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
Rhea-AI Summary
SeaStar Medical (Nasdaq: ICU) presented expanded real-world SAVE Registry pediatric data and investigator research at AKI & CRRT 2026. The registry showed no device-related adverse events and 69% survival at Day 28 and Day 60. In vitro gene-expression work indicates the SCD shifts monocytes toward an anti-inflammatory, reparative phenotype. The company hosted a pediatric AKI symposium and an Advanced Practice Provider Panel to promote QUELIMMUNE (SCD-PED) adoption.
Positive
- Survival 69% reported at Day 28 and Day 60 in SAVE Registry pediatric cohort
- No device-related adverse events observed in the reported pediatric real-world experience
- Mechanism data: in vitro gene expression shows monocyte shift to anti-inflammatory, reparative phenotype
Negative
- None.
News Market Reaction – ICU
In the Mar 30 session, ICU gained 32.12%, reflecting a significant positive market reaction. Argus tracked a peak move of +37.9% during that session. Our momentum scanner triggered 45 alerts that day, indicating elevated trading interest and price volatility. Trading volume was very high at 4.9x the daily average, suggesting strong buying interest.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Historical Context
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Mar 25 | Earnings and updates | Positive | +22.4% | 2025 revenue growth, narrower net loss, and pipeline progress updates. |
| Mar 18 | Earnings date notice | Neutral | -3.4% | Announcement of timing and access details for Q4 and full-year call. |
| Mar 05 | Registry enrollment complete | Positive | +2.8% | Completion of FDA-required SAVE Registry enrollment confirming QUELIMMUNE safety. |
| Feb 09 | Real-world AKI data | Positive | -2.0% | Publication of positive real-world QUELIMMUNE outcomes in Pediatric Nephrology. |
| Jan 29 | Conference presentation | Neutral | -2.3% | CEO presentation at Noble Capital Markets emerging growth conference. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Positive clinical and business updates have often led to upside, though one prior positive pediatric AKI real-world update saw a modest selloff.
Over recent months, ICU has reported growing QUELIMMUNE commercialization and registry progress. On Mar 25, 2026, earnings showed higher 2025 revenue and a narrower net loss, with the stock up 22.37%. Earlier in March, completion of FDA-required SAVE Registry enrollment also drew a positive reaction. However, publication of early real‑world pediatric AKI data on Feb 9, 2026 coincided with a -2.02% move, showing that even encouraging clinical updates have not always translated into near-term strength.
Key Terms
immunomodulatory medical
monocytes medical
phenotype medical
acute kidney injury medical
renal replacement therapy medical
gene expression medical
hyperinflammatory medical
immunosuppression medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
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 31st 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
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
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
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
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
Contact:
IR@SEASTARMED.COM
