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.

Press releases

Sequana Medical announces new share capital amount and new number of shares

Regulated Information Ghent, Belgium, 29 January 2020 – Sequana Medical NV (Euronext Brussels: SEQUA) (the “Company” or “Sequana Medical“), an innovator in the management of fluid overload in liver disease, malignant ascites and heart failure, announces, in accordance with Article 15 of the Belgian Act of 2 May 2007 on the disclosure of major participations...

Sequana Medical announces first-in-human data of Direct Sodium Removal (DSR) therapy published in Circulation

Positive pre-clinical and clinical proof-of-concept data of Sequana Medical’s innovative DSR therapy published in top tier peer-reviewed cardiovascular journal Data demonstrates potential for treatment of volume overload due to heart failure   Ghent, BELGIUM – 10 January 2020 – Sequana Medical NV (Euronext Brussels: SEQUA), an innovator in the management of fluid overload in liver...

Sequana Medical announces first patient enrolled in RED DESERT – REpeated Dose alfapump® DSR study for Treatment of diuretic-resistant heart failure patients

  The study aims to: Evaluate the safety of alfapump DSR in patients with heart failure Assess the feasibility of alfapump DSR to remove excess sodium and fluid from the body Explore the potential impact of DSR therapy to restore response to diuretics Ghent, BELGIUM – 7 January 2020 – Sequana Medical NV (Euronext Brussels:...

Sequana Medical announces 2019 Half Year Results and Year-to-date Business Update

Regulated information   Continued strong progress since IPO in February 2019: Commenced POSEIDON pivotal study to support approval of the alfapump® in the U.S. & Canada Achieved clinical proof-of-concept of Direct Sodium Removal (DSR), potential breakthrough therapy for volume overload due to heart failure Conference call with live webcast presentation today at 14:00 CET /...

Sequana Medical announces first patient enrolled in North American alfapump® pivotal study (POSEIDON)

Study aims to support the approval of the alfapump in U.S. and Canada Results anticipated by mid-2021 U.S. launch of the alfapump planned for H1 2022   Ghent, BELGIUM – 25 September 2019 – Sequana Medical NV (Euronext Brussels: SEQUA), innovators in the management of fluid overload in liver disease, malignant ascites and heart failure,...

Sequana Medical appoints leading experts as Heart Failure Scientific Advisors

Dr. Butler, Dr. Costanzo, Dr. Tang and Dr. Testani to advise on alfapump® DSR development   Ghent, BELGIUM – 19 September 2019 – Sequana Medical NV (Euronext Brussels: SEQUA), innovators in the management of fluid overload in liver disease, malignant ascites and heart failure, today announces the appointments of Dr. Javed Butler, Dr. Maria Rosa...

Sequana Medical to attend upcoming scientific conferences

Presentations on alfapump® and alfapump DSR at DGVS and TCT   Ghent, BELGIUM – 12 September 2019 – Sequana Medical NV (Euronext Brussels: SEQUA), innovators in the management of fluid overload in liver disease, malignant ascites and heart failure, today announces that it will be attending the following upcoming scientific conferences: HFSA 23rd Annual Scientific...

Sequana Medical announces date change for Half Year 2019 Business Update and Financial Results

Results and conference call with live webcast will take place on 25 September 2019   Ghent, BELGIUM – 14 August 2019 – Sequana Medical NV (Euronext Brussels: SEQUA), innovators in the management of fluid overload in liver disease, malignant ascites and heart failure, announces today that it has changed the date of its Half Year...

Sequana Medical announces unconditional IDE approval from U.S. FDA to start alfapump® pivotal study (POSEIDON)

REGULATED INFORMATION – INSIDE INFORMATION alfapump pivotal study for treatment of recurrent or refractory ascites due to liver cirrhosis Optimised clinical trial design of up to 50 patients implanted with alfapump in study cohort and shorter follow-up time for primary endpoint analysis Planned U.S. launch of alfapump moved forward to H1 2022 Proposed rule of...

Sequana Medical announces presentation of positive DSR clinical proof-of-concept data demonstrating potential in volume overload due to heart failure

REGULATED INFORMATION – INSIDE INFORMATION First-in-human single dose DSR study meets primary and secondary endpoints Direct Sodium Removal (DSR) was safe & well-tolerated Substantially higher sodium removal with DSR vs standard Peritoneal Dialysis (PD) solution Consistent results between treated patients First clinical study of repeated dose DSR with alfapump® (alfapump DSR) planned to commence in...
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