FDA Approves SCD Therapy for Pediatric Acute Kidney Injury
What happened
SeaStar Medical Holding Corporation received FDA approval for its Selective Cytopheretic Device (SCD) therapy, commercialized as QUELIMMUNE®, for pediatric patients with acute kidney injury (AKI). The company stated that the therapy was successfully developed in clinical trials of pediatric patients with severe AKI. Concurrently, SeaStar announced that Dr. Humes, a U-M faculty member, was being awarded the Distinguished University Innovator of the Year award for his pioneering work in the SCD therapy.
From manilatimes.net
Why it matters
The approval establishes the first and only FDA-approved therapy for this specific indication. The technology neutralizes over-active immune cells and aims to stop the cytokine storm that can lead to organ failure. SeaStar Medical's development pipeline suggests potential for additional indications.
The therapy was already adopted by Texas Children’s Hospital for patients with Acute Kidney Injury (AKI).
From manilatimes.net
Who's involved
- University of MichiganThe institution where the pioneering research leading to the therapy was conducted.
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The entities involved
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University of Michigan
public research university in Ann Arbor, Michigan