SeaStar Medical Soars 13.36% on Positive AKI Therapy Results

Generated by AI AgentAinvest Pre-Market Radar
Tuesday, Jul 22, 2025 9:14 am ET1min read
Aime RobotAime Summary

- SeaStar Medical's stock jumped 13.36% pre-market after reporting 75% 28-day survival rate in pediatric AKI/sepsis patients using QUELIMMUNE therapy.

- The therapy's Selective Cytopheretic Device (SCD) technology shows potential to halve mortality compared to historical AKI treatment outcomes.

- FDA Breakthrough Device Designation covers six indications including adult cardiac surgery and hepatorenal syndrome, with 200-patient NEUTRALIZE-AKI trial underway.

- Top U.S. children's hospitals are adopting the therapy, which targets hyperinflammation causing organ failure in critically ill patients.

On July 22, 2025, SeaStar Medical's stock surged by 13.36% in pre-market trading, reflecting significant investor optimism and market confidence in the company's recent developments.

SeaStar Medical recently announced positive preliminary results from the SAVE Surveillance Registry, which is evaluating the use of the QUELIMMUNE therapy in critically ill pediatric patients with life-threatening Acute Kidney Injury (AKI) and sepsis requiring Renal Replacement Therapy (RRT). The data from the first 20 pediatric patients showed a 75% survival rate through 28 days, suggesting a potential 50% reduction in mortality compared to historical standards. This data is on track to validate or potentially exceed the reduction in loss of life compared to historical data, as reported in Kidney Medicine.

The QUELIMMUNE therapy has been adopted by some of the highest-rated children’s medical centers in the United States. 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.

is currently conducting the NEUTRALIZE-AKI pivotal trial that is evaluating the safety and efficacy of the SCD therapy in 200 adults with AKI in the ICU receiving CRRT. It has received FDA Breakthrough Device Designation for this indication and five others, including systemic inflammatory response in adult cardiac surgery, pediatric cardiac surgery, adult cardiorenal syndrome awaiting left ventricular assist device (LVAD) implantation, end-stage renal disease (ESRD) requiring chronic dialysis, and adult hepatorenal Syndrome (HRS).

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