Nuwellis Announces the Submission of the AVOID-HF Clinical Analysis as a Late Breaking Clinical Trial at HFSA
July 26 2022 - 6:00AM
Nuwellis, Inc. (Nasdaq: NUWE) a commercial-stage company focused on
improving the quality of life for people with fluid overload, today
announced the submission of the AVOID-HF clinical study analysis
using the Finkelstein-Schoenfeld method of Win-Ratios (WR) as a
Late Breaking Clinical Trial at the Heart Failure Society of
America’s (HFSA) 2022 Annual Scientific Meeting in September.
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,
newer statistical methods like the Finkelstein-Schoenfeld method of
hierarchical Win Ratios increase statistical precision to evaluate
the clinical benefit and demonstrate significance between treatment
arms with the added benefit of requiring a smaller study sample
size.
“The Finkelstein-Schoenfeld method of hierarchical Win Ratios
provides a critical framework for evaluating the data obtained from
the 221 patients enrolled in the AVOID-HF study,” said Dr. Sean
Pinney, Professor of Medicine and Co-Director of the Heart and
Vascular Center at The University of Chicago Medicine. “We were
finally able to evaluate the role of ultrafiltration in treating
these fluid overloaded heart failure patients and share our
findings with the medical community.”
Heart failure can disrupt normal kidney function and lower the
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.1 In
addition to the higher mortality rate associated with repeat
hospitalizations for existing patients with HF2, hospitals receive
no reimbursement for patients that are readmitted within 30 days of
initial discharge. According to Premier Applied Sciences data, the
average total unreimbursed cost per inpatient encounter is $24,027,
which highlights the importance of reducing unscheduled 30-day
readmissions.
“The Win-Ratios analysis of the AVOID-HF clinical study will
provide additional evidence to support the use of ultrafiltration
to treat fluid-overloaded heart failure patients,” said Nestor
Jaramillo, Jr., President and CEO of Nuwellis. “We’re grateful to
Drs. Pinney, DeVita, and Costanzo, the authors of this manuscript,
for leading this reanalysis of the AVOID-HF data. 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. We hope the AVOID-HF Win-Ratios
analysis is accepted as a Late Breaking Clinical Trial at HFSA, and
we are excited to share these results with the broader heart
failure community.”
In addition to the AVOID-HF Win-Ratios analysis and submission,
Nuwellis recently announced the first patient enrolled in its
REVERSE-HF clinical study evaluating the clinical benefit 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. Nuwellis also
submitted information on REVERSE-HF to HFSA’s Clinical Trials
Central, as a currently enrolling heart failure randomized
controlled trial.
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.
1 Costanzo MR et al. J Am Coll Cardiol. 2017 May
16;69(19):2428-24452 Andrew H Lin et al. Mil Med. 2017
Sep.
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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