The SCD has been awarded FDA Breakthrough Device Designation (BDD) in three of the five indications included in the chart above, namely adult AKI, hepatorenal syndrome and cardiorenal syndrome with LVAD. The SCD was also awarded BDD for chronic dialysis in November 2024.
SeaStar Medical Estimates US Total Addressable Market For Its Proprietary, Patented Selective Cytopheretic Device In Five Clinical Indications Of $25B - $33B
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