Disclaimer

Das alfapump®-System ist derzeit weder in den Vereinigten Staaten noch in Kanada zugelassen. In den Vereinigten Staaten und Kanada befindet sich das alfapump®-System gegenwärtig in der klinischen Prüfung (POSEIDON-Studie) und wird bei erwachsenen Patienten mit refraktärem oder rezidivierendem Aszites aufgrund von Zirrhose untersucht. Weitere Informationen zur klinischen Studie POSEIDON finden Sie unter www.poseidonstudy.com.
Die DSR-Therapie befindet sich aktuell in der Entwicklung, und es ist zu beachten, dass alle Aussagen in Bezug auf Sicherheit und Wirksamkeit auf laufenden präklinischen und klinischen Untersuchungen beruhen, die noch nicht abgeschlossen sind.
Die DSR-Therapie ist derzeit in den Vereinigten Staaten oder Kanada nicht zur klinischen Forschung zugelassen. Es gibt keinen Zusammenhang zwischen der DSR-Therapie und laufenden Untersuchungen mit dem alfapump®-System in Europa.

Sequana Medical announces results of Annual and Extraordinary General Meetings of Shareholders

PRESS RELEASE – 28 May 2020, 06:00 PM CEST

REGULATED INFORMATION

Ghent, BELGIUM – 28 May 2020 – Sequana Medical NV (Euronext Brussels: SEQUA, the “Company” or “Sequana Medical”), an innovator in the management of fluid overload in liver disease, malignant ascites and heart failure, announces that all proposed resolutions submitted to the Annual and Extraordinary General Meeting of Shareholders were approved at the meetings held today at 09:00 am CEST.

The items on the agendas of the shareholders’ meetings included a number of resolutions relating to the financial year ended on 31 December 2019, as well as the adoption of an amended and restated version of the articles of associations, in accordance with the provisions of the new Belgian Companies and Associations Code and reflecting some technical changes.

All resolutions and the minutes of the shareholders’ meetings, as well as the revised versions of the Company’s articles of association, can be accessed on the Company’s website.

Exceptionally, and in accordance with the Belgian Royal Decree no. 4 of 9 April 2020 on miscellaneous provisions relating to co-ownership and corporate and association law in the context of the fight against the COVID-19 pandemic, the shareholders’ meetings were held behind closed doors without the physical presence of the holders of securities of the Company and their representatives.

 

For more information, please contact:

Sequana Medical

Lies Vanneste, Director IR

Tel: +32 498 05 35 79

Email: IR@sequanamedical.com

Consilium Strategic Communications

Amber Fennell, Sukaina Virji, Melissa Gardiner

Tel: +44 203 709 5000

Email: sequanamedical@consilium-comms.com

LifeSci Advisors

Chris Maggos

Tel: +41 79 367 6254

Email: chris@lifesciadvisors.com

 

About Sequana Medical

Sequana Medical is a commercial stage medical device company developing the alfapump platform for the management of fluid overload in liver disease, malignant ascites and heart failure. Fluid overload is a fast growing complication of advanced liver disease driven by NASH (non-alcoholic steatohepatitis) related cirrhosis and a common complication in heart failure. The U.S. market for the alfapump resulting from NASH-related cirrhosis is forecast to exceed €3 billion annually within the next 10-20 years. The heart failure market for the alfapump DSR (Direct Sodium Removal) is estimated to be over €5 billion annually in the U.S. and EU5 by 2026. Both indications leverage Sequana Medical’s alfapump, a unique, fully implanted wireless device that automatically pumps fluid from the abdomen into the bladder, where it is naturally eliminated through urination.

In the U.S., the company’s key growth market, the alfapump has been granted breakthrough device designation by the FDA. The North American pivotal study (POSEIDON) in recurrent and refractory ascites due to liver cirrhosis is currently underway, and is intended to support approval of the alfapump in the U.S. and Canada. In Europe, the alfapump is CE-marked for the management of refractory ascites due to liver cirrhosis and malignant ascites and is included in key clinical practice guidelines. Over 750 alfapump systems have been implanted to date. Building on its proven alfapump platform, Sequana Medical is developing alfapump DSR, a breakthrough, proprietary approach to fluid overload due to heart failure. Clinical proof-of-concept was achieved in a first-in-human single dose DSR study and a repeated dose alfapump DSR study (RED DESERT) in heart failure patients is currently underway.

Sequana Medical is headquartered in Ghent, Belgium. For further information, please visit www.sequanamedical.com.

 

Important Regulatory Disclaimers

The alfapump has not yet received regulatory approval in the U.S. and Canada. Any statement in this press release about safety and efficacy of the alfapump does not apply to the U.S. and Canada because the device is currently undergoing clinical investigation in these territories.

DSR therapy and alfapump DSR are still in development and it should be noted that any statements in this press release regarding safety and efficacy arise from pre-clinical studies and ongoing clinical investigations which have yet to be completed. There is no link between DSR therapy, alfapump DSR and ongoing investigations with the alfapump system in Europe, the U.S. and Canada.

 

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.

 

Download the full press release  

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