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CHF Solutions Announces that James A. Haley Veterans’ Hospital Receives Final Approval To Initiate Heart Failure Outpatient Study utilizing Aquadex FlexFlow® System

990 Days ago

First Study of Aquadex FlexFlow System Sponsored by United States Veterans Administration for Aquapheresis Treatment in Patients Suffering from Fluid Overload. First patient enrollment expected in the fourth quarter of 2019.

EDEN PRAIRIE, Minn., Oct. 10, 2019 (GLOBE NEWSWIRE) -- CHF Solutions (Nasdaq: CHFS), today announced that James A. Haley Veterans’ Hospital and Clinics (JAHVH), located in Tampa, Florida, has received Institutional Review Board approval to initiate an outpatient study using the Aquadex FlexFlow system (ultrafiltration therapy) to assist in the management of fluid overload in patients suffering from heart failure. In July 2018, CHF Solutions had announced that the Department of Veterans Affairs had awarded blanket purchase agreement for up to $6.5 million to the Company to supply the ultrafiltration therapy for a period of up to 5 years. This is the first study of its kind to be conducted exclusively through the United States Veterans Administration.

Dr. Ramona Gelzer Bell, the principal investigator on this study and the director for Advanced Heart Failure Program at JAHVH, commented, “We are excited about providing great care to our Veterans suffering from fluid overload with the use of ultrafiltration therapy in an outpatient setting. We believe that in addition to improving quality of life, we are reducing the cost of treating patients suffering from fluid overload.  The scientific literature is filled with evidence of the clinical and economic benefits offered by ultrafiltration.”

James A. Haley Veterans’ Hospital is a tertiary care facility classified as a Clinical Referral Level 1 Facility. JAHVH is a teaching hospital, providing a full range of patient care services, with state-of-the art technology as well as education and research. JAHVH consists of six Veterans Health Administration facilities located in Tampa, New Port RicheyZephyrhillsLakeland, Riverview and Brooksville, serving four counties in Central Florida.

“We are grateful to be working with JAHVH to initiate a study of the benefits of aquapheresis to manage fluid overload in our nations’ veterans suffering from heart failure,” said John Erb, chairman and CEO of CHF Solutions.  “Currently, heart failure patients suffering from fluid overload are re-admitted into the hospital, placing a heavy economic burden to the healthcare system.  We look forward to collaborating with the Veterans Administration to offer this treatment in their facilities for heart patients in the out-patient setting and demonstrating the potential savings to the Veterans Health Administration.” 

About CHF Solutions
CHF Solutions, Inc. (Nasdaq:CHFS) is a medical device company dedicated to changing the lives of patients suffering from fluid overload through science, collaboration, and innovative technology. The company is focused on developing, manufacturing, and commercializing the Aquadex FlexFlow system for ultrafiltration therapy. CHF Solutions is a Delaware corporation headquartered in Minneapolis, Minnesota with wholly owned subsidiaries in Australia and Ireland. The company has been listed on the Nasdaq Capital Market since February 2012.

About Aquadex FlexFlow® System
The Aquadex FlexFlow system is a clinically proven therapy that provides a safe, effective, and predictable method of removing excess fluid from patients suffering from fluid overload. The Aquadex FlexFlow system is indicated for temporary (up to eight hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy, and for extended (longer than 8 hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy and require hospitalization. The company has submitted an application to the FDA requesting for 510(k) clearance of the Aquadex FlexFlow system to include pediatric patients who weigh 20kg or more. All treatments must be administered by a healthcare provider, under physician prescription, both of whom having received training in extracorporeal therapies.

Forward-Looking Statements
Certain statements in this release may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including without limitation, the clinical and economic benefits of using the Aquadex FlexFlow system, including in the outpatient setting.  Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this release, including, without limitation, those risk associated with our ability to execute on our commercial strategy, the possibility that we may be unable to raise sufficient funds necessary for our anticipated operations, our post-market clinical data collection activities, benefits of our products to patients, our expectations with respect to product development and commercialization efforts, our ability to increase market and physician acceptance of our products, potentially competitive product offerings, intellectual property protection, our ability to integrate acquired businesses, our expectations regarding anticipated synergies with and benefits from acquired businesses, and other risks and uncertainties described in our filings with the SEC. Forward-looking statements speak only as of the date when made. CHF Solutions does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.



Claudia Napal Drayton
Chief Financial Officer
CHF Solutions, Inc.

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