Friday June 16th 2023

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Sequana Medical NV (Euronext Brussels: SEQUA) (the "Company" or "Sequana Medical"), a pioneer in the treatment of fluid overload in liver disease, heart failure and cancer, today announces that its alfapump has won the ‘Best Technology’ Award at the European Mediscience Awards in London last night.

The European Mediscience Awards event is the largest annual gathering of private and publicly quoted healthcare, biotech and life sciences companies in Europe. Bringing together the best of European mediscience companies to celebrate achievement and recognise success, its awards are hotly contested.

Ian Crosbie, Chief Executive Officer of Sequana Medical, commented: “We developed the alfapump to transform the lives of patients with recurrent or refractory ascites due to liver cirrhosis – a rapidly growing patient population due to NASH / NAFLD epidemic. Our objective is to replace the standard of care that has changed little in over 2,000 years and deliver improved clinical outcomes, quality of life and cost savings. The recognition of this work by our industry peers is a tremendous accolade for the Sequana team and celebrates all the hard work that has gone into developing this transformational device.”

About the alfapump

Sequana Medical’s alfapump is a fully implantable, wirelessly charged device which continuously collects ascites as it forms in the abdominal cavity and moves it into the bladder, where it is naturally passed from the body through urination. In Europe, the alfapump has received CE mark-approval for the treatment of refractory ascites due to liver cirrhosis and malignant ascites and has been included in key European treatment guidelines. In the US, the Company’s key growth market, the alfapump has been granted breakthrough device designation by the Food and Drug Administration (FDA) for the treatment of recurrent or refractory ascites due to liver cirrhosis. The POSEIDON study, intended to support the approval of the alfapump in North America, reported strong top-line results meeting all primary efficacy endpoints with statistical significance and safety in line with expectations. Filing of the Pre-Market Approval (PMA) application with the US FDA is planned for H2 2023. Sequana Medical plans to commercialize the alfapump directly in the US, using a specialized in-house sales force targeting 90 liver transplant centers (covering 95% of adult liver transplants). The North American market for the alfapump is forecast to grow at a Compound Annual Growth Rate (CAGR) of 6-7%, from over 75,000 patients in 2025, reaching a market opportunity of over $2.5 billion by 2035, with NASH being the major driver of growth.