Sequana Medical Reports Positive Long-term Data for Alfapump in Treating Ascites

One-year follow-up data from POSEIDON study

Patients maintained a 100% median reduction in therapeutic paracentesis in the 7-12 month post-implant period compared to the three months pre-implant, demonstrating the alfapump's sustained effect on controlling ascites. The safety profile remained robust, with stable renal function indicated by creatine and eGFR levels over 12 months. Quality of life measures showed clinically meaningful improvement at 12 months post-implant, despite disease progression. The survival trend was positive, with a Kaplan-Meier estimate indicating over 70% survival probability at 12 and 18 months post-implant.

Outcome Patient Preference study

A patient preference study conducted by RTI Health Solutions revealed that US patients with recurrent or refractory ascites due to liver cirrhosis have a strong preference for the alfapump over regular paracentesis procedures. Patients were willing to accept higher risks for improvements in treatment efficacy, supporting the alfapump as a desirable treatment option.

Matched interim analysis of NACSELD registry and POSEIDON pivotal cohort

A matched cohort analysis comparing outcomes of decompensated cirrhosis patients from the NACSELD-III registry to those from the POSEIDON study showed similar rates of all-cause hospitalization and death within six months. This analysis reaffirms the alfapump's safety profile as comparable to standard paracentesis procedures.

Sequana Medical is on track to submit a Pre-Market Approval (PMA) application with the FDA by year-end, following a positive pre-PMA meeting to align on clinical data and benefit-risk analysis for the submission package.