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.

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Inside information
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,...
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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...
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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...
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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...
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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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PRESS RELEASE REGULATED INFORMATION – INSIDE INFORMATION 18 October 2023, 07:00 am CEST First two US patients from non-randomized cohort successfully treated with DSR 2.0 Initial data indicate that DSR 2.0 is safe and well tolerated, restores diuretic response and improves cardiorenal status Biomarker analysis from RED DESERT and SAHARA studies supports DSR mechanism of...
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PRESS RELEASE REGULATED INFORMATION – INSIDE INFORMATION 14 September 2023, 07:00 CEST alfapump® – strong pivotal POSEIDON data presented at leading international liver congress / on track to file Pre-Market Approval (PMA) application to US FDA in Q4 2023 DSR® – safety of single dose DSR 2.0 demonstrated / Phase 1/2a US MOJAVE study in...
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PRESS RELEASE REGULATED INFORMATION – INSIDE INFORMATION 21 June 2023, 07:00 am CEST 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...
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SEQUANA MEDICAL SUCCESSFULLY RAISES EUR 15.78 MILLION IN AN EQUITY PLACEMENT Ghent, Belgium, 25 April 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, announces today that it successfully raised an amount of EUR 15.78 million...
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Ghent, Belgium, 24 April 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, announces today the launch of an equity offering to raise an amount of approximately EUR 15 million by means of a private placement...
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