Nuwellis Provides Regulatory Update on SeaStar Medical’s Selective Cytopheretic Device Use in Pediatric Acute Kidney Injury Under a Humanitarian Device Exemption
October 10 2023 - 8:00AM
Nuwellis, Inc. (Nasdaq: NUWE) (Nuwellis), a medical technology
company dedicated to transforming the lives of people with fluid
overload, today announced that its distribution partner, SeaStar
Medical (SeaStar), received correspondence from the U.S. Food and
Drug Administration’s (FDA) Center for Biologics Evaluation and
Research (CBER) indicating that the Agency considers SeaStar’s
Selective Cytopheretic Device (SCD) Pediatric (SCD-PED) to be
approvable under a Humanitarian Device Exemption (HDE) for use in
children weighing 10 kilograms or more with acute kidney injury
(AKI) and sepsis or a septic condition requiring continuous kidney
replacement therapy (CKRT) in the hospital intensive care unit
(ICU).
The correspondence indicates that an Approvable
Letter is expected to be issued within a month. The Approvable
Letter will outline conditions, including language for safety,
probable benefit and labeling for intended use, which will be
required for formal marketing approval.
In December of 2022, Nuwellis and SeaStar
entered into a U.S. license and distribution agreement for SeaStar
Medical’s SCD for pediatric AKI. Under this agreement, Nuwellis
will market and distribute the SCD through its direct salesforce to
nephologists and intensive care physicians who are trained in
pediatric extracorporeal therapy.
“This regulatory update is an important
milestone for our partner, SeaStar, who intends to follow the
regulatory path laid out by the FDA for marketing approval to
commercialize SCD for the pediatric indication by the end of 2023,”
said Nestor Jaramillo, Jr., President and CEO of Nuwellis.
“Nuwellis’ pediatric team is excited to finally bring this
lifesaving therapy to serve the needs of its growing network in the
pediatric clinical community.”
Each year in the U.S. approximately 4,000
children with AKI require CKRT and those patient profiles are
associated with high mortality. The mortality rate in children with
AKI requiring CKRT is approximately 50 percent. Children who
survive an AKI episode are at risk for long-term conditions,
including chronic kidney disease (CKD).1
About Nuwellis
Nuwellis, 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, Minnesota with a
wholly owned subsidiary in Ireland. For more information
visit www.nuwellis.com or visit us
on LinkedIn.
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.Goldstein, Stuart L., et al. “Use of the
Selective Cytopheretic Device in Critically Ill
Children.” Kidney International Reports, vol. 6, no. 3, 18
Dec. 2020, pp. 775–784.,
https://doi.org/10.1016/j.ekir.2020.12.010.
CONTACTS
INVESTORS:Vivian
CervantesGilmartin Group LLCir@nuwellis.com
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