiving the current best standard of care treatment of continuous renal replacement therapy.

Tim: Also known as C. R R T plus antibiotics.

Tim: Prior to the introduction of <unk>, there was no approved therapy or drug to stop the cytokine storm.

Tim: <unk> is a great risk of multiple organ failure and loss of life for these young patients.

Tim Varacek: The clinical data of QUELIMMUNE that was reviewed by FDA in their decision to approve the product under Humanitarian Device Exemption, or HDE, observed that almost 8 in 10 patients with pediatric Acute Kidney Injury and sepsis survived with QUELIMMUNE therapy on board versus only 5 in 10 patients on standard of care. That is a 60% observed higher survival rate. This data has fueled great interest from the most highly regarded children's medical centers through regional and community pediatric hospitals. Pediatric medical centers are truly interested in bringing QUELIMMUNE into their facilities, and I'm pleased to report that the number of pediatric hospitals going through the adoption process has doubled from Q3 to Q4 of 2024. That number increased further in Q1 of this year as we continue to add new pediatric hospitals into the queue that want to adopt QUELIMMUNE.

Tim: The clinical data that was reviewed by FDA and their decision to approve the product under a humanitarian device exemption or H D. He observed that almost eight in 10 patients with pediatric acute kidney injury and sepsis survived with quell immune therapy on board.

Tim: Versus only five in 10 patients on standard of care.

Tim: That is a 60% observed higher survival rate.

Tim: And this data has fueled great interest from most of the most highly regarded children's medical centers.

Tim: Through regional and community pediatric hospitals.

Tim: Pediatric medical centers are truly interested in bringing quell immune into their facilities and I am pleased to report that the number of pediatric hospitals going through the adoption process.

Tim: It has doubled from the third quarter to the fourth quarter of 2024 and that number increase further in the first quarter of this year as we continue to add new pediatric hospitals into the queue that want to adopt quell immune.

Tim Varacek: As mentioned, we currently have five pediatric hospitals that are up and running, have been purchased, and utilize QUELIMMUNE therapy. The process at these medical centers for the adoption of any new device can be lengthy, and it involves typical steps such as developing a product champion, going through a site's value assessment process, and getting set up as a qualified vendor. In the case of QUELIMMUNE, the post-approval registry requirement by the FDA adds an additional step to the process, and that typically takes more time. Each hospital system does things a bit differently within the required regulatory framework, and we adjust to support them and complete the process as quickly and efficiently as possible. Ultimately, this boils down to time to activation, and that can vary from several months to eight to 10 months.

Tim: As mentioned.

Tim: We currently have five pediatric hospitals that are up and running have been purchased and utilized call immune therapy.

Tim: The process at these medical centers for the adoption of any new device can be lengthy and involves typically steps such as <unk>.

Tim: Developing a product champion going through our sites value assessment process and getting set up as a qualified vendor and.

Tim: In the case of quell immune the post approval registry requirement by the FDA adds an additional step to the process and that typically takes more time.

Tim: Each hospital system does things a bit differently within the required regulatory framework.

Tim: And we adjust to support them and complete the process as quickly and efficiently as possible ultimately.

Tim: This boils down to time to activation and that can vary from several months to eight to 10 months.

Tim Varacek: We continually evolve our support for pediatric hospitals as we learn their specific processes and discover efficiencies that we can often carry forward. To be clear, I have provided additional detail on the activation process because I want to emphasize the significant gap that we bridge between the desire to adopt our QUELIMMUNE therapy and the lengthy process of pediatric hospital activation, and to highlight the strong commitment in terms of championing this effort that the pediatric nephrology and ICU teams are delivering as we go through the adoption process with them. In other words, we believe adoption is not a matter of if, but when at these pediatric hospitals, and our own internal tracking to date indicates that seven out of every 10 pediatric hospitals we approach to gauge interest ultimately commit to QUELIMMUNE therapy adoption.

Tim: We continually evolve our support for pediatric hospitals as we learn their specific processes and discover efficiencies that we can often carry forward to be clear I have provided additional detail on the activation process because I want to emphasize the significant gap that we bridge between the Dizzy.

Tim: Higher to adopt our call immune therapy, and the lengthy process of pediatric hospital activation and to highlight the strong commitment in terms of championing. This effort that the pediatric nephrology and ICU teams are delivering as we go through the adoption process with them in other words.

Tim: We believe adoption is not a matter of if but when these pediatric hospitals and our own internal tracking to date indicates that seven out of every 10 pediatric hospitals, we approach to gauge interest.

Tim: Ultimately committed to quality and therapy adoption.

Tim Varacek: I am very pleased to state that our current activated pediatric hospitals are reporting good results, and we have seen a nice increase in QUELIMMUNE sales in our Q1 2025 compared to the Q4 2024. As Eric said, sales will be lumpy until more pediatric hospitals are activated and we can gain an understanding of the cadence of patient presentation within these hospitals. With that framework of our QUELIMMUNE launch efforts, I'll now discuss our commercial opportunity for the SCD therapy platform. As mentioned, the pediatric AKI market is small, but there is a very high unmet medical need for treatment. When we obtained approval for QUELIMMUNE for this patient population, it was the realization of an incredibly important opportunity to deliver a therapy to treat children who so desperately need it.

I am very pleased to state that our current activated pediatric hospitals are reporting good results.

Eric Schwartz: And we have seen a nice increase in Columbian sales in our first quarter of 2025 compared to the fourth quarter of 2024, as Eric said sales will be lumpy until more pediatric hospitals are activated and we can gain an understanding of the cadence of patient presentation within these hospitals.

Eric Schwartz: With that framework of our quality and launch efforts I'll now discuss our commercial opportunity for the FCB therapy platform.

Eric Schwartz: As mentioned.

Eric Schwartz: The pediatric <unk> market is small, but there is a very high unmet medical need for treatment. When we obtained approval for <unk> for this patient population.

Eric Schwartz: It was the realization of an incredibly important opportunity to deliver a therapy to treat children, who so desperately need it one that could literally save their lives or reduce or eliminate the need for long term renal replacement therapy.

Tim Varacek: One that could literally save their lives or reduce or eliminate the need for long-term renal replacement therapy. To put the market opportunity in perspective from the standpoint of SeaStar Medical's initial product launch, in our estimation and based on our internal assumptions, we believe the total addressable market is in the range of $100 million. Now, we won't capture the full market, of course, but given the serious unmet clinical need and lack of any treatments today, we believe that over time, we will penetrate a significant portion of this patient population with QUELIMMUNE therapy, and that will lead to consistent initial revenue for SeaStar Medical. Our future indications address much larger markets, and we are on a solid development path to obtain additional approvals and build a presence in these markets.

Eric Schwartz: To put the market opportunity in perspective from the standpoint of <unk> Medical's initial product launch in our estimation and based on our internal assumptions. We believe the total addressable market is in the range of $100 million now.

Eric Schwartz: We won't capture the full market of course, but given the serious unmet clinical need and lack of any treatments. Today. We believe that over time, we will penetrate a significant portion of this patient population with quell immune therapy and that will lead to consistent initial revenue for <unk> medical.

Eric Schwartz: Our future indications address much larger markets and we are on a solid development path to obtain additional approvals and build our presence in these markets.

Tim Varacek: Our technology is scalable across multiple indications, and our Breakthrough Device designations should enable a tight review process of the SCD therapy by FDA. The adult AKI indication being studied in our pivotal trial, NEUTRALIZE-AKI, represents an opportunity approximately 50 times the size of the pediatric population. About 200,000 patients annually that face organ failure and potentially loss of life, with no FDA-approved treatment options beyond the current standard of care comprised of CRRT and antibiotics. Our current anticipated launch timeline in adult AKI is the H2 2026, assuming positive clinical trial results and FDA approval. We believe the time to adoption will be more favorable compared to pediatric AKI, as we should be able to leverage the customer learnings and experience with QUELIMMUNE in hospital systems where we already have a commercial presence, combined with the fact that there are no other therapies to address this condition.

Eric Schwartz: Our technology is scalable across multiple indications and our breakthrough device designation should enable a tight review process of the SPD therapy by FDA.

Eric Schwartz: The adult indication being studied in our pivotal trial neutralize Hai represents an opportunity approximately 50 times the size of the pediatric population about 200000 patients annually that face organ failure and potentially loss of life with no FDA approved treatment options.

Eric Schwartz: Beyond the current standard of care comprised of <unk> T and antibiotics.

Eric Schwartz: Our current anticipated launch timeline and adult AK I is the second half of 2026.

Eric Schwartz: Assuming positive clinical trial results and FDA approval.

Eric Schwartz: We believe the time to adoption will be more favorable compared to pediatric ATI as we should be able to leverage the customer learning learnings and experience with quantum Blue Moon and hospital systems, where we already have a commercial presence combined with the fact that there are no other therapies to address this condition.

Tim Varacek: At our current projected revenue per patient, this would present a total market opportunity of $4.5 billion. Even at modest market penetration projections, the revenue upside would be significant for SeaStar Medical. For us, the adult AKI indication is just the beginning of a long line of indications that could follow. We estimate a total market size of about 1 million patients that currently have no approved therapies to address conditions such as chronic dialysis, cardiorenal syndrome, hepatorenal syndrome, acute respiratory distress syndrome, and other indications that our SCD therapy may serve. This is why we are so excited at SeaStar Medical, and now I will turn the call over to our Chief Medical Officer, Kevin Chung. Kevin?

Eric Schwartz: At our current projected revenue per patient this would present, a total market opportunity of $4 $5 billion.

Eric Schwartz: Even at modest market penetration projections, the revenue upside would be significant for <unk> medical.

Eric Schwartz: And for US the adult indication is just the beginning of a long line of indications that could follow.

Eric Schwartz: We estimate a total market size of about 1 million patients that currently have no approved therapies to address conditions, such as chronic dialysis cardio renal syndrome apatow renal syndrome.

Eric Schwartz: Cute respiratory distress syndrome, and other indications that are FCB therapy may serve.

Eric Schwartz: This is why we are so excited at <unk> medical and now I will turn the call over to our Chief Medical Officer, Kevin Chung.

Eric Schwartz: Kevin.

Kevin Chung: Thanks, Tim. Thanks to our listeners for joining us today. I am pleased to report that our NEUTRALIZE-AKI pivotal trial continues at a steady enrollment pace with 94 of our anticipated 200 subjects enrolled in the trial. As many of you know, NEUTRALIZE-AKI is a randomized, controlled pivotal trial designed to determine whether up to 10 sequential 24-hour treatments with the SCD therapy will improve 90-day survival or recovery from kidney failure in patients with AKI requiring CRRT when compared to CRRT alone. We plan to enroll approximately 200 patients in an intensive care unit setting in the trial. The primary endpoint is a composite of mortality or dialysis dependency at 90 days. We plan to conduct an interim analysis once we have reached the 90-day primary endpoint in the first 100 enrolled subjects. Pooled data will be analyzed and presented to our Data Safety Monitoring Review Board or DSMB.

Kevin Chung: Thanks, Tim and thanks to our listeners for joining us today.

Speaker Change: I am pleased to report that our new neutralize ACI pivotal trial continues at a steady enrollment pace with 94 of our anticipated 200 subjects enrolled in the trial.

Speaker Change: As many of you know neutralized ACI is a randomized controlled pivotal trial designed to determine whether up to 10 sequential 24 hour treatments with the SCD therapy will improve 90 day survival or recovery from kidney failure in patients with AK I, requiring CRT when compared to CRT alone.

Speaker Change: We plan to enroll approximately 200 patients in an intensive care unit setting in the trial.

Speaker Change: The primary endpoint is a composite of mortality or dialysis dependency at 90 days.

Speaker Change: We plan to conduct an interim analysis. Once we have reached the 90 day primary endpoint in the first hundred enrolled subjects pull.

Speaker Change: Full data will be analyzed and presented to our data safety monitoring board or <unk>.

Kevin Chung: At that time, based on the differences in outcome between the treated subjects versus controls, the DSMB will provide a recommendation to SeaStar Medical and the NEUTRALIZE-AKI investigators as to how to proceed with the trial. While we can't be certain of the recommendation from the independent DSMB, we designed the interim analysis to ensure we powered the study properly, and if we did, the conclusion from the DSMB would be to continue the trial as planned towards our goal of 200. We know we will reach 100 patients enrolled sometime in April. Given our recent new site activations, we anticipate a steady, if not accelerated, pace of enrollment through the rest of the year. We have faced some challenges recently due a national shortage of citrate used in our CRRT circuits along with the SCD.

At that time based on the differences in outcome between the treated subjects versus controls. The DSM V will provide a recommendation to CCR medical and then neutralize ACI investigators as to how to proceed with the trial.

Speaker Change: We can't be certain of the recommendation from the independent the SMB.

Speaker Change: We designed the interim analysis to ensure we powered the study properly and if we did the conclusion from the SMB would be to continue the trial as planned towards our goal of 200.

Speaker Change: We know we will reach 100 patients enrolled sometime in April given our recent new site activation.

Speaker Change: <unk>, we anticipate a steady if not accelerated pace of enrollment through the rest of the year.

Speaker Change: We have faced some challenges recently through a national shortage of Citron used in our CRT circuits, along with the FCB.

Kevin Chung: In spite of this, we managed to enroll 24 new subjects in just the past 3 months. Thankfully, the shortage is now resolved. We are incredibly grateful to our fantastic investigators who jumped through many hoops to get subjects recruited. We have also added 2 new sites since the beginning of this year, most recently adding the University of Texas Southwestern in Dallas. As Eric mentioned, we have many notable medical institutions, including Stanford, Cleveland Clinic, and Mayo Clinic, that are now enrolling patients into the NEUTRALIZE-AKI study. I highlight these sites because they and other prominent sites are the ones that we anticipate will be our early clinical champions when the time comes to roll this therapy out to the adult ICU market. You can be sure they will be armed with definitive outcomes data from our pivotal trial.

Speaker Change: In spite of this we managed to enroll 24, new subjects in just the past three months.

Speaker Change: Thankfully the shortage is not resolved we are incredibly grateful to our fantastic investigators we jumped through many hoops to get subjects recruited.

Speaker Change: We have also added two new sites since the beginning of this year.

Speaker Change: Recently, adding the university of Texas, southwestern and Dallas.

Speaker Change: As Eric mentioned, we have many notable medical institutions, including Stanford Cleveland Clinic, and Mayo clinic that are now enrolling patients into the neutralize API study.

Speaker Change: I highlight these sites because day and other prominent sites are the ones that we anticipate will be our early clinical champions when the time comes to roll this therapy out to the adult ICU market.

Speaker Change: You can be sure there will be armed with definitive outcomes data from our pivotal trial.

Kevin Chung: We know many of these champions will share their personal experience with the international critical care and nephrology communities, with the eventual goal of including our therapy in clinical practice guidelines. A positive NEUTRALIZE-AKI trial will help elevate the current standard of care for all those suffering from life-threatening AKI. We are very fortunate to have the right investigators at the right sites participating in our trial. Once we complete the trial and achieve 100% data log, we intend to rapidly analyze and report our data to the international medical community. Provided we meet our primary endpoint, we plan to complete our PMA filing and submit it to the FDA. The Breakthrough Device designation, which we hold for adult AKI, should help facilitate speedy communication between us and the FDA during the review and approval process.

Speaker Change: Additionally, we know how many of these champions will share their personal experience with the international critical care in nephrology communities with the eventual goal of including our therapy in clinical practice guidelines.

Speaker Change: A positive neutralize API trial will help elevate the current standard of care for all of those suffering from life threatening a chaos we.

Speaker Change: We are very fortunate to have the right investigators at the right sites participating in our trial.

Speaker Change: Once we complete the trial and achieve 100% beta law.

Speaker Change: We intend to rapidly analyze and report our data to the international medical community.

Speaker Change: Provided we meet our primary endpoint, we plan to complete our PMA filing and submitted to the FDA.

Speaker Change: The breakthrough device designation, which we hope for adult Hai should help facilitate speedy communication between us and the FDA during the review and approval process and as such we hope to have this product available to patients sometime in the second half of 2026.

Kevin Chung: As such, we hope to have this product available to patients sometime in H2 2026. Looking into the future, our stepwise goal is to inspire wide clinical adoption of the SCD therapy. To treat as many of the approximate 200,000 patients with AKI in the United States, and when the time is right, expand beyond our US borders to treat as many of the millions of patients worldwide who could potentially benefit from our SCD therapy for this indication. Our strategic goal as a company is to widen the addressable market rapidly to target other critical unmet medical needs. I would like to emphasize that the NEUTRALIZE-AKI study is really 3 trials in one. We intend on analyzing and reporting the impact of the SCD in the cohort of patients with sepsis and ARDS as well.

Speaker Change: Now looking into the future our stepwise goal is to inspire while IDE clinical adoption of the SPD therapy first to treat as many of the approximate 200000 patients with ATI in the United States and when the time is right expand beyond our U S borders to treat as many of the millions of patients.

Speaker Change: Worldwide, who could potentially benefit from our LCD therapy for this indication.

Speaker Change: Our strategic goal as a company is to widen the addressable market rapidly the other target.

Speaker Change: To target other critical unmet medical needs.

Speaker Change: I would like to emphasize that neutralize the chaos that he is really three trials in one.

Speaker Change: We intend on analyzing and reporting the impact of the FCB and a cohort of patients with sepsis and <unk> as well.

Kevin Chung: Based on the mechanism of action of SCD, we have good reason to believe we will be able to show benefit in these two subpopulations. Beyond this indication, we have been awarded Breakthrough Device designation for three others, including the treatment of patients with cardiorenal syndrome, patients with hepatorenal syndrome, and patients with end-stage renal disease. Given the organ and disease-agnostic characteristic of our therapy, there are several more indications to come. We believe that AKI is just the beginning. Additionally, we announced last year that the NIH provided a $3.6 million grant for a clinical trial to evaluate our SCD therapy in patients with cardiorenal syndrome awaiting LVAD implantation. In January, the FDA approved a feasibility study for this indication. The trial will be led by the inventor of the SCD therapy, Dr. David Humes from the University of Michigan and one of our key scientific advisors.

Speaker Change: Based on the mechanism of action of that CD. We have good reason to believe we will be able to show benefit in these two subpopulations.

Speaker Change: Beyond this indication we had been awarded breakthrough device designation for three others, including the treatment of patients with cardio renal syndrome patients with renal syndrome in patients with end stage renal disease.

Speaker Change: Given the Oregon and disease agnostic characteristic of our therapy. There are several more indications to come.

Speaker Change: We believe that Hai is just the beginning.

Speaker Change: Additionally, we announced last year that the NIH provided a $3 $6 million grant for a clinical trial to evaluate our cell therapy in patients with cardio renal syndrome awaiting all of that implementation.

Speaker Change: Implantation and in January the FDA approved a feasibility study for this indication.

Speaker Change: The trial will be led by <unk>, the inventor of the SPD therapy, Dr. David <unk> from the University of Michigan, and one of our key scientific advisors.

Kevin Chung: The NEUTRALIZE-CRS trial is expected to enroll 20 patients at up to 5 clinical sites. The results from this pilot study will help inform our next steps for this indication. Our medical affairs and research team is working closely with Tim and his commercial team to identify the most appropriate next best disease state to tackle with our disease and organ-agnostic therapy. With that as a summary of our clinical development efforts and goals, I'll turn the call over to our CFO, Michael Messinger.

Speaker Change: The neutralized Crs trial is expected to enroll 20 patients at up to five clinical sites.

Speaker Change: The results from this pilot study will help inform our next steps for this indication.

Speaker Change: Our medical Affairs and research team is working closely with Tim and his commercial team to identify the most appropriate net that's in each state to tackle with our disease and organ agnostic therapy.

Speaker Change: With that as a summary of our clinical development.

Speaker Change: <unk> efforts Ingalls I'll turn the call over to our CFO David Green.

Michael Messinger: Thank you, Kevin, and thank you all for joining us today. I'll start with a few comments about our fiscal year ended 31 December 2024, and conclude with some of our expectations for 2025. First, for some housekeeping, please note that our Form 10-K will be filed with the SEC in the next 24 hours. You can find it at seastarmedical.com or at sec.gov. As you've heard from my colleagues, 2024 was a transformative year for SeaStar Medical. We made great strides in strengthening our financial position, gaining FDA approval to sell and launch QUELIMMUNE, our first commercial product for pediatrics, and pushing forward our NEUTRALIZE-AKI pivotal trial for adult AKI patients. From a financial perspective, I'm very pleased with our 2024 performance. We substantially improved the balance sheet by adding new capital and reducing debt and other liabilities.

David Green: Thank you Kevin and thank you all for joining us today.

David Green: I'll start with a few comments about our fiscal year ended December 31, 2024, and conclude with some of our expectations for 2025.

David Green: First for some housekeeping. Please note that our Form 10-K will be filed with the SEC in the next 24 hours you can find it at <unk> medical dot com or at SEC Gov.

David Green: As you've heard from my colleagues 2024 was a transformative year for <unk> medical.

David Green: We made great strides in strengthening our financial position.

David Green: Gaining FDA approval to sell and launched <unk>, our first commercial product for pediatrics.

David Green: And pushing forward, our neutralized 8-K pivotal trial for adult <unk> patients.

David Green: From a financial perspective, I'm very pleased with our 2020 for performance, we substantially improved our balance sheet by adding new capital and reducing debt and other liabilities.

Michael Messinger: We raised approximately $25 million. We were very careful with the use of the new capital. We used $16 million to fund operations, which are focused largely on our adult clinical trials and selling QUELIMMUNE for pediatrics. We extinguished approximately $6 million of debt. We reduced accounts payable by $1.3 million and ended the year with $1.8 million in cash. Further, as we reported last month, we also raised another $6 million in February of this year. In addition to strengthening the balance sheet, we overcame and addressed preexisting material weaknesses and implemented much stronger controls over financial reporting. With all of that hard work behind us, we've positioned the company to build on the first two quarters of commercial revenue for QUELIMMUNE and complete the adult AKI pivotal trial.

David Green: We raised approximately $25 million and we were very careful with the use of the new capital.

David Green: We used $16 million to fund operations, which are focused largely on our adult clinical trials.

Speaker Change: And Carl immune for pediatrics.

David Green: We extinguished approximately $6 million of debt.

David Green: We reduced accounts payable by $1 3 million and ended the year with $1.8 million in cash.

David Green: As we reported last month, we also raised another $6 billion in February of this year.

David Green: In addition to strengthening the balance sheet, we overcame and address three existing material weaknesses and implemented much stronger controls over financial reporting.

David Green: And with all of their hard work behind US we are positioning the company to build out in the first two quarters of commercial revenue required immune and complete the adult Hai pivotal trial.

Michael Messinger: From a commercial perspective, after receiving FDA approval for our pediatric product, QUELIMMUNE, in Q1 2024 and launching in Q3 2024, we made a significant strategic change from a distribution network model to a direct sales model. This change allows us to fully manage the sales and distribution cycle and avoid costly distribution fees. It also allows us to better leverage our product expertise and close relationships with ICU and nephrology clinicians at target hospitals. This move has been paying off. As Tim noted earlier, a very large percentage of hospitals we approach to gauge interest ultimately commit to bringing QUELIMMUNE therapy into their hospital for their pediatric patients. This will ultimately lead to a growing customer base and smooth out some of the initial uneven pace of orders, which is expected during an initial launch phase.

David Green: From a commercial perspective after receiving FDA approval for our pediatric product <unk> in Q1, 2024 and larger in Q3 2024.

David Green: Made a significant strategic change.

David Green: From a distribution network model to a direct sales model.

David Green: This change allows us to fully advantage, the sales and distribution cycle and avoid costly distribution fees.

David Green: It also allows us to better leverage our product expertise and close relationships with ICU and nephrology clinicians at target hospitals.

David Green: And this move has been paying off.

David Green: Tim noted earlier, a very large percentage of hospitals re approach to gauge your interest.

David Green: Ultimately commit to bringing quell immunotherapy into their hospital or their pediatric patients.

David Green: This will ultimately lead to a growing customer base and smooth out some of the initial uneven pace of orders, which is expected during an initial launch phase.

Michael Messinger: With the sales model realignment completed, we are well positioned to build on the first two quarters of commercial revenue for QUELIMMUNE and complete the adult AKI pivotal trial. Now for a few top-line comments on our income statement. With the launch of QUELIMMUNE in Q3, we booked our first product revenue in 2024 with net revenue of $134,000. This modest revenue reflects the timeliness for adoption by customers, as Tim described. While we anticipate that sales will be choppy in the initial phases of the launch, we expect that we will see an overall trend of increases in revenue as we expand the total number of customers purchasing QUELIMMUNE. In fact, I am pleased to report that with the continued addition of purchasing customers, we are seeing a nice uptick in sales so far in Q1.

David Green: With the sales realignment completed we are well positioned to build in the first two quarters of commercial revenues for quality man.

David Green: Complete the adult pivotal trial.

David Green: Now for a few topline comments in our income statement.

David Green: With the launch of quoting in the third quarter, we booked our first product revenue in 2024 net revenue of $134000.

Speaker Change: This modest revenue reflects the timing of events for adoption by customers as Tim described.

Speaker Change: And while we anticipate that sales will be choppy in the initial phases of the launch we expect that we will see an overall trend of increases in revenue as we expand the total number of customers purchasing quote Amanda.

Speaker Change: In fact, I am pleased to report that with the continued addition of purchasing customers.

Speaker Change: Seeing a nice uptick in sales so far in the first quarter.

Michael Messinger: Altogether, we are quite optimistic about new hospitals coming on as customers as we enable more children to benefit from our life-saving therapy. Moving on to our cost of goods sold. The current financial statements reflect no GAAP cost of goods sold from the sale of QUELIMMUNE. GAAP accounting requires inventory to be expensed as research and development costs for that inventory which was built prior to our FDA approval to sell QUELIMMUNE. As we acquire, build, and sell new inventory as a commercial company, we will record those expenses as cost of goods sold, consistent with GAAP accounting. We anticipate these costs to hit the P&L later this year. Our operating expenses for 2024 increased by approximately $3.6 million compared to 2023, primarily due to increased spending on our commercial launch and growing enrollment in the NEUTRALIZE-AKI trial.

Speaker Change: Altogether, we are quite optimistic about the hospital about new hospitals coming on this customers as we enable more children and should benefit from our lifesaving therapy.

Speaker Change: Moving to our cost of goods sold the current financial statements reflect no GAAP cost of goods sold from the sale of quality noon.

GAAP accounting requires inventory, which we expensed as research and development costs for that inventory, which was built prior to our FDA approval to sell quality man.

Speaker Change: As we acquire build and so new inventory as a commercial company, we will record those expenses as cost of goods sold consistent with GAAP accounting we.

Speaker Change: We anticipate these costs to hit the P&L later this year.

Speaker Change: Our operating expenses for 2024 increased by approximately $3 $6 million compared to 2023, primarily due to increased spending at our commercial wash and growing enrollment and then neutralize Hai trial.

Michael Messinger: Finally, our net loss for the year declined to $24.8 million versus a loss of $26.2 million in 2023. With approximately $6.9 million of the 2024 loss from non-cash items. Looking forward, we expect to focus our resources on our top three objectives. 1. Commercial sales of QUELIMMUNE. 2. Completing our NEUTRALIZE-AKI pivotal trial for adults. 3. Preparing to file a PMA following the completion of the adult pivotal trial. We are very excited about serving the adult AKI population, which is estimated to be roughly 50 times larger than the pediatric population. Finally, as we move our strategic objectives forward, we expect the momentum to continue as we bring our life-saving SCD therapy to more patients and clinicians, and as more investors notice the significant market opportunity developing for our products. With that, I'll hand the call back to Eric.

Speaker Change: And finally, our net loss for the year declined to $24 $8 million versus a loss of $26 $2 million in 2023.

Speaker Change: Approximately $6 9 million of the 2020 for loss from noncash items.

Speaker Change: Looking forward, we expect to focus our resources at our top three objectives, one commercial sales of quality in.

Speaker Change: Completing our neutralize Hai pivotal trial for results and number three.

Speaker Change: Preparing to file a PMA following the completion of the adult pivotal trial.

Speaker Change: Very excited about our survey.

Speaker Change: <unk> population, which is estimated to be roughly 50 times larger than the pediatric population.

Speaker Change: And finally, as we move our strategic objectives forward, we expect the momentum to continue as we bring our lifesaving STD therapy to more patients and clinicians and is for investors notice the significant market opportunity developing for our products and Wednesday.

Speaker Change: I'll hand, the call back to Eric.

Eric Schlorff: Yeah. Thanks, David. Our goal today for our first financial results conference call was to provide you with a summary of our past successes in 2024 and into early 2025, and also provide a clear picture of why we believe the future opportunities for SeaStar Medical are significant. With a commercial product on the market and a near-term opportunity to capture a sizable portion of a large market for treating adult patients with AKI on CRRT, we believe that SeaStar Medical is a highly differentiated company with de-risked assets and poised for growth. Beyond these indications, we believe our ability to bring life-saving products to patients in a commercial setting is accelerated by three key factors. 1, Breakthrough Device designations that enable the potential for a speedier pathway to approval. 2, the fact that our therapy is delivered through a device which requires only 1 pivotal trial for approval.

Speaker Change: Yeah. Thanks, David our goal today for our first financial results Conference call was to provide you with a summary of our past successes in 2024 and into early 2025 and also provide a clear picture of why we believe the future opportunities for <unk> medical are significant with a commercial <unk>.

Speaker Change: <unk> on the market in the near term opportunity to capture a sizable portion of a large market for treating adult patients with AK ion CRT, we believe that eastern medical is a highly differentiated company with derisked assets and poised for growth.

Speaker Change: Beyond these indications, we believe our ability to bring life saving products to patients in a commercial setting is accelerated by three key factors one breakthrough device designation that enable the potential for a speedier pathway to approval.

Speaker Change: The fact that our therapy is delivered through a device.

Speaker Change: Which requires only one pivotal trial for approval.

Eric Schlorff: Three, the fact that our existing device is applicable as is for multiple indications. In other words, we don't need to build specialized devices for each therapeutic indication that we seek approval for. We believe this offers reduced time to market and economies of scale that are not often achieved by companies in our industry. In short, we believe we are continuing to create strong value for our investors and stakeholders, and we'll be looking to close what we see as a substantial gap in our current market cap and the outlook that we have for the company. With that, I'll ask the operator to open the call for questions. Operator?

Speaker Change: And three the fact that our existing devices applicable as is for multiple indications in other words, we don't need to build specialized devices for each therapeutic indication that we seek approval for <unk>.

Speaker Change: We believe this offers reduced time to market and economies of scale that are not often achieve by companies in our industry in.

Speaker Change: In short we believe we are continuing to create strong value for our investors and stakeholders and we'll be looking to close what we see is as a substantial gap in our mark current market cap and the outlook that we have for the company.

Speaker Change: With that I'll ask the operator to open the call for questions operator.

Operator: Your first question comes from the line of Anthony Vendetti of Maxim Group. Please go ahead.

Speaker Change: Thank you, ladies and gentlemen, who will now begin the question and answer session. At this time I would like to remind everyone to ask a question. Please press the star button, followed by the number one on your telephone keypad. If you would like to withdraw your question. Please press star one again one moment. Please for your first question.

Speaker Change: Your first question comes from the line of Anthony Vendetti of Maxim Group. Please go ahead.

Anthony Vendetti: Thanks. Yes. I wanted just to first start on the NEUTRALIZE-AKI trial. I think, maybe Kevin, you said there is 94 of the expected 200 patients have been enrolled, and you are expecting to provide the interim analysis after 100 of them. You are close to getting them enrolled 90 days after that, right? After the 100th is enrolled. Is that correct? Since we are only six patients away from that, what is your best estimate for what quarter that is going to occur, or what month that will occur or expected?

Speaker Change: Thanks, Yes, so I wanted to just two.

Speaker Change: First start on the neutralize 8-K, 8-K I trial.

Speaker Change: I think maybe Kevin you said there is.

Speaker Change: 94 of the.

Speaker Change: We expect it to 200 patients have been enrolled.

Speaker Change: You expect them to provide the interim analysis. After I heard 100 of them. So youre close to getting them enrolled 90 days after that right. After the 100 is enrolled is that is that correct and what's your best estimate for since we're only six patients away from that.

Speaker Change: What's your best estimate for what quarter, that's going to occur what month that will occur.

Eric Schlorff: Yeah. Hi, Anthony. This is Eric. Thanks for joining today. Hey, I think Kevin did have to drop off, so let me take.

Speaker Change: I expect so.

Eric Schwartz: Hi, Anthony this is Eric thanks for joining today.

Speaker Change: I think Kevin did have to drop off so let me take your question.

Anthony Vendetti: Sure

Eric Schlorff: question in a couple parts. The first one is, yes, we are at 94 patients. We anticipate being able to get to that 100 sometime likely to be the beginning of April, somewhere in that first part of April. As it relates to the timing of once we get to 100 patients, yeah, it is 90 days. That's what the primary endpoint is. It's to get out in 90 days to either mortality and/or dialysis dependency. The data at that point will be collected and then presented to the IRB or to the DSMB for their review. We anticipate that shortly after we get to that 90 days, that we'll be able to share some of the outcomes from and the assessment from the DSMB or the Data Safety Monitoring Board.

Eric Schwartz: A couple of parts. So the first one is yes, we are at 94 patients.

Speaker Change: We anticipate.

Speaker Change: Being able to get to that 100 sometime likely to be the beginning of April some somewhere in that first part of April.

Speaker Change: As it relates to the timing of once we get to a 100 patients. Yes. It is 90 days that's what the primary end point is it's a 90 day.

Speaker Change: To get out 90 days to either mortality or <unk> dialysis dependency and then the data at that point will be collected and then presented to the IRB or to the DSM V.

Speaker Change: For their review and so.

Speaker Change: We anticipate that.

Speaker Change: Shortly after we get to that 90 days that we'll be able to share some of the outcomes from an assessment from the SMB or the data safety monitoring board.

Anthony Vendetti: Okay. If I was going to timeline this a little bit, Eric, it would be sometime in April, beginning of April, the 100 patients will be enrolled 90 days after that. Let's say that gets us to beginning of July, then 2 weeks of analysis before you provide it. End of July, beginning of August to provide an interim look or interim analysis?

Speaker Change: Okay. So so if I was going to timeline this a little bit.

Speaker Change: <unk> would be some.

Speaker Change: Sometime in April beginning of April.

Speaker Change: Patients will be enrolled 90 days after that let's say that gets us to beginning of July and then a couple of weeks of analysis. Before you provided so end of July beginning of August to provide an interim look or interim analysis.

Eric Schlorff: Yeah. That sounds about in the ballpark.

Speaker Change: Yes.

Linda: That sounds about in the ballpark Linda ballpark, Okay, great and then.

Anthony Vendetti: In the ballpark. Okay, great. Then, as I guess you continue to roll the QUELIMMUNE product out, what are your current plans in 2025 to expand your sales force capabilities? Maybe just give a little bit of an update on that. Yeah. Tim, why don't you tackle that one?

Speaker Change: As I guess.

Speaker Change: You continue to roll roll the call immune product out.

Speaker Change: But what are your.

Speaker Change: Current plans in 'twenty five.

Speaker Change: To expand your sales force capabilities.

Speaker Change: Maybe just maybe just give a little bit of.

Speaker Change: An update on that.

Speaker Change: Yeah. So.

Speaker Change: Tim why don't you tackle that one.

Tim Varacek: Sure. Anthony, the first thing I would say is, again, this is a small market, and I would say we're right-sized right now. We have field-facing staff, and we also importantly have operational support internally, and it really is a group effort. It's not just about the commercial team. We have skilled nurses that actually are on site that will train these accounts once they are ready for activation. They'll train them on how to use the product. We have no shortage of new accounts that are interested in terms of our pipeline, and we're working through the process with each of these folks, and they really are unique by themselves, one account to the next, in terms of the process they follow and the timeliness of that process. I think right now we feel good about where we're at.

Speaker Change: Sure so.

Anthony Vendetti: Anthony I mean, the first thing I would say is.

Speaker Change: Again this is a small market.

Anthony Vendetti: And.

Anthony Vendetti: I would say, we're right sized right now.

Anthony Vendetti: We have field field facing <unk>.

Anthony Vendetti: Staff and we also importantly have operational support inter.

Anthony Vendetti: Internally and it really is it's a group effort, it's not just about the commercial team we have skilled nurses that.

Anthony Vendetti: Actually around site that will train.

Anthony Vendetti: These accounts once they are ready for activation they will train them on how to use the product so.

Speaker Change: We have no shortage of.

Anthony Vendetti: New accounts that are interested in terms of our pipeline.

Anthony Vendetti: And we're working through the process with each of these folks and they really are.

Anthony Vendetti: Unique.

Anthony Vendetti: By themselves one account to the next in terms of the process they follow and the timeliness of that process. So I think right now we feel good about where we're at we have a healthy pipeline and we're just working through the IRB process and the customer set up process with them.

Tim Varacek: We have a healthy pipeline, and we're just working through the IRB process and the customer setup process with them as we go into 2025.

Anthony Vendetti: We go into 2025.

Anthony Vendetti: Okay, great. No, Tim, that's helpful. I know each customer's different. Maybe what have you learned from the first several hospital activations? What does a typical conversion look like from, you convert a customer from a pipeline to an activation? How long does that typically take? What does that look like? Like I said, what have you learned from the first hospital?

Speaker Change: Okay, great and Thats helpful, but maybe just and I know each customer is different but maybe.

Speaker Change: What have you learned from the first several hospital Activations and then what does a typical conversion look like from you convert.

Speaker Change: Customer from a pipeline to an activation how long does that typically take what is what does that look like and like I said what have you learned from the first.

Speaker Change: Hum.

Tim Varacek: I think some of the biggest learnings are the IRB itself. There's really a couple of components to it. There's our device, and then there is the patient registry, which we've talked about. The device piece of this is really the simpler portion of IRB review. The more complex portion of it is really the registry because it, in some ways, is a framework that's similar to. It's really a post-surveillance registry. There are more people involved in the hospital that will ultimately evaluate the patient. They'll take data that comes up with the initial profiling of that patient. All those things drive the whole administrative aspect of getting a registry set up within a hospital. That takes more careful review from an IRB standpoint. What was the second part of your question there, Anthony?

Speaker Change: I mean, I think some of the some of the biggest learnings are.

Speaker Change: The.

Speaker Change: The IRB itself.

Speaker Change: There's really a couple of components to it there is theres our device and then there is the patient registry, which we've talked about.

Speaker Change: The device piece of this is really the the.

Speaker Change: The simpler portion of IRB review the more complex portion of it is really the registry because it is in some ways.

Speaker Change: A framework that's similar to.

Speaker Change: It's really a post surveillance registries. So there are more people involved in the hospital that will ultimately evaluate the patient.

Speaker Change: They'll take data.

Speaker Change: That.

Speaker Change: It comes up with the initial profiling of that patient and all those things.

Drive the whole.

Speaker Change: Administrative aspect of getting a registry setup within a hospital and so that takes more careful review.

Speaker Change: And IRB standpoint, and what was the second part of your question there Anthony.

Anthony Vendetti: Yeah, I guess from the first several activations, was there anything particular that you've learned that you would tweak in terms of your process or you'd do differently?

Anthony Vendetti: Yeah, just I guess.

Speaker Change: From the first.

Speaker Change: Several activations was there anything particular.

Speaker Change: That.

Speaker Change: You've learned that you would tweak in terms of your process or you do differently.

Speaker Change: Okay.

Tim Varacek: I would say what we've learned is not really worth discussing on the call. It's nuanced aspects of just creating more efficient process for the customer once we understand their behavior and how they do things, and modifying ours and our support to get them there. In general, the process is the same for all hospitals at a high level. It just breaks down into different components once you get into an individual system. Some have a lot more support and resources than others, and so you kind of play the hand you're dealt. You work with these people, and we do everything we can on our end to move as quickly and efficiently as possible through the process with them.

Speaker Change: I think what I would say what we've learned is not really worth discussing on the call. It's more it's nuanced aspects of <unk>.

Speaker Change: Just creating more efficient process for the customer once we understand their behavior and how they do things and modifying hours and our support to get them there but.

Speaker Change: In general the process is the same for all hospitals at a high level. It just breaks down into <unk>.

Speaker Change: Different components once you get into an individual system. Some have a lot more support and resources than others and so you just you kind of play the hand, you're dealt you work with these people.

Speaker Change: And we do everything we can on our end to move as quickly and efficiently as possible through the process with them.

Anthony Vendetti: Okay, great.

Eric Schlorff: I would say the one thing, Anthony, to add on to all that is that probably one of the biggest key learnings that we had was the decoupling of the IRB process. As Tim explained, there's the HDE approval process, which then could include things like the value assessment committee and the purchasing, and then you've got the registry. I think what we've been able to do here lately is really start to be able to decouple those because through kind of our relationships with the FDA, they've also encouraged us that if we can treat patients, even though the registry isn't up and maybe going at that site, we should try to save a child's life. Which obviously, that's our primary goal, and that does allow us then to sell product directly to the hospital.

Speaker Change: Okay, all right I would say the one thing Anthony to add onto all of that is that probably one of the biggest key learnings that we had was the decoupling of the IRB process. So as Tim explained there is the HDD approval process.

Speaker Change: Which then could include things like the value assessment committee in the purchasing and then you've got the registry, but I think what we've been able to do here.

Speaker Change: Here lately is really start to be able to decouple those because.

Speaker Change: Through our relationships with the FDA they've also encourage us that if we can treat patients even though the registry is an up and maybe going at that site, we should try to save a child's life.

Speaker Change: Which obviously thats our primary goal and that does allow US then to sell product directly to the hospital.

Anthony Vendetti: Okay, great.

David Brown: Yeah, also which is very helpful that we've learned is getting the ICU docs and the nephrologists together in on the process early is also a big time saver.

Speaker Change: Okay, Great also.

Speaker Change: So which is very helpful that we've learned is getting the ICU docs and the nephrologist together in the <unk>.

Speaker Change: <unk> early there's also big time saver.

Anthony Vendetti: Okay, great. That's very helpful. Thanks for all the color. I appreciate it. I'll hop back in the queue.

Speaker Change: Okay, Great. That's very helpful. Thanks, Thanks for all the color I appreciate it I'll hop back in the queue.

Speaker Change: Yes.

Operator: There are no further questions at this time. With that, I will turn the call back over to Jackie Cosman for final closing remarks. Please go ahead.

Speaker Change: There are no further questions at this time with that I will turn the call back over to Jacky Kaufman for final closing remarks. Please go ahead.

Jackie Cosman: Thank you, Calvin. Thank you all for joining us today for the SeaStar Medical year-end financial results conference call. If you have questions, please don't hesitate to contact us at ir@seastarmed.com, or visit our website and see our latest news, product pipeline, and company information. Thank you. Goodbye.

Speaker Change: Thank you Kelvin and thank you all for joining us today for the <unk> Medical yearend financial results Conference call. If you have questions. Please don't hesitate to contact us at IR at <unk> Dot com or visit our website and see our latest news product pipeline and company infer.

Speaker Change: <unk>. Thank.

Speaker Change: Thank you and goodbye.

Operator: Ladies and gentlemen, that concludes your conference call. We thank you for participating and ask that you please disconnect your lines.

Speaker Change: Ladies and gentlemen that concludes your conference call. We thank you for participating and ask that you. Please disconnect your lines.

Speaker Change: Okay.

Speaker Change: [music].

Speaker Change: Sure.

Speaker Change: [music].