SeaStar Medical Gains FDA Approval for Pediatric Device

SeaStar Medical Holding ( (ICU) ) has issued an announcement.

SeaStar Medical announced the FDA approval of its QUELIMMUNE device for pediatric acute kidney injury, marking a significant milestone in its commercialization strategy. The company is currently enrolling patients in a pivotal trial for adult acute kidney injury, a market significantly larger than the pediatric segment. This progress underscores SeaStar’s potential to capture a substantial share of the multibillion-dollar market for inflammation-driven diseases, leveraging its proven SCD platform technology.

More about SeaStar Medical Holding

SeaStar Medical Holding operates within the medical technology industry, providing organ-restoring solutions to critically ill patients through its patented Selective Cytopheretic Device (SCD) platform. The company focuses on addressing life-threatening hyperinflammation and is engaged in developing therapeutic devices for acute kidney injury and other inflammation-driven diseases. With FDA approval for pediatric acute kidney injury and ongoing pivotal trials for adult acute kidney injury, SeaStar Medical is positioned to expand its market presence.

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