The Latest Cardiac and Vascular News
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 […]
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 […]
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 report top–line data in H2 2022 Long-term follow-up of RED DESERT patients shows durable improvement in diuretic response following alfapump DSR therapy Proprietary DSR Infusate 2.0 development on track to start MOJAVE […]
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 studies unaffected alfapump DSR® – Strong top-line results from RED DESERT; interim results […]
REGULATED INFORMATION – INSIDE INFORMATION 1 July 2021, 07:00 am CEST Interim data from 26 patients in the Roll-In Cohort reconfirm positive outcomes against all primary endpointsi Over 90% reduction in mean frequency of therapeutic paracentesis versus baseline All patients experienced at least 50% reduction in mean frequency of therapeutic paracentesis per month versus baseline Clinically important improvement in quality of life maintained even up to 12 months post-implantation Safety profile remains in line […]
GHENT, Belgium, Feb. 04, 2021 (GLOBE NEWSWIRE) — Sequana Medical NV (Euronext Brussels: SEQUA), an innovator in the treatment of diuretic-resistant fluid overload in liver disease, malignant ascites and heart failure, today announces the granting of key patents for the alfapump DSR (Direct Sodium Removal) programme in the U.S. and European Union. […]
Live webcast with Dr. Jeffrey Testani on 11 December 2020 at 03:00pm CET/09:00am EST GHENT, Belgium, Dec. 07, 2020 (GLOBE NEWSWIRE) — Sequana Medical NV (Euronext Brussels: SEQUA), an innovator in the management of fluid overload in liver disease, malignant ascites and heart failure, today announces that it will hold a key opinion […]
RED DESERT: Results from first five patients indicaterepeated dose alfapump DSR therapy to be safeandeffective Interim data support DSR hypothesis: kidneys eliminate free water to maintain patients’ serum sodium levels No patients required loop diuretic therapy during the six-week alfapump DSR treatment period Followingalfapump DSR treatment, loop diuretic responsiveness was restored to near normal levels; effect was durable for months post-treatmentwith majority of patients requiring little or no diuretic therapy Full RED DESERT data on track […]
