Nuwellis Marks First Commercial Sale of QUELIMMUNE™ Therapy to Cincinnati Children’s
July 17 2024 - 9:00AM
Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company
dedicated to transforming the lives of patients suffering from
fluid overload, is proud to announce its first commercial sale of
QUELIMMUNE™, a novel therapy developed by SeaStar Medical Holding
Corporation for pediatric patients suffering from an uncontrolled
inflammatory response triggered by their immune systems, to
Cincinnati Children’s. We believe this milestone marks a
significant advancement in pediatric critical care and underscores
Nuwellis’ commitment to revolutionizing pediatric patient outcomes.
QUELIMMUNE, or Selective Cytopheretic Device for
pediatrics, represents a transformative solution for pediatric
patients suffering from acute kidney injury (AKI) due to sepsis or
a septic condition on antibiotic therapy and requiring kidney
replacement therapy (KRT). Early clinical data suggest a 77%
survival rate for patients treated with this new therapy1. Through
Nuwellis’ exclusive U.S. license and distribution agreement with
SeaStar Medical (Nasdaq: ICU), the developer of QUELIMMUNE, this
therapy is now accessible under a Humanitarian Device Exemption
(HDE) from the Food and Drug Administration (FDA) to medical
institutions like Cincinnati Children’s, giving nephrologists and
intensive care physicians a novel option to address the needs of
these critically ill pediatric patients.
Dr. Stuart Goldstein, Director of the Center for
Acute Care Nephrology at Cincinnati Children’s Hospital, and
Principal Investigator of the multi-center studies that led to FDA
clearance of QUELIMMUNE, expressed his enthusiasm for the
introduction of QUELIMMUNE as standard of care: "We are excited to
integrate QUELIMMUNE into our arsenal of therapies for critically
ill children with sepsis and AKI requiring CKRT. This innovative
treatment offers new hope for this population that had not seen
improvement in outcomes for the last 20 years."
Nestor Jaramillo, President and CEO of Nuwellis,
emphasized the company’s dedication to advancing pediatric
healthcare through strategic collaborations and innovative
solutions: "The first commercial sale of QUELIMMUNE marks a
significant achievement in our pediatric business development
strategy. We are excited to collaborate with SeaStar Medical to
deliver this life-saving therapy to critically ill patients,
reinforcing Nuwellis’ commitment to driving positive change in
pediatric critical care."
About
QUELIMMUNEQUELIMMUNE is a patented cell-directed
extracorporeal device that employs immunomodulating technology to
selectively target proinflammatory neutrophils and monocytes during
KRT and reduces the hyperinflammatory milieu including the cytokine
storm that causes inflammation, organ failure and possible death in
critically ill patients. Unlike pathogen removal and other
blood-purification tools, the device is integrated with KRT
hemofiltration systems to selectively target and transition
proinflammatory monocytes to a reparative state and promote
activated neutrophils to be less inflammatory. QUELIMMUNE
selectively targets the most highly activated proinflammatory
neutrophils and monocytes. These cells are then returned back into
the body through the blood, and the body is signaled to lower its
inflammatory environment and focus on repair. This unique
immunomodulation approach may promote long-term organ recovery and
eliminate the need for future KRT, including dialysis.
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 X.
About SeaStar MedicalSeaStar Medical Holding
Corporation is a commercial-stage medical technology company
that is redefining how extracorporeal therapies may reduce the
consequences of excessive inflammation on vital organs. SeaStar
Medical’s novel technologies rely on science and innovation to
provide life-saving solutions to critically ill patients. SeaStar
Medical is developing and commercializing cell-directed
extracorporeal therapies that target the effector cells that drive
systemic inflammation, causing direct tissue damage and secreting a
range of pro-inflammatory cytokines that initiate and propagate
imbalanced immune responses. For more information
visit https://seastarmedical.com/ or visit us
on LinkedIn or X.
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 2024 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.
CONTACTS
Investors:Vivian CervantesGilmartin
Groupir@nuwellis.com
- Goldstein, Stuart L., et al. Use of the Selective Cytopheretic
Device to Support Critically Ill Children Requiring Continuous
Renal Replacement Therapy: A Probable Benefit-Risk Assessment.
medRxiv, 2023.08.22.23294378; doi:
https://doi.org/10.1101/2023.08.22.23294378
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