Sequana Medical announces results of Annual General Meeting of Shareholders

Ghent, Belgium, May 28, 2026 (GLOBE NEWSWIRE) -- PRESS RELEASE | REGULATED INFORMATION | 28 May 2026, 9:00 pm CEST

Ghent, Belgium – 28 May 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, announces today the results of the Annual General Meeting of Shareholders (the "AGM") held today at 09:00 am CEST, at which the treatment of certain agenda items was adjourned and all remaining agenda items submitted to a vote were approved.

As previously announced on 28 April 2026, the Company is conducting a review of a range of financial and strategic options to address its current financial position and the future of its business. This review may include, among other things, financing transactions, a strategic or corporate transaction (involving the Company or its assets), or other measures. At this stage, several options are being reviewed, but no decision has been taken, and there can be no assurance as to whether any final option will be available or whether any measures will be implemented, nor as to their outcome or timing. This review is still ongoing. Against this background, the Company's statutory and consolidated financial statements for the financial year ended 31 December 2025, together with the related reports of the board of directors and the statutory auditor, were not yet available at the time of the AGM.

In view hereof, and as announced on 28 April 2026, the board of directors decided, in accordance with Article 7:150 of the Belgian Companies and Associations Code, to adjourn the treatment of certain agenda items during the AGM, pending the availability of the financial statements and reports. The agenda items that were adjourned were already mentioned in the notice convening the AGM and included (among others) the approval of the statutory and consolidated financial statements and the related reports of the board of directors and the statutory auditor. The adjournment of these agenda items did not apply to and did not affect the other proposed resolutions on the agenda.

The proposed resolutions in relation to the other agenda items that were not adjourned were all approved, including (among others) the re-appointment of directors, and the resolution to continue the operations of the Company in accordance with Article 7:228 of the Belgian Companies and Associations Code.

The minutes of the shareholders' meeting can be accessed on the Company’s website.

For more information, please contact:
Sequana Medical
Investor relations
E: IR@sequanamedical.com
T: +44 (0) 797 342 9917

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 life¹^,².

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.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.

Important Safety Information: For important safety information regarding the alfapump® system, see https://www.sequanamedical.com/wp-content/uploads/ISI.pdf.

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.

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 P230044.

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.

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