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 15 November 2022, 07:00 am CET   Data from SAHARA with first-generation DSR product (DSR 1.0) confirm: Safe, effective and rapid elimination of persistent congestion following intensive DSR therapy Considerable benefit in cardio-renal status maintained till end of study (16 weeks post-intensive DSR therapy) Dramatic and sustained improvement...
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PRESS RELEASE REGULATED INFORMATION – INSIDE INFORMATION 25 October 2022, 07:00 am CET   alfapump achieves pre-specified primary effectiveness endpoints with statistical significance at six months post-implantation: 100% median per-patient reduction in therapeutic paracentesis (TP) post- vs pre-implantation (p<0.001) 77% of patients with at least 50% reduction in number of TP post- vs pre-implantation (p<0.001)...
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PRESS RELEASE REGULATED INFORMATION – INSIDE INFORMATION 8 September 2022, 07:00 CET   alfapump® – strong interim data / on track to report primary endpoint data of North American pivotal POSEIDON study in Q4 2022 DSR® – clinical evidence of disease-modifying heart failure drug therapy / preparations ongoing to start US phase 1b/2a MOJAVE study...
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PRESS RELEASE REGULATED INFORMATION – INSIDE INFORMATION 20 July 2022, 07:00 CET   Company’s cash runway extended into Q3 2023 Ghent, Belgium – 20 July 2022 – Sequana Medical NV (Euronext Brussels: SEQUA) (the “Company” or “Sequana Medical“), a pioneer in the treatment of drug-resistant fluid overload in liver disease and heart failure, today announces...
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PRESS RELEASE REGULATED INFORMATION – INSIDE INFORMATION 19 July 2022, 07:00 am CEsT   DSR (Direct Sodium Removal) heart failure drug development: Completed enrollment in SAHARA I[i] with first-generation DSR product (“DSR 1.0”) – extending study with second-generation DSR product (“DSR 2.0”) to support US IND[ii] filing by year end Proof-of-concept delivered in diuretic-resistant heart...
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Ghent, Belgium, 8 March 2022 – Sequana Medical NV (Euronext Brussels: SEQUA) (the “Company” or “Sequana Medical“), an innovator in the treatment of diuretic-resistant fluid overload in liver disease, malignant ascites and heart failure, announces today that it successfully raised an amount of EUR 28.4 million in gross proceeds by means of a private placement...
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Ghent, Belgium, 7 March 2022 – Sequana Medical NV (Euronext Brussels: SEQUA) (the “Company” or “Sequana Medical“), an innovator in the treatment of diuretic-resistant fluid overload in liver disease, malignant ascites and heart failure, announces today the launch of an equity offering to raise an amount of approximately up to EUR 28 million by means...
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PRESS RELEASE REGULATED INFORMATION – INSIDE INFORMATION 7 December 2021, 07:00 am CET   Interim data from six patients indicate that alfapump DSR therapy can: safely, effectively and rapidly eliminate persistent congestion and restore euvolemia in diuretic-resistant heart failure patients, considerably benefit cardio-renal status, and dramatically improve diuretic responsiveness for months post-treatment Recruitment on-track to...
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PRESS RELEASE REGULATED INFORMATION – INSIDE INFORMATION 4 October 2021, 07:00 CET   Completion of patient enrolment expected before end of year Primary endpoint read-out due in Q4 2022 59 patients already recruited in the Pivotal Cohort Ghent, Belgium – 4 October 2021 – Sequana Medical NV (Euronext Brussels: SEQUA, the “Company”), an innovator in...
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PRESS RELEASE REGULATED INFORMATION – INSIDE INFORMATION 2 September 2021, 07:00 CET   alfapump® – Positive results from second interim analysis of POSEIDON pivotal study; awaiting FDA approval on POSEIDON pivotal study expansion alfapump® – FDA regulatory submission now expected in mid-2023 due to worldwide supply shortage of electronic components; European commercial activities and clinical...
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