Nuwellis Provides More Children in Texas With Access to Its Unique Fluid Management Technology
May 13 2021 - 8:45AM
Reaffirming its commitment to expanding access to life-saving
ultrafiltration therapies for adult and pediatric patients
suffering from fluid overload, Nuwellis, Inc. (Nasdaq: NUWE),
formerly CHF Solutions, Inc., today announced that its Aquadex
SmartFlow® System is now available at Driscoll Children’s Hospital
in Corpus Christi, Texas.
Aquadex enables gentle, precise and adjustable fluid removal,
helping achieve the desired fluid balance with only 35 mL (around
2.5 tablespoons) of blood outside of the body. This is particularly
important for pediatric patients, who have a small amount of blood
in their bodies. Aquadex is clinically proven1 to be safe and
effective in children weighing 20 kg or more. The expansion into
pediatric hospitals like Driscoll Children’s Hospital further
validates the benefit if this technology offers children.
“Aquadex allows us to remove excess fluid according to each
patient’s specific needs, with very high precision, while using a
very small circuit which helps minimize hemodynamic instability in
very sick patients,” said Dr. Samhar Al-Akash, Medical Director of
Dialysis and Transplantation at Driscoll Children’s Hospital.
“Having the flexibility to customize therapy for each unique
patient is especially advantageous in smaller pediatric patients
who have a smaller margin of error. We are excited to offer this
innovative treatment to our patients.”
Fluid overload is associated with adverse outcomes in multiple
disease states including heart failure, kidney failure and critical
care. Alleviating the burden that fluid overload has on vital
organs helps mitigate poor outcomes and reduces the need for
re-hospitalization, leading to better efficiency, reduced costs and
improved outcomes.2
“We continue to deliver on our promise to expand access to
life-saving fluid management technology,” said Nestor Jaramillo,
Jr., President and CEO of Nuwellis. “Ensuring that providers have
the technology they need to help patients recover and thrive is
what motivates us most, and we’re doing it one hospital at a
time.”
About NuwellisNuwellis, Inc. (Nasdaq:NUWE),
formally CHF Solutions, Inc., is a medical device company dedicated
to changing 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. The Company has been listed on the Nasdaq Capital
Market since February 2012, previously branded as CHF Solutions
(Nasdaq:CHFS).
About the Aquadex SmartFlow SystemThe 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
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 about the
anticipated use of the net proceeds. 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 risk associated with our ability to execute on
our commercial 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
as a result of new information, future events or otherwise.
1 Menon S, et al. Clin J Am Soc Nephrol. 2019
Oct 7;14(10):1432-1440.
2 Watson, Ret al (2020). Journal of Cardiac
Failure, 26(10).
CONTACTS
INVESTORS: Nestor JaramilloPresident, Chief
Executive Officer and Chief Financial Officer, Nuwellis,
Inc.ir@nuwellis.com
Matt Basco, CFAGilmartin Group LLCMatt.basco@gilmartinir.com
MEDIA: Laurel
HoodHealth+Commercelaurel@healthandcommerce.com
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