Disclaimer

Het alfapump®-systeem is momenteel niet goedgekeurd in de Verenigde Staten of Canada. In de Verenigde Staten en Canada wordt het alfapump®-systeem momenteel klinisch onderzocht (POSEIDON-studie) en wordt het bestudeerd bij volwassen patiënten met refractaire of terugkerende ascites als gevolg van levercirrose. DSR®-therapie is nog in ontwikkeling en er dient te worden opgemerkt dat eventuele verklaringen met betrekking tot veiligheid en efficiëntie voortkomen uit lopende preklinische en klinische onderzoeken die nog moeten worden afgerond. Er is geen verband tussen de DSR®-therapie en de lopende onderzoeken met het alfapump®-systeem in Europa, de Verenigde Staten of Canada.

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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...
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PRESS RELEASE Regulated information 15 January 2024, 06:00 pm CET Ghent, Belgium – 15 January 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, announces today that it received a transparency notification from the shareholders listed...
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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...
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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...
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PRESS RELEASE REGULATED INFORMATION 10 November 2023, 06:00 pm CET Ids van der Weij appointed as non-executive director Ghent, Belgium – 10 November 2023 – 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, today announces that all...
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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...
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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...
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PRESS RELEASE REGULATED INFORMATION 06 October 2023, 07:00 am CEST Ghent, Belgium – 06 October 2023 – 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, today invites the holders of securities issued by the Company to attend...
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PRESS RELEASE REGULATED INFORMATION 4 October 2023, 06:00 pm CEST Ghent, Belgium, 4 October 2023 – 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, announces that, in the framework of the “restricted share unit” or “RSU” plan...
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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...
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