CHF Solutions Announces that James A. Haley Veterans’ Hospital Receives Final Approval To Initiate Heart Failure Outpatient...
October 10 2019 - 08:00AM
CHF Solutions (Nasdaq: CHFS), today announced that James A. Haley
Veterans’ Hospital and Clinics (JAHVH), located in Tampa, Florida,
has received Institutional Review Board approval to initiate an
outpatient study using the Aquadex FlexFlow system (ultrafiltration
therapy) to assist in the management of fluid overload in patients
suffering from heart failure. In July 2018, CHF Solutions had
announced that the Department of Veterans Affairs had awarded
blanket purchase agreement for up to $6.5 million to the Company to
supply the ultrafiltration therapy for a period of up to 5 years.
This is the first study of its kind to be conducted exclusively
through the United States Veterans Administration.
Dr. Ramona Gelzer Bell, the principal investigator on this study
and the director for Advanced Heart Failure Program at JAHVH,
commented, “We are excited about providing great care to our
Veterans suffering from fluid overload with the use of
ultrafiltration therapy in an outpatient setting. We believe that
in addition to improving quality of life, we are reducing the cost
of treating patients suffering from fluid overload. The
scientific literature is filled with evidence of the clinical and
economic benefits offered by ultrafiltration.”
James A. Haley Veterans’ Hospital is a tertiary care facility
classified as a Clinical Referral Level 1 Facility. JAHVH is a
teaching hospital, providing a full range of patient care services,
with state-of-the art technology as well as education and research.
JAHVH consists of six Veterans Health Administration facilities
located in Tampa, New Port
Richey, Zephyrhills, Lakeland, Riverview and Brooksville,
serving four counties in Central Florida.
“We are grateful to be working with JAHVH to initiate a study of
the benefits of aquapheresis to manage fluid overload in our
nations’ veterans suffering from heart failure,” said John Erb,
chairman and CEO of CHF Solutions. “Currently, heart failure
patients suffering from fluid overload are re-admitted into the
hospital, placing a heavy economic burden to the healthcare
system. We look forward to collaborating with the Veterans
Administration to offer this treatment in their facilities for
heart patients in the out-patient setting and demonstrating the
potential savings to the Veterans Health Administration.”
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 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 StatementsCertain 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, the clinical and economic
benefits of using the Aquadex FlexFlow system, including in the
outpatient setting. 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 DraytonChief Financial Officer CHF Solutions,
Inc.952-345-4205ir@chf-solutions.com
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