- alfapump achieves pre-specified primary effectiveness endpoints with statistical significance at six months post-implantation:
- 100% median per-patient reduction in therapeutic paracentesis (TP) post- vs pre-implantation (p<0.001)
- 77% of patients with at least 50% reduction in number of TP post- vs pre-implantation (p<0.001)
- alfapump primary safety endpoint data in line with expectations
- On track to file Pre-Market Approval (PMA) application with FDA in H2 2023
- Third party market analysis estimates prevalence of recurrent or refractory liver ascites in North America at over 60,000 patients in 2022, growing at six to seven percent annually
- Management to attend AASLD The Liver Meeting® from November 4 – 6 in Washington, DC
Ghent, Belgium – 25 October 2022 – Sequana Medical NV (Euronext Brussels: SEQUA, the “Company” or “Sequana Medical”), a pioneer in the treatment of drug-resistant fluid overload in liver disease, heart failure and cancer, today announces 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.