Sequana Medical's alfapump MOSAIC Study Results Published in Liver Transplantation

The MOSAIC study, a North American feasibility study, has demonstrated the utility, safety, and efficacy of the alfapump in the management of patients with recurrent and refractory ascites. Published in Liver Transplantation, the study involved 30 cirrhotic patients not eligible for transjugular intrahepatic portosystemic shunt (TIPS). The findings revealed a significant reduction in the mean large-volume paracentesis (LVP) frequency per patient per month from 2.4 to 0.2, alongside improvements in patients' quality of life and nutritional status.

Prof. Florence Wong, the lead author, emphasized the alfapump system's feasibility for treating recurrent ascites in cirrhosis patients unsuitable for TIPS, particularly those with relatively preserved liver function. Ian Crosbie, CEO of Sequana Medical, highlighted the publication's support for the alfapump's potential to address unmet medical needs in liver cirrhosis, especially with the forecasted growth in liver cirrhosis due to NASH.

The ongoing POSEIDON pivotal study aims to further support the alfapump's commercial marketing application in the U.S. and Canada by evaluating its effectiveness in reducing the frequency of paracentesis in patients with recurrent and refractory ascites due to liver cirrhosis. The study, which began enrolling patients in the second half of 2019, is expected to include up to 50 patients across approximately 20 centres.

Sequana Medical continues to develop the alfapump platform for managing fluid overload in liver disease, malignant ascites, and heart failure, with the alfapump DSR (Direct Sodium Removal) for heart failure currently under investigation. The alfapump has been granted breakthrough device designation by the FDA, underscoring its potential to significantly impact the treatment of severe and underserved medical conditions.