Brief: Sequana Completes alfapump Implantations In POSEIDON

Sequana Medical NV

05/04/2022 06:05

April 5 (Reuters) - SEQUANA MEDICAL NV  SEQUA.BR :
    * SEQUANA MEDICAL ANNOUNCES THE COMPLETION OF ALFAPUMP
IMPLANTATIONS IN POSEIDON, THE NORTH AMERICAN PIVOTAL ALFAPUMP
STUDY
    * REPORTING OF PRIMARY ENDPOINT ON TRACK FOR Q4 2022
    * FDA REGULATORY SUBMISSION ON TRACK FOR MID-2023
    * 70% SURVIVAL OF POSEIDON ROLL-IN PATIENTS AT ONE YEAR
POST-IMPLANTATION(1) COMPARES FAVOURABLY TO PUBLISHED LITERATURE
IN THIS HIGH-RISK PATIENT POPULATION
    * FOR OUR SAFETY EVALUATION, WE ARE INCLUDING DATA FROM
ROLL-IN
PATIENTS WHICH WILL BRING TOTAL NUMBER IN THAT ASSESSMENT TO
APPROXIMATELY 70
    * WE ARE CONFIDENT THAT THESE IMPLANTED PATIENTS IN PIVOTAL
COHORT
WILL GIVE US SUFFICIENT STATISTICAL POWER FOR PRIMARY EFFICACY
ENDPOINT

Source text for Eikon:  ID:nGNE970XLg 
Further company coverage:  SEQUA.BR 

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