Case Series of Three Critically Ill Children with Acute Kidney Injury Safely Treated with SeaStar Medical’s Selective Cytopheretic Device Published in the Journal Blood Purification
29 Agosto 2023 - 7:00AM
SeaStar Medical Holding Corporation (Nasdaq: ICU), a medical
device company developing proprietary solutions to reduce the
consequences of hyperinflammation on vital organs, announces the
publication of a case series of three critically ill children with
Shiga-toxin-associated hemolytic uremic syndrome (STEC-HUS), a
severe cause of acute kidney injury (AKI), who were safely treated
with SeaStar Medical’s Selective Cytopheretic Device for children
(SCD-PED).
All three children were in the ICU at two
different hospitals and treated with continuous kidney replacement
therapy (CKRT). Each show gradual improvement following treatment
with the SCD-PED and normalization or near normalization of kidney
function at 60-day follow up. The article, “Hemolytic Uremic
Syndrome-Induced Acute Kidney Injury Treated via Immunomodulation
with the Selective Cytopheretic Device: Cases of STEC-HUS Treated
with Immunomodulation via SCD CRRT Filter,” (H. Rhodes Hambrick, et
al.) was published in the peer-reviewed journal Blood Purification.
An abstract of the article is available here.
“Although most critically ill children with
STEC-HUS-associated AKI with multiorgan failure recover kidney
function, about 5% die and 30% develop chronic renal morbidity,”
said Stuart Goldstein, MD, Director of the Center for Acute Care
Nephrology at Cincinnati Children’s Hospital and senior author of
the paper. “HUS pathophysiology includes activated neutrophils
damaging vascular endothelial cells. We found that immunomodulatory
treatment with the SCD-PED in these three cases was associated with
improvements in multisystem disease of STEC-HUS-induced AKI and was
well-tolerated without any device-related adverse events.”
“The continued observation of favorable
experience with the SCD-PED for critically ill children with AKI is
highly encouraging,” said Kevin Chung, MD, Chief Medical Officer of
SeaStar Medical. “We are working diligently to make this
potentially life-saving therapy more broadly available to
critically ill children with AKI and achieving our corporate goal
of improving patient outcomes and saving lives.”
About Hyperinflammation
Hyperinflammation is the overproduction or
overactivity of inflammatory cells that can lead to damage of vital
organs. It occurs when the body overproduces inflammatory effector
cells and other molecules that can be toxic, damaging to vital
organs and result in multi-organ failure and even death. This is
known as the cytokine storm. Unlike pathogen removal and other
blood-purification tools, the SCD selectively targets the most
highly activated proinflammatory neutrophils and monocytes. The
Company has observed that these most highly activated immune cells
are turned off in a low calcium environment. The SCD therapy mimics
nature by creating a unique micro-environment, attracting these
highly activated effector cells and neutralizing them in such an
environment. These cells are then returned back into the body
through the blood, and the body is signaled to focus on repair.
About SeaStar
Medical
SeaStar Medical is a 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. The
Company 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
www.seastarmedical.com or visit us on LinkedIn or Twitter.
Forward-Looking Statements
This press release contains certain
forward-looking statements within the meaning of the “safe harbor”
provisions of the Private Securities Litigation Reform Act of 1955.
These forward-looking statements include, without limitation,
SeaStar Medical’s expectations with respect to the ability of SCD
to treat patients with AKI, and the potential benefits of SCD to
treat other diseases. Words such as “believe,” “project,” “expect,”
“anticipate,” “estimate,” “intend,” “strategy,” “future,”
“opportunity,” “plan,” “may,” “should,” “will,” “would,” “will be,”
“will continue,” “will likely result,” and similar expressions are
intended to identify such forward-looking statements.
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
significant risks and uncertainties that could cause the actual
results to differ materially from the expected results. Most of
these factors are outside SeaStar Medical’s control and are
difficult to predict. Factors that may cause actual future events
to differ materially from the expected results include, but are not
limited to: (i) the inability to recognize the anticipated benefits
of the business combination with LMAO, which may be affected by,
among other things, competition and the ability of the
post-combination company to grow and manage growth profitability
and retain its key employees, (ii) future capital requirements and
sources and uses of cash, (iii) the ability to obtain funding or
raise capital for its operations and future growth, (iv) the
ability to maintain the listing of its securities on Nasdaq, (v)
any delays or challenges in obtaining FDA approval Company’s SCD
product candidates, (vi) the risk of downturns and the possibility
of rapid change in the highly competitive industry in which SeaStar
Medical operates, (vii) the risk that SeaStar Medical and its
current and future collaborators are unable to successfully develop
and commercialize its products or services, or experience
significant delays in doing so, including failure to achieve
approval of its products by applicable federal and state
regulators, (viii) the risk that SeaStar Medical may never achieve
or sustain profitability; (ix) the risk that SeaStar Medical may
need to raise additional capital to execute its business plan,
which may not be available on acceptable terms or at all; (x) the
risk that third-parties suppliers and manufacturers are not able to
fully and timely meet their obligations, (xi) the risk of product
liability or regulatory lawsuits or proceedings relating to SeaStar
Medical’s products and services, (xii) the risk that SeaStar
Medical is unable to secure or protect its intellectual property,
and (xiii) other risks and uncertainties indicated in SeaStar
Medical’s Annual Report on Form 10-K, including those under “Risk
Factors” section therein, and other filings that have been made or
will be made with the SEC. These forward-looking statements speak
only as of the date they are made. Readers are cautioned not to put
undue reliance on forward-looking statements, and SeaStar Medical
assumes no obligation and does not intend to update or revise these
forward-looking statements, whether as a result of new information,
future events, or otherwise.
Contact:
LHA Investor RelationsJody Cain(310)
691-7100Jcain@lhai.com
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