Sequana's alfapump: A New Current in Chronic Liver Disease Treatment

GHENT, BELGIUM – December 11, 2025 – For patients with advanced liver cirrhosis, life can become a grueling cycle of fluid buildup and painful, repeated hospital procedures. This week, a significant development at the University of Pennsylvania signals a potential end to that cycle for many. Belgian med-tech firm Sequana Medical announced the first U.S. commercial implantations of its alfapump® System, an innovative device designed to manage a debilitating condition known as refractory ascites.

The implantation of two patients on a single day at a prestigious U.S. medical center is more than a clinical milestone; it represents the starting gun for Sequana's ambitious commercial entry into a substantial and underserved American market. Following a similar successful procedure at Mount Sinai in New York, the move validates a meticulously planned strategy years in the making, combining breakthrough technology with savvy navigation of the complex U.S. regulatory and reimbursement landscape. For investors and industry analysts, Sequana’s story is a case study in how a focused company can challenge a long-entrenched standard of care.

Beyond the Needle: A New Chapter for Patients

Refractory ascites is the severe, recurrent accumulation of fluid in the abdomen, a common complication of late-stage liver disease. The current standard of care, therapeutic paracentesis, is a procedure that has changed little over the centuries: a large-bore needle is inserted into the abdomen to drain liters of fluid. While providing temporary relief, the fluid inevitably returns, forcing patients into a relentless cycle of hospital visits, often every one to two weeks.

The burden is immense. Beyond the discomfort and risk of infection from the procedure itself, the constant fluid pressure causes severe pain, difficulty breathing, loss of appetite, and extreme fatigue. As one hepatologist not involved with the company noted, "We are managing a chronic condition with an acute, invasive intervention. It's disruptive, inefficient, and profoundly impacts a patient's ability to lead any semblance of a normal life."

The alfapump is engineered to fundamentally alter this paradigm. It is the first active implantable medical device approved in the U.S. for this indication. The small, battery-powered pump is surgically placed under the skin and connected via catheters to the abdominal cavity and the bladder. It automatically and continuously collects the ascites fluid and redirects it to the bladder, where it is eliminated from the body through normal urination. This transforms a burdensome medical ordeal into a manageable, background physiological process.

The impact on patient quality of life, as demonstrated in clinical trials, is profound. "The alfapump represents a welcomed advancement for our patients suffering from recurrent ascites," commented Dr. Ethan Weinberg, Associate Professor of Clinical Medicine at the University of Pennsylvania, in the company's announcement. "This engineering marvel offers our patients the potential for improved quality of life, allowing them to get back to their daily lives."

De-Risking the Path to a Multi-Billion Dollar Market

Bringing such an "engineering marvel" to market is fraught with financial and regulatory hurdles. Sequana Medical's journey, however, demonstrates a textbook execution of de-risking its commercial pathway. The foundation of this strategy was the robust clinical evidence generated by the pivotal POSEIDON study.

Conducted across 18 centers in the U.S. and Canada, the study's results were compelling. Six months after implantation, patients saw the need for therapeutic paracentesis virtually eliminated, dropping from an average of over three sessions per month to just 0.2. This efficacy was durable, with 24-month follow-up data confirming the long-term control of ascites. Critically, these clinical gains translated into statistically significant improvements in quality of life, with patients reporting an average of 10 additional "good health days" per month. The full six-month data was published in the prestigious American Journal of Gastroenterology in early 2025, lending peer-reviewed credibility to the company's claims.

Armed with this data, Sequana secured Premarket Approval (PMA) from the U.S. Food and Drug Administration in December 2024, following an earlier Breakthrough Device Designation in 2019. But clinical and regulatory validation is only half the battle; commercial success hinges on reimbursement. Here, Sequana scored a crucial victory by securing a New Technology Add-on Payment (NTAP) from the Centers for Medicare & Medicaid Services (CMS), effective October 1, 2025.

NTAP provides hospitals with additional reimbursement above the standard diagnosis-related group (DRG) payment for new, clinically superior technologies. This mechanism is designed to encourage the adoption of innovation by mitigating the initial financial risk for hospitals. For Sequana, it’s a powerful commercial accelerant, making the alfapump an economically viable option for institutions from day one of its launch.

Sizing the Opportunity and Competitive Dynamics

Sequana is now poised to tap a large and growing market. The company estimates that approximately 70,000 patients in the U.S. suffer from recurrent or refractory ascites, representing an immediate addressable market opportunity in excess of $2 billion. This figure is projected to climb, with the patient population forecast to reach 130,000 by 2032, pushing the potential market value towards $5 billion. This growth is largely fueled by the rising prevalence of Non-alcoholic Steatohepatitis (NASH), now rebranded as MASH (Metabolic dysfunction-associated steatohepatitis), and alcoholic liver disease.

While paracentesis is the primary treatment the alfapump aims to replace, the competitive landscape also includes the Transjugular Intrahepatic Portosystemic Shunt (TIPS). TIPS is a more invasive procedure that creates a new connection between blood vessels in the liver but is unsuitable for many patients and carries a significant risk of complications, most notably hepatic encephalopathy (a worsening of brain function). The POSEIDON data suggested that survival rates for alfapump patients were favorable and not worse than those reported for TIPS, positioning it as a strong alternative for a broader patient segment.

The ultimate treatment remains a liver transplant, but the scarcity of donor organs and strict eligibility criteria mean it is an option for only a fraction of patients. In this context, the alfapump carves out a critical niche, offering not a cure for the underlying liver disease, but a transformative improvement in managing one of its most severe symptoms.

A Strategy of Influence and Expansion

The choice of the University of Pennsylvania and Mount Sinai as initial commercial sites is no accident. It is the cornerstone of Sequana’s go-to-market strategy: partner with Key Opinion Leaders (KOLs) at elite, high-volume liver transplant centers. These institutions not only treat a large number of eligible patients but also serve as powerful influencers within the medical community.

"Here is another top-tier US hospital with a strong reputation in hepatology and interventional radiology starting to implant the alfapump in a commercial setting," stated Martijn Blom, Sequana Medical’s Chief Commercial Officer. "We are proud to work alongside them to deliver this breakthrough device."

This KOL-centric approach creates a ripple effect. Successful implementation at a leading center provides a powerful case study, encouraging adoption by other hospitals. These academic hubs also become crucial centers for training other physicians, building a network of skilled implanters necessary for a national rollout.

With the clinical data validated, FDA approval secured, and a favorable reimbursement pathway established, the implantations at Penn mark the transition from strategy to execution. The company reports a strong pipeline of additional centers completing the necessary approvals, suggesting the commercial momentum is building. The financial and medical communities will now be watching closely to see how effectively Sequana Medical can scale its operations and establish the alfapump as the new standard of care, turning a trickle of initial implants into a steady current of revenue and, more importantly, a new tide of hope for patients.