Sequana Medical announces FDA acceptance for substantive review of the Premarket Approval application for alfapump® in recurrent or refractory ascites due to liver cirrhosis
Sequana Medical NV, 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.”
For more information, please contact:
Sequana Medical
Lies Vanneste
Director Investor Relations
E: IR@sequanamedical.com
T: +32 (0)498 053579
About alfapump in recurrent or refractory ascites due to liver cirrhosis
Recurrent or refractory ascites is a severe condition characterized by the accumulation of fluid in the abdomen. The current standard treatment involves therapeutic paracentesis, an invasive and burdensome procedure that drains ascites from the abdomen using a large needle over an extended period. If approved by the FDA, the alfapump could become the first active implantable medical device in the US that automatically and continuously removes ascites from the abdomen into the bladder, where it is naturally eliminated through urination.
The PMA application submitted to the US FDA was based on the successful execution of Sequana Medical’s pivotal POSEIDON study, a landmark study across 18 centers in the US and Canada with a total of 69 patients implanted with the alfapump. The primary effectiveness endpoints at six months post-implantation in the Pivotal Cohorti exceeded the predefined thresholds with statistical significance, and primary safety endpoint data was in line with expectationsii. Data at 12 months post-implantation continued to show a strong and durable clinical profile, virtually eliminating the need for therapeutic paracentesis and delivering a clinically meaningful improvement in patients’ quality of lifeiii.
Data from the patient preference study and a matched cohort analysis of the NACSELDiv registry with the POSEIDON Pivotal Cohort indicated that US patients have a strong preference for the alfapump vs standard paracentesis procedures and that the safety profile of the alfapump is comparable to standard of care.
The North American market of recurrent and refractory ascites due to liver cirrhosis is forecast to grow 6-7% per year, from 78,000 patients in 2025, reaching a market opportunity for alfapump of over $2.5 billion by 2035, with NASH being the major driver of growthv. To date, over 1,000 alfapump systems have been implanted.