New Real-World Data Highlight the Clinical Benefits of Ultrafiltration Therapy with Hematocrit Monitoring for Pediatric Patients
29 November 2023 - 12:00AM
New real-world data demonstrate that pediatric patients with fluid
overload respond well to Aquadex® ultrafiltration therapy with
continuous hematocrit monitoring, announced Nuwellis, Inc. (Nasdaq:
NUWE), a medical technology company focused on transforming the
lives of people with fluid overload. The publication, “Using
Aquapheresis with Continuous Hematocrit Monitoring to Guide
Ultrafiltration,” was featured in Pediatric Nephrology. 1
The publication is a single-center case study review of
pediatric patients with hypoalbuminemia and severe fluid overload.
Patients were treated with Nuwellis’ Aquadex® ultrafiltration
therapy with continuous hematocrit monitoring to guide isotonic
fluid removal. The study concluded that the therapy successfully
treated small patients without hemodynamic instability or other
complications, demonstrating that Aquadex is an effective treatment
option for fluid overload.
“We’re proud to share new evidence supporting the clinical need
and applications for Aquadex among pediatric patients, and we’re
grateful to Dr. Michelle Starr and her colleagues for their trust
and confidence in our therapy,” said Nestor Jaramillo, Jr.,
President and Chief Executive Officer of Nuwellis. “Our proprietary
hematocrit sensor which is incorporated into the Aquadex console
was a result of physician feedback and observations from clinical
studies that drove us to make our Aquadex therapy even smarter. Our
team is committed to supporting diuretic-resistant patients
broadly, and I’m encouraged to see data validating this strategy as
Nuwellis works to expand access to ultrafiltration to even more
patients and clinicians.”
“Managing fluid overload for pediatric patients can be
challenging, but these new data and our growing library of evidence
support our view that Aquadex can provide a safe and effective
method for restoring fluid balance,” said John Jefferies, MD, Chief
Medical Officer of Nuwellis. “The continuous hematocrit monitoring
function within the Aquadex provides unique and proprietary
therapeutic direction, as demonstrated in this important
publication.”
Effectively managing fluid overload for pediatric patients is
critical. Fluid overload is associated with significant increases
in mortality in pediatric patients. Research has shown that a 3%
increase in mortality is observed for every 1% increase in fluid
overload among these patients. 2,3
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 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
www.nuwellis.com or visit us on LinkedIn or Twitter.
About the Aquadex SmartFlow®
System The 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 regarding the new
market opportunities and anticipated growth in 2023 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
due to new information, future events or otherwise.
1 Starr MC, et al. Pediatric Nephrology, September 20232
Sutherland SM, et al. American Journal of Kidney Diseases, vol. 55,
no. 2, pp. 316-325, February 2010.3 Gillespie RS, et al. Pediatric
Nephrology, vol. 19, no. 12, pp. 1394-1399, December 2004.
CONTACTS
Investors:Vivian CervantesGilmartin
Groupir@nuwellis.com
Media:Laurel
HoodHealth+Commercelaurel@healthandcommerce.com
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