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 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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PRESS RELEASE REGULATED INFORMATION – INSIDE INFORMATION 1 July 2021, 07:00 am CEST   Interim data from 26 patients in the Roll-In Cohort reconfirm positive outcomes against all primary endpoints[i] Over 90% reduction in mean frequency of therapeutic paracentesis versus baseline All patients experienced at least 50% reduction in mean frequency of therapeutic paracentesis per...
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PRESS RELEASE REGULATED INFORMATION – INSIDE INFORMATION 11 May 2021, 07:00 am CEST   RED DESERT data of all patients confirm: alfapump DSR is highly effective at managing fluid and sodium balance in diuretic-resistant heart failure patients without need for loop diuretics restoration of diuretic response and improvement in cardio-renal function improvement in diuretic response...
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Ghent, Belgium, 9 February 2021 – 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 22.5 million in gross proceeds by means of a private placement...
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Ghent, Belgium, 9 February 2021 – 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 17.5 million by means...
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REGULATED INFORMATION – INSIDE INFORMATION 19 November 2020, 08:00 am CET   Results from first 13 patients in Roll-In Cohort showed over 90% reduction in mean frequency of therapeutic paracentesis versus baseline Indication of rapid and persistent clinically relevant improvement in patients’ quality of life Safety profile in line with expectations Interim data of the...
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PRESS RELEASE REGULATED INFORMATION – INSIDE INFORMATION 22 October 2020, 07:00am CET   RED DESERT: Results from first five patients indicate repeated dose alfapump DSR therapy to be safe and effective Interim data support DSR hypothesis: kidneys eliminate free water to maintain patients’ serum sodium levels No patients required loop diuretic therapy during the six-week...
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PRESS RELEASE REGULATED INFORMATION – INSIDE INFORMATION 03 September 2020, 07:00 CEST   POSEIDON – Implants in Canada continue; interim results expected H1 2021 RED DESERT – Implants continue; interim results expected Q4 2020 DSR (Direct Sodium Removal) – Fundamental patents allowed in U.S. and Europe Continued growth in European commercial implants Secured additional funding...
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