SMILE-HF trial of ReDS shows reduction in readmission for heart failure.- Medicure

Medicure Inc. announced the primary results of the late-breaking SMILE-Heart Failure (SMILE-HF) Clinical Trial. The SMILE-HF trial demonstrated that when used as intended, Remote Dielectric Sensing (ReDS) treatment guided heart failure management prevented 58% of heart failure readmission(s). Data was collected from 268 patients by 43 centers across the United States, constituting the largest randomized control trial to date on the impact of ReDS on managing heart failure. Patients were recruited for the study during hospitalization and followed for up to 9 months at home. Daily measurements were taken using ReDS with the goal of keeping lung fluid content within the normal range of 20-35%. Data aggregated in the cloud was sent to physicians to monitor and adjust medication with the goal to keep each patient's fluid status balanced and avoid hospital readmission. Data were presented at the recent Heart Failure Society of America conference.

The SMILE-HF study was a U.S. based prospective, randomized controlled multicenter trial conducted to investigate Remote Dielectric Sensing (ReDS) guided treatment versus standard of care (SOC) following acute decompensated heart failure (ADHF) hospitalization. The primary endpoint of this study was to determine the rate of recurrent events of heart failure readmissions during the follow-up period.

Comment: On January 28, 2019, Medicure entered into an agreement with Sensible Medical Innovations Inc. to become the exclusive marketing partner for ReDS in the United States and Medicure continues to hold a 7.71% equity stake on a fully diluted basis in Sensible.