SeaStar Medical to present QUELIMMUNE pediatric registry data at symposium

DENVER - SeaStar Medical Holding Corporation (Nasdaq:ICU), a micro-cap medical device company valued at $27.91 million with a notably high gross profit margin of 96.48%, will present preliminary results from its SAVE Surveillance Registry at the 5th International Symposium on Acute Kidney Injury in Children on September 27, 2025, the company announced Tuesday. According to InvestingPro data, analysts anticipate sales growth for the company in the current year.

The presentations will focus on real-world clinical experience with QUELIMMUNE, a Selective Cytopheretic Device for Pediatrics (SCD-PED) therapy used to treat critically ill pediatric patients with life-threatening Acute Kidney Injury (AKI) and sepsis requiring Renal Replacement Therapy.

QUELIMMUNE received FDA approval in February 2024 under a Humanitarian Device Exemption for children with AKI and sepsis weighing 10 kilograms or more who are on antibiotics and being treated in intensive care with Renal Replacement Therapy.

The SAVE Registry is designed to collect real-world evidence on up to 300 patients treated with QUELIMMUNE, tracking 90-day survival rates, dialysis dependency, and safety data. The company plans to compare these outcomes to an existing control group of patients with similar illness severity.

Previous clinical studies of QUELIMMUNE showed a 77% survival rate in treated patients versus standard care, representing approximately a 50% reduction in mortality compared to historical data. No dialysis was required for survivors, and 87.5% of survivors demonstrated normal kidney function 60 days after ICU discharge, according to data published in Kidney Medicine. For deeper insights into SeaStar Medical’s financial health and growth prospects, including 13 additional exclusive ProTips, visit InvestingPro, where you’ll find comprehensive analysis and Fair Value estimates.

SeaStar Medical is also conducting a pivotal trial of its SCD therapy in adult patients with AKI requiring continuous renal replacement therapy, a condition that affects over 200,000 adults annually in the United States.

The company stated that initial results from the registry will support broader adoption of the therapy and inform discussions with healthcare payers. The information in this article is based on a company press release.

In other recent news, SeaStar Medical Holding Corp reported a 15% sequential increase in revenue for the second quarter of 2025, reaching $338,000. The company also saw its net loss narrow compared to the previous year, while maintaining a strong cash position due to recent fundraising efforts. Additionally, SeaStar Medical announced changes to its executive team. The Board of Directors terminated the employment of David Green, the Chief Financial Officer and Treasurer, effective August 14. The termination was made without "Cause" as defined in his employment agreement. SeaStar Medical plans to compensate Green with approximately $300,000 in base salary over a 12-month period, along with COBRA health coverage for up to 18 months if elected, and accelerated vesting of his unvested restricted stock units. These developments come as the company continues to navigate its financial and operational strategies.

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