Disclaimer

Actuellement, le système alfapump® n’est pas approuvé aux États-Unis ou au Canada. Aux États-Unis et au Canada, le système alfapump® se trouve actuellement en phase d’examen clinique (étude POSEIDON), et il est étudié sur des patients adultes souffrant d’ascites réfractaires ou récurrentes dues à une cirrhose du foie. Pour de plus amples informations concernant l’étude clinique POSEIDON, cf. www.poseidonstudy.com.
Le traitement DSR (élimination directe de sodium) se trouve encore en phase de développement, et il convient de tenir compte du fait que toute déclaration concernant la sécurité et l’efficacité émane d’examens pré-cliniques et cliniques en cours, ceux-ci n’ayant pas encore été finalisés.
Actuellement, le traitement DSR n’est pas approuvé pour la recherche clinique aux États-Unis ou au Canada. Il n’y a aucun lien entre le traitement DSR et les examens avec le système alfapump® en cours en Europe.

Sequana Medical announces Annual and Extraordinary General Meetings of Shareholders on 28 May 2020

PRESS RELEASE 28 April 2020 07:00 CEST

REGULATED INFORMATION

 

Publication of Annual Report 2019

Ghent, BELGIUM – 28 April 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, today invites the holders of securities issued by the Company to attend the Annual and Extraordinary General Meetings of Shareholders on Thursday 28 May 2020. Furthermore, the annual report for the financial year 2019 has been published on Sequana Medical’s website and can be accessed here.

The items on the agendas of the meetings include the proposed approval of 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.

The Annual and Extraordinary General Meetings of Shareholders will take place at the Company’s registered offices in Ghent and will start at 09:00 CEST. The full convening notice with the agenda and proposed resolutions can be accessed on the Sequana Medical website: www.sequanamedical.com/investors/shareholder-information.

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 Board of Directors of the Company has decided to hold the meetings behind closed doors without the physical presence of the holders of securities of the Company and their representatives. As a result, the shareholders of the Company can exercise their voting rights only by voting by mail or by means of a handwritten proxy to the Chairman of the Board of Directors. Furthermore, holders of securities of the Company can only exercise their right to ask questions related to the items on the respective agendas of the meetings by means of written questions prior to the respective meetings. For more information, please see the full convening notice on the Company’s website.

As postal services may be disrupted due to the COVID-19 pandemic, the Company recommends the holders of its securities use e-mail for all communications with the Company regarding the general shareholders’ meetings. The Company’s e-mail address for such communications is: IR@sequanamedical.com.

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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