Sequana Medical N.V. is a commercial-stage medical device company specializing in innovative treatments for fluid overload related to liver disease, heart failure, and malignant ascites. The company develops and markets proprietary medical technologies including the alfapump® system, an implantable active device designed to manage recurrent or refractory ascites in patients with liver cirrhosis; and the DSR® (Direct Sodium Removal) technology which targets diuretic-resistant fluid overload. These products are intended to improve patient quality of life while reducing healthcare costs. Sequana Medical operates primarily in the US and European markets, with headquarters in Ghent, Belgium, and was founded in 2007.
Recent major developments include the U.S. FDA approval of the alfapump® system in December 2024, marking it as the first U.S.-approved active implantable medical device for treatment of recurrent ascites due to liver cirrhosis. The company has commenced U.S. commercialization focusing on liver transplant centers, supported by a specialty commercial sales team targeting 90 major centers. In 2025, the U.S. Centers for Medicare and Medicaid Services (CMS) approved New Technology Add-on Payment (NTAP) reimbursement for the alfapump®, enhancing its market access and reimbursement prospects. Additionally, Sequana Medical secured a €24 million financing package in early 2025 including convertible loans and a share subscription facility to support its commercial rollout and ongoing innovation. These strategic advancements underscore the company’s expansion into the U.S. market and reinforcement of its innovative treatment platforms.
Sequana Medical targets healthcare providers managing patients with diuretic-resistant fluid overload conditions and operates across key Western healthcare systems, focusing on hospitals and transplant centers. Its proprietary alfapump® and DSR® platforms are recognized for clinical efficacy supported by peer-reviewed publications, underscoring its role in medical device innovation for complex fluid management. The company maintains ongoing collaborations with clinicians and continues development initiatives to expand clinical evidence and broaden therapeutic applications. Sequana Medical’s product portfolio and strategic focus situate it as a leader in advanced treatment solutions for fluid overload management with a growing global footprint.