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.

Sequana Medical Notice of 2019 Full Year Results and 2020 Outlook

Ghent, BELGIUM – 12 March 2020 – Sequana Medical NV (Euronext Brussels: SEQUA), an innovator in the management of fluid overload in liver disease, malignant ascites and heart failure, will announce its results for the full year ended 31 December 2019 and outlook for 2020 on Thursday 19 March 2020.

The management team will host a conference call with a live webcast presentation at 14.00 CET / 09:00 ET on the day of the results.

The webcast can be accessed by registering via the investors homepage of the Sequana Medical website or by clicking here. To participate in the Q&A, please dial one of the numbers below, using confirmation code 9932969.  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 2 792 0434

The Netherlands:                            +31 20 794 8426

Switzerland:                                     +41 43 456 9986

UK:                                                     +44 20 3003 2666

U.S.:                                                   +1 212 999 6659

 

For more information, please contact:

Sequana Medical

Lies Vanneste, Director IR

Tel: +32 498 05 35 79

Email: IR@sequanamedical.com

 

Consilium Strategic Communications

Amber Fennell, Marieke Vermeersch, Sukaina Virji, Melissa Gardiner

Tel: +44 203 709 5000

Email: sequanamedical@consilium-comms.com

 

LifeSci Advisors

Chris Maggos

Tel: +41 79 367 6254

Email: chris@lifesciadvisors.com

 

About Sequana Medical

Sequana Medical is a commercial stage medical device company developing the alfapump® platform for the management of fluid overload in liver disease, malignant ascites and heart failure. Fluid overload is a fastgrowing complication of advanced liver disease driven by NASH (non-alcoholic steatohepatitis) related cirrhosis and a common complication in heart failure. The U.S. market for the alfapump resulting from NASH-related cirrhosis is forecast to exceed €3 billion annually within the next 10-20 years. The heart failure market for the alfapump DSR (Direct Sodium Removal) is estimated to be over €5 billion annually in the U.S. and EU5 by 2026. Both indications leverage Sequana Medical’s alfapump, a unique, fully implanted wireless device that automatically pumps fluid from the abdomen into the bladder, where it is naturally eliminated through urination.

In the U.S., the company’s key growth market, the alfapump has been granted breakthrough device designation by the FDA. The North American pivotal study (POSEIDON) in recurrent and refractory ascites due to liver cirrhosis is underway, with interim results expected in H2 2020, and a commercial launch in the U.S. is planned for H1 2022. In Europe, the alfapump is CE-marked for the management of refractory ascites due to liver cirrhosis and malignant ascites and is included in key clinical practice guidelines. Over 750 alfapump systems have been implanted to date. Building on its proven alfapump platform, Sequana Medical is developing alfapump DSR, a breakthrough, proprietary approach to fluid overload due to heart failure. Clinical proof-of-concept was achieved in a first-in-human single dose DSR study and a repeated dose alfapump DSR study (RED DESERT) in heart failure patients is underway with results expected in Q2 and Q3 2020.

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

 

Important Regulatory Disclaimers

The alfapump has not yet received regulatory approval in the U.S. and Canada. 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. DSR therapy and alfapump DSR are still in development and it should be noted that any statements in this press release regarding safety and efficacy arise from pre-clinical studies and ongoing clinical investigations which have yet to be completed. There is no link between DSR therapy, alfapump DSR and ongoing investigations with the alfapump system in Europe, the U.S. and Canada.

 

Download the full press release  

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