Sequana Medical announces FDA acceptance for substantive review of the Premarket Approval application for alfapump® in recurrent or refractory ascites due to liver cirrhosis
PRESS RELEASE
Acceptance and filing review is a first step in the PMA review process
Indicates PMA application is sufficiently complete for in-depth review
Received in advance of anticipated timing
Ghent, Belgium – 29 January 2024 – Sequana Medical NV (Euronext Brussels: SEQUA) (the "Company" or "Sequana Medical"), a pioneer in the treatment of fluid overload in liver disease, heart failure and cancer, today announces that the Premarket Approval (PMA) application for its alfapump has been accepted for substantive review by the US Food and Drug Administration (FDA). The alfapump is the Company’s fully implantable, wirelessly charged device for patients with recurrent or refractory ascites due to liver cirrhosis and received breakthrough device designation from the US FDA in 2019.
The PMA application for the alfapump system, which was based on the successful execution of Sequana Medical’s pivotal POSEIDON study, was submitted with a filing date of 28 December 2023, and is now under substantive review by the FDA. This notification from the FDA was anticipated on 11 February 2024. Pending FDA approval, which the Company anticipates in the second half of 2024, alfapump could become the first active implantable medical device in the US for treating liver ascites.
Timur Resch, Global Vice President QM/QA/RA at Sequana Medical, commented: “The acceptance of our PMA file for substantive review by the FDA is an important milestone that reflects the tremendous efforts of our team. This achievement means that the FDA recognizes the completeness of our application and will now begin an in-depth review. We look forward to working closely with the FDA during the review process, with the ultimate goal of making the alfapump available to US patients as soon as possible.”