Sequana Medical has achieved a significant milestone in its US commercialization strategy with the Centers for Medicare and Medicaid Services (CMS) approving New Technology Add-on Payment (NTAP) reimbursement for the alfapump system. The approval, announced in August 2025, provides "top-up" reimbursement of up to $21,450 in addition to standard Medicare Severity Diagnosis Related Group payments when the procedure is performed in hospital inpatient settings.
The Belgian medical device company is progressing with its phased US launch following FDA approval of the alfapump system in December 2024 for treating recurrent or refractory ascites due to liver cirrhosis. CEO Ian Crosbie emphasized the strong clinical interest, stating that discussions are underway with more than ten US hospitals to complete necessary approvals and contracting for alfapump implants.
Commercial Launch Strategy
Sequana Medical has established comprehensive US infrastructure to support the commercial launch, including a team of ten individuals focused on this key activity. Seven hospitals have completed alfapump training for hepatologists, interventional radiologists and their teams. The company anticipates first commercial implants early in the fourth quarter of 2025.
The company forecasts completing at least 70 US commercial implants across eight hospitals during the "Soft Launch" phase, which extends through Q1 2026. Following this initial phase, the "Full Launch" is planned to commence in Q2 2026 with approximately five additional centers opening per quarter.
Clinical Evidence and Publications
The alfapump system's clinical efficacy was demonstrated in the POSEIDON study, a multicenter, open-label, single-arm study with a within-subject crossover design. Results published in the American Journal of Gastroenterology in January 2025 covered six-month data for forty implanted patients in the pivotal cohort. The authors reported that the alfapump system effectively controlled ascites and improved quality of life, as defined by subjective physical health and ascites symptoms.
Notably, results from the literature indicate that overall survival of patients with the alfapump was higher than reported for standard of care large volume paracentesis (LVP). A case study published in the journal Hernia in July 2025 presented a patient from the POSEIDON study who received an alfapump for ascites control and subsequently underwent robotic repair of an umbilical hernia.
Market Access and Reimbursement
The NTAP approval represents a crucial reimbursement milestone for Sequana Medical's US commercialization plans. The reimbursement will be effective from October 1, 2025, providing additional financial support for hospitals performing the procedure. Sequana Medical's specialty commercial team is targeting the 90 US liver transplant centers that perform more than 90% of liver transplants.
Financial Position and Outlook
Despite challenging market conditions, Sequana Medical secured €13.6 million of financing in the first half of 2025. The company ended H1 2025 with a total liquidity position of €7.31 million, compared to €3.81 million at the end of 2024. Management anticipates that current financing, together with proceeds from the GEM share subscription facility, will extend the financing runway to at least Q1 2026.
The company also reduced net debt by €2 million through partial conversion of the Kreos loan and 2025 convertible loan into equity. Total operating expenses decreased from €9.82 million in H1 2024 to €8.97 million in H1 2025 due to measures taken to reduce cash burn.
Device Profile and Safety
The alfapump system is indicated for single patient use in adult patients with refractory or recurrent ascites due to liver cirrhosis. It removes excess peritoneal fluid from the peritoneal cavity into the bladder, where it can be eliminated through normal urination. The device received FDA Breakthrough Device Designation in 2019 prior to full approval.
Important safety considerations include MRI incompatibility and potential risks such as peritoneal cavity infections, coagulopathy, and various catheter-related complications. The system is currently not approved in Canada, and Sequana Medical continues to explore financing options for its DSR heart failure program.
