Multi-Center, Retrospective Study Evaluates Use of Ultrafiltration Therapy with Aquadex FlexFlow® System in Pediatric Patien...
September 24 2019 - 8:00AM
CHF Solutions, Inc. (Nasdaq:CHFS) today announced the publication
of a multi-center, retrospective study in the Clinical Journal of
the American Society of Nephrology1 evaluating the use of
hemofiltration and ultrafiltration therapy with the company’s
Aquadex FlexFlow system in pediatric patients. The Aquadex FlexFlow
system is not yet cleared by FDA for use in pediatric patients.
The study, titled “Kidney Support in Children Using an
Ultrafiltration Device,” included 117 patients in three weight
categories: <10 kgs; 10-20 kgs; and >20 kgs, suffering from
volume overload, acute kidney injury or end-stage kidney disease.
All patients across the three weight categories were treated with
the Aquadex FlexFlow system, using one of the following three
modalities: slow continuous ultrafiltration (SCUF); continuous
veno-venous hemofiltration (CVVH); or prolonged intermittent kidney
replacement therapy, based on patient condition.
The primary outcome was survival to the end of therapy. In
patients weighing over 20 kgs (n=32), 97% survived to the end of
therapy. In patients weighing between 10-20 kgs (n=13), 100%
survived to the end of therapy. In patients weighing under 10 kgs
(n=72), 60% survived to the end of therapy.
“We report the first multi-center experience in pediatrics in
which we use an ultrafiltration device to provide kidney support
therapy in younger patients," said David Askenazi, M.D., M.S.P.H.,
Professor of Pediatrics at the University of Alabama
Birmingham/Children’s of Alabama. “For many of the types of
patients in the study, available therapies require very high
relative extracorporeal blood volumes, which can be challenging.
With the use of an ultrafiltration device with a small blood
volume, we were able to initiate therapy with excellent hemodynamic
stability.”
As previously announced, the company will be hosting a
conference call and webcast with investigators from the study
tomorrow, September 25, at 1:00 pm Eastern Time. To access
the live webcast, please visit the Investors page of the CHF
Solutions website at http://ir.chf-solutions.com or access the
webcast directly at http://ir.chf-solutions.com/events.
Alternatively, you may access the live conference call by dialing
(877) 303-9826 (U.S.) or (224) 357-2194 (international) and using
conference ID: 6985754. An audio archive of the webcast will be
available following the call on the Investor page at
http://ir.chf-solutions.com/events.
About CHF SolutionsCHF Solutions, Inc.
(Nasdaq:CHFS) is a medical device company focused on developing,
manufacturing and commercializing the Aquadex FlexFlow system for
aquapheresis therapy. The Aquadex FlexFlow system is a clinically
proven therapy that provides a safe, effective, and predictable
method of removing excess sodium and 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 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. CHF
Solutions expects to submit an application to the FDA requesting a
modification to the 510(k) clearance for the Aquadex FlexFlow
system to include pediatric patients above 20kg in the near future.
The company is dedicated to changing the lives of patients
suffering from fluid overload through science, collaboration, and
innovative. 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.
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 use of the Aquadex Flex
Flow system in pediatric patients. 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.
1.
https://cjasn.asnjournals.org/content/early/2019/08/27/CJN.03240319
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
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