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 […]
Tag: Alfapump
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- […]
Sequana Medical announces positive interim results of SAHARA DESERT, the alfapump DSR® study in heart failure patients with persistent congestion
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 […]
Sequana Medical announces H1 2021 results and provides business update
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 announces positive results from second interim analysis of North American pivotal alfapump® study (POSEIDON)
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 […]
Sequana Medical Announces Granting of Key alfapump DSR® Patents in U.S. and Europe
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 […]
Sequana Medical to Host KOL Event on “The Challenge of Diuretic Resistance in the Management of Heart Failure Patients and the Potential for alfapump® DSR therapy”
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 […]
Sequana Medical Announces Strong Interim Results From RED DESERT alfapump® DSR Study and Provides Business Update
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 […]