Sequana Medical NV (Euronext Brussels: SEQUA), innovators in the management of fluid overload in liver disease, malignant ascites and heart failure, today announces that the first patient has been enrolled in the North American pivotal study (POSEIDON) of the alfapump for the treatment of recurrent and refractory ascites due to liver cirrhosis. The POSEIDON study intends to support marketing approval and reimbursement of the alfapump in the U.S. and Canada.

The POSEIDON study is a single-arm, open-label study and is expected to include up to 50 patients to be implanted with the alfapump in approximately 15 centres across the U.S. and Canada for primary endpoint analysis. The primary effectiveness outcome of the study will include the proportion of patients with a 50% reduction in overall average frequency of paracentesis per month post-implantation versus pre-implantation. This endpoint will be evaluated at nine months after enrolment. Patients will be followed for up to two years after implantation for analysis of secondary outcome measurements.

Top-line results from the study are anticipated in mid-2021 and, taking into account the Breakthrough Device Designation of the alfapump granted by the U.S. FDA in January of this year, the Company expects to launch the alfapump in the U.S. in the first half of 2022.

Professor Florence Wong at the University of Toronto, Hepatologist at Toronto General Hospital, Ontario, Canada and Principal Investigator in the POSEIDON study, commented: “The medical community in North America is becoming increasingly aware of other treatment options for patients with cirrhosis complicated by recurrent or refractory ascites, rather than accepting large volume paracentesis as the only treatment option. The alfapump has a proven track record in Europe, where it is already being used commercially, and we believe this technology has the potential to address this difficult-to-treat condition in these patients and significantly improve their quality of life.”

Ian Crosbie, Chief Executive Officer at Sequana Medical, added: “The start of the POSEIDON study is another important milestone for Sequana Medical and the next step in bringing the alfapump as a treatment option to patients in North America. We believe there is significant growth potential in this growing and dynamic market where we anticipate the alfapump will have a stronger competitive position due to the increasing prevalence of NASH-related cirrhosis and the inconveniences posed by the current standard of care. We look forward to reporting further progress of the study and expect patient recruitment to be completed by mid-2020 with top-line results anticipated by mid-2021.”