SeaStar Medical Immunomodulator Therapy Designated an FDA Breakthrough Device

SeaStar Medical’s Selective Cytopheretic Device (SCD) — an immunomodulator designed to reduce inflammation in acute kidney injuries — has received a Breakthrough Device designation from the FDA.

The extracorporeal device selectively targets neutrophils and monocytes, the cellular drivers of inflammation, to restore immune balance in the body and potentially reverse the damage that can lead to organ failure or death.

CSD clinical studies in both adults and pediatric patients have shown a reduction of mortality and dialysis dependency, said SeaStar Medical CEO Eric Schlorff.

The Denver, Colo.-based device company is focused on developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs.