DSMB recommends continuation of SeaStar Medical’s AKI trial

DENVER - The independent Data Safety Monitoring Board (DSMB) has recommended the continuation of SeaStar Medical Holding Corporation’s (NASDAQ:ICU) pivotal trial for its Selective Cytopheretic Device (SCD) therapy in adult patients with acute kidney injury, according to a press release statement issued Wednesday. The micro-cap company, currently valued at $34 million, has seen its stock surge over 34% in the past week, according to InvestingPro data.

The DSMB’s interim analysis of the first 100 patients enrolled in the NEUTRALIZE-AKI trial reported zero device-related adverse events and indicated a potential clinical benefit in the treatment group across key outcome measures. While the company maintains an impressive 96% gross profit margin, InvestingPro analysis reveals it is not yet profitable, with earnings per share at -$2.02 over the last twelve months.

Based on these findings, the DSMB recommended increasing the trial’s enrollment from 200 to 339 patients to strengthen statistical power. Currently, 137 patients have been enrolled, with the company estimating completion of enrollment by late 2026.

"Sample size re-estimations are well established practices in pivotal trials, and while an upward re-estimation will extend the trial timeline, we are optimistic it will strengthen the statistical power," said Kevin Chung, Chief Medical Officer of SeaStar Medical.

The NEUTRALIZE-AKI trial’s primary endpoint is a composite of 90-day mortality or dialysis dependency in patients treated with the SCD therapy plus continuous renal replacement therapy (CRRT), compared to patients receiving only CRRT.

SeaStar Medical’s SCD therapy received FDA approval in 2024 for use in pediatric patients with life-threatening acute kidney injury due to sepsis, and is marketed under the brand name QUELIMMUNE. The therapy is designed to neutralize over-active immune cells and stop cytokine storms that cause destructive hyperinflammation.

The company reported that preliminary results from its SAVE Surveillance Registry showed no device-related safety events among the first 20 pediatric patients using QUELIMMUNE commercially, with 75% of patients surviving through 28 days. With analysts forecasting revenue growth of 8.85% for the current year, investors seeking deeper insights into SeaStar Medical’s growth potential can access comprehensive analysis through the InvestingPro Research Report, which is part of the platform’s coverage of over 1,400 US stocks.

In other recent news, SeaStar Medical Holding Corp reported a 15% increase in revenue for the second quarter of 2025, totaling $338,000. Despite the revenue growth, the company still reported a net loss, although it has narrowed compared to the previous year. SeaStar Medical also made changes to its executive team, terminating the employment of CFO David Green without cause, and appointing interim financial officers. Additionally, the company plans to present preliminary results from its SAVE Surveillance Registry at an upcoming symposium, focusing on the QUELIMMUNE therapy used in pediatric patients with acute kidney injury and sepsis. These developments highlight ongoing adjustments and advancements within the company.

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