CHF Solutions’ Aquadex FlexFlow® Aquapheresis System Receives FDA IDE Approval for Clinical Study for Pediatric Use
June 29 2017 - 7:00AM
CHF Solutions, Inc., (fka Sunshine Heart, Inc.) (NASDAQ:CHFS)
announced today that researchers in the Stanford University School
of Medicine’s Department of Pediatrics have received FDA
Investigational Device Exemption (IDE) approval to conduct a
clinical study to evaluate the safety and effectiveness of CHF
Solutions’ Aquadex FlexFlow Aquapheresis System for
diuretic-resistant fluid overload in children with acute
decompensated heart failure. The randomized multi-center,
non-blinded clinical study will assess up to 45 children and young
adults ages 6 months to 21 years with heart failure and
diuretic-resistant fluid overload. Heart failure is the
leading cause of death in children with cardiomyopathy and
congenital heart disease.
The study seeks to determine whether Aquapheresis
therapy is associated with greater weight loss and a non-inferior
rate of renal dysfunction compared to optimal medical therapy. In
addition, the impact on heart failure symptoms using a novel
pediatric heart failure symptoms score developed by the
investigators, adverse outcomes and the need for medical management
will be evaluated as secondary endpoints. The study is being led by
Stanford’s Christopher Almond, Associate Professor of Pediatrics
(Cardiology), and David Kwiatkowski, Clinical Assistant Professor
of Pediatrics (Cardiology).
“We are pleased that the researchers have received
FDA approval to proceed with this IDE study,” said John Erb,
Chairman and CEO of CHF Solutions. “Given the limitations of
patient unresponsiveness to diuretic therapies over time, our
solution represents a potentially transformative future standard of
care. We look forward to the clinical data results and to
continuing our efforts to provide patients with additional
treatment options for the treatment of heart failure,” Mr. Erb
concluded.
About CHF Solutions
CHF Solutions, Inc. (NASDAQ:CHFS) is an early-stage
medical device company focused on commercializing the Aquadex
FlexFlow Aquapheresis System. The Aquadex FlexFlow Aquapheresis
System, is indicated for temporary (up to eight hours)
ultrafiltration treatment of patients with fluid overload who have
failed diuretic therapy, and 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. The company's objective is to
improve the quality of life for patients with heart failure and
related conditions. CHF Solutions is a Delaware corporation
headquartered in Minneapolis with wholly owned subsidiaries in
Australia and Ireland. The company has been listed on the NASDAQ
Capital Market since February 2012.
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 statements the
potential for Aquapheresis therapy to be a transformative standard
of care for the treatment of fluid overload in heart failure
patients and our efforts to evolve ultrafiltration as such, and the
receipt of future clinical results. 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, sources of funding for the
approved clinical study, the timing and results of the approved
clinical study, those risk associated with our ability to execute
on our recently announced strategic realignment, 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.
For further information, please contact:
Claudia Napal Drayton
Chief Financial Officer
CHF Solutions Inc.
T: +1-952-345-4205
Investor Relations:
CHF Solutions, Inc.
ir@chf-solutions.com
-or-
Bret Shapiro
Managing Partner
CORE IR
516 222 2560
brets@coreir.com
www.coreir.com
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