Brief: Sequana Medical Announces Positive Top-Line Results From The North American Pivotal Alfapump® Study (POSEIDON)

Sequana Medical NV

25/10/2022 07:20

Oct 25 (Reuters) - Sequana Medical NV  SEQUA.BR :
    * SEQUANA MEDICAL ANNOUNCES POSITIVE TOP-LINE RESULTS FROM
THE
NORTH AMERICAN PIVOTAL ALFAPUMP® STUDY (POSEIDON)
    * ON TRACK TO FILE PRE-MARKET APPROVAL (PMA) APPLICATION
WITH FDA
IN H2 2023
    * ALFAPUMP PRIMARY SAFETY ENDPOINT DATAIN LINE WITH
EXPECTATIONS
    * ALFAPUMP ACHIEVES PRE-SPECIFIED PRIMARY EFFECTIVENESS
ENDPOINTS
WITH STATISTICAL SIGNIFICANCE AT SIX MONTHS POST-IMPLANTATION
    * 100% MEDIAN PER-PATIENT REDUCTION IN THERAPEUTIC
PARACENTESIS
(TP) POST- VERSUS PRE-IMPLANTATION(P<0.001)
    * 77% OF PATIENTS WITH AT LEAST 50% REDUCTION IN NUMBER OF
TP
POST- VERSUS PRE-IMPLANTATION(P<0.001)

Source text for Eikon:  ID:nGNE4THZRn 
Further company coverage:  SEQUA.BR 
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