The Centers for Medicare and Medicaid Services (CMS) has proposed including Sequana Medical's alfapump system in its New Technology Add-on Payment (NTAP) program, a significant step toward improving Medicare beneficiary access to this breakthrough technology for treating recurrent or refractory ascites due to liver cirrhosis.
The proposal, included in the Fiscal Year 2026 Hospital Inpatient Prospective Payment System (IPPS) Proposed Rule published on April 14, 2025, recommends that alfapump system cases be eligible for incremental payment when performed in hospital inpatient settings. If finalized as expected in August 2025, the NTAP would take effect by October 1, 2025.
Under the proposed rule, CMS would provide additional payments of up to $19,500 per case—representing 65 percent of incremental device costs—on top of standard Medicare Severity Diagnosis Related Group (MS-DRG) payments to hospitals. This financial support aims to facilitate patient access while CMS collects cost data on the new technology.
Revolutionary Treatment for Ascites
The alfapump system represents the first active implantable medical device approved in the US that automatically and continuously removes ascites—accumulated fluid in the abdomen—into the bladder, where it is naturally eliminated through urination. This approach offers a significant advancement over the current standard treatment of therapeutic paracentesis, an invasive procedure requiring large-needle drainage of abdominal fluid.
"This is another step forward in our US commercial launch and making this breakthrough therapy available to the large and growing US universe of patients that for too long have had to put up with large volume paracentesis, a treatment that is virtually unchanged for thousands of years and has such a devastating impact on clinical outcomes and quality of life," said Martijn Blom, Chief Commercial Officer of Sequana Medical NV.
The company received FDA approval for the alfapump System in December 2024, following the agency's Breakthrough Device Designation granted in 2019. To date, over 1,000 alfapump systems have been implanted globally.
Compelling Clinical Evidence
The FDA's approval was based on Sequana Medical's pivotal POSEIDON study, conducted across 18 centers in the US and Canada with 69 patients receiving the alfapump. The study demonstrated that the device exceeded predefined effectiveness thresholds with statistical significance at six months post-implantation, with safety data in line with expectations.
Long-term data has been particularly impressive. At 12 months post-implantation, the alfapump continued to show a strong and durable clinical profile, virtually eliminating the need for therapeutic paracentesis while delivering improvements in quality of life. At 24 months, key POSEIDON investigators reported at the American Association for the Study of Liver Diseases (AASLD) Liver Meeting that the alfapump maintained elimination of large volume paracentesis with overall survival of 62%.
A manuscript published in the American Journal of Gastroenterology in January 2025 concluded that "the overall survival of patients with the alfapump was not worse as compared to TIPS [transjugular intrahepatic portosystemic shunt] and was higher than reported for standard of care."
Market Opportunity and Commercial Plans
The US market for recurrent and refractory ascites due to liver cirrhosis is forecast to grow by an average of 9% annually, from approximately 70,000 patients in 2025 to 130,000 patients by 2032. This growth is primarily driven by the increasing prevalence of non-alcoholic steatohepatitis (NASH) and metabolic dysfunction-associated steatohepatitis (MASH).
Sequana Medical estimates the total market opportunity for alfapump at over $2 billion in 2025, with projections reaching over $5 billion by 2035. The company plans to begin US commercialization in Q3 2025 through a specialized sales force targeting the 90 US liver transplant centers that perform 95% of liver transplants.
Training for launch centers is on track to be completed by the end of April 2025, positioning the company to meet its commercial timeline goals.
Broader Portfolio Development
Beyond the alfapump system, Sequana Medical is developing DSR (Direct Sodium Removal) therapy for fluid overload in heart failure. Recent results from the company's RED DESERT and SAHARA proof-of-concept studies, published in the European Journal of Heart Failure in April 2024, support DSR's mechanism of action in addressing cardiorenal syndrome.
Early results from the non-randomized cohort of MOJAVE, a US randomized controlled multi-center Phase 1/2a clinical study, showed that all three patients treated with DSR experienced dramatic improvement in diuretic response and virtual elimination of loop diuretic requirements.
The proposed NTAP designation for alfapump represents a critical milestone in Sequana Medical's efforts to address the significant unmet need for effective treatments for drug-resistant fluid overload, a serious complication affecting patients with liver disease, heart failure, and cancer.
