SeaStar Medical Provides Regulatory Update Regarding Selective Cytopheretic Device Use in Pediatric Acute Kidney Injury Under a Humanitarian Device Exemption
03 Octubre 2023 - 3:05PM
SeaStar Medical Holding Corporation (Nasdaq: ICU), a medical device
company developing proprietary solutions to reduce the consequences
of dysregulated immune responses including hyperinflammation on
vital organs, announces receipt of a correspondence from the U.S.
Food and Drug Administration’s (FDA) Center for Biologics
Evaluation and Research (CBER) indicating that the Agency considers
the 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 further indicates that an
Approvable Letter, which is a standard part of CBER’s approval
process, 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.
“The correspondence provides a clear path
forward in making this much needed therapy accessible to critically
ill children suffering with AKI and sepsis,” said Eric Schlorff,
SeaStar Medical CEO. “Only about half of the children in the ICU
with AKI requiring CKRT survive and those who do are at increased
risk of long-term conditions such as chronic kidney disease. We
understand the agency’s appropriate caution in these medically
fragile septic patients whose care requires significant resources,
and we appreciate the agency’s willingness to work collaboratively
with SeaStar Medical and our advisors to review the HDE
application, as well as its recognition of SCD as a therapy with
probable benefit for these children. This is an important milestone
for SeaStar Medical, and we intend to follow the regulatory path
laid out by the FDA to commercialize SCD for this indication by the
end of 2023.”
The SCD is a patented cell-directed
extracorporeal device designed to be used as an adjunct therapy
that selectively targets and transitions pro-inflammatory monocytes
to promote reparative processes and reduce the acute inflammatory
and damaging effects of activated neutrophils. In the HDE
regulatory approval process of SCD-PED for children with AKI and
sepsis, the FDA considered clinical results showing safety and
probable clinical benefit to these patients who have few treatment
options. Pooled analysis from two non-controlled studies,
SCD-PED-01 (funded by the FDA Office of Orphan Products
Development) and SCD-PED-02 showed that pediatric patients ≥10kg
with AKI requiring CKRT treated with the SCD had no device-related
serious adverse events or infections, a 77% reduction in mortality
rate, and no dialysis dependency at Day 60. The SCD-PED-01 (weight
range ≥15 kg) and PED-02 (weight range ≥10 kg) studies demonstrated
75% and 83% reductions in mortality, respectively. The Company
believes the SCD could become the new standard of care for AKI
patients requiring CKRT in the ICU and could also have significant
benefit in additional indications where dysregulated immune
processes are involved.
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.
About the Selective Cytopheretic
DeviceThe Selective Cytopheretic Device (SCD) is a medical
device that employs immunomodulating technology to selectively
target pro-inflammatory neutrophils and monocytes during CKRT and
disrupt 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 works with
hemofiltration systems to enable precise fluid and solute balance
control to selectively target and transition pro-inflammatory
monocytes to reparative and promote activated neutrophils to be
less inflammatory. SCD 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 focus on repair. This unique immunomodulation
approach may reverse injury and eliminate the need for CKRT going
forward.
About SeaStar MedicalSeaStar
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 StatementsThis
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 regulatory approval process for
HDE; the anticipated timing for commercialization of SCD; and the
benefits of SCD to treat acute kidney injury (AKI) and 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 risk that SeaStar Medical may not be able to
obtain regulatory approval of its SCD product candidates; (ii) the
risk that SeaStar Medical may not be able to raise sufficient
capital to fund its operations, including clinical trials; (iii)
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, (iv) the risk that SeaStar
Medical may never achieve or sustain profitability; (v) the risk
that SeaStar Medical may not be able to access funding under
existing agreements, including the equity line of credit and
forward purchase agreements; (vi) the risk that third-parties
suppliers and manufacturers are not able to fully and timely meet
their obligations, (vii) the risk of product liability or
regulatory lawsuits or proceedings relating to SeaStar Medical’s
products and services, (viii) the risk that SeaStar Medical is
unable to secure or protect its intellectual property, and (ix)
other risks and uncertainties indicated from time to time in
SeaStar Medical’s Annual Report on Form 10-K, including those under
the “Risk Factors” section therein and in SeaStar Medical’s other
filings with the SEC. The foregoing list of factors is not
exhaustive. 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 assume no
obligation and do 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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