Sequana Medical NV announced positive 24-month results from its POSEIDON study of the alfapump system in patients with recurrent and refractory ascites due to liver cirrhosis. The data, presented at The Liver Meeting of the American Association for the Study of Liver Diseases (AASLD) in San Diego, California, demonstrate the device's long-term efficacy in ascites management and its potential to reduce the need for frequent paracentesis.
The POSEIDON study, a single-arm, open-label, within-subject crossover trial, evaluated the alfapump in approximately 20 centers across the US and Canada. The study included a Pivotal Cohort for primary endpoint analysis and a Roll-In Cohort for new centers. The 24-month data indicated that the alfapump system effectively controlled ascites, virtually eliminating the need for large volume paracentesis (LVP) long term. Specifically, the frequency of LVP requirement in the roll-in cohort decreased by more than 50% from pre-implantation to 3 months post-implant and persisted to 24 months (mean LVP/month 2.7±1.3 to 0.1±0.2). Ascites volume removed by LVP fell from 22.8 ±12.5L/month pre- to 2.6± 6 L/month 3 months post-alfapump system implant. Overall survival at 24 months in the alfapump pivotal cohort was 62%.
Clinical Insights
Dr. H.E. Vargas, M.D., Professor of Medicine for the Mayo Clinic College of Medicine, presented the poster and commented, "The alfapump system was very effective in control of ascites, virtually eliminating the need for LVP long term, up to 24 months. However, close monitoring is needed for the development of AKI (Acute Kidney Injury) or infection, which must be treated promptly to prevent adverse outcomes. Data from the roll-in cohort provides evidence the alfapump can work well in circumstances close to clinical practice. For patients requiring refractory ascites management for more than 6 months, the alfapump is a safe and effective tool."
Management Perspective
Ian Crosbie, Chief Executive Officer of Sequana Medical NV, stated, "We are delighted with the two year results from the POSEIDON study confirming the long term benefits to alfapump patients, particularly the virtual elimination of large volume paracentesis, which has such a devastating impact on the life of these patients. Overall survival of over 60% at two years in the pivotal cohort compares very favourably to the published literature and we will continue to explore this further. We are pleased with the constructive and positive ongoing discussions with the FDA to address the remaining topics of our PMA application. We continue to plan for PMA approval before the end of Q1 2025 and US commercial launch in H2 2025, delivering a step change in the treatment options available to these patients."
Regulatory and Market Outlook
The Premarket Approval (PMA) application for the alfapump was submitted to the US FDA in December 2023 and accepted for substantive review in January 2024. Sequana Medical anticipates US market approval before the end of Q1 2025, with a commercial launch planned for H2 2025. The North American market for recurrent and refractory ascites due to liver cirrhosis is projected to grow at an average of 9% per year, reaching approximately 147,000 patients by 2032, driven primarily by the increasing prevalence of NASH/MASH. The total market opportunity for alfapump is estimated at $2.4 billion in 2025.
About the alfapump
The alfapump is an active implantable medical device designed to automatically and continuously remove ascites from the abdomen into the bladder, where it is naturally eliminated through urination. If approved, it would be the first device of its kind in the US. The PMA application was based on the POSEIDON study, which enrolled 69 patients across 18 centers in the US and Canada. The study met its primary effectiveness endpoints at six months post-implantation, with statistically significant reductions in the need for therapeutic paracentesis.
