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 results of Annual and Extraordinary General Meetings of Shareholders

PRESS RELEASE

REGULATED INFORMATION

27 May 2021, 06:00 pm CEST

 

Ghent, BELGIUM – 27 May 2021 – Sequana Medical NV (Euronext Brussels: SEQUA) (the “Company” or “Sequana Medical”), an innovator in the treatment of diuretic-resistant fluid overload in liver disease, malignant ascites and heart failure, today 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 the approval of a number of resolutions relating to the financial year ended on 31 December 2020, as well as the re-appointment of directors and the statutory auditor, the approval of a number of change of control clauses, the issuance of a new share option plan, and the renewal of the authorization to the Board of Directors to increase the share capital within the framework of the authorized capital.

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.

 

For more information, please contact:

Sequana Medical

Lies Vanneste

Director Investor Relations

Tel: +32 498 05 35 79

Email: IR@sequanamedical.com

 

LifeSci Advisors

Guillaume van Renterghem

Tel: +41 76 735 01 31

Email: gvanrenterghem@lifesciadvisors.com

 

About Sequana Medical

Sequana Medical is a commercial stage medical device company utilizing its proprietary alfapump® and DSR® (Direct Sodium Removal) technologies to develop innovative treatments for fluid overload in liver disease, malignant ascites and heart failure where diuretics are no longer effective. Fluid overload is a frequent complication of many large diseases including advanced liver disease driven by NASH (non-alcoholic steatohepatitis)-related cirrhosis and heart failure, with diuretic resistance being widespread. 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 DSR and the alfapump DSR® is estimated to be over €5 billion annually in the U.S. and EU5 by 2026.

The alfapump is a unique, fully implanted wireless device that automatically pumps fluid from the abdominal cavity into the bladder, where it is naturally eliminated through urination. DSR is Sequana Medical’s proprietary approach to managing sodium and fluid overload through use of a sodium-free infusate administered into the abdominal cavity.

In the U.S., the Company’s key growth market, the alfapump has been granted breakthrough device designation by the FDA for recurrent or refractory ascites due to liver cirrhosis. Interim data from the ongoing North American pivotal study (POSEIDON) showed positive outcomes against all primary endpoints of the study. This study is intended to support a future marketing application 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 850 alfapump systems have been implanted to date.

Sequana Medical has combined its proven alfapump and proprietary DSR therapy, and is developing the alfapump DSR, a breakthrough approach to fluid overload due to heart failure. RED DESERT, the repeated dose alfapump DSR study in diuretic-resistant heart failure patients has demonstrated that repeated DSR therapy is able to both manage the fluid and sodium balance of these patients as well as restore their diuretic response and improve their cardio-renal status.

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

 

Important Regulatory Disclaimers

The alfapump® system is not currently approved in the United States or Canada. In the United States and Canada, the alfapump® system is currently under clinical investigation (POSEIDON Study) and is being studied in adult patients with refractory or recurrent ascites due to cirrhosis. For more information regarding the POSEIDON clinical study see www.poseidonstudy.com. The DSR® therapy is still in development and it should be noted that any statements regarding safety and efficacy arise from ongoing pre-clinical and clinical investigations which have yet to be completed. The DSR® therapy is not currently approved for clinical research in the United States or Canada. There is no link between the DSR® therapy and ongoing investigations with the alfapump® system in Europe, the United States or Canada.

 

Note: alfapump® is a registered trademark. DSR® and alfapump DSR® are registered trademarks in the Benelux.

 

Download the full press release

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