Disclaimer

The alfapump® system is currently not approved in the United States or Canada. In the United States and Canada, the alfapump® system is currently under clinical investigation (POSEIDON Study) and is being studied in adult patients with refractory or recurrent ascites due to cirrhosis. DSR® therapy is still in development and it should be noted that any statements regarding safety and efficacy arise from ongoing pre-clinical and clinical investigations which have yet to be completed. There is no link between the DSR® therapy and ongoing investigations with the alfapump® system in Europe, the United States or Canada.

Press releases

Strong data from DSR® proof-of-concept studies in heart failure accepted for late-breaking presentation at THT 2024

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...

Sequana Medical announces FDA acceptance for substantive review of the Premarket Approval application for alfapump® in recurrent or refractory ascites due to liver cirrhosis

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...

Transparency Notifications from Shareholders

PRESS RELEASE Regulated information 24 January 2024, 06:00 pm CET Ghent, Belgium – 24 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 transparency notifications from the shareholders listed below,...

Sequana Medical announces DSMB approval to start randomized MOJAVE cohort – US Phase 1/2a study of DSR® 2.0 for treatment of heart failure

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...

Transparency Notifications from Shareholders

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...

Sequana Medical granted US CPT® III reimbursement codes for alfapump® system

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...

Sequana Medical submits Premarket Approval application to US FDA for alfapump® in recurrent or refractory ascites due to liver cirrhosis

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...

Sequana Medical announces positive data from non-randomized cohort in US Phase 1/2a MOJAVE study of DSR® 2.0 for treatment of heart failure

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...

Sequana Medical announces results of Extraordinary General Meeting of Shareholders

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...

Sequana Medical announces additional alfapump data supporting strong and durable clinical profile; PMA on track for year-end submission

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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