Nuwellis Announces First Patient Enrolled in its Pivotal Trial REVERSE-HF
June 29 2022 - 6:00AM
Nuwellis, Inc. (Nasdaq: NUWE) today announced the first patient has
been enrolled in the company’s pivotal REVERSE-HF
(Ult
rafiltration V
ersus
I
V Diur
etics in
Wo
rsening
Heart
Failure) clinical study. REVERSE-HF will evaluate
the clinical outcomes and economic value of its Aquadex®
ultrafiltration therapy in comparison to intravenous (IV) diuretics
for the treatment of fluid overload in patients with worsening
heart failure. The first patient was enrolled by Dr. Sirish
Vullaganti, M.D. at Northwell Health in New York City.
"Heart failure is among the leading causes of hospitalizations
due to the accumulation of fluid requiring decongestion in the
hospital setting. Unfortunately, approximately 1 in 4 patients are
readmitted to the hospital within 30 days of discharge," said Dr.
Vullaganti. "Some patients do not respond well to intravenous
diuretics, and this can prolong hospital stays which can burden
both patients and the healthcare system. We should remain open to
improving treatment for these patients and this study has the
potential to demonstrate that ultrafiltration can improve patient
outcomes, overall quality of life and economic benefits to the
healthcare system."
Heart failure can disrupt normal kidney functions and lower
their ability to remove sodium from the body, resulting in
excessive water retention that can ultimately lead to fluid
overload. Over 1 million heart failure hospitalizations occur
annually in the United States, and fluid overload is the
predominant cause in 90% of the patients. 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.
REVERSE-HF is a multicenter, open-label, randomized controlled
trial that will be conducted across the United States. The study is
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.
“The first patient enrolled in REVERSE-HF marks an exciting
milestone in this study,” said Nestor Jaramillo, Jr., President and
CEO of Nuwellis. “We’re grateful to Drs. Vullaganti, DeVita and
Pinney for their efforts in getting the study off the ground and
gathering additional evidence supporting ultrafiltration to treat
these patients. As a company, we are committed to the ultimate goal
of making Aquadex therapy the standard of care for fluid management
in heart failure patients that are resistant to diuretics. In
talking to medical societies, Nuwellis has been told that
REVERSE-HF will produce the necessary evidence these societies need
to have ultrafiltration included within their medical guidelines.
We look forward to forthcoming clinical publications that support
our belief that REVERSE-HF will be a very positive study.”
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 IV loop diuretics. The study
will assess safety parameters, including, but not limited to,
cardiovascular and renal-related adverse events of special
interest.
REVERSE-HF will use a newer statistical method that increases
precision in demonstrating significance between the ultrafiltration
and IV diuretic treatment arms of the study. This statistical
method, called Finkelstein-Schoenfeld method of Win-Ratios, has
also been used recently to re-evaluate data obtained during the
AVOID–HF prospective, multicenter, randomized controlled trial,
which was the first to propose that patients should be treated with
adjustable ultrafiltration when compared to those receiving
adjustable loop diuretics. The AVOID-HF
(Aquapheresis Versus
Intravenous Diuretics
and Hospitalization for Heart
Failure) trial tested the hypothesis that patients
hospitalized for heart failure and treated with ultrafiltration
would have a longer time to their first heart failure event within
90 days after hospital discharge compared to those receiving IV
loop diuretics. AVOID-HF was trending favorably when it was
terminated before reaching full enrollment for reasons unrelated to
patient safety or clinical futility. The Win-Ratio analysis of
AVOID-HF, which showed superiority of ultrafiltration over
diuretics, is expected to be published in a peer reviewed journal
later this year.
In addition to Northwell Health, Nuwellis is currently
partnering with other clinical institutions that will soon be
enrolling patients for the REVERSE-HF study as well. The company
anticipates at least 12 clinical institutions will ultimately
participate in the study.
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:
George Montague, CFA
Chief Financial Officer, Nuwellis, Inc.
ir@nuwellis.com
Matt Bacso, CFA
Gilmartin Group LLC
Matt.Bacso@gilmartinir.com
MEDIA:
Sarah Lundberg
Health+Commerce
sarahlundberg@healthandcommerce.com
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