SeaStar Medical

ICUApproved

SeaStar Medical is on a mission to save lives by calming the cytokine storm, a destructive hyperinflammatory response that leads to organ failure in critically ill patients. The company has achieved its first FDA approval under a Humanitarian Device Exemption for its lead product, Quelimmune, to treat pediatric acute kidney injury, and has launched it commercially. With a robust pipeline backed by multiple FDA Breakthrough Device Designations, SeaStar is advancing its Selective Cytopheretic Device (SCD) technology into pivotal and feasibility studies for adult acute kidney injury, cardiorenal syndrome, and other severe inflammatory conditions.

Market Cap

$2.2B

ICU · Stock Price

USD 577.501872.50 (-76.43%)

Historical price data

AI Company Overview

Technology Platform

The Selective Cytopheretic Device (SCD) is an extracorporeal immunomodulatory cartridge that selectively targets and deactivates highly activated neutrophils and monocytes to calm the cytokine storm, integrating into standard continuous renal replacement therapy (CRRT) systems.

Funding History

Total raised: $25M

PIPE$25MUndisclosedDec 15, 2022

Opportunities

SeaStar Medical's primary growth opportunity lies in expanding its SCD therapy from its initial pediatric approval into the massive adult critical care market, particularly for Acute Kidney Injury and Cardiorenal Syndrome.

The platform's design allows for minimal modification to address multiple hyperinflammatory conditions, creating a pipeline-in-a-product scenario.

Successful penetration could establish a new standard of care in the ICU.

Risk Factors

Key risks include the failure of the pivotal NEUTRALIZE-AKI trial to meet its endpoints, which would severely impact the adult program.

The company also faces commercialization challenges in driving hospital adoption and likely requires additional capital to fund operations and trials, posing dilution risk.

Competitive Landscape

SeaStar competes against standard supportive care (CRRT) and broad-spectrum cytokine adsorbers like CytoSorb. Its key differentiation is the selective targeting of activated immune cells to modulate rather than broadly suppress the immune response, a mechanism supported by multiple FDA Breakthrough Device Designations.