NEWS
SeaStar Medical Announces that Enrollment in its Adult Acute Kidney Injury Pivotal Trial Has Exceeded the Halfway Point Toward an Interim Analysis
SeaStar Medical Holding (Nasdaq: ICU) announces that its NEUTRALIZE-AKI pivotal trial has enrolled 51 subjects, surpassing the halfway point towards the 100-subject target for an interim analysis. The trial evaluates the safety and efficacy of SeaStar's Selective Cytopheretic Device (SCD) in adults with acute kidney injury (AKI) in ICU receiving continuous kidney replacement therapy (CKRT).
Key points:
Enrollment pace has accelerated since summer, with 5 subjects enrolled in October
SCD received FDA Breakthrough Device Designation for adults with AKI
Centers for Medicare & Medicaid Services granted Category B coverage for certain expenses in July 2024
SeaStar began shipping SCD Pediatric (QUELIMMUNE™) in July 2024
The company extinguished all interest-bearing debt in September 2024
The NEUTRALIZE-AKI trial aims to enroll up to 200 adults at up to 30 clinical sites, with a primary endpoint of 90-day mortality or dialysis dependency.
SeaStar Medical Holding (Nasdaq: ICU) announces that its NEUTRALIZE-AKI pivotal trial has enrolled 51 subjects, surpassing the halfway point towards the 100-subject target for an interim analysis. The trial evaluates the safety and efficacy of SeaStar's Selective Cytopheretic Device (SCD) in adults with acute kidney injury (AKI) in ICU receiving continuous kidney replacement therapy (CKRT).
Key points:
Enrollment pace has accelerated since summer, with 5 subjects enrolled in October
SCD received FDA Breakthrough Device Designation for adults with AKI
Centers for Medicare & Medicaid Services granted Category B coverage for certain expenses in July 2024
SeaStar began shipping SCD Pediatric (QUELIMMUNE™) in July 2024
The company extinguished all interest-bearing debt in September 2024
The NEUTRALIZE-AKI trial aims to enroll up to 200 adults at up to 30 clinical sites, with a primary endpoint of 90-day mortality or dialysis dependency.
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