news
-
25 October 2022Sequana Medical announces positive top-line results from the North American pivotal alfapump® study (POSEIDON)
Sequana Medical NV (Euronext Brussels: SEQUA, the “Company” or “Sequana Medical”), a pioneer in the treatment of drug-resistant fluid overload in liver disease, heart failure and cancer, today announces positive top-line results from the North American pivotal POSEIDON study of the alfapump, a fully implantable, wirelessly charged, breakthrough device for the treatment of recurrent or refractory ascites due to liver cirrhosis. Data from 40 patients implanted with the alfapump in the Pivotal Cohort met all primary effectiveness endpoints of the study with statistical significance and primary safety endpoint data was in line with expectations. These positive data will enable the Company to file a Pre-Market Approval (PMA) application with the FDA, planned for H2 2023, intended to support the approval of the alfapump in the US.
Professor Florence Wong, University of Toronto, Hepatologist at Toronto General Hospital, Ontario, Canada and Principal Investigator for the POSEIDON study, commented: “Ascites imposes a significant health care burden and negative impact on quality of life for this large and growing patient population of patients with liver cirrhosis. 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. The safety data regarding the primary safety endpoint are in line with expectations and reassuring for the potential of the alfapump as a long-term treatment in this patient population. I look forward to presenting these data at a scientific congress in due course to discuss this important innovation for a patient population that is in clear need of expanded treatment options.”
Ian Crosbie, Chief Executive Officer at Sequana Medical, added: “We are delighted with these excellent results, and the team is focused on bringing the alfapump to this large and growing patient population. We are grateful to the patients, clinicians and their teams who participated in this landmark study. 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 commercialize the alfapump through our focused commercial team.”
Related
Sequana Medical announces H1 2022 results and provides business update
Alexandra Clyde appointed to Sequana Medical Board of Directors
Sequana Medical secures EUR 10 million loan facility with Kreos Capital
Sequana Medical announces new Share Capital Amount and New Number of Shares
Sequana Medical receives certification under MDR, the new European Medical Device Regulation
Sequana Medical announces H1 2021 results and provides business update
Sequana Medical appoints Jackie Fielding, former Medtronic VP, to its Board of Directors
Sequana Medical announces first patient enrolled in SAHARA DESERT
Sequana Medical announces 2020 Full Year Results and 2021 Outlook
Sequana Medical announces granting of key alfapump DSR® patents in U.S. and Europe
Sequana Medical announces H1 2020 results and provides business update
Sequana Medical announces €7.3 million debt financing and provides clinical update
Sequana Medical announces 2019 Full Year Results and 2020 Outlook
Sequana Medical announces new share capital amount and new number of shares
Sequana Medical announces 2019 Half Year Results and Year-to-date Business Update
Sequana Medical appoints leading experts as Heart Failure Scientific Advisors
Sequana Medical to host webcast on 27 May 2019
Sequana Medical announces 2018 Full Year Results and 2019 Outlook
Sequana Medical raises €27.5 million in successful Initial Public Offering
Sequana Medical Announces Publication of Results of Multicentre Randomized Controlled Study
Sequana Medical Announces Results of the MOSAIC trial data presented at 2017 AASLD
Sequana Medical Announces Sudden Passing of Founder, President & CEO
Ian Crosbie Joins Sequana Medical as Chief Financial Officer
Sequana Medical has been selected as a finalist for the 2012 MEDTEC EMDT Innovation Awards
Sequana Medical receives CE Mark Approval for the ALFApumpTM System and adds key executive to team
NovaShunt announces the launch of its new corporate identity: Sequana Medical