Tag: Sequana Medical

Sequana Medical completes enrollment in Phase 2a SAHARA I DSR study, reports disease-modifying profile for Short Term DSR and provides business update

DSR (Direct Sodium Removal) heart failure drug development: Completed enrollment in SAHARA Ii with first-generation DSR product (“DSR 1.0”) – extending study with second-generation DSR product (“DSR 2.0”) to support US INDii filing by year end Proof-of-concept delivered in diuretic-resistant heart failure patients with dramatic and durable improvements in validated clinical measures Heart […]

Sequana Medical announces 2021 Full Year Results and 2022 Outlook

alfapump® in liver disease Positive results from second interim analysis of POSEIDON pivotal study; encouraging survival data at 12 months vs. published literature Patient enrolment and implants completed; primary endpoint on track for Q4 2022 FDA regulatory submission planned for mid-2023 DSR® in heart failure RED DESERT study demonstrated safety, cardio-renal benefit and […]

Sequana Medical receives MDSAP certification and expands its Quality Management System towards North America

Ghent, Belgium – 3 November 2021 – Sequana Medical NV (Euronext Brussels: SEQUA, the “Company”), an innovator in the treatment of diuretic-resistant fluid overload in liver disease, malignant ascites and heart failure, today announces it has received Medical Device Single Audit Program (MDSAP) certification from […]