EDEN PRAIRIE, Minn., Feb. 12, 2020 (GLOBE NEWSWIRE) — CHF Solutions (Nasdaq: CHFS) today announced the initiation of distribution agreements covering Germany, Austria and Switzerland with Neucomed Group and its affiliates, further expanding its commercial presence in the European Union. The company now has distribution partnerships covering 13 countries worldwide.
Approximately 2.0 million individuals suffer from heart failure in these three countries, including 1.4 million individuals in Germany.1,2,3 The company further estimates that, in Germany, there are approximately 225,000 hospitalizations each year for heart failure due to fluid overload, of which approximately 150,000 patients (68%) experience fluid overload with less than optimal diuretic response.4
“We continue to execute on our goal to expand worldwide access to aquapheresis therapy,” said John Erb, chairman and CEO of CHF Solutions. “With the recently-announced receipt of the CE Mark for our next generation Aquadex SmartFlow™ console, we are able to provide this simple, flexible and smart solution to patients in the EU suffering from fluid overload due to heart failure, cardiovascular surgery and other critical care conditions and are looking forward to working with Neucomed.”
“We are pleased to be partnering with CHF Solutions, and look forward to bringing the new Aquadex SmartFlow system to heart failure patients in central Europe,” said Erwin Mueller, Chief Executive Officer of Neucomed Group.
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.
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.
Claudia Napal Drayton
Chief Financial Officer
CHF Solutions, Inc.
JQA Partners, Inc.
1. Cardiac Failure Review 2017; 3(1):7-11.
2. Swiss Med Wkly. 2011;141:w13171.
3. The European Journal of Heart Failure 6 (2004) 947– 952.
4. Testani, et.al. “Early Rapidly and Highly Accurate Prediction of Poor Loop Diurectic
Natriuretic Response in Patients with Heart Failure.” Circ Heart Fail. 2016; 9:e002370.