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DENVER - SeaStar Medical Holding Corporation (NASDAQ:ICU), a micro-cap biotech company with a market capitalization of $16.81 million, reported preliminary results from its SAVE Surveillance Registry showing positive outcomes for its QUELIMMUNE therapy in treating pediatric patients with acute kidney injury (AKI) and sepsis requiring renal replacement therapy. According to InvestingPro analysis, the stock is currently trading near its Fair Value, despite showing high price volatility with a beta of -0.97.
Data from the first 21 pediatric patients demonstrated a 76% survival rate at Day 28 and Day 60, and 71% at Day 90, according to the company’s presentation at the 5th International Symposium on Acute Kidney Injury in Children on Saturday. The company stated these results could potentially represent a 50% reduction in mortality compared to historical data. While the clinical results appear promising, InvestingPro data shows the company maintains a high gross profit margin of 96.48%, though it remains unprofitable over the last twelve months.
The registry reported zero device-related adverse events or infections with the QUELIMMUNE therapy, which received FDA approval in February 2024 under a Humanitarian Device Exemption.
Among the five patients simultaneously treated with QUELIMMUNE and extracorporeal membrane oxygenation (ECMO), 60% survived to Day 90. For pediatric survivors without end-stage renal disease history or recent kidney transplant, 75% were dialysis-free at Day 28 and 82% at Day 90.
"These results and my own clinical experience provide encouraging evidence to show early benefit of SCD-PED therapy in critically ill patients with AKI requiring RRT," said Stuart Goldstein, MD, of Cincinnati Children’s, in the press release.
The SAVE Surveillance Registry is designed to collect real-world evidence from up to 300 patients treated with QUELIMMUNE at participating medical institutions. SeaStar Medical indicated the registry data will support broader adoption of the therapy and inform payer discussions.
The company is also conducting the NEUTRALIZE-AKI pivotal trial of its Selective Cytopheretic Device therapy in adult patients with AKI requiring continuous renal replacement therapy.
In other recent news, SeaStar Medical Holding Corporation reported a 15% sequential increase in revenue for the second quarter of 2025, totaling $338,000. Despite a reduction in net loss from the previous year, the company continues to experience financial challenges. Additionally, the independent Data Safety Monitoring Board recommended the continuation of SeaStar Medical’s pivotal trial for its Selective Cytopheretic Device therapy in adult patients with acute kidney injury. The interim analysis indicated no device-related adverse events and suggested potential clinical benefits. SeaStar Medical also announced it will present preliminary results from its SAVE Surveillance Registry at an upcoming international symposium, focusing on its pediatric therapy for life-threatening acute kidney injury and sepsis. In executive news, SeaStar Medical terminated its Chief Financial Officer, David Green, without cause, and appointed interim financial officers. The company plans to provide Green with a separation package, including salary and benefits. These developments reflect ongoing efforts and changes within the company.
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