CHF Solutions submits 510(k) application for Use of Aquadex FlexFlow® System with Pediatric Patients
October 01 2019 - 8:00AM
CHF Solutions, Inc. (Nasdaq:CHFS) today announced that it 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. Subject to FDA review, the company expects
clearance for this pediatric population by the end of the year.
“We are excited to have achieved this significant milestone in
our corporate strategy to make the Aquadex FlexFlow technology
available to pediatric patients,” said John L. Erb, chairman and
CEO of CHF Solutions. “Following FDA clearance, we look forward to
expanding use for these most vulnerable patients, who have limited
alternative solutions.”
“We are pleased with CHF Solutions’ commitment to taking the
regulatory steps to support our efforts in delivering this therapy
to pediatric patients,” said Dr. Stuart L. Goldstein, Director of
the Center for Acute Care Nephrology at Cincinnati Children's
Hospital Medical Center. “Devices like this will address a
significant unmet need in the treatment options available to
children.”
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 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 and the likelihood
and timing of receipt of FDA clearance. 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.
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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