Sequana Medical NV (Euronext Brussels: SEQUA, the “Company” or “Sequana Medical”), a pioneer in the treatment of drug-resistant fluid overload in liver disease, heart failure and cancer, today announces positive top-line results from the North American pivotal POSEIDON study of the alfapump, a fully implantable, wirelessly charged, breakthrough device for the treatment of recurrent or refractory ascites due to liver cirrhosis. Data from 40 patients implanted with the alfapump in the Pivotal Cohort met all primary effectiveness endpoints of the study with statistical significance and primary safety endpoint data was in line with expectations. These positive data will enable the Company to file a Pre-Market Approval (PMA) application with the FDA, planned for H2 2023, intended to support the approval of the alfapump in the US.

Professor Florence Wong, University of Toronto, Hepatologist at Toronto General Hospital, Ontario, Canada and Principal Investigator for the POSEIDON study, commented: “Ascites imposes a significant health care burden and negative impact on quality of life for this large and growing patient population of patients with liver cirrhosis. These positive top-line results are very encouraging, indicating that the alfapump could provide great benefits to patients with cirrhosis and ascites, and dramatically reduce their visits to the hospital for paracentesis. The safety data regarding the primary safety endpoint are in line with expectations and reassuring for the potential of the alfapump as a long-term treatment in this patient population. I look forward to presenting these data at a scientific congress in due course to discuss this important innovation for a patient population that is in clear need of expanded treatment options.”

Ian Crosbie, Chief Executive Officer at Sequana Medical, added: “We are delighted with these excellent results, and the team is focused on bringing the alfapump to this large and growing patient population. We are grateful to the patients, clinicians and their teams who participated in this landmark study. The third party market assessment highlights the large number of recurrent or refractory liver ascites patients, with strong forecast growth driven in part by the Non-Alcoholic Steatohepatitis (“NASH”) epidemic. We believe that there is a clear need for improved treatment options for this important patient group, and we are preparing to commercialize the alfapump through our focused commercial team.”

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