POSEIDON STUDY

This is a single-arm, open-label, within subject crossover study of the alfapump^® in patients with recurrent or refractory ascites due to liver cirrhosis in centres across the U.S. and Canada. All patients have been enrolled in the study and implanted with the alfapump^®. Pivotal Cohort patients entered into a 3-month pre-implant observation period in which they received standard of care therapy (consisting of paracentesis) before the alfapump^® was implanted. Of the 71 patients enrolled in the Pivotal Cohort, 40 patients have been implanted with the alfapump^®. The study allowed for additional patients to be enrolled in a Roll-In Cohort, to ensure centres were experienced with the alfapump^® implantation prior to enrolment in the Pivotal Cohort. Finally, 29 patients from the Roll-In Cohort have been implanted with the alfapump^®.

The primary effectiveness outcomes of the study include the proportion of patients with a 50% reduction in therapeutic paracentesis in the post-implant observation period (month four to month six after implantation) as compared to the pre-implant observation period. The primary safety endpoint is the rate of alfapump^® related re-interventions adjudicated by the Clinical Events Committee. Patients will be followed for up to two years for analysis of secondary outcome measurements including safety (device and/or procedure-related adverse events), quality of life (assessed by general SF-36 as well as disease-specific Ascites-Q questionnaires), patients’ nutritional status, health economics and overall survival. For more information about the study, please visit clinicaltrials.gov (NCT03973866).

• One-year follow-up data from POSEIDON Pivotal Cohort: Press release on 19 October 2023
• Additional results POSEIDON Pivotal Cohort presented at EASL 2023: Webcast by Sequana Medical on 21 June 2023
• Top-line results POSEIDON Pivotal Cohort: Webcast by Sequana Medical on 25 October 2022
• Interim results POSEIDON Roll-In Cohort: Webcast by Sequana Medical on 1 July 2021

ARIA pump STUDY

This is a prospective, multi-centre, open-label, randomised, health-economic study in France to evaluate the cost utility of the alfapump® versus standard of care in 90 patients with liver refractory ascites, 60 patients not waiting for liver transplant and 30 patients as bridge to transplant, over 12 months. The goal of the study is to support French reimbursement. The study is funded by the French government and being conducted and sponsored by leading French clinicians (NCT03506893).

TOPMOST REGISTRY

This is a European registry to collect data from prospectively enrolled patients that have been implanted with the alfapump^® across commerical centres in Europe. The registry is supported by key opinion leaders and will assess the adverse event profile of the alfapump^® following the technical improvements in product design and care protocols, as well as the effectiveness in real world circumstances. Patients are being enrolled on a continual basis and interim readouts will take place at regular time points.