Tag Archive for: alfapump

Sequana Medical Announces US FDA Approval of alfapump® for the Treatment of Recurrent or Refractory Ascites due to Liver Cirrhosis

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alfapump® is the first US approved active implantable medical device (Class III) for the treatment of recurrent or refractory ascites due to liver cirrhosis PMA Approval and FDA Breakthrough Device Designation US market opportunity estimated at over $2 billion in 2025, growing at 9%[1] due to MASH/NASH[2] and alcoholic liver disease US commercial launch planned for H2 2025 […]

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Sequana Medical – 1,000th alfapump® implant completed

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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 of fluid overload in liver disease, […]

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Sequana Medical announces additional data on safety, quality of life and survival from North American pivotal alfapump® study (POSEIDON)

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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 safety events Clinically meaningful and statistically significant improvement in patients’ quality of life […]

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Sequana Medical wins Best Technology Award for alfapump® at European Mediscience Awards

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Ghent, Belgium – 16 June 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 its alfapump has won the ‘Best Technology’ Award at the European Mediscience Awards in London last night. Read more…

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Sequana Medical announces 2022 Full Year Results and 2023 Outlook

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alfapump® – successful primary endpoint read-out of North American pivotal POSEIDON study / PMA[1] filing planned for H2 2023 DSR® (Direct Sodium Removal) – clinical evidence of disease-modifying heart failure drug therapy, on track to start US Phase 1/2a MOJAVE study in Q2 2023 Total cash position of €18.9 million at end 2022 and cash runway […]

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