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Abington Hospital Begins a 344 Patient Retrospective Clinical Study to Analyze Experience with CHF Solutions’ Aquadex FlexFlow® System

976 Days ago

EDEN PRAIRIE, Minn., Oct. 24, 2019 (GLOBE NEWSWIRE) -- CHF Solutions (Nasdaq: CHFS) today announced that investigators at Abington Hospital-Jefferson Health in Abington, Pennsylvania are conducting a retrospective analysis of their experience using the company’s Aquadex FlexFlow System in heart failure patients with fluid overload.

The study, titled “Retrospective Review of a Single Center Experience with Aquapheresis in the Treatment of 344 Heart Failure Patients with Volume Overload,” is designed to identify patient characteristics, ultrafiltration rates, and renal function response to the utilization of aquapheresis therapy with the Aquadex FlexFlow system. The Abington-Jefferson Health Principal Investigators, Robert Watson, MD, chief of Cardiology and co-director of the Comprehensive Heart Failure program and Donald Haas, MD, medical director, Ventricular Assist Device Program, co-director, Comprehensive Heart Failure Program along with the Sub-Investigators Maureen Hummel, CRNP and Patricia Barrella, RN, MSN are conducting the analysis with the intention of publishing their findings in a peer-reviewed medical journal. Dr. Haas noted, “In our experience of 10 years performing ultrafiltration via Aquadex, we have appreciated a significant benefit for many patients with marked refractory volume overload when properly selected. The question that exists for many institutions is which patient will benefit and how does the clinician select the appropriate rate of fluid removal to achieve decongestion while preserving renal function. We hope that this retrospective review of 344 patients will highlight the patient selection criteria and ultrafiltration rates associated with safe and effective mechanical decongestion in heart failure patients.”

“Regular analysis of professional experience with our Aquadex FlexFlow system is helpful to healthcare providers to better understand optimal management of fluid overload and use of our system,” said John Erb, chairman and CEO of CHF Solutions.  “We are grateful to Drs. Watson and Haas and the Sub-Investigators for studying their center’s experience with Aquadex FlexFlow and look forward to helping other care providers learn from their findings.”

Abington Hospital, founded in 1914, is the largest community teaching hospital in Montgomery and Bucks counties in Pennsylvania. Staff members have the privilege of working with medical students, residents and fellows from Thomas Jefferson University's Sidney Kimmel Medical College and other medical schools and training programs in the Philadelphia area.

Each year, Abington- Jefferson Health treats over 123,000 patients in its two Emergency Departments with Abington Hospital having the distinction of having one of only two Level II trauma centers in Montgomery County. Abington Hospital – Jefferson Health has a comprehensive stroke center and offers highly advanced programs in cancer, cardiac and orthopedic care.

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 are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including without limitation, statements regarding the results of the restrospective study.  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.


Claudia Napal Drayton
Chief Financial Officer
CHF Solutions, Inc.
Bret Shapiro
Managing Partner

Jules Abraham
JQA Partners, Inc.

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