SeaStar Medical, Nuwellis Ink US Licensing Pact For Acute Kidney Injury Device For Pediatric Patients

  • 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.
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