Sequana Medical NV

Sequana Medical’s alfapump® System Featured in Presentation at 2025 Portal Intervention Symposium

, Sept. 30, 2025 (GLOBE NEWSWIRE) -- Dr. Rahul Patel of Icahn School of Medicine at Mount Sinai presented “alfapump®: Totally Implantable Peritoneal Drain Pump with Urinary Bladder Drainage”

Ghent, Belgium – September 30, 2025 – 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 that the alfapump® System was featured in a podium presentation at the 2025 Portal Intervention Symposium in Chicago, IL. The presentation, titled “alfapump®: Totally Implantable Peritoneal Drain Pump with Urinary Bladder Drainage,” focused on the surgical and technical aspects of the alfapump implant procedure for interventional radiologists.

Dr. Rahul Patel, Assistant Professor of Radiology and Surgery, Icahn School of Medicine at Mount Sinai, who presented at the symposium, commented: “The alfapump system represents a significant advancement in the management of recurrent or refractory ascites due to liver cirrhosis. From an intervention perspective, the implant procedure builds on established interventional radiology techniques while providing patients with a new treatment option. The ability to continuously and automatically remove ascites from the abdomen into the bladder offers our patients freedom from the burden of repeated large volume paracentesis procedures.”

Dr. Gijs Klarenbeek, Chief Medical Officer of Sequana Medical, continued: “We are delighted to see the alfapump system featured at this important specialty conference for the interventional radiology community. This presentation will raise awareness of the alfapump amongst the interventional radiologist community and is key in ensuring they have the knowledge and confidence to offer this innovative device to their patients. For too long, many patients with recurrent or refractory ascites due to liver cirrhosis have had to put up with a standard of care that has changed little in over 2,000 years. The alfapump is a 21^st century solution recognising that cirrhosis is increasingly a mainstream disease and patients are demanding and deserving better treatment options.”

The alfapump® system received U.S. FDA Premarket Approval in December 2024 for the treatment of recurrent or refractory ascites due to liver cirrhosis. It is the first active implantable medical device in the U.S. that automatically and continuously removes ascites from the abdomen into the bladder.

For more information, please contact:

Sequana Medical
Investor relations
E: IR@sequanamedical.comT: +44 (0) 797 342 9917

Media Relations:
Jon Yu
ICR Healthcare
E: Sequana@icrhealthcare.com
T: +1 (646) 677-1855

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^1,2.

Sequana Medical has commenced US commercialisation through a small specialty salesforce initially targeting US liver transplant centers – 90 of these centers perform more than 90% of US liver transplants annually. CMS has 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.³ 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.

¹ alfapump system SSED (summary of safety and effectiveness) PMA 230044
² as defined by subjective physical health (assessed by SF-36 PCS) and ascites symptoms (assessed by Ascites Q)
³ 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

• 20250930 Press Release Sequana Medical - Portal Intervention Symposium (ENG)
• 20250930 Press Release Sequana Medical - Portal Intervention Symposium (NL)