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. There is no link between the DSR® therapy and ongoing investigations with the alfapump® system in Europe.

Sequana Medical Notice of 2018 Full Year Results and 2019 Outlook

Ghent, BELGIUM – 28 March 2019 – Sequana Medical NV (Euronext Brussels: SEQUA), a commercial stage medical device company focused on innovative treatment solutions for the management of liver disease, heart failure, malignant ascites and other fluid imbalance disorders, will announce its results for the full year ended 31 December 2018 and outlook for 2019 on Thursday 4 April 2019.


The management team will host a conference call with a live webcast presentation at 14.00 CET / 08:00 ET (U.S.) on the day of the results.

The webcast can be accessed by registering via Sequana Medical’s website, https://www.sequanamedical.com/investors/. To participate in the Q&A, please dial one of the numbers below, using confirmation code 5731205.  The webcast and conference call will be conducted in English and a replay will be available on the Company’s website shortly thereafter.


Belgium:                                           +32 2 789 8603

Switzerland:                                     +41 43 456 9986

The Netherlands:                            +31 20 794 8426

U.K.:                                                  +44 20 3003 2666

U.S.:                                                  +1 866 966 5335



Sequana Medical

Lies Vanneste

Director IR

Tel: +32 (0) 498 05 35 79

Email: IR@sequanamedical.com


Consilium Strategic Communications

Alexandra Harrison, Marieke Vermeersch, Sukaina Virji

Tel: +44 (0) 203 709 5000

Email: sequanamedical@consilium-comms.com


About Sequana Medical

Sequana Medical is a commercial stage medical device company focused on innovative treatment solutions for the management of liver disease, heart failure, malignant ascites and other fluid imbalance disorders.

Sequana Medical’s technology is based on its proprietary alfapump® platform, a fully implantable, programmable, wirelessly-charged, battery-powered system for automatic and continuous removal of fluid from the abdomen, which is applicable across multiple life-threatening disorders. The alfapump is being commercialised in Europe for the management of refractory ascites (chronic fluid build-up in the abdomen) due to liver cirrhosis and malignant ascites. The number of patients with refractory liver ascites is forecast to increase dramatically due to the growing prevalence of NASH (Non-alcoholic Steatohepatitis).

Over 700 alfapump systems have been implanted to date and since April 2018, the alfapump has been included in the EASL (European Association for the Study of the Liver) clinical practice guidelines for decompensated cirrhosis. In January 2019, the FDA has granted Breakthrough Device designation for the alfapump for the treatment of recurrent or refractory liver ascites. The alfapump has not yet received regulatory approval in the U.S. and Canada and the Company expects to start POSEIDON, the North American pivotal study in in the second half of 2019 to support approval of the alfapump in recurrent or refractory liver ascites.

The alfapump is one of the first safe and effective, long-term alternatives to large-volume paracentesis (LVP) for the management of ascites, offering major advantages to patients, clinicians and healthcare systems. By automatically and continuously moving ascites to the bladder, where the body eliminates it naturally through urination, the alfapump prevents fluid build-up and its possible complications, improving patient quality of life and nutrition, and potentially reducing hospital visits and healthcare costs. The alfapump DirectLink technology allows clinicians to receive pump performance information and more effectively manage patients treated by the alfapump.

Sequana Medical is developing the alfapump DSR, built upon the proven alfapump platform, to deliver a convenient and fully implanted system for Direct Sodium Removal (DSR) therapy, a novel and proprietary approach for the management of volume overload in heart failure. A first-in-human study for DSR therapy is ongoing. Treatment of volume overload in diuretic-resistant heart failure patients is a major clinical challenge. There are an estimated one million hospitalisations due to heart failure in the U.S. each year, of which 90% are due to symptoms of volume overload. The estimated cost of heart failure-related hospitalisations in the U.S. is $13 billion a year.

Sequana Medical is headquartered in Ghent, Belgium. For further information, please visit www.sequanamedical.com.


Important Regulatory Disclaimer

Any statement in this press release about safety and efficacy of the alfapump does not apply to the U.S. and Canada because the device is currently undergoing clinical investigation in these territories.


Download the full press release

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