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 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...

Sequana Medical announces results of Annual General Meeting of Shareholders

Experienced MedTech Executive Jason Hannon appointed as Non-Executive Director Ghent, BELGIUM – 23 May 2019 (18:00 CEST) – Sequana Medical NV (Euronext Brussels: SEQUA), a commercial stage medical device company focused on the development of innovative treatment solutions for the management of liver disease, heart failure, malignant ascites and other fluid imbalance disorders, announces today...

Sequana Medical to host webcast on 27 May 2019

Company to discuss late-breaking abstract of DSR therapy for volume overload in heart failure presented at the Heart Failure 2019 Congress Ghent, BELGIUM – 21 May 2019 – Sequana Medical NV (Euronext Brussels: SEQUA), a commercial stage medical device company focused on the development of innovative treatment solutions for the management of liver disease, heart...

Sequana Medical announces inclusion of alfapump® in German treatment guidelines (DGVS) for complications of liver cirrhosis

Further validation builds on U.S. FDA[1] Breakthrough Device status and inclusion in U.K. NICE[2] recommendations and EASL[3] guidelines   Ghent, BELGIUM – 15 May 2019 – Sequana Medical NV (Euronext Brussels: SEQUA), a commercial stage medical device company focused on the development of innovative treatment solutions for the management of liver disease, heart failure, malignant...

Sequana Medical announces acceptance of late-breaking abstract of DSR therapy for volume overload in heart failure at Heart Failure 2019 Congress

Ghent, BELGIUM – 30 April 2019 – Sequana Medical NV (Euronext Brussels: SEQUA), a commercial stage medical device company focused on the development of innovative treatment solutions for the management of liver disease, heart failure, malignant ascites and other fluid imbalance disorders, today announces that results from the first-in-human single dose DSR (Direct Sodium Removal)...
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