Tag Archive for: DSR

Sequana Medical announces FDA clearance of IND application for DSR® 2.0 for treatment of congestive heart failure

MOJAVE study on track to start in Q2 2023 as planned, with initial data by year-end Randomized, controlled study in US seeking to confirm strong efficacy data seen in RED DESERT and SAHARA studies DSR well positioned as disease-modifying heart failure therapy Ghent, Belgium – 02 May 2023 – Sequana Medical NV (Euronext Brussels: SEQUA) (the “Company” or “Sequana Medical“), […]

Sequana Medical announces submission of Investigational New Drug (IND) application for DSR® 2.0 for treatment of congestive heart failure

Ghent, Belgium – 03 April 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 that it has submitted an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) on 31 March 2023 for its second-generation […]

Sequana Medical announces additional patents for DSR® in China and the United States

Ghent, Belgium – 22 March 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 further strengthening of the intellectual property portfolio for its DSR (Direct Sodium Removal) program. A key composition of matter patent was allowed in China […]

Sequana Medical announces positive results from CHIHUAHUA, Phase 1 clinical trial of second-generation DSR product for congestive heart failure

Phase 1 clinical trial (CHIHUAHUA) demonstrates that single dose of second-generation DSR product (DSR 2.0) is safe and well-tolerated, and indicates a compelling dosing profile On track to file IND[i] application to US FDA in Q1 2023 Start of MOJAVE, a US multi-center randomized controlled Phase 1/2a clinical trial of DSR 2.0, planned for Q2 2023 […]

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

Data from GLP[i] animal studies demonstrate safety of second-generation DSR[ii] product (DSR 2.0) Data from Phase 1 study of DSR 2.0 in Mexico (CHIHUAHUA) and IND[iii] 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 Q2 2023 Ghent, Belgium – 08 February 2023 – Sequana […]