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

Sequana Medical announces 2023 Full Year Results and 2024 Outlook

PRESS RELEASE REGULATED INFORMATION – INSIDE INFORMATION 28 March 2024, 08:00 a.m. CET alfapump® – PMA[1] submitted to US FDA and accepted for substantive review, extensive feedback just received from FDA which is currently under review by the Company DSR® – potential treatment for cardiorenal syndrome in heart failure presented at international heart failure conference,...

SEQUANA MEDICAL ANNOUNCES NEW SHARE CAPITAL AMOUNT AND NEW NUMBER OF SHARES

PRESS RELEASE REGULATED INFORMATION 26 March 2024, 07:00 a.m. CET Ghent, Belgium, 26 March 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 in the context of the private placement of new shares...

Sequana Medical announces three month follow-up data from MOJAVE non-randomized cohort confirming dramatic improvement in diuretic response and virtual elimination of loop diuretics following DSR® therapy

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...

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...
1 2 3 17

Subscribe to our Press Releases

    PRESS RELEASES

    SUBSCRIBE TO OUR PRESS RELEASES