First Patient Enrolled in SeaStar Medical’s Pivotal Clinical Trial with the Selective Cytopheretic Device in Adults with Acute Kidney Injury
21 6월 2023 - 5:05AM
SeaStar Medical Holding Corporation (Nasdaq: ICU), a medical device
company developing proprietary solutions to reduce the consequences
of hyperinflammation on vital organs, announces enrollment of the
first patient in the NEUTRALIZE-AKI pivotal clinical trial to
evaluate the safety and efficacy of its patented, first-in-class,
cell-directed Selective Cytopheretic Device (SCD) extracorporeal
therapy in critically ill adults with acute kidney injury (AKI)
requiring continuous kidney replacement therapy (CKRT).
“We are delighted to enroll the first patient
into our pivotal trial following the successful resolution of a
supply-chain issue that temporarily impacted the sourcing of tubing
connectors that are part of the SCD sets,” said Kevin Chung, MD,
Chief Medical Officer of SeaStar Medical. “Nearly two dozen
hospitals and academic centers have signed on to begin the process
of onboarding as clinical trial sites. These sites are at various
stages of activation with several anticipated to begin enrollment
very soon.”
“We believe that reprogramming activated
neutrophils and monocytes represents a major breakthrough for
managing hyperinflammation in acute illness. Initiating trial
enrollment is another important step in making the potentially
lifesaving SCD therapy available to more than 200,000 U.S. adult
patients each year with AKI who require CKRT as part of their
standard of care,” said Eric Schlorff, CEO of SeaStar Medical.
About the NEUTRALIZE-AKI Pivotal
Trial
The NEUTRALIZE-AKI (NEUTRophil
and monocyte deActivation via
SeLective CytopheretIic Device -
a randomiZEd clinical trial in
Acute Kidney
Injury) pivotal trial is expected to enroll up to
200 patients. The trial’s primary endpoint is a composite of 90-day
mortality or dialysis dependency of patients treated with SCD in
addition to CKRT as the standard of care, compared with the control
group receiving only CKRT standard of care. Secondary endpoints
include mortality at 28 days, ICU-free days in the first 28 days,
major adverse kidney events at Day 90 and dialysis dependency at
one year. The study will also include subgroup analyses to explore
the effectiveness of SCD therapy in AKI patients with sepsis and
acute respiratory distress syndrome.
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 timing of
regulatory approval of its products, the expected timing on
enrollment, generation of study results, submission of PMA and
other corporate milestones, 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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SeaStar Medical (NASDAQ:ICU)
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부터 6월(6) 2024 으로 7월(7) 2024
SeaStar Medical (NASDAQ:ICU)
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부터 7월(7) 2023 으로 7월(7) 2024