Sequana Medical NV, an innovator in the treatment of diuretic-resistant fluid overload in liver disease, malignant ascites and heart failure, announces that is has received approval from the U.S. Food and Drug Administration (FDA) to expand patient enrolment to 70 (an increase of 10) in the Pivotal Cohort of POSEIDON, the North American pivotal study of the alfapump for the treatment of recurrent or refractory ascites due to liver cirrhosis. This patient enrolment expansion was requested by Sequana Medical to compensate for the higher rate of attrition between study enrolment and alfapump implantation in the Pivotal Cohort, with the objective to reach 50 patients implanted with the alfapump.
To date, 59 patients have been enrolled in the Pivotal Cohort. The Company expects completion of patient enrolment by end of year with primary endpoint read-out in Q4 2022, on time for FDA regulatory submission mid-2023.
Ian Crosbie, Chief Executive Officer at Sequana Medical, commented: "We welcome the approval from the FDA to expand patient recruitment in POSEIDON and look forward to announcing completion of enrolment. We will now resume our efforts to enrol these additional patients, having had to pause these pending this approval. The interim POSEIDON data has produced strong results which indicate the potential of the alfapump to provide an efficacious treatment that can dramatically improve the quality of life for patients with recurrent or refractory liver ascites. We will continue to work diligently to bring the alfapump one step closer to the growing number of patients that need a 21st century treatment for this terrible disease."