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367,956 Results for "sequana medical".
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Sequana Medical announces data on alfapump® safety and quality of life to be presented at EASL Congress 2024
Sequana Medical NV announces data from its North American pivotal POSEIDON study of the alfapump® demonstrating significantly improved quality of life focused on ascites symptoms and physical functions compared to baseline, which is not seen in refractory ascites patients enrolled contemporaneously in the prospective NACSELD3 cohort.
June 6, 2024
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8 min read
Policy
Press news: Sequana Medical announces positive outcome of Day 100 meeting with FDA regarding PMA application for alfapump®
Sequana Medical NV, a pioneer in the treatment of fluid overload in liver disease, heart failure and cancer, announces the agreed outcome of the “Day 100” meetingi with the US Food and Drug Administration, following receipt of the “Day 90” major deficiency Letter.
May 22, 2024
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8 min read
Business
Sequana Medical announces 2023 Full Year Results and 2024 Outlook
Sequana Medical NV, a pioneer in the treatment of fluid overload in liver disease, heart failure and cancer, announces its financial results for the year ended 31 December 2023, and provides a business update and outlook for 2024 and beyond.
March 28, 2024
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21 min read
Sequana Medical granted US CPT® III reimbursement codes for alfapump® system
Sequana Medical NV announces that the American Medical Association has issued six new Category III Current Procedural Terminology codes for the alfapump system, an important step in facilitating reimbursement for the Company’s innovative medical device for the treatment of recurrent or refractory ascites due to liver cirrhosis.
January 3, 2024
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7 min read
Sequana Medical announces results of Extraordinary General Meeting of Shareholders - November 10, 2023
Sequana Medical NV announces that all proposed resolutions submitted to the Extraordinary General Meeting of Shareholders were approved at the meeting held today at 09:00 am CET.
November 10, 2023
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5 min read
Policy
Sequana Medical submits Premarket Approval application to US FDA for alfapump® in recurrent or refractory ascites due to liver cirrhosis
Sequana Medical NV announces that it has submitted a Premarket Approval application to the US Food and Drug Administration for alfapump, the Company’s fully implantable, wirelessly charged device for patients with recurrent or refractory ascites due to liver cirrhosis.
December 28, 2023
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11 min read
Drug Development
Sequana Medical announces DSMB approval to start randomized MOJAVE cohort – US Phase 1/2a study of DSR® 2.0 for treatment of heart failure
Sequana Medical NV announces that an independent Data and Safety Monitoring Board approved the start of the randomized cohort in MOJAVE, the US Phase 1/2a study of DSR 2.0 for treatment of patients with diuretic-resistant heart failure, following review of the safety data reported from the non-randomized cohort.
January 23, 2024
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10 min read
Sequana Medical announces additional alfapump data supporting strong and durable clinical profile; PMA on track for year-end submission
Conference call with live webcast by Sequana Medical today at 03:00 pm CEST / 09:00 am EST
October 19, 2023
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11 min read
Sequana Medical Notice of 2023 Half-year Results and Business Update
Sequana Medical NV, 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.
September 6, 2023
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3 min read
Sequana Medical announces H1 2023 results and provides business update
Sequana Medical NV, a pioneer in the treatment of fluid overload in liver disease, heart failure and cancer, announces its business highlights and financial results for the six-month period ending 30 June 2023 and its outlook for the remainder of the year.
September 14, 2023
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17 min read
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