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 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 – 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 – 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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PRESS RELEASE REGULATED INFORMATION – INSIDE INFORMATION 21 June 2023, 07:00 am CEST Data presented at EASL Congress 2023 alfapump was effective in the control of ascites, virtually eliminating needle paracentesis Safety in line with expectations – particularly given disease progression in these patients – six primary safety events and limited number of key secondary...
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SEQUANA MEDICAL SUCCESSFULLY RAISES EUR 15.78 MILLION IN AN EQUITY PLACEMENT Ghent, Belgium, 25 April 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 today that it successfully raised an amount of EUR 15.78 million...
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Ghent, Belgium, 24 April 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 today the launch of an equity offering to raise an amount of approximately EUR 15 million by means of a private placement...
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PRESS RELEASE REGULATED INFORMATION – INSIDE INFORMATION 15 November 2022, 07:00 am CET   Data from SAHARA with first-generation DSR product (DSR 1.0) confirm: Safe, effective and rapid elimination of persistent congestion following intensive DSR therapy Considerable benefit in cardio-renal status maintained till end of study (16 weeks post-intensive DSR therapy) Dramatic and sustained improvement...
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PRESS RELEASE REGULATED INFORMATION – INSIDE INFORMATION 25 October 2022, 07:00 am CET   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- vs pre-implantation (p<0.001) 77% of patients with at least 50% reduction in number of TP post- vs pre-implantation (p<0.001)...
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PRESS RELEASE REGULATED INFORMATION – INSIDE INFORMATION 8 September 2022, 07:00 CET   alfapump® – strong interim data / on track to report primary endpoint data of North American pivotal POSEIDON study in Q4 2022 DSR® – clinical evidence of disease-modifying heart failure drug therapy / preparations ongoing to start US phase 1b/2a MOJAVE study...
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