Nuwellis Initiates REVERSE-HF Study to Evaluate Ultrafiltration for Heart Failure Patients with Fluid Overload
February 17 2022 - 8:00AM
Nuwellis, Inc. (Nasdaq: NUWE) today announced the company will
evaluate the clinical outcomes and economic value of its Aquadex®
therapy in comparison to intravenous diuretics for the treatment of
fluid overload in patients with worsening heart failure through its
randomized controlled trial, Ultrafiltration Versus IV Diuretics in
Worsening Heart Failure, the REVERSE-HF Study.
REVERSE-HF is a multicenter, open-label, randomized
controlled trial with an adaptive design that will be conducted
across the United States. The study will be led by Sean Pinney,
M.D., Professor of Medicine and Co-Director of the Heart and
Vascular Center at The University of Chicago Medicine, and Maria V.
DeVita, M.D., Professor of Medicine at Hofstra School of
Medicine/Northwell and Chief of the Division of Nephrology at Lenox
Hill Hospital. Enrollment in the trial will begin this year.
“Traditional diuretics can result in mixed
outcomes, and people with heart failure who are experiencing fluid
overload don’t always respond to them,” said Dr. Pinney. “We’re
excited to further evaluate how ultrafiltration with Aquadex may
optimally treat these patients.”
The primary effectiveness endpoint of REVERSE-HF
will evaluate mortality and heart failure events within 30 days and
90 days as a comparison between Aquadex therapy and intravenous
(IV) loop diuretics. The study will assess safety parameters,
including but not limited to cardiovascular and renal related
adverse events of special interest.
Heart failure can disrupt normal kidney functions
and lower their ability to remove sodium from the body, which can
cause excessive water retention resulting in fluid overload. Over 1
million heart failure hospitalizations occur annually in the United
States, and fluid overload is the predominant cause. Furthermore,
nearly one quarter of heart failure patients will be readmitted to
the hospital within 30 days of their initial discharge, and half
will be readmitted within 6 months.1
“Heart failure patients suffering from fluid
overload are frequently readmitted to the hospital, resulting in a
tremendous burden to both patients and our healthcare systems,”
said Dr. DeVita. “We’re looking forward to learning more about how
ultrafiltration can improve patient quality of life and prevent
these readmissions.”
About NuwellisNuwellis, Inc.
(Nasdaq: NUWE) is a medical device company dedicated to
transforming 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. Nuwellis is
headquartered in Minneapolis, with a wholly-owned subsidiary in
Ireland.
About the Aquadex SmartFlow®
SystemThe Aquadex SmartFlow system delivers
clinically proven therapy using a simple, flexible and predictable
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 StatementsCertain
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 new market opportunities and anticipated growth in
2022 and beyond. 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
risks associated with our ability to execute on our
commercialization strategy, the impact of the COVID-19 pandemic,
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. Nuwellis 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:Matt Bacso, CFAGilmartin
Group LLC
MEDIA:Sarah
LundbergHealth+Commerce
1 Costanzo MR, et al. J Am Coll Cardiol. 2017 May
16;69(19):2428-2445.
CONTACTS
INVESTORS:
Matt Bacso, CFA
Gilmartin Group LLC
matt.bacso@gilmartinir.com
MEDIA:
Sarah Lundberg
Health+Commerce
sarahlundberg@healthandcommerce.com
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