CHF Solutions (Nasdaq: CHFS), a medical device company dedicated to
improving the lives of patients suffering from fluid overload
conditions, today announced it will be providing testimony to the
U.S. International Trade Commission (USITC) concerning the
availability of U.S.-sourced medical supplies to treat COVID-19 and
future pandemics.
USITC is highly regarded across the U.S. and the world as an
independent, nonpartisan, quasi-judicial federal agency that
fulfills a range of trade-related mandates. Under its mandate,
USITC provides detailed analysis of international trade issues to
the President and the Congress, and it serves as the forum for the
adjudication of intellectual property and trade disputes.
On August 13, 2020, two Congressional committees – the House
Committee on Ways and Means and the Senate Committee on Finance –
jointly issued a formal request to USITC calling on it to further
its investigation into COVID-19 related supply chain challenges and
to submit its findings in a report to Congress. This report is
widely anticipated to aid Congress in making what the committees
term “critical policymaking decisions” concerning U.S.
COVID-related industry sectors, including the medical device
industry.
On Wednesday, September 23, 2020, USITC will hear from industry
experts, including Nestor Jaramillo, President and Chief Operating
Officer of CHF Solutions. In his testimony, Mr. Jaramillo will
focus on the need for medical supply security in the U.S., and he
will offer CHF Solutions as an example of how U.S.-sourced
solutions can rapidly scale to meet critical needs, such as those
arising during pandemics like COVID-19.
“CHF Solutions is grateful for the opportunity to participate in
USITC’s hearing, and we are honored that our President and Chief
Operating Officer, Nestor Jaramillo, will be speaking with USITC
Commissioners about our experience and recommendations,” said John
Erb, CEO of CHF Solutions. “Our team works hard every day to
deliver the Aquadex SmartFlow™ system, a state-of-the-art solution
that aids specialists caring for patients suffering fluid overload.
It is deeply gratifying for our team’s efforts to be recognized in
such an important and impactful setting.”
When COVID-19 struck, frontline medical teams quickly realized
the pandemic was causing many patients to suffer a complication
known as hypervolemia, an overload of fluids resulting from cardiac
or renal dysfunction. Unless addressed, hypervolemia causes
COVID-19 patients to face a much higher risk of dying due to fluid
in their lungs, respiratory failure, kidney injury and failure,
septic shock, and multi-system organ failure.
Aquadex™ therapy has been deployed in COVID-19 frontline
hospitals as an adjunct therapy for patients afflicted by the
pandemic, enabling physicians to treat volume overload before
patients succumbed to the ravages of hypervolemia. At the same
time, the Aquadex systems also enabled frontline hospitals to free
up dialysis equipment and supplies, both of which experienced
extreme shortages in COVID-19 hot spots.
“We are proud of the clinical outcomes the Aquadex system is
helping to make possible,” continued John Erb, “and we recognize
this progress may have been impossible but for Aquadex’s domestic
production, supply, and servicing. The COVID-19 pandemic produced
an unanticipated demand for our device and support. Because CHF
Solutions manufactures, services, and supplies Aquadex entirely in
the United States, we were able to leverage our domestic presence
to scale rapidly and meet demand, even as the COVID-19 pandemic was
posing serious challenges to international trade. Were Aquadex
foreign sourced, I simply do not know if we would have been able to
scale up, meet demand, and enable frontline care teams to save
their patients from this devastating virus.”
Policy consensus is forming in Washington, D.C. that medical
supply security may only be realized in the U.S. if the domestic
manufacture of essential medications, medical devices, and
protective equipment is established, nurtured, and supported.
Towards that end, federal and state decision makers are giving
priority consideration to coverage, regulatory, and related
policies that may encourage and sustain domestic sources of the
medical items and services the U.S. is likely to need during
COVID-19 and future pandemics.
The Aquadex SmartFlow system is produced in Minnesota and is
used as an adjunct therapy for fluid management by COVID-19
frontline hospitals, especially when dialysis equipment and staff
are limited. As recently cited, isolated ultrafiltration has proven
to be an optimal strategy that primarily focuses on fluid
extraction and optimization of volume status.1 A portable
ultrafiltration device with small extracorporeal volume (i.e. 35
ml), the Aquadex SmartFlow system provides a predictable method for
fluid extraction, making it more likely to achieve precise fluid
balance in COVID-19 patients.
1 https://pubmed.ncbi.nlm.nih.gov/32336959/
About CHF Solutions
CHF Solutions, Inc. (CHFS) is a medical device company dedicated
to changing the lives of patients suffering from fluid overload
through science, collaboration, and innovation. 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 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 about the testimony to be presented to the
U.S. International Trade Commission, the outcome of the report from
the U.S. International Trade Commission, and supply security
provided by domestic manufacturing. 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 expectations regarding
the potential impacts of the COVID-19 pandemic on our business
operations, 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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