SeaStar, Nuwellis up on regulatory update for kidney injury treatment device

Conavi Medical

10/10/2023 14:02

** Shares of Med-tech co SeaStar Medical Holding Corp
 ICU.O  up about 4.5% to $0.49 premarket 
    ** Co's distribution partner Nuwellis Inc  NUWE.O  reports
that ICU received correspondence from the U.S. FDA for its
kidney injury treatment device
    ** ICU's medical device performs extracorporeal therapy to
treat acute kidney injury (AKI) in children 
    ** Correspondence indicates that the agency considers ICU's
device to be approvable for use in children weighing 10
kilograms or more with AKI and sepsis 
    ** An approvable letter is expected to be issued within a
month outlining conditions required for formal marketing
approval 
    ** Medical device maker NUWE entered into a pact with ICU
last year to market and distribute the device
    ** NUWE stock up 1.6% to $1.3 premarket
    ** As of last close, NUWE and ICU stock down ~88% YTD

 (Reporting by Pratik Jain in Bengaluru)
 ((Pratik.Jain@thomsonreuters.com;))