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.

Communiqués de presse

Sequana Medical to attend 11th Annual LifeSci Partners Corporate Access Event and H.C. Wainwright BIOCONNECT Virtual Conference

CEO Ian Crosbie to participate in a panel discussion on “MedTech and digital tools: What is the Mindset for 2022?” Ghent, Belgium – 17 December 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,...

Sequana Medical announces positive interim results of SAHARA DESERT, the alfapump DSR® study in heart failure patients with persistent congestion

PRESS RELEASE REGULATED INFORMATION – INSIDE INFORMATION 7 December 2021, 07:00 am CET   Interim data from six patients indicate that alfapump DSR therapy can: safely, effectively and rapidly eliminate persistent congestion and restore euvolemia in diuretic-resistant heart failure patients, considerably benefit cardio-renal status, and dramatically improve diuretic responsiveness for months post-treatment Recruitment on-track to...

Sequana Medical announces the completion of patient enrolment in POSEIDON, the North American pivotal alfapump® study

Positive interim analysis reported in July 2021 Reporting of primary endpoint planned for Q4 2022 Ghent, Belgium – 6 December 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 the completion of...

Sequana Medical to present at Jefferies London Healthcare Conference

Ghent, Belgium – 9 November 2021 – Sequana Medical NV (Euronext Brussels: SEQUA, the “Company”), an innovator in the treatment of diuretic-resistant fluid overload in liver disease, malignant ascites and heart failure, today announces that Ian Crosbie, Chief Executive Officer, will present at the Jefferies London Healthcare Conference, taking place in-person and virtually from 16...

Sequana Medical receives MDSAP certification and expands its Quality Management System towards North America

Ghent, Belgium – 3 November 2021 – Sequana Medical NV (Euronext Brussels: SEQUA, the “Company”), an innovator in the treatment of diuretic-resistant fluid overload in liver disease, malignant ascites and heart failure, today announces it has received Medical Device Single Audit Program (MDSAP) certification from its auditing organisation British Standards Institution (BSI), thereby expanding its...

Sequana Medical announces FDA approval to expand patient enrolment in North American pivotal alfapump® study (POSEIDON)

PRESS RELEASE REGULATED INFORMATION – INSIDE INFORMATION 4 October 2021, 07:00 CET   Completion of patient enrolment expected before end of year Primary endpoint read-out due in Q4 2022 59 patients already recruited in the Pivotal Cohort Ghent, Belgium – 4 October 2021 – Sequana Medical NV (Euronext Brussels: SEQUA, the “Company”), an innovator in...

Sequana Medical to present at 8th Annual HealthTech Investment Forum

Participating in Next Generation Medtech & Device Panel on October 5th, 2021 Ghent, Belgium – 28 September 2021 – Sequana Medical NV (Euronext Brussels: SEQUA, the “Company”), an innovator in the treatment of diuretic-resistant fluid overload in liver disease, malignant ascites and heart failure, today announces that Ian Crosbie, Chief Executive Officer, will participate in...

Sequana Medical announces H1 2021 results and provides business update

PRESS RELEASE REGULATED INFORMATION – INSIDE INFORMATION 2 September 2021, 07:00 CET   alfapump® – Positive results from second interim analysis of POSEIDON pivotal study; awaiting FDA approval on POSEIDON pivotal study expansion alfapump® – FDA regulatory submission now expected in mid-2023 due to worldwide supply shortage of electronic components; European commercial activities and clinical...

Sequana Medical appoints Jackie Fielding, former Medtronic VP, to its Board of Directors

  Ghent, Belgium – 31 August 2021 – Sequana Medical NV (Euronext Brussels: SEQUA, the “Company”), an innovator in the treatment of diuretic-resistant fluid overload in liver disease, malignant ascites and heart failure, today announces that it has appointed Jackie Fielding, a former Vice President of Medtronic with more than 30 years of experience in...

Sequana Medical Notice of 2021 Half Year Results and Business Update

  Ghent, BELGIUM – 26 August 2021 – Sequana Medical NV (Euronext Brussels: SEQUA, the “Company”), an innovator in the treatment of diuretic-resistant fluid overload in liver disease, malignant ascites and heart failure, will announce its half year results ended 30 June 2021 on Thursday, 2 September 2021. The management team will host a conference...
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