EDEN PRAIRIE, Minn., March 19, 2020 (GLOBE NEWSWIRE) — CHF Solutions (Nasdaq: CHFS) today announced the Aquadex FlexFlow system has been licensed and approved for sale in India, making ultrafiltration therapy available for patients suffering from hypervolemia, or fluid overload, in one of the largest countries in the world.
“We are pleased to have reached this important regulatory milestone and look forward to working with our distributor, Wayinia Lifesciences, to launch the Aquadex system in India this year and provide a safe and effective solution for heart failure patients, our primary clinical focus in this country,” said John Erb, chairman and CEO of CHF Solutions.
Approximately 4.5 million individuals suffer from heart failure in India.1 The company further estimates that there are approximately 485,000 hospitalizations each year for heart failure due to fluid overload, of which approximately 330,000 patients (68%) experience fluid overload with less than optimal diuretic response.2
About CHF Solutions
CHF Solutions, Inc. (Nasdaq: CHFS) is a medical device company dedicated to improving the lives of patients suffering from fluid overload with its novel ultrafiltration therapy system. The company is focused on developing, manufacturing and commercializing the Aquadex FlexFlow® and Aquadex SmartFlow™ systems for ultrafiltration therapy. CHF Solutions is headquartered in Minneapolis, Minn., 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. 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 in India. 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 MEDIA: Brad Perriello Health+Commerce 617-817-1385