New Case Series Demonstrates Potential of Aquadex Therapy for End-Stage Liver Disease Patients with Fluid Overload
07 February 2024 - 1:00AM
Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company
focused on transforming the lives of people with fluid overload,
today announced the publication of new data demonstrating the
potential value of the Aquadex SmartFlow® system’s aquapheresis
therapy when treating patients with fluid overload as a result of
end-stage liver disease. The publication, “Utilization of
Aquapheresis Among Hospitalized Patients with End-Stage Liver
Disease: A Case Series and Literature Review,” is a single-center
retrospective case series featured in Clinical Transplantation.
“This study presents an exciting new market opportunity for
Nuwellis, and we look forward to gathering additional data
demonstrating how Aquadex can benefit these patients,” said Nestor
Jaramillo, Jr., president and chief executive officer of Nuwellis.
“Four and a half million adults in the U.S. have been diagnosed
with liver disease.1 To date, there has been little to no clinical
evidence gathered demonstrating the benefits of aquapheresis for
patients with liver disease. This publication lays the foundation
for a new clinical application already within our current labeling
that requires no additional regulatory clearances from the
FDA.”
The case series assessed the utilization of aquapheresis therapy
with Aquadex in the intensive care unit (ICU) setting at Mount
Sinai Hospital between January 2020 and July 2023. Fourteen
severely ill patients with end-stage liver disease were treated
with aquapheresis during this period. The most common cause of
liver disease was alcohol-related, with nine of the 14 patients
presenting with alcohol-associated cirrhosis. Key findings from the
case series include:
- Six patients were able to receive physical therapy following
treatment to help improve their mobility while in the ICU.
- Five patients were transferred out of the ICU following
treatment, three of whom were discharged from the hospital.
- There were no catheter-related bloodstream infections or
circuit complications attributed to aquapheresis access.
“For clinicians treating patients with end-stage liver disease,
it can be an enormous challenge to safely and effectively remove
fluid when patients don’t respond to or can’t tolerate diuretic
therapy,” said John Jefferies, M.D., chief medical officer of
Nuwellis. "In such cases, fluid removal via aquapheresis can
enhance patients' mobility and allow them to receive more effective
physical therapy. This can reduce cirrhosis-related frailty and
enhance their ability to receive a life-saving liver transplant in
a more timely manner."
Patients with end-stage liver disease are currently treated with
diuretics, but studies show that the longer a patient is on
diuretics, the less effective they become.2,3 End-stage liver
disease patients are also prone to developing ascites, which
requires paracentesis – a painful procedure using a needle to
remove fluid from the peritoneal cavity. In this case series,
Aquadex was shown to provide a potential additional solution to
mitigate these clinical gaps.
Aquadex is proven to simply, safely, and precisely remove excess
fluid from patients suffering from fluid overload who have not
responded to conventional medical management, including diuretics.
Providers can specify and adjust the rate of fluid removed for each
individual patient, resulting in a gradual reduction of excess
fluid. The device’s built-in, customizable hematocrit monitoring
technology provides real-time measurement of percent blood volume
changes that can be tailored to individual patients’ needs. A
customizable fluid removal rate is particularly important for
pediatric patients who have a small amount of blood in their
bodies. The Aquadex system is cleared by the U.S. Food and Drug
Administration (FDA) for use in adults and pediatric patients
weighing 20 kg (44 lbs.) or more.
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
ir.nuwellis.com or visit us on LinkedIn or X.
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 2024 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
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 due to new
information, future events or otherwise.
CONTACTS
Investors:Vivian CervantesGilmartin
Groupir@nuwellis.com
Media:Dunia
CristanHealth+Commercedunia@healthandcommerce.com
1 CDC. Chronic Liver Disease and Cirrhosis.
https://www.cdc.gov/nchs/fastats/liver-disease.htm2 Felker MG and
Mentz RJ. J Am Coll Cardiol. 2012;59(24):2145-53. 3 Doering A, et
al. Int J Emerg Med. 2017;10(17).
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