SeaStar Medical Holding Corporation (NASDAQ: ICU) is experiencing a notable ascent in its market performance as dawn approaches. The shares of SeaStar Medical are currently exhibiting a remarkable surge, standing at 33.59% with a value of $1.03 during the pre-market trading session at last check. This remarkable upturn in the valuation of ICU shares can be attributed to a recently obtained regulatory approval for its product.
SeaStar Medical (ICU) has achieved the Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its groundbreaking Selective Cytopheretic Device (SCD), a cell-directed innovation tailored for use in hospital intensive care units (ICUs) treating acute kidney injury (AKI) and acute on chronic liver failure.
This marks the third such accolade bestowed upon SeaStar Medical for the SCD device, promising a swifter journey through clinical development and regulatory review, focusing on the specific requirements of this patient group.
Hepatorenal syndrome, a grave condition characterized by abrupt kidney function deterioration often linked to advanced liver cirrhosis, carries a high mortality rate. SeaStar’s SCD has demonstrated potential in enabling kidney recovery, opening doors for life-saving liver transplants. A pivotal investigator-led study at the University of Michigan explored the effects of SCD treatment on two patients afflicted with type 1 hepatorenal syndrome.
Encouragingly, both cases exhibited favorable clinical outcomes. The first patient, struggling with hepatorenal syndrome resulting from acute alcoholic hepatitis, survived 90 days post a week of SCD treatment and underwent evaluation for liver transplantation. The second patient, facing hepatorenal syndrome due to non-alcoholic steatohepatitis (NASH), successfully received a liver transplant six days after concluding SCD therapy.
These findings suggest that SCD’s immunomodulatory capabilities could play a crucial role in managing acute on chronic liver failure, offering a path toward liver transplantation. These noteworthy cases have been published in the prestigious American Society for Artificial Internal Organs Journal. This recognition underscores ICU’s potentially life-saving approach of addressing dysregulated immune responses.
Furthermore, SCD has displayed promise in enhancing the performance of vital organs across a range of preclinical and clinical studies, spanning conditions such as sepsis, AKI, cardiorenal syndrome, and even COVID-19 management. ICU foresees that the ongoing pilot study at the University of Michigan will yield valuable insights for the design and execution of a pivotal study within this particular medical context.
