Company Profile
Sequana Medical NV is a Belgium-based manufacturer of implantable therapeutic devices for fluid overload management, headquartered in Ghent, Belgium. Founded in 2006, the publicly traded company is listed on the Euronext Brussels (SEQUA) since 11 February 2019 and employs 48 people. Sequana Medical is led by CEO Ian Crosbie, CFO Kirsten Van Bockstaele, and CCO Martijn Blom, pioneering automated ascites removal technology for patients with liver cirrhosis, heart failure, and malignant ascites.
Core Products ＆ Technologies
alfapump® System
• Active Implantable Pump: Battery-powered implantable pump system that automatically and continuously moves ascites fluid from the abdominal cavity into the bladder, where it is eliminated through normal urination
• CE Marked: CE-marked for the management of refractory ascites due to liver cirrhosis and malignant ascites
• FDA PMA Approved: First and only US-approved active implantable medical device (Class III) for recurrent or refractory ascites due to liver cirrhosis; approved December 2024 with Breakthrough Device Designation granted in 2019
• CMS Reimbursement: New Technology Add-on Payment (NTAP) approved September 2025, effective October 1, 2025, providing up to USD 21,450 per inpatient procedure
• Clinical Evidence: POSEIDON pivotal study across 18 US and Canadian centers demonstrated virtual elimination of therapeutic paracentesis and improvement in quality of life at 6 and 24 months post-implantation; over 1,000 alfapump systems implanted cumulatively
Direct Sodium Removal (DSR®) Therapy
• DSR® Technology: Proprietary platform for treating fluid overload spread across the body; works with the body's natural mechanisms to remove excess sodium and fluid
• Clinical Development: RED DESERT and SAHARA proof-of-concept studies published in European Journal of Heart Failure (April 2024); MOJAVE US randomized controlled multi-center Phase 1/2a study in heart failure ongoing
Market Position ＆ Certifications
Sequana Medical holds a pioneering position in the implantable ascites management market, competing with Boston Scientific, Merit Medical, and Endologix. Key strengths include:
• 19+ years of fluid overload innovation heritage
• First-mover advantage: First US-approved active implantable device for automated ascites removal, replacing repeated painful paracentesis procedures
• Regulatory compliance: CE marked in Europe, FDA PMA approved in the US, and ISO certified manufacturing
• Reimbursement secured: CMS NTAP coverage enabling sustainable US commercial adoption at liver transplant centers
• Market opportunity: Estimated 70,000 US patients with recurrent or refractory ascites, representing over USD 2 billion market in 2025, forecast to reach 130,000 patients and over USD 5 billion by 2035 driven by NASH/MASH and alcoholic liver disease
Corporate Timeline
2006 — Founded in Ghent, Belgium
2019 — Listed on Euronext Brussels (SEQUA); granted FDA Breakthrough Device Designation for alfapump
2024 — Received FDA Premarket Approval (PMA) for alfapump in recurrent or refractory ascites due to liver cirrhosis; cumulative implants exceeded 1,000 systems
2025 — CMS approved NTAP reimbursement (September); first US commercial implant completed at Mount Sinai Hospital, New York (November); University of Pennsylvania completed first two same-day implantations (December); soft launch targeting at least 70 US implants; full launch on track for Q2 2026
2026 — Expanded to 5 US medical centers including a leading liver transplant center, Mount Sinai, University of Pennsylvania, Dartmouth Hitchcock Medical Center, and University Medical Center of Southern Nevada (February)
Target Markets ＆ Applications
• Liver Cirrhosis Ascites: Primary indication for recurrent or refractory ascites in patients with decompensated liver disease
• Malignant Ascites: Fluid accumulation due to abdominal cancers requiring chronic drainage
• Heart Failure Fluid Overload: Expansion into diuretic-resistant congestion via DSR platform
• Transplant Bridge: Ascites management for patients awaiting liver transplantation at transplant centers
• Global Hepatology Centers: Tertiary hospitals, interventional radiology departments, and liver transplant programs in the US and Europe
Contact Information
Global Headquarters
Address: Kortrijksesteenweg 1112, 9052 Sint-Denijs-Westrem (Ghent), Belgium
Phone: +32 9 292 8065
Email: IR@sequanamedical.com
Website: www.sequanamedical.com
