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DENVER - SeaStar Medical Holding Corporation (Nasdaq:ICU), a micro-cap biotech company with a market capitalization of $15.38 million, announced Tuesday preliminary results from its SAVE Surveillance Registry showing a 75% 28-day survival rate among the first 20 pediatric patients treated with its QUELIMMUNE therapy for acute kidney injury (AKI) and sepsis. According to InvestingPro data, analysts anticipate revenue growth of 7.46% for the company this year.
The company stated these early results could validate or potentially exceed a 50% reduction in mortality compared to historical data previously reported in Kidney Medicine. No device-related safety events were reported with the therapy, which is used for critically ill pediatric patients requiring renal replacement therapy. While the company shows promise in its clinical developments, InvestingPro analysis reveals it is not yet profitable, with a net loss of $15.9 million in the last twelve months. Get access to 12+ additional ProTips and comprehensive financial metrics with InvestingPro.
"Many of the patients who were treated with QUELIMMUNE were incredibly sick, with most receiving this therapy as a last resort," said Kevin Chung, MD, Chief Medical Officer of SeaStar Medical, according to the company’s statement.
The QUELIMMUNE therapy, which received FDA approval in February 2024 under a Humanitarian Device Exemption, is being used at several children’s medical centers across the United States. The therapy is designed for children with AKI and sepsis weighing 10 kilograms or more who are on antibiotics and receiving treatment in intensive care units.
SeaStar Medical is also conducting the NEUTRALIZE-AKI pivotal trial evaluating the safety and efficacy of its Selective Cytopheretic Device (SCD) therapy in 200 adults with AKI in intensive care settings. The technology has received FDA Breakthrough Device Designation for six indications, including various inflammatory conditions affecting kidney function.
The company plans to submit additional data from the registry, including 60-day and 90-day survival results, to a pediatric nephrology conference later this year. SeaStar Medical indicated that these initial results could support broader adoption of the therapy and inform discussions with healthcare payers. The stock, currently trading at $0.68, has shown significant momentum with a 22% return last week, though InvestingPro’s Fair Value analysis suggests the stock may be overvalued at current levels. Discover detailed valuation metrics and access the comprehensive Pro Research Report, available for over 1,400 US stocks.
The information is based on a company press release statement.
In other recent news, SeaStar Medical Holding Corporation announced a significant development with a Texas-based children’s hospital joining its customer base for QUELIMMUNE therapy. This therapy, which treats pediatric patients with rare Acute Kidney Injury due to sepsis, received FDA approval in 2024. SeaStar Medical has also raised approximately $4 million through a registered direct offering of common stock and a concurrent private placement of warrants. The offering includes the issuance of over 5 million shares at $0.763 each and unregistered warrants for the same number of shares at an exercise price of $0.638.
Additionally, SeaStar Medical shareholders approved all proposals at the company’s annual meeting, including the election of Eric Schlorff and Kenneth Van Heel as Class III directors. The company has regained compliance with Nasdaq’s minimum stockholders’ equity requirement of $2.5 million, allowing it to focus on its commercial and clinical activities. SeaStar Medical had faced a potential delisting but implemented financial transactions and operational improvements to meet Nasdaq’s continued listing requirements. These recent developments reflect the company’s efforts to strengthen its financial position and expand its market presence.
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