Disclaimer

The alfapump® system is not currently 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. For more information regarding the POSEIDON clinical study see www.poseidonstudy.com.
The 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.
The DSR® therapy is not currently approved for clinical research in the United States or Canada. There is no link between the DSR® therapy and ongoing investigations with the alfapump® system in Europe.

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Regulated
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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PRESS RELEASE REGULATED INFORMATION 27 May 2022, 06:00 pm CEST   Ghent, Belgium – 27 May 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, today announces that all proposed resolutions submitted to the...
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PRESS RELEASE REGULATED INFORMATION 27 April 2022, 07:00 am CEST   Publication of Annual Report 2021 Ghent, Belgium – 27 April 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, today invites the holders...
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PRESS RELEASE REGULATED INFORMATION 12 April 2022, 07:00 CET   alfapump® in liver disease Positive results from second interim analysis of POSEIDON pivotal study; encouraging survival data at 12 months vs. published literature Patient enrolment and implants completed; primary endpoint on track for Q4 2022 FDA regulatory submission planned for mid-2023 DSR® in heart failure...
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PRESS RELEASE Regulated information 28 March 2022, 6 p.m. CET   Ghent, Belgium – 28 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 received a transparency notification from...
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PRESS RELEASE Regulated information 18 March 2022, 6 p.m. CET   Ghent, Belgium – 18 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 received transparency notifications from the...
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