CHFS CHF Solutions Inc

CHF Solutions (Nasdaq: CHFS) today announced results from an investigator-initiated retrospective analysis of utilization of the Aquadex FlexFlow aquapheresis system at Lenox Hill Hospital in New York City. The study was presented at the American Society of Nephrology’s Kidney Week in Washington, D.C. in November 2019.

“We have found that aquapheresis with Aquadex FlexFlow can be safely utilized in situations other than diuretic resistant heart failure, such as critical care in patients experiencing cardiogenic shock, anasarca, ATN with fluid overload, ESRD with bridge ultrafiltration between hemodialysis treatment, and post-op volume overload,” said Dr. Maria V. DeVita, Nephrologist, Lenox Hill Hospital. “Because the Aquadex FlexFlow system is safe and easy to use when compared to more complex hemodialysis systems, these patients were treated in different critical care settings including the cardiothoracic ICU, CCU, medical ICU and the post-op ICU.”

“These results continue to support our assertion that the Aquadex FlexFlow system is a key component in cardiorenal care. This analysis from a leading center in New York City is further validation of this assertion,” said John Erb, CEO of CHF Solutions. “We are extremely pleased with the feedback we consistently receive from healthcare providers on the benefits of aquapheresis with the Aquadex FlexFlow system to manage fluid volume in a variety of contexts.”

The analysis looked at 23 patients who received aquapheresis treatment following cardiogenic shock, including post cardiothoracic procedure, anasarca, acute tubular necrosis (ATN) with volume overload, bridge ultrafiltration in end-stage renal disease (ESRD) between hemodialysis, and post-operative volume overload. The average duration of treatment with Aquadex FlexFlow per patient was 4.26 days. Researchers noted that, despite the significant volume removed per day (1,954 mls) and per encounter (8,323mls), there was no significant change in creatinine (an indicator of renal function). Investigators also noted the ease of using the Aquadex FlexFlow system compared to the more complicated operation of hemodialysis equipment.

About CHF SolutionsCHF Solutions, Inc. (Nasdaq: CHFS) is a medical device company dedicated to changing the lives of patients suffering from fluid overload through science, collaboration, and innovation. 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 StatementsCertain statements in this release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including without limitation, statements regarding the clinical performance of the Aquadex FlexFlow system. 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 commercialization 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
ir@chf-solutions.com
-or-
Bret Shapiro
Managing Partner
CORE IR
516-222-2560
brets@coreir.com
www.coreir.com

MEDIA
Jules Abraham
JQA Partners, Inc.
917-885-7378
jabraham@jqapartners.com