Ghent, Belgium, May 29, 2026 (GLOBE NEWSWIRE) — <\/p>\n
- \n
- Post-hoc analysis from the POSEIDON study demonstrates long-term resolution of ascites and early signs of liver function recovery in over 20% of patients with alfapump in situ for over six months<\/i><\/b><\/li>\n
- This important finding builds upon the virtual elimination of therapeutic paracentesis and an improvement in quality of life in the POSEIDON study previously reported<\/i><\/b>1<\/i><\/b><\/sup><\/li>\n<\/ul>\n
Ghent, Belgium, 29 May 2026 – Sequana Medical NV (Euronext Brussels: SEQUA, the \u201cCompany\u201d or \u201cSequana Medical\u201d)<\/b>, a pioneer in the treatment of drug-resistant fluid overload in liver disease, heart failure and cancer, today announced the presentation of data from a post-hoc analysis of the Phase 3 POSEIDON study of alfa<\/b>pump at the European Association for the Study of the Liver (EASL) Congress 2026 in Barcelona, Spain. EASL Congress is one of the world\u2019s premier events dedicated to liver health, bringing together physicians, scientists, and allied health professionals from across the globe to share knowledge and highlight breakthroughs across the full spectrum of hepatology. The poster, titled \u201cRecompensation of decompensated cirrhosis and long-term resolution of ascites in patients undergoing alfa<\/b>pump placement: experience from the multi-centre POSEIDON study,\u201d was presented in the Portal Hypertension session.<\/p>\n
The alfa<\/b>pump is a subcutaneous implantable device that automatically and continuously moves ascites fluid from the abdominal cavity into the bladder, where it is eliminated naturally, freeing patients from dependence on repeated large-volume paracentesis procedures. Of 48 subjects with a functioning alfa<\/b>pump at six months post-implant, 10 achieved recompensation, with a median time to recompensation of 519 days. Key markers of recovery, including declining MELD-Na (Model for End-Stage Liver Disease-Sodium, a standard measure of liver disease severity) scores and rising serum albumin, differentiated those who recompensated from those who did not. Both the Recompensation group (n\u00a0=\u00a010) and those with Ongoing Decompensation (n\u00a0=\u00a038) experienced similar post-implant improvements in ascites complaints (Ascites-Q). These findings are preliminary and further data collection is ongoing.<\/p>\n
Dr. Ethan Weinberg, Associate Professor of Clinical Medicine at the University of Pennsylvania, presenter of the poster and co-investigator on the POSEIDON study, commented<\/b>: \u201cThese findings challenge the assumption that decompensated cirrhosis is an irreversible state. We are seeing objective signals including declining MELD-Na, improving albumin, and sustained resolution of ascites, suggesting that a meaningful proportion of patients may achieve recompensation through long-term ascites control with the <\/i>alfa<\/i><\/b>pump. It is particularly meaningful to see these findings emerge from the POSEIDON study as we are implanting patients with the <\/i>alfa<\/i><\/b>pump commercially at the University of Pennsylvania, bringing this technology directly to the patients who need it.\u201d<\/i><\/p>\n
Dr. Gijs Klarenbeek, Chief Medical Officer of Sequana Medical, added:<\/b> \u201cBy removing the burden of ascites continuously and automatically, we are seeing that the <\/i>alfa<\/i><\/b>pump may create the conditions for patients to recover nutritional status and liver function in ways that have not previously been possible. The similar improvement in quality of life in patients from both the Recompensation and the Ongoing Decompensation groups, as evidenced through the improvement in the Ascites-Q score, demonstrates the important benefits from <\/i>alfa<\/i><\/b>pump implantation in all POSEIDON patients. These clinical findings from our pivotal study come at an exciting time as adoption of the <\/i>alfa<\/i><\/b>pump continues to grow across leading US centers.\u201d<\/i><\/p>\n
The alfa<\/b>pump 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 and currently only U.S.-approved active implantable medical device (Class III) that automatically and continuously removes ascites from the abdomen into the bladder. In August 2025, CMS approved the New Technology Add-on Payment for the alfa<\/b>pump when performed in the hospital inpatient setting, effective October 1, 2025.<\/p>\n
For more information, please contact:<\/b><\/p>\n
Sequana Medical<\/b>
Investor Relations
E: IR@sequanamedical.com<\/a>
<\/a>T: +44 (0) 797 342 9917<\/p>\nMedia Relations:<\/b>
Josephine Galatioto
ICR Healthcare
E: Sequana@icrhealthcare.com<\/a>
T: +1 (332) 242-4388<\/p>\nImportant Safety Information<\/u><\/b><\/p>\n
Indication for Use: <\/b>The alfa<\/b>pump\u00ae 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.<\/p>\n
Contraindications:<\/b>\u00a0MRI Safety Information: The alfa<\/b>pump\u00ae System is MRI unsafe. This diagnostic procedure is contraindicated due to possible movement of the alfa<\/b>pump\u00ae, damage to the pump circuitry, tissue damage in the vicinity of the alfa<\/b>pump\u00ae 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 alfa<\/b>pump\u00ae System.<\/p>\n
Warnings, Risks, and Precautions:<\/b>\u00a0The implantation of the alfa<\/b>pump\u00ae may result in infection that could delay liver transplant or impact transplant listing status. Additional risks associated with implanting the alfa<\/b>pump\u00ae System including risk of peritoneal cavity infections\/peritonitis, Coagulopathy, Small bladder capacity and\/or obstructive uropathy. The following procedures or therapies could impact the alfa<\/b>pump\u00ae 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.<\/p>\n
Adverse Events:<\/b>\u00a0In 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\u00a0disease, and other systemic effects.<\/p>\n
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.<\/p>\n
The alfa<\/b>pump\u00ae System is currently not approved in Canada.<\/p>\n
DSR\u00ae therapy is still in development and is currently not approved in any country.\u00a0The safety and effectiveness of DSR\u00ae therapy has not been established.<\/p>\n
Note: alfa<\/b>pump\u00ae and DSR\u00ae are registered trademarks.<\/p>\n
About Sequana Medical<\/b><\/p>\n
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 \u201cdiuretic resistant\u201d patient population. alfa<\/b>pump\u00ae and DSR\u00ae are Sequana Medical\u2019s 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.<\/p>\n
The Company received US FDA approval for the alfa<\/b>pump 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\u2019s POSEIDON study, a landmark study across 18 centers in the US and Canada, the pivotal cohort of 40 patients implanted with the alfa<\/b>pump showed at 6 and 24 months post-implantation the virtual elimination of therapeutic paracentesis and an improvement in quality of life.2<\/sup>,<\/sup>3<\/sup><\/p>\n
Sequana Medical is commercializing the alfa<\/b>pump through a specialty commercial team initially targeting US liver transplant centers \u2013 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 alfa<\/b>pump when performed in the hospital inpatient setting as of October 1, 2025.<\/p>\n
Results of the Company\u2019s RED DESERT and SAHARA proof-of-concept studies in heart failure published in European Journal of Heart Failure in April 2024 support DSR\u2019s 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.4<\/sup> 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.<\/p>\n
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<\/a>.<\/p>\n
Forward-looking statements<\/i><\/b><\/p>\n
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.<\/i><\/p>\n
1<\/sup> \u201cThe Effects of Alfapump on Ascites Control and Quality of Life in Patients with Cirrhosis and Recurrent or Refractory Ascites\u201d American Journal of Gastroenterology. <\/i>2025 Oct 1;120 (10):2291-2301.<\/p>\n
2<\/sup> A<\/b>lfa<\/b>pump system SSED (summary of safety and effectiveness) PMA P230044.<\/p>\n
3<\/sup> As defined by subjective physical health (assessed by SF-36 PCS) and ascites symptoms (assessed by Ascites Q).<\/p>\n
4<\/sup> Data reported in press release of March 25, 2024<\/a>; 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.<\/p>\n
- \n
- \n Sequana Medical — Press Release EASL (ENG) 29 May 26<\/a>\n <\/li>\n
- \n Sequana Medical — Press Release EASL (NL) 29 May 26<\/a>\n <\/li>\n<\/ul>\n
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- \n Sequana Medical — Press Release EASL (NL) 29 May 26<\/a>\n <\/li>\n<\/ul>\n
- This important finding builds upon the virtual elimination of therapeutic paracentesis and an improvement in quality of life in the POSEIDON study previously reported<\/i><\/b>1<\/i><\/b><\/sup><\/li>\n<\/ul>\n