Nuwellis Announces Peer Reviewed Data Demonstrating 71% Survival with Kidney Replacement Therapy Using a Modified Aquadex in Low-Birth-Weight Preterm Neonates
November 03 2022 - 6:00AM
Nuwellis, Inc. (NasdaqCM: NUWE), a medical technology company
focused on transforming the lives of people with fluid overload,
today announced the publication of promising clinical data
supporting the use of kidney replacement therapy with
ultrafiltration to treat preterm, low weight neonates with
end-stage kidney disease in Pediatrics.
The investigator-led, retrospective study examined seven preterm
neonates with end-stage kidney disease who were successfully
managed using an innovative approach to kidney replacement therapy
using a physician modified Aquadex SmartFlow ultrafiltration
system, which is cleared by the U.S. Food and Drug Administration
only for use in adults and pediatric patients weighing 20 kg (44
lbs.) or more. Five of the seven newborns (71%) survived to
hospital discharge.
Managing neonates with kidney failure can be challenging, as
dialysis and other therapies used to treat kidney failure are
typically designed for adults or larger pediatric patients. These
challenges are especially pronounced in preterm neonates.
Interventions are sometimes not available for these small patients,
who are typically transitioned to palliative care, or a medical
caregiving approach aimed at optimizing quality of life and
mitigating suffering among neonates with serious, complex, and
often terminal illnesses. However, many of these patients are
otherwise healthy and would be considered survivable if kidney
replacement therapy were available.1
“Physicians continue to express the urgent need for neonatal
fluid management therapies designed to support small children and
infants,” said Nestor Jaramillo, Jr., President and CEO of
Nuwellis. “We remain committed to developing safe innovations and
bringing them to market as quickly as possible to address this
critical unmet need. This patient population continues to be an
important and fast-growing segment of our business.”
Nuwellis, which did not sponsor the study that is the subject of
the publication, is currently developing a new, fully integrated
pediatric continuous renal replacement therapy (CRRT) device
designed to provide care for small babies and children under 20 kg.
This device is 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.
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
developing, manufacturing and commercializing the Aquadex
SmartFlow® system for ultrafiltration therapy. Nuwellis is
headquartered in Minneapolis, MN, with a wholly owned subsidiary in
Ireland.
About the Aquadex SmartFlow® SystemThe Aquadex
SmartFlow system delivers clinically superior 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 are 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 Sutherland SM, Davis AS, Powell D, Tanaka J, Woo M, Josephs S,
Wong CJ. Kidney Replacement Therapy in Low Birth Weight Preterm
Newborns. Pediatrics. 2022 Sep 1;150(3):e2022056570. doi:
10.1542/peds.2022-056570. PMID: 35945293.
CONTACTS
INVESTORS:
Lynn Blake
Chief Financial Officer, Nuwellis, Inc.
ir@nuwellis.com
Vivian Cervantes
Gilmartin Group
Vivian.Cervantes@gilmartinir.com
MEDIA:
Sarah Lundberg
Health+Commerce
sarahlundberg@healthandcommerce.com
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