SeaStar Medical Reports Statistically Significant Survival Findings from Post-Approval QUELIMMUNE® SAVE Registry Analysis in Pediatric Sepsis-Associated AKI

The observational comparison showed higher survival, although the landmark analysis did not reach statistical significance.

Rhea-AI Summary

SeaStar Medical (ICU) reported statistically significant higher survival with QUELIMMUNE in a post-approval analysis of children with sepsis-associated acute kidney injury.

The observational study compared treated patients with historical hospital database cohorts requiring continuous kidney replacement therapy. In the primary analysis, Day 90 survival was 65.1% versus 47.4% (P=0.043), with 43 treated patients and 196 comparators. Survival to hospital discharge was also higher (P=0.04). A landmark sensitivity analysis found Day 90 survival of 63.8% versus 48.7%, but did not reach statistical significance (P=0.074).

No device-related adverse events occurred among treated SAVE registry patients. At Day 90, 20 of 24 survivors not requiring kidney replacement therapy at baseline were independent of it. The company expects final results and interpretations in a peer-reviewed manuscript.

6 points · 0 major

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Positive

• Moderate pointPrimary Day 90 survival reached 65.1% versus 47.4% in historical comparators (P=0.043).
• Minor pointSurvival to hospital discharge was statistically significantly higher in the primary analysis (P=0.04).
• Minor pointLandmark Day 90 survival was 63.8% versus 48.7%, without statistical significance (P=0.074).
• Minor pointFour Day 90 mortality models estimated 34% to 40% lower mortality hazard; frequentist results were not statistically significant.
• Minor pointDay 90 kidney replacement independence occurred in 20 of 24 survivors (83%) not requiring it at baseline.
• Minor pointSAVE registry patients experienced no device-related adverse events during QUELIMMUNE treatment.

Negative

• Moderate pointEvidence comes from an observational, exploratory historical-control study, rather than a randomized comparison.
• Minor pointNew bloodstream infections occurred in 12% overall and 6% during treatment; independent reviewers judged them unrelated to QUELIMMUNE.

News Explained

The additional survival endpoint broadens favorable reported findings, while mortality results differ across frequentist and Bayesian analyses.

SeaStar Medical reported a statistically significant Day 60 survival result in its post-approval, observational external-control analysis of QUELIMMUNE-treated pediatric patients.

All four Day 90 mortality models favored the treated cohort, estimating a 34% to 40% lower mortality hazard; frequentist models did not reach statistical significance, while Bayesian time-to-death models exceeded the 95% probability threshold.

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Key Figures

Day 90 survival: 65.1% vs. 47.4% Bayesian probability of higher survival: 98.2% Day 90 landmark survival: 63.8% vs. 48.7%; 15.1 percentage points higher +3 more

Day 90 survival

65.1% vs. 47.4%

Primary analysis; P=0.043; OR 2.07 (95% CI 1.04–4.11)

Bayesian probability of higher survival

98.2%

Primary analysis

Day 90 landmark survival

63.8% vs. 48.7%; 15.1 percentage points higher

Landmark sensitivity analysis; P=0.074; OR 1.86 (95% CI 0.96–3.60)

In-hospital survival

P=0.04

Primary analysis; survival to hospital discharge was significantly higher in the QUELIMMUNE cohort

Day 90 mortality hazard ratio

0.60–0.66

Range across four mortality models versus the combined KID cohort

RRT independence

20 of 24 survivors (83%)

At Day 90 among QUELIMMUNE cohort survivors not requiring RRT at baseline

Key Terms

crrt, aki, odds ratio, confidence interval, +1 more

5 terms

crrt medical

"sepsis requiring CRRT"

Continuous Renal Replacement Therapy (CRRT) is a hospital treatment that uses a machine to slowly and continuously filter a patient’s blood when the kidneys have failed, similar to a home water filter running all day instead of a quick rinse. For investors, CRRT signals demand for critical-care equipment, supplies and specialized staffing, and changes in its use or reimbursement can affect revenues and costs for medical-device makers, hospitals and dialysis service providers.

aki medical

"pediatric sepsis-associated AKI"

Acute kidney injury (AKI) is a sudden decline in kidney function that prevents the body from clearing waste and balancing fluids and salts, like a plumbing system that abruptly clogs and overflows. For investors, AKI matters because it can drive demand for treatments, affect the safety and outcomes of clinical trials, trigger regulatory scrutiny or product liability risks, and influence revenue and cost forecasts for healthcare companies.

odds ratio technical

"odds ratio [OR] 2.07"

The odds ratio compares how likely an outcome is in one group versus another by dividing the odds of the event in the first group by the odds in the second. Think of it like comparing the odds of a coin landing heads in two different scenarios; a number above 1 means the event is more likely in the first group, below 1 means it is less likely. Investors use it to quantify how strongly a treatment, risk factor, or policy changes the chance of an outcome, which helps assess clinical trial results, regulatory risk, and potential impact on a company’s prospects.

confidence interval technical

"95% confidence interval, [CI] 1.04-4.11"

An interval estimate that shows a range of values within which a true number (like a company’s expected earnings, a projected return, or a model input) is likely to lie, together with a stated level of confidence in that range. For investors it turns a single point forecast into a band—like a weather forecast saying 60–70°F instead of just 65°F—making uncertainty explicit so you can judge risk and size positions more sensibly.

extracorporeal membrane oxygenation medical

"extracorporeal membrane oxygenation (ECMO)"

A life-support technique that temporarily pumps a patient’s blood through an external machine to add oxygen and remove carbon dioxide, acting like an artificial lung when the patient’s own lungs or heart can’t function. Investors care because its use drives demand for specialized medical devices, trained staff and hospital capacity, influences treatment costs and reimbursement, and can materially affect revenue and risk for device makers, hospitals and healthcare suppliers.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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New late-breaking data presented today at ASN Kidney Week 2026

QUELIMMUNE (SCD-PED) treatment group demonstrates statistically significant higher survival in the primary analysis at Day 60, Day 90, and at hospital discharge versus comparator cohort

No device-related adverse events (AEs) occurred in patients treated with QUELIMMUNE

DENVER, Oct. 22, 2026 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage healthcare company focused on transformational treatments for critically ill patients facing organ failure and potential loss of life, announced today new positive data from the late-breaking presentation at ASN Kidney Week 2026 in Denver, Colorado.

The late-breaking poster, titled “Improved Outcomes in Pediatric Sepsis-Associated (SA) AKI: Comparison of the Selective Cytopheretic Device for Pediatrics (SCD-PED) Surveillance Registry (SAVE) with a Historical Cohort,” compared survival in QUELIMMUNE (SCD-PED)-treated critically ill pediatric patients from its post-approval SAVE registry and one non-registry patient with life-threatening acute kidney injury (AKI) and sepsis requiring CRRT (QUELIMMUNE SCD-PED cohort) with clinically aligned cohorts from Kids’ Inpatient Database (KID), the largest publicly available, all-payer pediatric inpatient care database in the United States representing broad clinical complexity. To assess the robustness of the findings, the authors used a multi-pronged analytic approach that included both Bayesian and frequentist methods across primary, landmark, and time-to-event analyses. Key results are reported. A separate safety analysis of QUELIMMUNE (SCD-PED)-treated patients was also presented.

Summary of Key Highlights:

• Day 90 Survival:   The primary exposure-defined analysis at Day 90 resulted in a statistically significant increase in survival of the QUELIMMUNE (SCD-PED) cohort achieving 65.1% survival compared to 47.4% for the KID cohort (P = 0.043), representing more than double the odds of survival for QUELIMMUNE (SCD-PED)-treated patients (odds ratio [OR] 2.07; 95% confidence interval, [CI] 1.04-4.11). The Bayesian probability of higher survival in QUELIMMUNE (SCD-PED) patients was 98.2%. A second landmark sensitivity analysis favored the QUELIMMUNE (SCD-PED) cohort achieving 63.8% Day 90 survival, an increase of 15.1 percentage points over the KID cohort survival of 48.7% (P= 0.074), representing 86% higher estimated odds of survival (OR 1.86; 95% CI, 0.96-3.60). The Bayesian probability of higher survival in the QUELIMMUNE (SCD-PED) landmark cohort was 96.8%.
• In-Hospital Survival: Survival to hospital discharge was significantly higher with the QUELIMMUNE (SCD-PED) cohort compared to KID in the primary analysis (P = 0.04). Bayesian analyses were directionally consistent, with 98.5% and 97.3% posterior probabilities of higher QUELIMMUNE (SCD-PED) survival in the primary and landmark analyses, respectively.
• Mortality: All four Day 90 mortality models favored the QUELIMMUNE (SCD-PED) cohort showing 34% to 40% reduction in estimated hazard of mortality (Hazard Ratio range, 0.60-0.66) compared with combined KID. While frequentist models did not reach statistical significance, both Bayesian time-to-death models exceeded the 95% probability threshold, providing supportive evidence of a lower mortality hazard with QUELIMMUNE therapy.
• Renal Replacement Therapy (RRT) Independence: 20 of the 24 survivors (83%) in the QUELIMMUNE (SCD-PED) cohort who did not require RRT at baseline were independent of RRT at 90 days.
• Adverse Events (AEs): No device-related AEs occurred in patients treated with the QUELIMMUNE (SCD-PED) therapy from SAVE registry patients. All new bloodstream infections (12% overall and 6% during treatment) within 28 days of SCD-PED initiation were adjudicated by an independent data and safety monitoring board to be unrelated to QUELIMMUNE therapy.
  

“These real-world, post-approval data show a significant association with higher survival and a consistent safety profile in the QUELIMMUNE (SCD-PED)-treated patients with sepsis-associated AKI requiring CRRT with a broad range of clinical complexities,” said Stuart Goldstein, MD, Director, Center for Acute Care Nephrology at Cincinnati Children’s and a member of the SeaStar Medical Scientific Advisory Board.* “The consistency of the survival signal across analyses support continued and further exploration of these and additional data that is forthcoming from new patients. Given the urgency of this rare and life-threatening condition combined with no device-related adverse events, I believe there is a clear observed potential benefit from the SCD-PED therapy with a favorable safety profile.”

“Selection as a late-breaker at ASN Kidney Week reflects the urgent need for better options for critically ill children with sepsis-associated AKI,” said Kevin Chung, MD, Chief Medical Officer of SeaStar Medical. “These real-world findings are consistent with our previous clinical results and the association with higher survival held across every analytic approach we applied. Sharing them with the nephrology community at its premier meeting is an important step toward making QUELIMMUNE therapy available to every child who may benefit.”

Statistical Design and Analyses:

The observational external-control exploratory study compared all known eligible QUELIMMUNE (SCD-PED)-treated pediatric patients (SAVE Registry patients plus one non-registry patient) with available outcome data through completion of the pre-specified SAVE enrollment target of 50 patients versus clinically aligned patients from the 2019 and 2022 Healthcare Cost and Utilization Project Kids’ Inpatient Databases (KID). KID is the largest publicly available all-payer pediatric inpatient care database in the United States, containing unweighted data from over three million pediatric discharges per data year, representing a broad range of patients, comorbidities, and complexities, including extracorporeal membrane oxygenation (ECMO), thus provided the broadest available pediatric comparator population. Both cohorts included critically ill pediatric patients with life-threatening AKI and sepsis requiring CRRT with high clinical complexities, such as malignancy, immunocompromised status and transplant. Greater than 95% required invasive mechanical ventilation, vasopressor use, and/or management for shock in both groups. Advanced life support therapy, such as ECMO, was administered in 33% to 34% of patients in the SAVE cohort and 28% to 29% of patients in the KID cohort.

The primary exposure-defined analysis compared the QUELIMMUNE (SCD-PED) cohort patients who received greater than one day of QUELIMMUNE therapy (N=43) versus clinically aligned patients in the KID cohort (N=196).

The landmark sensitivity analysis compared the QUELIMMUNE (SCD-PED) cohort patients who were alive one day post-initiation of QUELIMMUNE therapy (N=47) versus patients from the KID cohort who survived beyond one calendar day of CRRT initiation (N=191).

Safety outcomes for the QUELIMMUNE (SCD-PED) cohort included new bloodstream infections and Day 90 renal replacement therapy (RRT)-free status among survivors not RRT-dependent at baseline.

Data Source: The authors acknowledge the source of the data as the Kids’ Inpatient Database (KID), Healthcare Cost and Utilization Project (HCUP), Agency for Healthcare Research and Quality, Interpretations and conclusions from these data are those of the authors and do not constitute the findings, policies, or recommendations of the U.S. Government, the U.S. Department of Health and Human Services, or AHRQ.

The poster with all results as of the presentation will be available on the Healthcare Professional section of the SeaStar Medical website. Please note data from the original posted abstract was updated and the poster presentation of data is the official data source. Final study results and interpretations are expected to be reported in a peer-reviewed manuscript.

About QUELIMMUNE

The QUELIMMUNE^® (SCD-PED) therapy is being commercialized for children with AKI and sepsis or septic condition weighing 10 kilograms or more and aged ≤22 years who are on antibiotics and being treated in the ICU with RRT. It was approved in February 2024 under a Humanitarian Device Exemption application.

Data from two clinical trials of the QUELIMMUNE therapy, published in Kidney Medicine, showed a 77% survival rate in patient treated with QUELIMMUNE versus standard of care, representing an approximate 50% reduction in loss of life compared to historical data in this patient population. No dialysis was required for survivors, and 87.5% of survivors had normal kidney function at Day 60 after ICU discharge.

In February 2026, data published in the prestigious, peer-reviewed journal, Pediatric Nephrology, highlighted the early experience from the QUELIMMUNE SAVE Registry, a post-approval surveillance registry, evaluating the role of the QUELIMMUNE therapy in the treatment of critically ill pediatric patients with life-threatening Acute Kidney Injury (AKI) and sepsis requiring renal replacement therapy. The publication reported observations from the first 21 pediatric patients with AKI and sepsis requiring renal replacement therapy. Data showed no device-related adverse events or infections and no reports of immunosuppressive effects by the device. In addition, preliminary outcomes analyses show a 76% survival rate at Day 28 and Day 60, and a 71% survival rate at Day 90. These findings are broadly consistent with the survival observations reported in the registration studies reported in Kidney Medicine.

The patented technology behind QUELIMMUNE is known as the Selective Cytopheretic Device (SCD) therapy and could have broad applications for treating the destructive hyperinflammation that shuts down organ function and causes loss of life.

QUELIMMUNE was approved by FDA under a Humanitarian Device Exemption based on safety and probable benefit.  The effectiveness of this device for this use has not been demonstrated. Adverse reactions observed in clinical studies include hypotension, hypothermia, tachycardia, hyperglycemia, and thrombocytopenia. Additional risks may include blood loss or extracorporeal circuit complications. QUELIMMUNE must be used with citrate anticoagulation.

For complete risk information, please see: https://seastarmedical.com/quelimmune 

About the SeaStar Medical Selective Cytopheretic Device (SCD) Therapy

The SCD therapy is designed as a disease-modifying device that neutralizes over-active immune cells and stops the cytokine storm that yields destructive hyperinflammation and creates a cascade of events that wreak havoc in the patient’s body. The SCD therapy is designed for broad applications in multiple acute and chronic kidney and cardiovascular diseases, representing patients who today have no FDA-approved options for treating their disease. Unlike pathogen removal and other blood-purification tools, the SCD therapy is integrated with an existing CRRT hemofiltration system to selectively target and transition proinflammatory monocytes to a reparative state and promote activated neutrophils to be less inflammatory. This unique immunomodulation approach may promote long-term organ recovery, eliminate the need for future CRRT, including dialysis, and prevent loss of life.  

About NEUTRALIZE-AKI Pivotal Trial

The NEUTRALIZE-AKI (NEUTRophil and monocyte deActivation via SeLective Cytopheretic Device – a randomIZEd clinical trial in Acute Kidney Injury) pivotal trial is evaluating the safety and efficacy of the SCD therapy in 339 adults with AKI in the ICU receiving CRRT. The trial’s primary endpoint is a composite of 90-day mortality or dialysis dependency of patients treated with the SCD therapy in addition to CRRT as the standard of care, compared with the control group receiving only CRRT standard of care. Secondary endpoints include mortality at 28 days, ICU-free days in the first 28 days, major adverse kidney events at Day 90 and dialysis dependency at one year. The study will also include subgroup analyses to explore the effectiveness of the SCD therapy in AKI patients with sepsis and acute respiratory distress syndrome. 

About Acute Kidney Injury (AKI) and Hyperinflammation 

AKI is characterized by a sudden and temporary loss of kidney function and can be caused by a variety of conditions such as severe infections or other septic conditions, severe trauma, surgery, and organ failures. AKI can cause destructive hyperinflammation, which is the overproduction or overactivity of inflammatory effector cells and other molecules that can be toxic. Damage resulting from this destructive hyperinflammation in AKI can progress to other organs, such as the heart or liver, and potentially to multi-organ dysfunction or even failure that could result in worse outcomes, including increased risk of death. Even after resolution, these patients may face complications including chronic kidney disease or end-stage renal disease (ESRD) requiring dialysis. Extreme hyperinflammation may also contribute to added healthcare costs, such as prolonged ICU stays and increased reliance on dialysis and mechanical ventilation.

About SeaStar Medical

SeaStar Medical is a commercial-stage healthcare company focused on transformational treatments for critically ill patients facing organ failure and potential loss of life. SeaStar Medical’s first commercial product, QUELIMMUNE (SCD-PED), was approved in 2024 by the U.S. Food and Drug Administration (FDA). It is the only FDA approved product for the ultra-rare condition of life-threatening Acute Kidney Injury (AKI) due to sepsis or a septic condition requiring renal replacement therapy (RRT) in critically ill pediatric patients. SeaStar Medical’s Selective Cytopheretic Device (SCD) therapy has been awarded Breakthrough Device Designation for six therapeutic indications by the FDA, enabling the potential for a speedier pathway to approval and preferable reimbursement dynamics at commercial launch. The company is currently conducting the NEUTRALIZE-AKI pivotal clinical trial of its SCD therapy in adult patients with AKI requiring continuous renal replacement therapy, a life-threatening condition with no effective treatment options that impacts over 200,000 adults in the U.S. annually.

For more information visit www.seastarmedical.com or visit us on LinkedIn or X.

Forward-Looking Statements

This press release contains certain forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, without limitation, SeaStar Medical’s expectations with respect to the potential benefit from the SCD-PED therapy with a favorable observed safety profile; anticipated improved survival in real-world critical care practice; anticipated adoption our products; the ability of SCD to treat patients with AKI and other diseases; the expected regulatory approval process and timeline for commercialization; and the ability of SeaStar Medical to meet the expected timeline. Words such as “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “strategy,” “future,” “opportunity,” “plan,” “may,” “should,” “will,” “would,” “will be,” “will continue,” “will likely result,” and similar expressions are intended to identify such forward-looking statements. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to significant risks and uncertainties that could cause the actual results to differ materially from the expected results. Most of these factors are outside SeaStar Medical’s control and are difficult to predict. Factors that may cause actual future events to differ materially from the expected results include, but are not limited to: (i) the risk that SeaStar Medical may not be able to obtain regulatory approval of its SCD product candidates; (ii) the risk that SeaStar Medical may not be able to raise sufficient capital to fund its operations, including current or future clinical trials; (iii) the risk that SeaStar Medical and its current and future collaborators are unable to successfully develop and commercialize its products or services, or experience significant delays in doing so, including failure to achieve approval of its products by applicable federal and state regulators, (iv) the risk that SeaStar Medical may never achieve or sustain profitability; (v) the risk that SeaStar Medical may not be able to secure additional financing on acceptable terms; (vi) the risk that third-party suppliers and manufacturers are not able to fully and timely meet their obligations, (vii) the risk of product liability or regulatory lawsuits or proceedings relating to SeaStar Medical’s products and services, (viii) the risk that SeaStar Medical is unable to secure or protect its intellectual property, and (ix) other risks and uncertainties indicated from time to time in SeaStar Medical’s Annual Report on Form 10-K, including those under the “Risk Factors” section therein and in SeaStar Medical’s other filings with the SEC. The foregoing list of factors is not exhaustive. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and SeaStar Medical assumes no obligation and do not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. 

Contact:  
IR@SEASTARMED.COM

QUELIMMUNE is a registered trademark of SeaStar Medical Holding Corporation.

*As a member of the SeaStar Medical Scientific Advisory Board, Dr. Goldstein has received financial compensation for his service in this capacity.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did SeaStar Medical's QUELIMMUNE analysis show about Day 90 survival?

The primary analysis found 65.1% Day 90 survival with QUELIMMUNE versus 47.4% in the historical KID cohort (P=0.043). The odds ratio was 2.07, with a 95% confidence interval of 1.04–4.11. The Bayesian probability of higher survival was 98.2%.

What safety findings did SeaStar Medical report for QUELIMMUNE in the SAVE registry?

No device-related adverse events occurred among QUELIMMUNE-treated SAVE registry patients. New bloodstream infections within 28 days of treatment initiation occurred in 12% overall and 6% during treatment. An independent data and safety monitoring board judged all of these infections unrelated to QUELIMMUNE.

How were patients selected for SeaStar Medical's QUELIMMUNE survival comparisons?

The primary analysis included patients receiving greater than one day of QUELIMMUNE therapy, while the landmark analysis included treated patients alive one day after initiation. The landmark comparison comprised 47 treated patients and 191 KID patients who survived beyond one calendar day after continuous kidney replacement therapy began. Historical controls came from the 2019 and 2022 KID databases.