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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PERSBERICHT NIET-GEREGLEMENTEERDE INFORMATIE 18 november 2024, 07:00 am CET De alfapump was zeer effectief bij het onder controle houden van ascites, waardoor de noodzaak voor groot-volume paracentesis  (‘Large Volume Paracentesis’ of ‘LVP’) op lange termijn vrijwel geëlimineerd werd POSEIDON-onderzoekers melden dat alfapump een veilig en effectief hulpmiddel is voor patiënten die langer dan zes maanden...
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Comparison of POSEIDON Pivotal Cohort vs. NACSELD-III Supports Strong Commercial Messaging for alfapump Poster presentation by Dr. Jasmohan S. Bajaj on 7 June 2024 Ghent, Belgium – 10 April 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...
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Serial Direct Sodium Removal in Patients with Heart Failure and Diuretic Resistance Ghent, Belgium – 3 April 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, today announces that the results from two proof-of-concept studies, RED...
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MOJAVE – US Phase 1/2a study of DSR 2.0 for treatment of heart failure Previously reported strong data maintained after three-months follow-up:Diuretic response remained nearly normalized, with a mean increase of 326% in six-hour urinary sodium excretion vs baseline All three patients remained on no or low dose loop diuretics, with a reduction of at...
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Presentation by Key Opinion Leader Dr. Testani on Wednesday, March 6th 2024 Ghent, Belgium – 28 February 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, today announces that the late-breaking abstract including data from the...
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PRESS RELEASE Acceptance and filing review is a first step in the PMA review process Indicates PMA application is sufficiently complete for in-depth review Received in advance of anticipated timing Ghent, Belgium – 29 January 2024 – Sequana Medical NV (Euronext Brussels: SEQUA) (the “Company” or “Sequana Medical“), a pioneer in the treatment of fluid...
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PRESS RELEASE Strengthens US reimbursement position Builds upon PMA application submitted to the US FDA on 27 December 2023 Ghent, Belgium – 03 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, today announces that...
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Ghent, Belgium – 6 September 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, will announce its half-year results ended 30 June 2023 on Thursday, 14 September 2023. The management team will host a conference call...
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US study seeking to confirm strong efficacy data reported in RED DESERT and SAHARA Initial data expected in Q4 2023 Ghent, Belgium – 10 July 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...
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Extensive real world alfapump experience derisks planned US & Canadian launch Strong clinical alfapump profile demonstrated in North American POSEIDON study All approvals received to commence US MOJAVE study of DSR 2.0 Ghent, Belgium – 06 July 2023 – Sequana Medical NV (Euronext Brussels: SEQUA) (the “Company” or “Sequana Medical“), a pioneer in the treatment...
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