Nuwellis, Inc. (Nasdaq: NUWE), a commercial-stage company focused
on transforming the lives of people with fluid overload, today
announced the activation of three additional sites for its pivotal
REVERSE-HF (Ultrafiltration Versus IV Diuretics in Worsening Heart
Failure) clinical study. Jefferson Abington Hospital in
Pennsylvania, the University of California San Francisco (UCSF),
and Baycare Morton Plant Hospital in Florida are now eligible to
enroll patients and evaluate the clinical outcomes and economic
value of the Aquadex® ultrafiltration therapy in comparison to
intravenous (IV) diuretics for the treatment of fluid overload in
patients unresponsive to diuretics with worsening heart failure.
"We have significant experience providing ultrafiltration
therapy to patients with acute decompensated heart failure and our
recent 10-year retrospective study showed that it compares
favorably in reducing heart failure rehospitalizations, renal
function response, and weight and fluid volume loss1,” said Dr.
Donald Haas, M.D., Medical Director, Mechanical Circulatory Support
and Director, Comprehensive Heart Failure Program at Jefferson
Abington Hospital. “The REVERSE-HF study has the potential to yield
the highest level of evidence yet demonstrating the clinical,
economic, and quality-of-life benefits of using ultrafiltration to
treat heart failure patients who are unresponsive to
diuretics.”
Heart failure can disrupt normal kidney function 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, 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.2 Clinical
studies have shown that ultrafiltration can reduce these
readmissions by half.
“Fluid overload is a significant contributor to morbidity and
mortality in heart failure patients. In addition, the frequent
hospital readmissions to treat these patients result in a
tremendous burden to our healthcare system,” said Dr. Liviu Klein,
M.D., Professor of Clinical Medicine and Director, Cardiology
Clinical Research at the University of California San Francisco.
“Ultrafiltration has the potential to more adequately decongest
heart failure patients that are unresponsive to diuretics, thus
reducing readmissions, improving clinical and economic outcomes,
and patient quality of life. We look forward to participating in
the REVERSE-HF study.”
REVERSE-HF is a multicenter, open-label, randomized controlled
trial that is being 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 current standard of care for treating fluid-overloaded
heart failure patients has led to mixed outcomes due to a
significant number of them not responding to traditional
diuretics,” said Dr. Leslie Miller, Director of Heart Failure at
BayCare Morton Plant. “Early application of ultrafiltration therapy
in the appropriate patients could improve their outcomes and
quality of life by more adequately decongesting them, thus reducing
the risk of rehospitalizations. We’re excited to further evaluate
the benefits of ultrafiltration with Aquadex in treating these
patients.”
“We are excited about the activation of Jefferson Abington
Hospital, the University of California San Francisco, and BayCare
Morton Plant as REVERSE-HF study sites,” said Nestor Jaramillo,
Jr., President and CEO of Nuwellis. “All three institutions have a
long history of clinical excellence and experience that will
contribute to its successful enrollment. We are grateful to Drs.
Haas, Klein, Miller, and their clinical teams for their
contributions in gathering additional evidence supporting the
benefits of ultrafiltration therapy in heart failure 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 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 uses a statistical method that increases precision in
demonstrating significant differences in clinical outcomes between
treatment arms. This statistical method, called the
Finkelstein-Schoenfeld method of Win-Ratios, has also been used
recently to re-evaluate data obtained during the AVOID–HF
(Aquapheresis Versus Intravenous Diuretics and Hospitalization for
Heart Failure) 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 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 will be presented as a late-breaking abstract
at the Heart Failure Society of America Annual Scientific Meeting
in Washington D.C., on September 30. This paper is also expected to
be published in a peer reviewed journal later this year.
In addition to Jefferson Abington, USCF, and BayCare Morton
Plant, 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 participate in the study.
About Nuwellis
Nuwellis, 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, Minn., with a wholly-owned
subsidiary in Ireland.
About the Aquadex SmartFlow System
The 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 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 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.
1. Watson R, et al. J Card Fail. 2020; 26(10): S56.
2. Costanzo MR, et al. J Am Coll Cardiol.
2017;69(19)2428-2445
CONTACTS
INVESTORS:
George Montague, CFA
Chief Financial Officer, Nuwellis, Inc.
ir@nuwellis.com
Leigh Salvo
Gilmartin Group LLC
leigh@gilmartinir.com
MEDIA:
Sarah Lundberg
Health+Commerce
sarahlundberg@healthandcommerce.com
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