CHF Solutions Receives CE Mark for its New Aquadex SmartFlow™ Console

EDEN PRAIRIE, Minn., Feb. 05, 2020 (GLOBE NEWSWIRE) -- CHF Solutions (Nasdaq: CHFS) today announced the receipt of a CE Mark for its Aquadex SmartFlow console, its next generation ultrafiltration system. The console is a simple, flexible and smart solution for treatment of patients suffering from fluid overload and will be used in the European Union with adult and pediatric patients who weigh 20kg or more.

“We are proud of achieving this milestone this early in the first quarter,” said John Erb, chairman and CEO of CHF Solutions. “The CE Mark for our new Aquadex SmartFlow console allows us to continue the expansion of our business internationally and demonstrates our commitment to changing the lives of patients suffering from fluid overload throughout the world.”

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® and Aquadex SmartFlow systems 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 and Aquadex SmartFlow Systems

The Aquadex FlexFlow and Aquadex SmartFlow systems are clinically proven therapies that provide 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 SmartFlow system, including 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, statements about the company’s growth internationally. 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.

CONTACTS:

INVESTORS:

Claudia Napal Drayton

Chief Financial Officer

CHF Solutions, Inc.

952-345-4205

 

-or-

Bret Shapiro

Managing Partner

CORE IR

516-222-2560

 

 

MEDIA

Jules Abraham

JQA Partners, Inc.

917-885-7378