Transparency Notification from Shareholder
Ghent, Belgium – 13 October 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, announces today that it received a transparency notification in relation to the entity listed below, notifying the number of voting rights attached to the shares mentioned next to its name in the table below.
| Reason for notification | Aggregate
number of shares and voting rights held |
% of total outstanding shares (1) | |
| Midelco NV / Philippe Vlerick (2) | Passive crossing of a threshold / Downward crossing of the lowest threshold | 1,806,897 | 2.86% |
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Notes:
(1) The total number of outstanding shares of the Company mentioned in the relevant transparency notification amounts to 63,145,080, each share giving right to one (1) vote (being 63,145,080 voting rights in total).
(2) A parent undertaking or a controlling person of Midelco NV (“Midelco“) informed the Company, by means of a notification dated 9 October 2025 and received by the Company on 13 October 2025, that on 26 September 2025, the shareholding of Midelco NV (holding 1,806,897 shares and voting rights, which corresponds to 2.86% of the outstanding voting rights of the Company), crossed below the lowest threshold of 3% of the outstanding voting rights of the Company. The joint notification specifies furthermore that Midelco is controlled by Philippe Vlerick.
This announcement is made in accordance with Article 14 of the Belgian Act of 2 May 2007 on the disclosure of major participations in issuers of which shares are admitted to trading on a regulated market and regarding miscellaneous provisions.
To access a copy of the aforementioned transparency notification, reference is made to Sequana Medical’s website (https://www.sequanamedical.com/investors/shareholder-information/).
Pursuant to the Belgian Transparency Act and the articles of association of the Company, a notification to the Company and the Belgian Financial Services and Markets Authority (FSMA) is required by all natural and legal persons in each case where the percentage of voting rights attached to the securities held by such persons in the Company reaches, exceeds or falls below the threshold of 3%, 5%, 10%, and every subsequent multiple of 5%, of the total number of voting rights in the Company.
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 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 requirements3. 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 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.
- Sequana Medical — Transparency Notification PR (Midelco) (NL) (13 October 2025).docx
- Sequana Medical — Transparency Notification PR (Midelco) (ENG) (13 October 2025)
- Sequana Medical — Transparency Notification PR (Midelco) (NL) (13 October 2025).docx
- Sequana Medical — Transparency Notification PR (Midelco) (ENG) (13 October 2025)
