CHF Solutions Announces First Commercial Shipments of Aquadex Systems to Brazil, following Regulatory Approval
October 29 2020 - 8:00AM
CHF Solutions (Nasdaq: CHFS), a medical device company dedicated to
changing the lives of patients suffering from fluid overload, today
announced it has shipped the first commercial orders of its Aquadex
SmartFlow™ system to Brazil, following approval from the Brazilian
Health Surveillance Agency, commonly known as ANVISA. CHF Solutions
has partnered with Bragenix Ltda, to serve patients in Brazil.
These shipments expand the company’s worldwide sales outreach into
South America and the largest market in the region.
“The expansion of Aquadex™ into the Brazilian market
demonstrates our commitment to providing physicians and medical
staff throughout the world with effective solutions for treating
fluid overload,” said John Erb, CEO of CHF Solutions. “Regulatory
approval of Aquadex in Brazil was rapidly obtained, highlighting
the impact ultrafiltration therapy can have on patients suffering
from fluid overload due to heart failure, cardiovascular surgery
and other critical care conditions.”
“The Aquadex system provides a simple and predicable method for
removing excess fluid from patients suffering from heart failure,
COVID-19 and other critical care conditions,” said Mario Padovani,
Managing Director of Bragenix. “We are excited to partner with CHF
Solutions and bring this life-saving therapy to Brazil.”
It is estimated that approximately 3.9 million individuals in
Brazil suffer from heart failure.1 CHF Solutions further estimates
that there are approximately 470,000 hospitalizations each year for
heart failure, of which approximately 290,000 patients experience
fluid overload with less than optimal diuretic response.
Ultrafiltration with Aquadex allows clinicians to remove excess
fluid from the body at a very customizable and gentle rate. The
device can remove up to 500 mL of fluid per hour, in increments of
10 mL/hr, enabling providers to customize their treatment approach
specific to the patient being treated.
1 Stevens B., et. al. The Economic Burden of Heart Conditions in
Brazil, Health Economics and Social Policy, Deloitte Access
Economics, Australia. 2016.
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 SmartFlow
system 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 Bragenix
LtdaBragenix is focused on
identifying innovative technologies in the medical, hospital,
commercial and industrial areas and providing sustainable products
of proven international quality to the Brazilian market.
About the Aquadex SmartFlow System The Aquadex
SmartFlow system delivers clinically proven therapy using a simple,
flexible and smart method of removing excess fluid from patients
suffering from hypervolemia (fluid overload). The Aquadex SmartFlow
system is indicated for temporary (up to 8 hours) or extended
(longer than 8 hours in patients who require hospitalization) use
in adult and pediatric patients weighing 20 kg or more whose fluid
overload is unresponsive to medical management, including
diuretics. All treatments must be administered by a health care
provider, within an outpatient or inpatient clinical setting, under
physician prescription, both 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 regarding the use of
the Aquadex system in Brazil. 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:
Jessica Stebing
Health+Commerce
260-336-6202
jstebing@healthandcommerce.com
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