Sequana Medical Announces US FDA Approval of alfapump® for the Treatment of Recurrent or Refractory Ascites due to Liver Cirrhosis
- alfapump® is the first US approved active implantable medical device (Class III) for the treatment of recurrent or refractory ascites due to liver cirrhosis
- PMA Approval and FDA Breakthrough Device Designation
- US market opportunity estimated at over $2 billion in 2025, growing at 9%[1] due to MASH/NASH[2] and alcoholic liver disease
- US commercial launch planned for H2 2025 through speciality salesforce targeting liver transplant centers
- POSEIDON pivotal study shows virtual elimination of therapeutic paracentesis and improvement in quality of life[3][4]
- Over 1,000 alfapump Systems implanted
KOL webcast January 8th, 2025 at 15:00 CET / 09:00 am EST
Ghent, Belgium – 23 December 2024 – 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 that it has received Premarket Approval (PMA) from the US Food and Drug Administration (FDA) to market alfapump® for the treatment of recurrent or refractory ascites due to liver cirrhosis in the United States. With this major regulatory milestone, achieved earlier than market expectations, alfapump is the first active implantable medical device in the US that automatically and continuously removes ascites from the abdomen into the bladder. The Company estimates there will be approximately 70,000 patients in the US with recurrent or refractory ascites, representing a market opportunity in excess of $2 billion for the alfapump in 2025. This population is forecast to reach 130,000 patients by 2032, primarily driven by NASH/MASH and alcoholic liver disease[1].
