Nuwellis Announces Peer-Reviewed Publication of Clinical Trials Analysis Advocating the Use of Ultrafiltration for Heart Failure Patients Resistant to Diuretics
March 21 2023 - 7:00AM
Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company focused
on transforming the lives of people with fluid overload, today
announced the peer-reviewed publication of an analysis of available
ultrafiltration clinical trials with findings that support
ultrafiltration as a safe and effective therapeutic option for
acute decompensated heart failure (ADHF) patients who are resistant
to diuretics or who have a history of multiple hospitalizations for
fluid overload. The publication highlights the scale of clinical
burden: “ADHF has the highest rate of hospital readmissions among
all medical conditions and portends a significant financial burden
on healthcare systems worldwide.”1
The publication, “Extracorporeal Ultrafiltration
for Acute Heart Failure,” featured in Cardiorenal Medicine Journal,
includes the review of pooled data from seven randomized controlled
trials of ultrafiltration with a total of 771 patient participants.
A. Kazory, et al, highlight the clinical application and value of
ultrafiltration, including:
- Predictable, adjustable, and more
efficient fluid removal with ultrafiltration compared to diuretics,
without clinically adverse impact on renal function, leads to a
reduction in hospital readmissions and financial burden;
- Applicability of ultrafiltration
therapy in other clinical settings, such as cardiac surgery, burn
and other specialty units, where active and prompt volume
management is of utmost importance; and
- Expansion of use of ultrafiltration
into outpatient centers and other ambulatory settings.
John Jefferies, M.D., Chief Medical Officer of
Nuwellis, said, “Hospitalizations for ADHF are primarily driven by
fluid overload, with nearly 50% of these patients leaving the
hospital with inadequate or minimal weight loss, in part due to
unpredictability of diuretic therapy. As such, it also has the
highest rehospitalization rate among all medical conditions.” Dr.
Jefferies added, “Ultrafiltration, however, provides an opportunity
to overcome the shortcomings of diuretics, as the Aquadex® system’s
decongestion technique safely provides for adjustable fluid and
sodium removal. It can also be considered early after admission,
with volume and rate of fluid removal specific to patient
characteristics for more predictable results, which diuretics often
times cannot achieve.”
“We are excited to add this peer-reviewed analysis of
ultrafiltration trials to our growing body of clinical evidence,
which we are leveraging to change practice guidelines to make
Aquadex the standard of care for fluid overload and increase its
use across multiple specialty units in hospitals and outpatient
centers,” said Nestor Jaramillo, President and CEO of Nuwellis. “In
the last six months we have announced various new publications
demonstrating results that favor ultrafiltration over IV diuretics
when using Nuwellis’ Aquadex system. This publication is different
because it outlines the reasons why healthcare providers should use
ultrafiltration and the consequences of not using it to treat ADHF.
We look forward to increased sales momentum as we expand awareness
of the benefits of ultrafiltration over diuretics using the
arguments presented by the authors.”
About NuwellisNuwellis, Inc. (Nasdaq:
NUWE) is a medical technology company dedicated to transforming the
lives of patients suffering from fluid overload through science,
collaboration, and innovation. The company is focused on
commercializing the Aquadex SmartFlow® system for ultrafiltration
therapy. Nuwellis is headquartered in Minneapolis, with a
wholly owned subsidiary in Ireland. For more information visit
www.nuwellis.com or visit us on
LinkedIn.
About the Aquadex SmartFlow®
System The Aquadex SmartFlow system
delivers clinically proven therapy using a simple, flexible, and
smart 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 healthcare 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 2023 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 Kazory A, Sgarabotto L, Ronco C:
Extracorporeal Ultrafiltration for Acute Heart Failure. Cardiorenal
Med 2023;13:1-8. doi: 10.1159/000527204
CONTACTS
INVESTORS: Vivian CervantesGilmartin Group
ir@nuwellis.com
MEDIA: Annika
ParishHealth+Commerceannika@healthandcommerce.com
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