CHF Solutions Receives CE Mark for its New Aquadex SmartFlow™ Console
February 05 2020 - 08:00AM
CHF Solutions (Nasdaq: CHFS) today announced the receipt of a CE
Mark for its Aquadex SmartFlow console, its next generation
ultrafiltration system. The console is a simple, flexible and smart
solution for treatment of patients suffering from fluid overload
and will be used in the European Union with adult and pediatric
patients who weigh 20kg or more.
“We are proud of achieving this milestone this early in the
first quarter,” said John Erb, chairman and CEO of CHF Solutions.
“The CE Mark for our new Aquadex SmartFlow console allows us to
continue the expansion of our business internationally and
demonstrates our commitment to changing the lives of patients
suffering from fluid overload throughout the world.”
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® and Aquadex SmartFlow systems
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 and Aquadex SmartFlow
Systems
The Aquadex FlexFlow and Aquadex SmartFlow systems are
clinically proven therapies that provide 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 SmartFlow
system, including 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 may be considered
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995, including without
limitation, statements about the company’s growth internationally.
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 -or-Bret ShapiroManaging
PartnerCORE
IR516-222-2560brets@coreir.com www.coreir.com
MEDIAJules AbrahamJQA Partners,
Inc.917-885-7378jabraham@jqapartners.com
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