SeaStar Medical reaches 60% enrollment milestone in AKI trial

DENVER - SeaStar Medical Holding Corporation (NASDAQ:ICU), a micro-cap healthcare company with a market capitalization of $16.9 million, has enrolled 125 patients, representing over 60% of the anticipated 200 participants in its NEUTRALIZE-AKI pivotal clinical trial, the company announced Wednesday. According to InvestingPro data, the stock has shown significant price volatility, with analysts anticipating sales growth in the current year.

The commercial-stage healthcare company also activated Methodist Hospital Metropolitan of San Antonio as its 16th clinical trial site. The company’s Chief Medical Officer, Kevin Chung, noted that Methodist Hospital’s affiliate is already one of the highest enrolling sites in the trial. While SeaStar Medical’s InvestingPro Financial Health Score indicates challenges with a ’WEAK’ overall rating, the company maintains more cash than debt on its balance sheet.

SeaStar Medical confirmed it remains on track to receive results from the prespecified interim analysis of the first 100 patients in the third quarter of 2025. This analysis will be conducted by the trial’s independent Data Safety Monitoring Review Board (DSMB), with the company planning to disclose only the top-line decision to preserve the trial’s integrity.

The NEUTRALIZE-AKI trial is evaluating the company’s Selective Cytopheretic Device (SCD) therapy for adult patients with acute kidney injury (AKI) requiring continuous renal replacement therapy. The primary endpoint is a composite of 90-day mortality or dialysis dependency compared to standard care.

The trial includes notable institutions such as Cleveland Clinic, Mayo Clinic, and Stanford Medical Center among its 16 clinical sites. The SCD therapy has received Breakthrough Device Designation from the FDA for six indications, including the treatment of adult AKI requiring continuous renal replacement therapy.

SeaStar Medical’s first commercial product, QUELIMMUNE, received FDA approval in 2024 for pediatric patients with life-threatening acute kidney injury due to sepsis.

The information in this article is based on a company press release statement. For deeper insights into SeaStar Medical’s financial health and growth prospects, including 11 additional exclusive ProTips and comprehensive valuation metrics, visit InvestingPro to access the detailed Pro Research Report, part of the platform’s coverage of over 1,400 US equities.

In other recent news, SeaStar Medical Holding Corporation announced a registered direct offering to raise approximately $4.4 million, issuing 4,960,544 shares of common stock at $0.887 per share. Concurrently, the company will issue unregistered warrants to purchase an equal number of shares at an exercise price of $0.762 per share. Additionally, SeaStar Medical also entered into another agreement to raise about $4 million through a similar offering, issuing 5,242,464 shares at $0.763 per share, along with warrants priced at $0.638 per share. On the clinical front, the company reported promising preliminary results from its SAVE Surveillance Registry, showing a 75% 28-day survival rate for pediatric patients treated with its QUELIMMUNE therapy for acute kidney injury and sepsis. No device-related safety events were noted, suggesting potential validation of reduced mortality rates. A prominent Texas children’s hospital has joined the list of users for QUELIMMUNE therapy, which has FDA approval under a Humanitarian Device Exemption. Furthermore, SeaStar Medical’s shareholders approved all proposals at the recent annual meeting, including the election of Eric Schlorff and Kenneth Van Heel as Class III directors. These developments highlight SeaStar Medical’s ongoing efforts in both financial and clinical advancements.

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