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DENVER - SeaStar Medical Holding Corporation (NASDAQ:ICU), a healthcare company specializing in treatments for organ failure with a market capitalization of $11.69 million, announced today that the U.S. Food and Drug Administration (FDA) has granted two new Breakthrough Device Designations for its Selective Cytopheretic Device (SCD) therapy. These designations are for the treatment of systemic inflammatory response in adult and pediatric patients undergoing cardiac surgery. According to InvestingPro data, the company maintains a stronger cash position than debt on its balance sheet, positioning it to pursue these regulatory advances.
The FDA's Breakthrough Device Designation is intended to expedite the development and review process for medical devices that promise more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases. This status is granted to devices that represent a breakthrough technology, offer significant advantages over existing alternatives, or are in the best interest of patients.
The SCD therapy is designed to reduce hyperinflammation, which can lead to organ damage and is particularly dangerous following cardiac surgery. According to SeaStar Medical, approximately 15 percent of the 300,000 adults and one third of the 40,000 pediatric patients undergoing cardiac surgery each year could potentially benefit from SCD therapy to prevent post-surgical complications. With analysts forecasting 6.41% revenue growth for the upcoming fiscal year, the company appears positioned to capitalize on this substantial market opportunity. InvestingPro analysis reveals 10+ additional insights about SeaStar Medical's growth prospects and market position, available to subscribers.
SeaStar Medical's CEO, Eric Schlorff, emphasized the critical need for effective treatments for hyperinflammation. Chief Medical Officer Kevin Chung, MD, also highlighted the potential of SCD therapy to improve recovery outcomes after heart surgery.
Currently, SeaStar Medical is commercializing its first SCD therapy, QUELIMMUNE, for critically ill pediatric patients with acute kidney injury (AKI) due to sepsis or septic conditions under a Humanitarian Device Exemption. The company is also conducting a pivotal clinical trial, NEUTRALIZE-AKI, in adult patients with AKI and an investigational study in patients with cardiorenal syndrome awaiting left ventricular assist device implantation. With a current ratio of 0.55 and negative earnings per share of -$6.63, the company faces near-term financial challenges as it works to bring these promising therapies to market. Investors can access comprehensive financial analysis and Fair Value estimates through InvestingPro's detailed research reports, which cover over 1,400 US stocks including SeaStar Medical.
The two new Breakthrough Device Designations add to the four previously granted to SeaStar Medical, bringing the total to six. The company believes these designations will extend its market opportunity and support its strategic commercial plans.
This announcement is based on a press release statement from SeaStar Medical. The company's forward-looking statements involve risks and uncertainties, including the potential for delays in regulatory approval and the need for additional funding. SeaStar Medical has cautioned that these statements are not guarantees of future performance and that actual results may differ materially from those projected.
In other recent news, SeaStar Medical Holding Corp reported its financial results for the fourth quarter of 2024, highlighting a net loss of $24.8 million, which was an improvement from the $26.2 million loss in 2023. The company's revenue for the year was modest, totaling $134,000. SeaStar Medical raised $25 million in capital and extinguished $6 million in debt, ending the year with $1.8 million in cash. Additionally, the company raised another $6 million in February 2025. A significant development for SeaStar Medical was the launch of its Quellimmune product for pediatric acute kidney injury (AKI), which received FDA approval. The company is also focused on the ongoing Neutralize AKI pivotal trial, with 94 out of 200 patients enrolled and an interim analysis expected by mid-2025. Despite these strategic initiatives, the company's stock experienced a sharp decline following the earnings announcement, reflecting investor concerns over ongoing financial challenges.
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