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

Loading...
Loading...
  • 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
Market News and Data brought to you by Benzinga APIs
Comments
Loading...
Posted In: NewsPenny StocksHealth CareContractsMoversTrading IdeasGeneralBriefspremarket tradingwhy it's moving
Benzinga simplifies the market for smarter investing

Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.

Join Now: Free!

Loading...