NEWS
SeaStar Medical Reports Enrollment Momentum in Its Pivotal Adult AKI Trial
SeaStar Medical Holding (Nasdaq: ICU) reports progress in its pivotal NEUTRALIZE-AKI trial, with four new subjects enrolled in 10 days, bringing total enrollment to 46. The trial evaluates the company's Selective Cytopheretic Device (SCD) for adults with acute kidney injury (AKI) in ICU receiving continuous kidney replacement therapy (CKRT).
Key points:
Trial aims to enroll up to 200 adults
Primary endpoint: 90-day mortality or dialysis dependency
Interim analysis planned at halfway point
Company plans to expand trial sites to accelerate enrollment
The SCD is designed to reduce hyperinflammation in AKI patients, potentially improving outcomes and reducing healthcare costs. SeaStar Medical's pediatric version, QUELIMMUNE™, received FDA approval in February 2024 for children with AKI and sepsis.
SeaStar Medical Holding (Nasdaq: ICU) reports progress in its pivotal NEUTRALIZE-AKI trial, with four new subjects enrolled in 10 days, bringing total enrollment to 46. The trial evaluates the company's Selective Cytopheretic Device (SCD) for adults with acute kidney injury (AKI) in ICU receiving continuous kidney replacement therapy (CKRT).
Key points:
Trial aims to enroll up to 200 adults
Primary endpoint: 90-day mortality or dialysis dependency
Interim analysis planned at halfway point
Company plans to expand trial sites to accelerate enrollment
The SCD is designed to reduce hyperinflammation in AKI patients, potentially improving outcomes and reducing healthcare costs. SeaStar Medical's pediatric version, QUELIMMUNE™, received FDA approval in February 2024 for children with AKI and sepsis.
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