Sequana Medical announces positive outcome of Day 100 meeting with FDA regarding PMA application for alfapump®

Sequana Medical, a pioneer in the treatment of fluid overload in liver disease, heart failure and cancer, today announces the agreed outcome of the “Day 100” meeting with the US Food and Drug Administration (FDA), following receipt of the “Day 90” major deficiency Letter. 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 accepted for substantive review on 29 January 2024. Following a review of this application by the FDA, the Company received a “Day 90” major deficiency letter and a “Day 100” meeting was held with FDA to align on key findings. The FDA confirmed completion of the substantive review and no further new questions on the clinical study or the pre-clinical data, unless related to the Company’s response to the “Day 90” Letter. The FDA had a number of non-clinical questions that require additional work and the Company currently anticipates to submit this additional information by the end of September 2024. In light of the FDA’s feedback and the rapidly evolving cybersecurity environment, the Company intends to exclude RPMS/DirectLink (the software for remote uploading of performance data from the alfapump) from the PMA application and the initial alfapump commercialisation, and to submit a next-generation version in a PMA supplement post-approval.

The Company now forecasts FDA approval before the end of Q1 2025, with no change to the planned US commercial launch in H2 2025. The Company continues to evaluate its financing options to achieve FDA approval and prepare for commercial launch of the alfapump.

Timur Resch, Global Vice President QM/QA/RA at Sequana Medical, commented: “The receipt of the PMA Day 90 letter and completion of the Day 100 meeting is another huge milestone for Sequana, and reflects the significant amount of work by the team for the preparation of the marketing application. We appreciate the positive interaction with the FDA and believe that the outstanding questions are manageable. We intend to complete these activities in time for a response to the FDA by the end of Q3 this year.”

Ian Crosbie, Chief Executive Officer of Sequana Medical, commented: “We are very pleased with the progress of our alfapump PMA application and grateful for the collaborative nature of discussions with the FDA for our breakthrough device. The completion of the substantive review and confirmation there will be no further new questions related to the clinical study data or pre-clinical data, unless related to our responses, is a very important event for us, providing clarity on the approval path forward and derisking the alfapump program. We look forward to addressing the remaining questions from FDA and anticipate approval before the end of Q1 2025.”