Sequana Medical NV announced positive top-line results from its North American pivotal POSEIDON study, evaluating the alfapump system for treating recurrent or refractory ascites due to liver cirrhosis. The study met all primary effectiveness endpoints with statistical significance, demonstrating a substantial reduction in the need for therapeutic paracentesis. These results pave the way for a planned Pre-Market Approval (PMA) application to the FDA in the second half of 2023.
The POSEIDON study, a single-arm, open-label, within-subject crossover trial, enrolled 40 patients in its Pivotal Cohort across approximately 20 centers in the US and Canada. Participants had recurrent or refractory ascites due to liver cirrhosis.
Key Findings on Ascites Reduction
The primary effectiveness endpoints focused on the frequency of therapeutic paracentesis (TP). The results showed:
- A 100% median per-patient reduction in TP frequency during the three-month post-implant observation period (months four to six) compared to the pre-implant period (p<0.001).
- 77% of patients achieved at least a 50% reduction in TP frequency during the same period (p<0.001).
Specifically, among the 26 patients who completed alfapump therapy through day 180 post-implantation, the median reduction in TP frequency was 100% (mean reduction of 93%), with 92% experiencing at least a 50% reduction.
Safety Profile
The primary safety endpoint, a composite of open surgical re-intervention, pump explant, or pump system-related death, was in line with company expectations. There were six primary safety events among the 40 patients. Three explants were due to wound or skin erosion, and three were due to patient-reported discomfort, all adjudicated as moderate severity by the Clinical Events Committee (CEC).
Expert Commentary
Professor Florence Wong, University of Toronto and Principal Investigator, stated, "These positive top-line results are very encouraging, indicating that the alfapump could provide great benefits to patients with cirrhosis and ascites, and dramatically reduce their visits to the hospital for paracentesis."
Market Opportunity
According to a third-party market analysis, the prevalence of recurrent or refractory liver ascites in North America is estimated at over 60,000 patients in 2022, growing at 6-7% annually, driven in part by the Non-Alcoholic Steatohepatitis (NASH) epidemic.
About the Alfapump
The alfapump is a fully implantable, wirelessly charged device designed to automatically remove ascites fluid as it accumulates, diverting it to the bladder for natural elimination through urination. This reduces the need for repeated paracentesis procedures, improving patient quality of life.
Sequana Medical plans to present detailed results from the POSEIDON study at a future medical liver meeting in 2023.
