SeaStar Medical Holding Corporation, a company specializing in medical devices designed to address hyperinflammation's impact on vital organs, has reported the enrollment of 12 subjects in its NEUTRALIZE-AKI pivotal clinical trial. This trial evaluates the safety and effectiveness of SeaStar's patented Selective Cytopheretic Device (SCD) extracorporeal therapy for critically ill adults with acute kidney injury (AKI) requiring continuous kidney replacement therapy (CKRT). The company is dedicated to offering an improved treatment option for the considerable number of adult AKI patients in need of CKRT.

SeaStar Medical is optimistic about obtaining U.S. Food & Drug Administration (FDA) approval for its SCD Pediatric (SCD-PED) within the next 30 to 45 days under a Humanitarian Device Exemption (HDE). This approval would be for use in children weighing 10 kilograms or more with AKI and sepsis. The commercial launch of SCD-PED is slated for Q1 2024. The NEUTRALIZE-AKI trial, aiming to enroll up to 200 patients, focuses on a primary endpoint that combines 90-day mortality and dialysis dependency for patients treated with SCD in addition to CKRT, compared to those receiving only CKRT standard care in the control group. Secondary endpoints include mortality at 28 days, ICU-free days in the initial 28 days, major adverse kidney events at Day 90, and dialysis dependency at one year.

The trial addresses hyperinflammation, particularly the cytokine storm, which can lead to multi-organ failure and death due to the excessive production or activity of inflammatory cells. SeaStar Medical's SCD aims to mitigate these risks, offering potential benefits in terms of mortality, ICU-free days, and long-term dialysis dependency.

Source: seastarmedical

 

 

 

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