Sequana Medical NV: Sequana Medical Reports Strong US Commercial Progress with Five Centers Completing alfapump System Implants Since Launch

Ghent, Belgium, Feb. 26, 2026 (GLOBE NEWSWIRE) --

• Leading US liver transplant center completes its first two implantations
• Mount Sinai Hospital and University of Pennsylvania also complete multiple implantations
• Dartmouth Hitchcock Medical Center and University Medical Center of Southern Nevada each conduct first implantation
  
  

Ghent, Belgium, 26 February 2026 - Sequana Medical NV (Euronext Brussels: SEQUA, the "Company" or "Sequana Medical"), a pioneer in the treatment of drug-resistant fluid overload in liver disease, heart failure and cancer, today announced strong commercial US progress with implants of the alfapump System having been completed at five leading centers since launch in Q4 2025. One of the leading US liver transplant centers has completed its first two implantations, and both Mount Sinai Hospital in New York and University of Pennsylvania have also implanted multiple patients. In addition, Dartmouth Hitchcock Medical Center and University Medical Center (UMC) of Southern Nevada have each completed their first implantation. Reflecting the strong interest in alfapump therapy across the US, the Company is actively progressing the hospital approval process to complete implants at a further 20 leading institutions.

Sequana Medical is executing a US commercialization strategy through its own specialty salesforce targeting the 90 US liver transplant centers that perform more than 90% of liver transplants. The alfapump is the first and only active implantable medical device approved in the US for treating recurrent or refractory ascites due to liver cirrhosis. The device automatically and continuously removes ascites fluid from the abdomen to the bladder, offering patients an alternative to paracentesis procedures.

Martijn Blom, Chief Commercial Officer of Sequana Medical, commented: "We are excited by the building commercial momentum for alfapump in the United States, including our latest expansion to one of the largest solid organ transplant centers in the US, as well as Dartmouth Hitchcock, New Hampshire's only Level 1 trauma center and academic medical center and University Medical Center of Southern Nevada, which features Nevada's only Level 1 trauma and transplant centers. This expansion further demonstrates the broadening interest in alfapump's role in advancing treatment for recurrent or refractory liver ascites, and reflects the strong clinical need for improved care."

Recurrent or refractory ascites is a severe condition characterized by the accumulation of fluid in the abdomen. The current standard treatment involves therapeutic paracentesis, an invasive and burdensome procedure that drains ascites from the abdomen using a large needle. This procedure often needs to be repeated weekly or monthly, requiring frequent hospital visits and causing significant disruption to patients' daily lives.¹

Ian Crosbie, Chief Executive Officer of Sequana Medical, added: "The medical centers that have already implanted multiple patients with the alfapump demonstrate the benefits they see to their patients and how it fits into their clinical practice as well as the overall value delivered to the healthcare system in reducing hospital visits and enabling patients to focus on living rather than managing their condition. As we continue to engage with leading hospitals and advance our commercialization strategy, we are thrilled to see the alfapump's continued adoption by additional medical institutions to reach more patients across the US."

Sequana Medical estimates there are more than 70,000 patients in the US with recurrent or refractory ascites, representing a market opportunity in excess of $2 billion for the alfapump, forecast to reach 130,000 patients and over $5 billion by 2035, primarily driven by MASH and alcoholic liver disease.²

For more information, please contact:

Sequana Medical
Investor Relations
E: [e-mail]
T: [phone]

Media Relations:
Josephine Galatioto
ICR Healthcare
E: [e-mail]
T: [phone]

Important Safety Information

Indication for Use: The alfapump System is intended for single patient use only in adult patients with refractory or recurrent ascites due to liver cirrhosis. It is indicated for the removal of excess peritoneal fluid from the peritoneal cavity into the bladder, where it can be eliminated through normal urination.

Contraindications: MRI Safety Information: The alfapump System is MRI unsafe. This diagnostic procedure is contraindicated due to possible movement of the alfapump, damage to the pump circuitry, tissue damage in the vicinity of the alfapump and/or catheter dislocation. Hyperbaric oxygen therapy is contraindicated because the environmental conditions entailed in this therapy are out of the defined range of use for the alfapump System.

Warnings, Risks, and Precautions: The implantation of the alfapump may result in infection that could delay liver transplant or impact transplant listing status. Additional risks associated with implanting the alfapump System including risk of peritoneal cavity infections/peritonitis, Coagulopathy, Small bladder capacity and/or obstructive uropathy. The following procedures or therapies could impact the alfapump System function: Supersonic therapy and high-frequency heat therapy, Transcutaneous Electrical Nerve Stimulation (TENS), Lithotripsy, Defibrillation, Radiation therapy, Electrocautery, or use of other implantable medical devices and wearable devices.

Adverse Events: In addition to procedure related risks the following Adverse Events may occur: pump pocket hematoma, skin erosion, infection, pump migration, catheter clogging or other catheter complications resulting in tissue damage or loss of or change in therapy, genito-urinary complications, reduced kidney function, hepatic encephalopathy, progression of liver disease, and other systemic effects.

Caution: the law restricts the sale by or on the order of a physician. Refer to package insert provided with the product for complete Instructions for Use, Contraindications, Potential Adverse Effects, Warnings and Precautions prior to using this product.

The alfapump System is currently not approved in Canada.

DSR therapy is still in development and is currently not approved in any country. The safety and effectiveness of DSR therapy has not been established.

Note: alfapump and DSR are registered trademarks.

About Sequana Medical

Sequana Medical NV is a pioneer in treating fluid overload, a serious and frequent clinical complication in patients with liver disease, heart failure and cancer. This causes major medical issues including increased mortality, repeated hospitalizations, severe pain, difficulty breathing and restricted mobility. Although diuretics are standard of care, they become ineffective, intolerable or exacerbate the problem in many patients. There are limited effective treatment options, resulting in poor clinical outcomes, high costs and a major impact on their quality of life. Sequana Medical is seeking to provide innovative treatment options for this large and growing "diuretic resistant" patient population. alfapump and DSR are Sequana Medical's proprietary platforms that work with the body to treat diuretic-resistant fluid overload, and are intended to deliver major clinical and quality of life benefits for patients, while reducing costs for healthcare systems.

The Company received US FDA approval for the alfapump System for the treatment of recurrent or refractory ascites due to liver cirrhosis in December 2024, following the grant of FDA Breakthrough Device Designation in 2019. In Sequana Medical's POSEIDON study, a landmark study across 18 centers in the US and Canada, the pivotal cohort of 40 patients implanted with the alfapump showed at 6 and 24 months post-implantation the virtual elimination of therapeutic paracentesis and an improvement in quality of life.^3,4

Sequana Medical is commercializing the alfapump through a specialty commercial team initially targeting US liver transplant centers - 90 of these centers perform more than 90% of US liver transplants annually. In August 2025, CMS announced that it approved the New Technology Add-on Payment for the alfapump when performed in the hospital inpatient setting as of October 1, 2025.

Results of the Company's RED DESERT and SAHARA proof-of-concept studies in heart failure published in European Journal of Heart Failure in April 2024 support DSR's mechanism of action as breaking the vicious cycle of cardiorenal syndrome. All three patients from the non-randomized cohort of MOJAVE, a US randomized controlled multi-center Phase 1/2a clinical study, have been successfully treated with DSR, resulting in a dramatic improvement in diuretic response and virtual elimination of loop diuretic requirements.⁵ The independent Data Safety Monitoring Board approved the start of the randomized MOJAVE cohort of up to a further 30 patients, which is dependent on securing additional financing.

Sequana Medical is listed on the regulated market of Euronext Brussels (Ticker: SEQUA.BR) and headquartered in Ghent, Belgium. For further information, please visit www.sequanamedical.com.

Forward-looking statements

This press release may contain predictions, estimates or other information that might be considered forward-looking statements. Such forward-looking statements are not guarantees of future performance. These forward-looking statements represent the current judgment of Sequana Medical on what the future holds, and are subject to risks and uncertainties that could cause actual results to differ materially. Sequana Medical expressly disclaims any obligation or undertaking to release any updates or revisions to any forward-looking statements in this press release, except if specifically required to do so by law or regulation. You should not place undue reliance on forward-looking statements, which reflect the opinions of Sequana Medical only as of the date of this press release.

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¹ Wong F, Bendel E, Sniderman K, et al. Improvement in Quality of Life and Decrease in Large-Volume Paracentesis Requirements With the Automated Low-Flow Ascites Pump. Liver Transpl. 2020;26(5):651-661. doi:10.1002/lt.25724.

² Based on US market assessment conducted by highly experienced international consulting group.

³Alfapump system SSED (summary of safety and effectiveness) PMA 230044.

⁴ As defined by subjective physical health (assessed by SF-36 PCS) and ascites symptoms (assessed by Ascites Q).

⁵ Data reported in press release of March 25, 2024; mean increase of 326% in six-hour urinary sodium excretion at 3 months follow up vs baseline, and 95% reduction of loop diuretics over same period.

Attachments

• Sequana Medial -- Press Release (ENG) 26 February 26
• Sequana Medical -- Press Release (NL) 26 February 26