Tag: Sequana Medical

Sequana Medical announces the successful completion of pre-clinical studies with its second-generation DSR product for congestive heart failure

Data from GLPi animal studies demonstrate safety of second-generation DSRii product (DSR 2.0) Data from Phase 1 study of DSR 2.0 in Mexico (CHIHUAHUA) and INDiii filing to US FDA expected in Q1 2023 Planning to start MOJAVE, a US Phase 1/2a randomized controlled multi-center study of DSR 2.0, in […]

Sequana Medical announces grant of additional DSR® patent in United States

Ghent, Belgium – 1 February 2023 – Sequana Medical NV (Euronext Brussels: SEQUA) (the “Company” or “Sequana Medical“), a pioneer in the treatment of fluid overload in liver disease, heart failure and cancer, today announces the grant of an additional US patent for its DSR (Direct Sodium Removal) program. US patent number 11,559,618 B2 has been granted on 24 […]

Sequana Medical announces positive top-line results from SAHARA Ph. 2a study of DSR 1.0 in diuretic-resistant heart failure patients with persistent congestion and first patient dosed successfully with DSR 2.0 in YUKON

PRESS RELEASE REGULATED INFORMATION – INSIDE INFORMATION 15 November 2022, 07:00 am CET Data from SAHARA with first-generation DSR product (DSR 1.0) confirm: Safe, effective and rapid elimination of persistent congestion following intensive DSR therapy Considerable benefit in cardio-renal status maintained till end of study (16 weeks post-intensive DSR therapy) Dramatic and sustained improvement in diuretic response up to 15 months post […]

Sequana Medical announces positive top-line results from the North American pivotal alfapump® study (POSEIDON)

alfapump achieves pre-specified primary effectiveness endpoints with statistical significance at six months post-implantation: o 100% median per-patient reduction in therapeutic paracentesis (TP) post- vs preimplantation (p<0.001) o 77% of patients with at least 50% reduction in number of TP post- vs pre-implantation (p<0.001) alfapump primary safety endpoint data in line […]

Sequana Medical announces H1 2022 results and provides business update

alfapump® – strong interim data / on track to report primary endpoint data of North American pivotal POSEIDON study in Q4 2022 DSR® – clinical evidence of disease-modifying heart failure drug therapy / preparations ongoing to start US phase 1b/2a MOJAVE study in H1 2023 Total liquidity position of €23.8 million and cash runway into Q3 2023             Conference call with live webcast presentation today at 03:00 pm CET / 09:00 am ET Ghent, Belgium – 8 September 2022 – Sequana Medical NV (Euronext Brussels: SEQUA) (the “Company” […]

Alexandra Clyde appointed to Sequana Medical Board of Directors

Seasoned medtech leader with more than 30 years’ healthcare experience Ghent, Belgium – 25 August 2022 – Sequana Medical NV (Euronext Brussels: SEQUA) (the “Company” or “Sequana Medical“), a pioneer in the treatment of drug-resistant fluid overload in liver disease, heart failure and cancer, today announces the appointment of Alexandra Clyde as an independent Non-Executive Director of the Company. Ms. Clyde is a highly experienced global business executive […]

Sequana Medical secures EUR 10 million loan facility with Kreos Capital

Company’s cash runway extended into Q3 2023 Ghent, Belgium – 20 July 2022 – Sequana Medical NV (Euronext Brussels: SEQUA) (the “Company” or “Sequana Medical“), a pioneer in the treatment of drug-resistant fluid overload in liver disease and heart failure, today announces it has entered into a secured loan facility agreement of EUR 10 million […]

Sequana Medical completes enrollment in Phase 2a SAHARA I DSR study, reports disease-modifying profile for Short Term DSR and provides business update

DSR (Direct Sodium Removal) heart failure drug development: Completed enrollment in SAHARA Ii with first-generation DSR product (“DSR 1.0”) – extending study with second-generation DSR product (“DSR 2.0”) to support US INDii filing by year end Proof-of-concept delivered in diuretic-resistant heart failure patients with dramatic and durable improvements in validated clinical measures Heart failure disease-modifying profile – safe, rapid and effective decongestion with no congestion-related heart failure re-hospitalizations observed […]

Sequana Medical announces 2021 Full Year Results and 2022 Outlook

alfapump® in liver disease Positive results from second interim analysis of POSEIDON pivotal study; encouraging survival data at 12 months vs. published literature Patient enrolment and implants completed; primary endpoint on track for Q4 2022 FDA regulatory submission planned for mid-2023 DSR® in heart failure RED DESERT study demonstrated safety, cardio-renal benefit and long-term improvement in diuretic response SAHARA DESERT study interim data shows ability […]