PRESS RELEASE REGULATED INFORMATION – INSIDE INFORMATION 2 December 2024, 08:00 a.m. CET Ghent, Belgium – 2 December 2024 – Sequana Medical NV (Euronext Brussels: SEQUA) (the “Company” or “Sequana Medical”), a pioneer in the treatment of fluid overload in liver disease, heart failure and cancer, provides an update on the Convertible Bridge Loan previously...Read More
alfapump® – US FDA approval anticipated Q1 2025 and US launch planned for H2 2025; Strong progress with US reimbursement – CPT III codes issued & NTAP Application filed DSR® – Publication of RED DESERT and SAHARA data in peer-reviewed “European Journal of Heart Failure” highlights potential as treatment for Cardiorenal Syndrome; Positive data from...Read More
PRESS RELEASE REGULATED INFORMATION – INSIDE INFORMATION 22 MAY 2024, 07:00 CEST Positive and collaborative meeting with FDA PMA substantive review complete; No further new questions on clinical or pre-clinical data FDA Advisory Panel no longer expected FDA Marketing Approval now anticipated in Q1 2025 Planned US commercial launch remains H2 2025 Ghent, Belgium –...Read More
PRESS RELEASE REGULATED INFORMATION – INSIDE INFORMATION 28 March 2024, 08:00 a.m. CET alfapump® – PMA[1] submitted to US FDA and accepted for substantive review, extensive feedback just received from FDA which is currently under review by the Company DSR® – potential treatment for cardiorenal syndrome in heart failure presented at international heart failure conference,...Read More
PRESS RELEASE REGULATED INFORMATION – INSIDE INFORMATION 23 January 2024, 07:00 am CET DSMB[i] rates DSR 2.0 as safe following review of data from non-randomized cohort Data from non-randomized cohort confirms dramatic improvement in diuretic response and at least 95% reduction in loop diuretic requirements up to almost four months after last DSR therapy First...Read More
PRESS RELEASE REGULATED INFORMATION – INSIDE INFORMATION 28 December 2023, 07:00 am CET Pending FDA approval, alfapump could become the first active implantable medical device in the US for treating liver ascites Ghent, Belgium – 28 December 2023 – Sequana Medical NV (Euronext Brussels: SEQUA) (the “Company” or “Sequana Medical“), a pioneer in the treatment...Read More
PRESS RELEASE REGULATED INFORMATION – INSIDE INFORMATION 29 November 2023, 07:00 am CET Data from all three patients in non-randomized cohort treated with DSR 2.0 indicatesafe and effective maintenance of euvolemia without the need for loop diuretics,considerable benefit in cardiorenal status and dramatic improvement in diuretic response and loop diuretic requirements up to 11 weeks...Read More
PRESS RELEASE REGULATED INFORMATION – INSIDE INFORMATION 19 October 2023, 07:00 am CEST One-year alfapump data from POSEIDON shows safety and strong efficacy profile is maintained at 12 months Patient preference study indicates that US patients have a strong preference for the alfapump vs large volume paracentesis[i] Matched interim analysis of patients from NACSELD[ii] registry...Read More
PRESS RELEASE REGULATED INFORMATION – INSIDE INFORMATION 18 October 2023, 07:00 am CEST First two US patients from non-randomized cohort successfully treated with DSR 2.0 Initial data indicate that DSR 2.0 is safe and well tolerated, restores diuretic response and improves cardiorenal status Biomarker analysis from RED DESERT and SAHARA studies supports DSR mechanism of...Read More
PRESS RELEASE REGULATED INFORMATION – INSIDE INFORMATION 14 September 2023, 07:00 CEST alfapump® – strong pivotal POSEIDON data presented at leading international liver congress / on track to file Pre-Market Approval (PMA) application to US FDA in Q4 2023 DSR® – safety of single dose DSR 2.0 demonstrated / Phase 1/2a US MOJAVE study in...Read More
