Nuwellis to Advance Treatment of Critically-Ill Children and Babies Under $1.7 Million NIH Grant
05 August 2021 - 10:00PM
Critically-ill children and babies with kidney failure or who are
dependent on artificial kidney support currently do not have enough
therapeutic options. Nuwellis (Nasdaq: NUWE) plans to fill this
unmet need with the development of a fully integrated pediatric
continuous renal replacement therapy (CRRT) device designed to
provide care for small babies and children. Nuwellis is a medical
device company dedicated to transforming care for patients
suffering from fluid imbalance.
The new device will build on the existing technology of the
company’s Aquadex SmartFlow® system, and 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.
“Historically, providers who treat children face tremendous
challenges as we try to adapt therapies designed for adults to
small children,” said David Askenazi, MD, MSPH and director of the
Pediatric and Infant Center for Acute Nephrology (PICAN) at
Children’s of Alabama and University of Alabama at Birmingham.
“Using Aquadex at Children’s of Alabama has enhanced the way we
care for children as the small circuit improves how we treat our
young patients. Now, with this grant, Nuwellis has the opportunity
to create a machine that is a game-changer by addressing the
additional unmet needs that we still face on a day-to-day
basis.”
CRRT machines are fluid management devices designed to aid or
replace kidney function by removing excess fluid and toxins when
the patient’s kidneys are unable to support the demands of the
body. The new device will be designed to lower the potential
complications, enhance the functionality of traditional CRRT
machines, and incorporate technologies that are needed to address
issues relevant to small children.
Newborns who are born without sufficient kidney function need
life-sustaining therapies until they are big enough for chronic
dialysis machines. In addition, those who develop sudden temporary
kidney failure will ultimately benefit from the innovation by
enabling the clinician to support them while their kidneys are not
working. Nuwellis and KBT plan to design a pediatric-specific CRRT
device to address limitations of the current therapy options on the
market. Sahar Fathallah, MD, professor of pediatrics and director
of pediatric dialysis at Children’s of Alabama and University of
Alabama at Birmingham will serve as the site principal investigator
of the future study analyzing the technology, and Dr. Askenazi will
serve as the sub investigator. Both physicians contributed to the
grant application by determining the most-needed features in the
device.
“The gentle, predictable and effective fluid management design
of Aquadex SmartFlow makes it uniquely beneficial for pediatric
patients,” said Nestor Jaramillo, Jr., President and CEO
of Nuwellis. “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’re committed to getting safe innovation to market
as fast as possible. We’re immensely grateful to the NIH, KBT, and
our pediatric nephrologist medical advisors, such as Dr. Askenazi
and Dr. Fathallah, for making the development of our pediatric CRRT
device possible.”
Aquadex SmartFlow® ultrafiltration is currently approved for
adults and pediatric patients weighing 20 kg (44 lbs) or more, and
works to remove excess fluid to alleviate kidney burden.
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, 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 Statements Certain 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 2021 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.
CONTACTS
INVESTORS:
George Montague
Chief Financial Officer, Nuwellis, Inc.
ir@nuwellis.com
Matt Bacso, CFA
Gilmartin Group LLC
Matt.bacso@gilmartinir.com
MEDIA:
Jessica Stebing
Health+Commerce
jstebing@healthandcommerce.com
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