SeaStar Medical Showcases New Positive Data from the QUELIMMUNE SAVE Registry and an Analysis of the Unique Immunomodulatory Mechanism of the SCD Therapy at AKI & CRRT 2026

Results from pediatric patients in the SAVE Registry shows no device-related adverse events or immunosuppression and continued strong survival data 

In vitro analysis of the SeaStar Medical SCD indicates modulation of the immune response, shifting monocytes towards an anti-inflammatory, reparative phenotype

SeaStar Medical hosts an industry symposium and panel discussion focused on innovation in the treatment of pediatric AKI, supporting its emerging leadership in this community

DENVER, March 30, 2026 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (NASDAQ:ICU), a commercial-stage healthcare company focused on transforming treatments for critically ill patients facing organ failure and potential loss of life announced today the presentations of new SAVE Registry data and investigator led research on the mechanism of action of the Selective Cytopheretic Device (SCD) therapy at the 31^st International Conference on Advances in Critical Care Nephrology, also known as AKI & CRRT 2026.

SeaStar Medical highlights two poster presentations that were presented at the meeting, including new expanded real-world data from the treatment of pediatric patients from the SAVE Registry, as well as investigator led gene expression research on the immunomodulatory effects of the Company's SCD therapy.

SeaStar Medical has also assembled leading experts in the treatment of pediatric Acute Kidney Injury (AKI) to speak at its educational symposium to discuss the complex pathophysiology of the condition, the QUELIMMUNE SAVE Registry, the immunomodulatory effects of the SCD therapy which may ameliorate dysregulated hyperinflammatory disease states, and other topics of interest to the nephrology community. In addition, the Company is hosting a discussion by the first ever Advanced Practice Provider Panel, to enable broader community adoption of QUELIMMUNE, the Company's approved therapy for the treatment of critically ill pediatric patients with life-threatening AKI and sepsis requiring Renal Replacement Therapy (RRT)

"We are establishing a growing presence in the pediatric AKI community with strong support from experts in the field," stated Kevin Chung, Chief Medical Officer of SeaStar Medical. "Our goal is to expand awareness and treatment options for this serious, life-threatening condition. Every one of these kids deserves the best possible chance of survival, and with historical mortality rates of 50%, we believe that is just not good enough. We thank the pediatric AKI health care community for their dedication to these kids, and to searching for all available options to give sick children a chance."

Presentations:

Presentations were available starting on Sunday, March 29, 2026, at 5:30 p.m. Pacific Time and will be made available on the Company's website following the conference.

Presentation Title: The Selective Cytopheretic Device (SCD) in Pediatric AKI Requiring CRRT – Eighteen-Month Post-Approval Clinical Experience From the SAVE Registry

Authored by: Krallman KA, Basu RK, Askenazi DJ, Menon S, Zinter MS, Gorga SM, Zolezzi DA, Drake K, Gillespie RS, Goldstein SL

Summary: This presentation expands on previously published real-world data from the treatment of the QUELIMMUNE (SCD-PED) therapy in the commercial setting. Results show no device-related adverse events and preliminary outcomes analysis show survival rates of 69% (Day 28 and Day 60), which are consistent with the clinical trial experience of the SCD-PED in this same population.

Presentation Title: The Selective Cytopheretic Device Induces Monocyte Phenotype Switching Towards an Anti-Inflammatory, Reparative Phenotype

Authored by: Odum JD, Pino C, Mendendorp T, Humes HD

Summary: This presentation focuses on in vitro gene expression research demonstrating immunomodulation of pro-inflammatory monocytes towards an anti-inflammatory and reparative profile by the SeaStar Medical Selective Cytopheretic Device (SCD). The research builds on the previous research and adds deeper insights on the mechanism of action of the SCD.

Symposium:

March 30, 2026, 12:30 – 2:00 p.m. Pacific Time, Room I2: New Horizons in Pediatric Acute Kidney Injury

The luncheon symposium will feature leading experts discussing:

• The pathophysiology of pediatric AKI
• The role of hyperinflammation and immune dysfunction in AKI
• The SCD technology and its role in modulating immune effector cells that promote hyperinflammation
• Real-world experience of QUELIMMUNE (SCD-PED) in treatment of inflammation in pediatric AKI
• Panel discussions on key topics in the treatment of pediatric AKI.
  
  
  
  

Speakers include:

• Danielle Soranno, MD, Riley Children's Hospital
• Ayse Akcan-Arikan, MD, Texas Children's Hospital
• Stu Goldstein, MD, FAAP, FNKP, Cincinnati Children's Hospital
• Stephen Gorga, MD, MSC, FAAP, University of Michigan
• Theresa Mottes*, APRN-NP, CDN, Lurie Children's Hospital
• David Zolezzi*, MSPAS, PA-C, UTSW Children's Dallas
• Katie Plomaritas*, BSN, RN, Mott Children's Hospital
  
  
  
  

*Member of the Advanced Practice Provider Panel

About QUELIMMUNE

The QUELIMMUNE™ therapy is being commercialized for children with AKI and sepsis or septic condition weighing 10 kilograms or more who are on antibiotics and being treated in the ICU with Renal Replacement Therapy (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 January 2025, SeaStar Medical was awarded the 2025 Corporate Innovator Award by the National Kidney Foundation for its significant contribution to improving the lives of pediatric patients with AKI based on the approval and introduction of the QUELIMMUNE therapy.

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. Observations from the first 21 pediatric patients with AKI and sepsis requiring renal replacement therapy 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 new data are on track to validate a 50% reduction in patient mortality at 60 days compared to historical data, similar to what was observed in the registration study reported in Kidney Medicine.

The patented technology behind QUELIMMUNE is known as the Selective Cytopheretic Device (SCD) therapy and has broad applications for treating the destructive hyperinflammation that shuts down organ function and causes 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 continuous renal replacement therapy (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 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 continuous renal replacement therapy (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 SeaStar Medical

SeaStar Medical is a commercial-stage healthcare company focused on transforming 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 1955. These forward-looking statements include, without limitation, SeaStar Medical's expectations with respect to anticipated patient enrollment and the expansion of the clinical trial sites; the total addressable market for the SCD applications; the ability of SeaStar Medical to commercialize SCD applications and gain market share; broadening QUELIMMUNE adoption by the addition of top-ranked children's medical centers; the ability of SCD to treat patients with AKI and other diseases and the anticipated 50% reduction in patient mortality at 60 days; 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:  

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