SeaStar jumps as FDA gives approvable letter for firm's Selective Cytopheretic Device

SeaStar Medical Holding

30/10/2023 15:53

** Shares of medtech company SeaStar Medical Holding  ICU.O 
rise 6.75% to $1.08 
    ** Co says U.S. FDA's Center for Biologics Evaluation and
Research (CBER) has issued an Approvable Letter for the
company's proprietary Selective Cytopheretic Device (SCD) for
use in pediatric patients
    ** Expects to commence commercialization of the SCD by the
end of 2023 or the first quarter of 2024 - Co
    ** The FDA issues approvable letters when it classifies a
device as approvable pending additional information.
    ** Including session's move, shares are down ~71.5% YTD 

 (Reporting by Jaiveer Singh Shekhawat in Bengaluru)
 ((JaiveerSingh.Shekhawat@thomsonreuters.com;))