Nuwellis Announces Data Demonstrating Statistically Superior Clinical Benefit of Aquadex Therapy in Reducing Heart Failure Events and Mortality at the 2022 HFSA Meeting
03 October 2022 - 10:00PM
Nuwellis, Inc. (Nasdaq: NUWE), a commercial-stage company focused
on transforming the lives of people with fluid overload, today
announced the results of the AVOID-HF clinical study analysis
presented at the Heart Failure Society of America’s (HFSA) 2022
Annual Scientific Meeting. The results of the analysis performed
using the Finkelstein-Schoenfeld method of Win-Ratios (WR)
demonstrated a statistically superior benefit when using
ultrafiltration over diuretics for fluid-overloaded heart failure
patients.
“The re-evaluation of AVOID-HF, using the
Win-Ratios calculation, shows that adjustable ultrafiltration is
safe and more effective than adjustable IV diuretics in reducing
heart failure events for hospitalized heart failure patients,” said
Maria DeVita, M.D., Professor of Medicine at Hofstra School of
Medicine/Northwell and Chief of the Division of Nephrology at Lenox
Hill Hospital. “The results favored ultrafiltration over diuretics
in reducing heart failure events within 30 days and cardiovascular
mortality within 90 days. These results give us great confidence in
REVERSE-HF, the ongoing prospective, multicenter, randomized
controlled trial.”
The AVOID-HF outcomes were evaluated using a
composite endpoint consisting of cardiovascular (CV) mortality
within 90 days, heart failure (HF) events within 30-days, and
time-to-first HF event within 90 days. Adjustable Ultrafiltration
(AUF) was statistically superior compared to Adjustable IV Loop
Diuretics (ALD) with 81% more wins (Win Ratio=1.81, p=0.0429). A
secondary WR analysis was also performed with a composite endpoint
consisting of CV mortality within 30 days, HF events within
30-days, and time-to-first HF event within 90 days and found that
AUF was statistically superior to ALD with 109% more wins (Win
Ratio=2.09, p=0.0278). Results from this analysis are aligned with
multiple systematic reviews that have demonstrated adjustable
ultrafiltration to be more effective than diuretics in fluid
removal, weight loss, and reducing hospital readmissions.1-3
“The results of this analysis support the
clinical benefits of providing ultrafiltration with the Aquadex
System in reducing readmissions and rehospitalization in fluid
overloaded heart failure patients,” said Nestor Jaramillo, Jr.,
President and CEO of Nuwellis. “The Aquadex System creates the
potential to provide significant cost savings to hospitals and the
health care system, but more importantly, improved quality of life
for many patients. We’re grateful to Drs. Pinney, DeVita, and
Costanzo, the authors of this manuscript, for leading this
reanalysis of the AVOID-HF data. Nuwellis is committed to making
Aquadex therapy the standard of care for fluid management in heart
failure patients that are unresponsive to diuretics.”
The AVOID-HF (Aquapheresis Versus Intravenous
Diuretics and Hospitalization for Heart Failure) prospective,
multicenter, randomized controlled trial tested the hypothesis that
patients hospitalized for heart failure (HF) 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. The study was trending favorably
when the study sponsor terminated it before reaching full
enrollment for reasons unrelated to patient safety or clinical
futility. At the time, analysis of the AVOID-HF trial data was
inconclusive due to the lower-than-planned sample size. However,
the Finkelstein-Schoenfeld method of hierarchical Win Ratios
increases statistical precision in demonstrating significant
differences in clinical outcomes between treatment arms, while
requiring a smaller study sample size.
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, 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.
CONTACTS
INVESTORS: George Montague, CFA Chief
Financial Officer, Nuwellis, Inc. ir@nuwellis.com
Leigh SalvoGilmartin Group
LLC leigh@gilmartinir.com
MEDIA: Sarah
Lundberg Health+Commerce sarahlundberg@healthandcommerce.com
- Wang, M.J., et al. Medicine (Baltimore), 2021. 100(50): p.
e28029.
- Wobbe, B., et al. Heart Fail Rev, 2021. 26(3): p. 577-585.
- Jain, A., et al. Heart Fail Rev, 2016. 21(5): p. 611-9.
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