CHF Solutions Submits Patent Application for Pediatric Use of Aquadex FlexFlow® System
April 03 2019 - 8:30AM
CHF Solutions (Nasdaq: CHFS) today announced the submission of a
method of use application to the United States Patent and Trademark
Administration for pediatric use of its Aquadex Flex Flow System.
Illustrative claims in the application include customizable
circuit volume for optimizing pediatric patient hemodynamics and a
mechanism to ensure the safety of pediatric patients.
“We remain dedicated to the innovation of our technology and to
optimizing the application of our Aquadex FlexFlow system, a safe,
effective and clinically-proven solution to manage fluid overload,”
said John Erb, chairman and CEO of CHF Solutions. “As we seek FDA
clearance to modify the label of Aquadex to include pediatric
patients, we intend to ensure that we have intellectual property
protection to support the expanded use when the expected clearance
is received.”
About CHF Solutions
CHF Solutions, Inc. (Nasdaq:CHFS) is a medical device
company focused on commercializing the Aquadex FlexFlow system for
aquapheresis therapy. 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. The company's
mission is to predict, measure, and control patient fluid balance
through science, collaboration, and innovative medical technology.
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 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, that this patent will provide sufficient intellectual
property protection and the modification to the label of Aquadex
FlexFlow system for pediatric use will receive clearance from the
FDA. 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, 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 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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