CHF Solutions Announces Registry for Fluid Overload Conditions in Pediatric Patients
July 16 2020 - 8:00AM
CHF Solutions (Nasdaq: CHFS), a medical device company dedicated to
improving the lives of patients suffering from fluid overload,
today announced the development of a pediatric registry through a
partnership with the Acute Kidney Injury Critical Care Research
Foundation and Watermark Research Partners. The registry will
collect real-world evidence on the use of the Aquadex SmartFlow™
ultrafiltration system in pediatric patients with fluid overload.
The registry will include data on ultrafiltration utility,
performance, and safety profile in pediatric patients from
approximately ten research institutions over an anticipated time
period of two and a half years. The parties anticipate
collecting data on up to 500 patients, and the registry is expected
to be operational by the end of this year.
“Fluid overload is associated with increased mortality and
adverse outcomes in pediatric patients. Improving our understanding
of ultrafiltration performance in clinical conditions, such as
cardiac or renal diseases, will be critically important to
effectively inform our treatment strategies,” said Dr. Stuart
Goldstein, M.D., Professor of Pediatrics and Director, Center for
Acute Care Nephrology at Cincinnati Children’s Hospital Medical
Center and Chairman of the Acute Kidney Injury Critical Care
Research Foundation. “To date there has not been a large
prospective multicenter evaluation of the use of the Aquadex system
in pediatric patients. We expect this registry to expand knowledge
about fluid overload to help healthcare providers determine the
best solutions available for their patients.”
“CHF Solutions is committed to supporting the collection of
robust and current clinical data to allow medical professionals to
make well-informed treatment decisions on behalf of their
patients,” said John Erb, CEO of CHF Solutions. “We believe that
this investment will lead to a broad database of important clinical
information to support life-saving interventions to treat fluid
overload in pediatric patients.”
About Fluid Overload in Pediatric PatientsFluid
overload (hypervolemia), which occurs when there is too much fluid
in the body, is a major issue among critically ill children and
adults, and when left untreated, it can lead to life-threatening
consequences. Available therapies require very high relative
extracorporeal blood volumes, which can be challenging for
pediatric patients. In a retrospective, multi-center study, 32
critically ill pediatric patients weighing over 20 kgs and
predominantly suffering from hypervolemia were treated with the
Aquadex FlexFlow System and 97% (31/32) survived to the end of
therapy. 1
- https://pubmed.ncbi.nlm.nih.gov/31462396/
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.
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 Acute Kidney Injury Critical Care Research
FoundationThe Acute Kidney Injury Critical Care Research
Foundation (AKI Foundation) is a non-profit organization dedicated
to research and education in kidney injury over the last
decade. The AKI Foundation is actively involved in multiple
outcome registries as well as ongoing educational endeavors to help
physicians stay on the cutting edge of patient care.
About Watermark Research Partners, IncWatermark
Research Partners, Inc. (Watermark) is a company dedicated to
regulatory support for DSMB and Adjudication Panels during clinical
trials. In the post-market setting, Watermark establishes and
manages Post Market Outcomes and Registry studies including the
registry publication board. Watermark is providing management
and support to the AKI Critical Care Research Foundation and their
education and research activities. Watermark has provided services
for pharmaceutical and medical device companies for nearly 20
years.
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
development of the registry and value of the clinical data
collected in the registry. 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, the risks associated with our expectations regarding
the potential impacts of the COVID-19 pandemic on our business
operations, the risks 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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