- Nuwellis Inc NUWE has announced an exclusive U.S. license and distribution agreement for SeaStar Medical Holding Corporation's ICU Selective Cytopheretic Device (SCD) for acute kidney injury (AKI) in children.
- Nuwellis will market and distribute the SCD through its direct salesforce.
- SeaStar Medical expects the FDA to complete a substantive review of a Humanitarian Device Exemption (HDE) for the use of SCD in children (>20 kg) with AKI during Q1 of 2023, with a potential commercial introduction in Q2 of 2023.
- SCD is a cell-directed extracorporeal therapy that selectively targets the most activated pro-inflammatory neutrophils and monocytes to stop the cytokine storm that frequently causes organ failure and possible death in critically ill patients.
- Also see: Nuwellis Touts Data Supporting Lower Heart Failure Hospitalizations & Readmissions With Aquadex.
- Clinical studies have demonstrated SCD's potential to eliminate dialysis dependency, shorten ICU time and restore the lives of critically ill patients.
- Each year in the U.S., approximately 4,000 children with AKI require CKRT. The mortality rate in children with AKI requiring CKRT is approximately 50%.
- Price Action: NUWE shares are up 36.42% at $12.51, and ICU shares are up 33.33% at $5.24 during the premarket session on the last check Thursday.
- Photo Via Company
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