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Sequana Medical N.V. — Investor Relations & Filings

Ticker · SEQUA ISIN · BE0974340722 LEI · 8755009AN12Y4PEOII07 BR Manufacturing
Open in API
Filings indexed 501 across all filing types
Latest filing 2024-01-24 Declaration of Voting R…
Country BE Belgium
Listing BR SEQUA

About Sequana Medical N.V.

https://www.sequanamedical.com/

Sequana Medical N.V. is a commercial-stage medical device company focused on developing treatments for drug-resistant fluid overload, a frequent complication in patients with liver disease, heart failure, and cancer. The company's primary product is the alfapump®, a fully implanted, wirelessly charged system that automatically and continuously removes ascites (fluid accumulation in the abdomen) into the bladder for natural elimination. It is the first U.S. FDA-approved active implantable medical device for treating recurrent or refractory ascites due to liver cirrhosis, designed to reduce or eliminate the need for therapeutic paracentesis. Sequana Medical is also advancing its DSR® (Direct Sodium Removal) therapy platform, a novel approach for managing fluid overload in heart failure patients.

Recent filings

Filing Released Lang Actions
Press release_Transparency Notification_24 January 2024_ENG_vF.pdf
Declaration of Voting Results & Voting Rights Announcements Classification · 100% confidence The document is titled "Transparency Notifications from Shareholders" and explicitly states that the company received notifications regarding changes in voting rights due to a share transfer following the winding down of a fund (NeoMed IV). It details the acquisition and disposal of voting securities by specific entities (MCMI, Erik Amble/NeoMed Management/NeoMed IV) and references the Belgian Act on the disclosure of major participations, which mandates notifications when shareholding crosses thresholds (3%, 5%, 10%, etc.). This content directly corresponds to the definition of a Major Shareholding Notification, which in the provided schema is mapped to 'MRQ' (Major Shareholding Notification). Although it is a press release announcing the notifications, the core subject matter is the change in major shareholdings, making MRQ the most specific fit over a general RPA or RNS.
2024-01-24 English
Press release_Transparency Notification_24 January 2024_NL_vF.pdf
Major Shareholding Notification Classification · 99% confidence The document is titled "Transparantiekennisgevingen van Aandeelhouders" (Shareholder Transparency Notifications) and details the receipt of notifications regarding changes in voting rights due to an in-kind contribution/share transfer involving entities like NeoMed IV, MCMI, Erik Amble, and NeoMed Management. It explicitly mentions compliance with Belgian transparency laws (Article 14 of the law of May 2, 2007) and the crossing of voting rights thresholds (3%, 5%, 10%). This content directly relates to changes in significant share ownership and voting rights, which aligns perfectly with the definition of Major Shareholding Notification (MRQ). Although it is presented as a press release, the core subject matter is the notification of major shareholding changes.
2024-01-24 Dutch
Press release_DSMB MOJAVE_23 January 2024_ENG_vF.pdf
Earnings Release Classification · 93% confidence The document is a press release announcing clinical trial progress (DSMB approval, enrollment start, interim data plans) and presenting key efficacy and safety data from the non-randomized cohort of the MOJAVE study for DSR 2.0. It contains financial/operational updates but is not a formal regulatory filing like a 10-K, nor is it a transcript (CT) or a formal earnings release (ER) which typically focuses on P&L figures. It is a detailed update on clinical development and results, which aligns best with an Investor Presentation (IP) or a general announcement. Given the structure—a headline announcement followed by detailed clinical data and background on the technology—it functions as a detailed update for investors, making 'Investor Presentation' (IP) the most appropriate fit, although it is formatted as a press release. It is not a short announcement of a report (RPA/RNS), as it contains substantial data itself. Since 'IP' covers detailed presentations on strategy and financials, this clinical data update fits well within that scope for communicating progress to investors. Q1 2024
2024-01-23 English
Press release_DSMB MOJAVE_23 January 2024_NL_vF.pdf
Earnings Release Classification · 95% confidence The document is a press release from Sequana Medical NV, dated January 23, 2024, announcing the approval by the DSMB to start the randomized cohort of the MOJAVE study for DSR 2.0, and providing positive interim results from the non-randomized cohort. This type of announcement, detailing clinical trial progress, safety data, and future plans (like expected enrollment dates and interim data releases), is characteristic of an Earnings Release (ER) or a general press release regarding operational updates. Since it focuses on announcing key financial/operational milestones (clinical trial progress) rather than being a comprehensive periodic report (10-K, IR) or a transcript (CT), the most fitting category is Earnings Release (ER), as these often contain such operational updates alongside financial highlights, or it could be classified as a Regulatory Filing (RNS) if it were purely regulatory. Given the structure and content focusing on study results and next steps, ER is a strong fit for a major operational update press release. However, since the primary focus is a clinical trial update and not necessarily tied to a quarterly earnings period announcement, and it is a formal announcement of a significant event, it fits well under the general 'Regulatory Filings' (RNS) as a catch-all for important, non-standard reports, or ER if we interpret 'Earnings Release' broadly to include major operational milestones announced via press release. Given the specific nature of clinical trial updates, and the lack of a dedicated 'Clinical Trial Update' code, ER is often used for such material news releases. Let's re-evaluate against the definitions. It is not a 10-K, AR, CT, or IR. It is an announcement of results and progress. It is most similar to an Earnings Release (ER) which announces period results/milestones, or RNS for general regulatory announcements. Since it is a formal press release detailing significant operational progress (clinical trial advancement), ER is the best fit among the specific options, as these releases often precede or accompany formal financial reporting periods. Q1 2024
2024-01-23 Dutch
Press release_Transparency Notification_15 Jan 2024_ENG_vF.pdf
Major Shareholding Notification Classification · 99% confidence The document is titled "Transparency Notifications from Shareholders" and explicitly states that the company received a notification regarding the number of voting rights held by certain shareholders, detailing the disposal of voting securities. It references compliance with Article 14 of the Belgian Act on the disclosure of major participations, which mandates reporting when ownership crosses thresholds (3%, 5%, 10%, etc.). This content directly relates to changes in significant share ownership or voting rights, which aligns perfectly with the definition of Major Shareholding Notification (MRQ). It is not an earnings release (ER), a full annual report (10-K), or a general regulatory filing (RNS), as it concerns a specific type of ownership disclosure.
2024-01-15 English
Press release_Transparency Notification_15 Jan 2024_NL_vF.pdf
Major Shareholding Notification Classification · 99% confidence The document is titled 'Transparantiekennisgevingen van Aandeelhouders' (Shareholder Transparency Notifications) and explicitly states that the company received a notification from shareholders regarding the number of voting rights attached to their shares. The content details changes in shareholdings and voting rights percentages (e.g., 9.93%) and references the Belgian law regarding the disclosure of major shareholdings (Article 14 of the law of May 2, 2007). This directly corresponds to notifications about changes in significant share ownership levels, which aligns with the definition for Major Shareholding Notification (MRQ). Although it is a regulatory announcement, MRQ is more specific than the general RNS category.
2024-01-15 Dutch

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