Sequana Medical NV (Euronext Brussels: SEQUA, the “Company” or “Sequana Medical”), an innovator in the treatment of diuretic-resistant fluid overload in liver disease, malignant ascites and heart failure, today announces the completion of patient enrolment in POSEIDON, the North American pivotal study to support regulatory approval of the alfapump system in the U.S. and Canada, for the treatment of recurrent or refractory ascites due to liver cirrhosis.

70 patients have been enrolled in the Pivotal Cohort, with the objective to implant up to 50 patients with the alfapump by the end of Q1 2022 and to evaluate up to 40 patients for the primary endpoint six months post-implantation. Reporting of the primary endpoint is planned for Q4 2022. A further 40 patients were enrolled in the Roll-In Cohort and implanted with the alfapump.

Ian Crosbie, Chief Executive Officer of Sequana Medical, commented: “Completing the patient enrolment in our POSEIDON study is an important step in bringing the alfapump closer to market approval in the U.S. and Canada. We are grateful to the patients and the clinicians involved in this study. They are allowing us to evaluate the alfapump as a potential treatment option for recurrent or refractory ascites due to liver cirrhosis, which is a growing healthcare problem due to the dramatic rise in non-alcoholic steatohepatitis (NASH). The positive interim results reported in July 2021 demonstrated that the alfapump brings great benefits, including a reduction of more than 90% in the rate of therapeutic paracentesis and clinically important improvements in quality of life. We look forward to reporting the primary endpoint data in Q4 2022, followed by Premarket Approval (PMA) submission to the FDA in mid-2023.”

Summary of the 2nd Interim Analysis reported in July 2021

In July 2021, the Company reported the second interim analysis on 26 patients from the Roll-In Cohort (underlying etiology: 50% alcohol, 23% non-alcoholic steatohepatitis (NASH), 4% NASH-alcohol, 4% hepatitis and 19% other/mixed etiology) implanted with the alfapump. The results of this analysis substantially exceeded the primary endpoints as defined for the Pivotal Cohort in the study and demonstrated (i) over 90% reduction in mean frequency of therapeutic paracentesis (TP) versus baseline, (ii) all patients having at least a 50% reduction in mean frequency of TP per month versus baseline, (iii) clinically important improvement in quality of life maintained even up to 12 months post-implantation and (iv) safety profile in line with expectations.