Brief: Cytosorbents Provides Update On The Star-T Trial And Reports Final Independent Data And Safety Monitoring Board Recommendation

Cytosorbents

28/12/2023 12:05

Dec 28 (Reuters) - Cytosorbents Corp  CTSO.O :
    * CYTOSORBENTS PROVIDES UPDATE ON THE STAR-T TRIAL AND
REPORTS
FINAL INDEPENDENT DATA AND SAFETY MONITORING BOARD
RECOMMENDATION
    * DSMB ME CONCLUDED THERE WERE NO ISSUES WITH DEVICE SAFETY,
MEETING PRIMARY SAFETY ENDPOINT OF STUDY
    * HAS ALSO PERFORMED INITIAL DATA ANALYSIS ON PRIMARY
EFFECTIVENESS ENDPOINT OF STAR-T.
    * STUDY DID NOT MEET PRIMARY EFFECTIVENESS ENDPOINT IN
OVERALL
PATIENT POPULATION THAT UNDERWENT DIFFERENT TYPES OF CARDIAC
SURGERIES
    * IF ACCEPTED, FULL RESULTS OF STAR-T TRIAL ARE EXPECTED TO
BE
PRESENTED NEXT APRIL 2024 IN ATLANTA
    * STUDY DID DEMONSTRATE EVIDENCE OF REDUCED BLEEDING
COMPLICATIONS
IN PATIENTS IN PRE-SPECIFIED ISOLATED CABG SURGERY POPULATION
    * EXPECTS TO COMPLETE ANALYSIS OF FULL TRIAL RESULTS IN NEXT
SEVERAL WEEKS
    * BELIEVES SAFETY AND EFFECTIVENESS DATA FROM STAR-T MAY
SUPPORT
REGULATORY SUBMISSION OF DRUGSORB-ATR TO U.S. FDA AND HEALTH
CANADA

Source text for Eikon:  ID:nGNX7xY86K 
Further company coverage:  CTSO.O 

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