Sequana Medical NV announced 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.

Positivetop-line data from 40 patients in the Pivotal Cohort: Forty patients with recurrent or refractory ascites due to liver cirrhosis have been implanted with the alfapump in the Pivotal Cohort of the POSEIDON study. Over one third of these patients had NASH or combined NASH etiology. The primary effectiveness endpoint hypotheses include: 1) median per-patient ratio of post-implant three-month observation period (month four to six) (“Post-Implant Observation Period”) to the pre-implant three-month observation period (“Pre-Implant Observation Period”) with respect to number of therapeutic paracentesis (“TP”) is less than 0.5 (or a median reduction of at least 50%); and 2) at least 50% of patients achieve a 50% reduction in the requirement for TP in the same period.

Of the 40 patients implanted with the alfapump in the Pivotal Cohort, 26 patients completed alfapump therapy through day 180 post-implantation. These 26 patients have a median reduction of 100% (mean reduction of 93%) in frequency of TP in the Post-Implant Observation Period vs Pre-Implant Observation Period and 92% of patients have at least a 50% reduction in number of TP in the same periodiii. Pre-specified imputation methods were used to calculate the primary effectiveness endpoints in the other 14 patients that had exited the study prior to completing the six months post-implantation period.

Of these 14 patients, eight were due to reasons such as death or withdrawal due to unrelated adverse event or for liver transplant and six were due to alfapump system, procedure or therapy related reasons. The primary safety endpoint is the combined rate of i) open surgical re-intervention (requiring general anesthesia or laparotomy) due to pump system related adverse event or to restore pump functionality, ii) pump explant (without replacement) due to pump system related adverse event, or iii) pump system related death from time of pump implant through six months post-implantation as adjudicated by the Clinical Events Committee (CEC). There were six primary safety events in the 40 Pivotal Cohort patients, which is in line with Company expectations.

Of the six primary safety events, three were explants due to wound or skin erosion, and three were explants due to patient-reported discomfort (all patient-reported discomfort events were adjudicated by the CEC as moderate severity). At the time of the primary endpoint analysis, no unanticipated adverse device effects (UADEiv) occurred during the course of the POSEIDON study.