Sequana Medical has reported positive top-line data from the North American pivotal POSEIDON study of the alfapump system.
The open-label, single-arm, within-subject crossover study is being conducted in patients diagnosed with refractory or recurrent ascites caused due to liver cirrhosis.
It is being carried out in nearly 20 centres in Canada and the US.
The findings, obtained from 40 participants implanted with the alfapump system in the Pivotal Cohort, showed that all the study’s primary effectiveness endpoints were achieved.
The trial found that participants had a 100% median per-patient reduction in the frequency of therapeutic paracentesis (TP) after implantation compared to pre-implantation.
Nearly 77% of patients had at least a 50% TP reduction after implantation compared to pre-implantation.
The company stated that the positive data from the POSEIDON study will enable it to file an application with the US Food and Drug Administration (FDA) for Pre-Market Approval (PMA) of the alfapump system.
The PMA application is planned to be submitted in the first half of next year.
Sequana Medical CEO Ian Crosbie said: “The third-party market assessment highlights the large number of recurrent or refractory liver ascites patients, with strong forecast growth driven in part by the Non-Alcoholic Steatohepatitis (NASH) epidemic.
“We believe that there is a clear need for improved treatment options for this important patient group, and we are preparing to commercialise the alfapump through our focused commercial team.”
The alfapump system is a fully implantable, wirelessly charged, breakthrough device that is designed to treat recurrent or refractory ascites caused due to liver cirrhosis.
The device collects ascites as it forms and moves it to the bladder, where it is passed naturally from the body through urination.
Further secondary efficacy and safety endpoints of the POSEIDON study are currently being investigated, with detailed results anticipated to be submitted for presentation next year.