CHF Solutions’ Aquadex FlexFlow® System is licensed and approved for sale in India
March 19 2020 - 8:00AM
CHF Solutions (Nasdaq: CHFS) today announced the Aquadex FlexFlow
system has been licensed and approved for sale in India, making
ultrafiltration therapy available for patients suffering from
hypervolemia, or fluid overload, in one of the largest countries in
the world.
“We are pleased to have reached this important regulatory
milestone and look forward to working with our distributor, Wayinia
Lifesciences, to launch the Aquadex system in India this year and
provide a safe and effective solution for heart failure patients,
our primary clinical focus in this country,” said John Erb,
chairman and CEO of CHF Solutions.
Approximately 4.5 million individuals suffer from heart failure
in India.1 The company further estimates that there are
approximately 485,000 hospitalizations each year for heart failure
due to fluid overload, of which approximately 330,000 patients
(68%) experience fluid overload with less than optimal diuretic
response.2
About CHF Solutions CHF Solutions, Inc.
(Nasdaq: CHFS) is a medical device company dedicated to improving
the lives of patients suffering from fluid overload with its novel
ultrafiltration therapy system. The company is focused on
developing, manufacturing and commercializing the Aquadex FlexFlow®
and Aquadex SmartFlow™ systems for ultrafiltration therapy. CHF
Solutions is headquartered in Minneapolis, Minn., 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. 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 in India. 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 Drayton
Chief Financial Officer,
CHF Solutions, Inc.
952-345-4205
ir@chf-solutions.com
MEDIA:
Brad Perriello
Health+Commerce
617-817-1385
brad@healthandcommerce.com
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