Orgenesis rises on FDA nod for device trial in COVID-19 patients

Orgenesis

06/05/2021 13:46

** Shares in biopharma co  ORGS.O  up ~14% at $5.11
premarket
    ** ORGS gets Investigational Device Exemption (IDE) approval
from U.S. FDA for pilot clinical trial of its tissue genesis
icellator 
    ** Device to treat acute respiratory distress syndrome
(ARDS) resulting from COVID-19  urn:newsml:reuters.com:*:nGNXb4mwPr
    ** The FDA IDE approval covers 21 patients at one clinical
site in the United States
    ** Orgenesis will monitor and evaluate current clinical
needs prior to initiating this approved pilot trial
    ** Orgenesis may consider amending clinical development plan
to target treatment of non-COVID-19 related ARDS or treatment of
patients who have not recovered from prior COVID-19 infections
    ** Shares down marginally so far this year

 (Reporting by Arundhati Sarkar in Bengaluru)
 ((Arundhati.Sarkar@thomsonreuters.com;
twitter.com/Arundhati_05; +1 646 223 8780 Ext: 2776))