Nuwellis Expands Pediatric Access to Ultrafiltration Therapy at Hospitals in Florida and Arkansas
14 June 2022 - 9:00PM
Improving access to life-saving fluid management therapies is a
commitment by which Nuwellis, Inc. (Nasdaq: NUWE) stands. The
company today announced its Aquadex SmartFlow® system is now
available at two new pediatric hospitals in Florida and Arkansas.
“By expanding access to Aquadex, we are another step closer to
fulfilling our purpose-driven mission of positively transforming
the lives of people suffering from fluid overload,” said Nestor
Jaramillo, Jr., President and CEO of Nuwellis. “Fluid overload can
quickly lead to severe complications, and children have limited
treatment options. Our current technology gives providers a tool
they can rely on to remove excess fluid effectively and
efficiently.1 This commitment to pediatric patients has resulted in
significant growth for this segment of our business.”
Acute kidney injury (AKI) and volume overload are common and are
associated with morbidity and mortality in critically ill pediatric
patients.234 These patients require gentle treatment approaches,
which makes Aquadex uniquely beneficial for children. The Aquadex
device is designed to remove small amounts of fluid over time and
only requires 35 mL (around 2.5 tablespoons) of blood outside of
the body. This is a key differentiator compared to other larger and
more complex fluid management devices that can be taxing on the
small bodies of children. Aquadex is cleared by the FDA for use in
children weighing 20 kg or more.
Nuwellis’ therapy meets an unmet need in pediatric patients, and
the benefit of the clinically-proven5 technology can be
demonstrated through its recent expansion to health centers in
Florida and Arkansas.
In addition to bringing its existing technology to new pediatric
health centers, Nuwellis is currently developing a new, fully
integrated pediatric continuous renal replacement therapy (CRRT)
device designed to provide care for small babies and children. This
device will be funded in part by a $1.7 million grant from the
National Institutes of Health (NIH). Nuwellis has partnered with
Minneapolis-based research and development firm Koronis Biomedical
Technologies Corporation (KBT), the grant recipient, to design and
develop a custom pediatric product that will enable clinicians to
better care for babies with limited kidney function.
“The simple, gentle, and smart design of Aquadex SmartFlow makes
it uniquely beneficial for pediatric patients,” said Mr. Jaramillo.
“But when it comes to patient care, especially the care of children
and babies, we can’t settle for good enough. Physicians have
expressed a real need for neonatal fluid management therapies
designed specifically to support the small body size of children
and we are fully committed to getting safe innovation to market as
fast as possible to help these pediatric patients. We’re immensely
grateful to the NIH, KBT, and our pediatric nephrologist medical
advisors in supporting the development of our pediatric CRRT
device. I want to personally thank the medical staff at all
pediatric institutions that dedicate their lives to treating so
many children needing the right medical attention.”
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 Watson R, et al. (2020). Journal of Cardiac Failure, 26(10). 2
Kaddourah A, et al. N Engl J Med 376: 11–20, 20173 Jetton JG, et
al. Lancet Child Adolesc Health 1: 184–194, 20174 Menon S, et al.
Nephrol Dial Transplant 31: 586–594, 20165 Menon S, et al. Clin J
Am Soc Nephrol. 2019 Oct 7;14(10):1432-1440
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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