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News Medicure Announces SMILE™-HF Study Demonstrates Use of ReDS™ Results in 58% Reduction in Hospital Readmission Rate

Medicure Inc.
Oct 15, 2019, 08:30 ET

WINNIPEG, Oct. 15, 2019 /PRNewswire/ - Medicure Inc. ("Medicure" or the "Company") (TSXV:MPH, OTC:MCUJF), a cardiovascular pharmaceutical company, is pleased to announce the primary results of the late-breaking SMILETM-Heart Failure (SMILE-HF) Clinical Trial which was presented at the recent Heart Failure Society of America ("HFSA") conference in Philadelphia, PA by Dr. William T. Abraham, the SMILE-HF national principal investigator.

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.

As previously announced on January 28, 2019, Medicure entered into an agreement with Sensible Medical Innovations Inc. ("Sensible") to become the exclusive marketing partner for ReDSTM in the United States and Medicure continues to hold a 7.71% equity stake on a fully diluted basis in Sensible.

"ReDS™ is an easy-to-use, non-invasive, point-of-care tool that we believe should be in the hands of every healthcare team who monitors and manages patients living with heart failure. We are extremely excited about these new results and believe this adds further evidence and value to support the use of ReDS™ as a primary tool to keep patients living with heart failure out of the hospital" said Dr. Albert Friesen, Chief Executive Officer for Medicure.

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.

About ReDS™ System
The ReDS™ is an accurate measurement tool to evaluate pulmonary congestion providing additional information to assist a physician in their assessment of a patient's condition. Assessment with the aid of ReDS™ technology has helped physicians at facilities across the country to better manage their patients' heart failure, with the goal of avoiding readmissions. For more information please visit www.medicure.com/reds.

Indications and Contraindications
ReDS is intended for use by qualified health care practitioners and by patients, under the direction of a physician, in hospitals, hospital-type facilities and home environment, for the non-invasive monitoring and management of patients with fluid management problems in a variety of medically accepted clinical applications.

ReDS is indicated for patients:
With fluid management problems
Taking diuretic medication
Living with Heart Failure
Recovering from Coronary Artery Disease related event
The ReDS system is not appropriate for patients with rib fractures, with or without flail chest.

About Medicure
Medicure is a pharmaceutical company focused on the development and commercialization of therapies for the U.S. cardiovascular market. The present focus of the Company is the marketing and distribution of AGGRASTAT® (tirofiban hydrochloride) injection, ZYPITAMAGTM (pitavastatin) tablets and the ReDS™ device in the United States, where they are sold through the Company's U.S. subsidiary, Medicure Pharma Inc. For more information on Medicure please visit www.medicure.com.

About Sensible Medical
Sensible Medical is a market leader in medical radar monitoring and imaging technology. ReDS™ was adapted for medical use from military 'see-through-wall' technology. The technology is well-positioned to be a difference maker in a wide range of applications and to become the next-generation lung fluid monitoring modality. www.sensible-medical.com.

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