Belgium-based Sequana Medical has completed the 1,000th implant of its alfapump device for ascites treatment, with the company now shifting its focus to its imminent US MOJAVE study in congestive heart failure patients.
Sequana Medical’s implantable device collects fluid build-up and moves it to the bladder to be eliminated through urination. Though CE-marked, the company is aiming to secure approval in North America and Canada. In June, the company released positive results from its POSEIDON study demonstrating safety and significant clinical improvement.
Sequana Medical will use results from the pivotal North American trial (NCT03973866) to support pre-market approval (PMA) application submission to the US Food and Drug Administration (FDA) later this year.
Sequana Medical CEO Ian Crosbie commented: “We believe that the data recently presented at the EASL Liver meeting demonstrates the potential for alfapump to transform patient lives – virtually eliminating needle paracentesis and delivering clinically important improvement in patient quality of life.”
“We look forward to submitting our pre-market approval to the US FDA later this year and are preparing for the commercial launch of the alfapump in North America through our own speciality salesforce.”
The medical device company also announced it expects to enrol the first patient in its US MOJAVE study imminently after the FDA granted an investigational new drug (IND) application for its direct sodium removal (DSR) therapy in May.
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The company will investigate its second-generation DSR therapy in patients with congestive heart failure. The therapy aims to treat fluid overload which often presents in patients with heart failure.
Data from the randomised, controlled Phase I/IIa study is expected by the end of 2023.
In a May statement, Crosbie said: “For the estimated 200,000 diuretic-resistant congestive heart failure patients in the US, there is an urgent need for new therapies that can safely and effectively eliminate congestion, reduce repeated hospitalisation and improve clinical outcomes.”
“Following the strong safety and efficacy data reported from our RED DESERT and SAHARA proof-of-concept studies, we believe that our DSR therapy has the potential to be a disease-modifying heart failure therapy.”