DENVER — October 7, 2026
SeaStar Medical announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to its Selective Cytopheretic Device (SCD) therapy for treating hyperinflammation in adults with sepsis or a septic condition. The designation is intended to support accelerated development, assessment and review of medical devices addressing life-threatening or irreversibly debilitating conditions. SeaStar said the designation represents the seventh Breakthrough Device Designation awarded to the SCD therapy across multiple indications. The company is developing the technology to selectively modulate dysregulated immune responses associated with severe inflammation and organ injury.
SCD Targets Dysregulated Inflammatory Responses
Sepsis can trigger an uncontrolled immune response that contributes to hyperinflammation, endothelial injury, organ dysfunction and septic shock. SeaStar said there are currently no FDA-approved therapies specifically addressing the dysregulated inflammatory host response associated with sepsis. The SCD therapy is designed to work with an existing continuous renal replacement therapy (RRT) hemofiltration system and selectively modulate inflammatory immune cells rather than broadly suppressing the immune system. According to the company, the approach is intended to transition proinflammatory monocytes toward a reparative state and reduce inflammatory activity of activated neutrophils, potentially addressing the inflammatory cascade associated with critical illness.
NEUTRALIZE-AKI Includes Sepsis Subgroup Analysis
The new designation comes as SeaStar continues the NEUTRALIZE-AKI pivotal clinical trial, which is evaluating the SCD therapy in 339 adults with acute kidney injury (AKI) in the intensive care unit who require continuous RRT. The study’s primary endpoint is a composite of 90-day mortality or dialysis dependency, comparing patients treated with SCD therapy plus standard-of-care continuous RRT with patients receiving continuous RRT alone. Secondary measures include 28-day mortality, ICU-free days, major adverse kidney events at Day 90 and dialysis dependency at one year. The protocol also includes prespecified subgroup analyses in patients with sepsis and acute respiratory distress syndrome, which SeaStar expects could provide data relevant to discussions with the FDA regarding the new sepsis indication.
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SeaStar Advances Multiple SCD Indications
The sepsis designation expands the regulatory development pathway for the SCD platform, which SeaStar says has now received Breakthrough Device Designation for seven indications spanning AKI, cardiac surgery inflammation, pediatric cardiac surgery, cardiorenal syndrome, end-stage renal disease, hepatorenal syndrome and sepsis. SeaStar’s QUELIMMUNE® SCD-PED therapy is already FDA-approved under a Humanitarian Device Exemption for critically ill pediatric patients weighing at least 10 kilograms with life-threatening AKI due to sepsis or a septic condition requiring RRT. The company is continuing to develop the SCD platform for adult critical-care applications, with the NEUTRALIZE-AKI trial serving as a key clinical development program. SeaStar said it plans to submit relevant sepsis subgroup data to the FDA as the evidence becomes available.
Source::SeaStar Medical, press release
