SeaStar Medical Provides Updates on Enrollment of Adult Pivotal Clinical Study and Commercial Launch of Quelimmune, FDA-Approved in Pediatric Patients
March 12 2024 - 8:30AM
SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial
stage medical device company developing proprietary solutions to
reduce the consequences of hyperinflammation on vital organs,
provides updates on the acute kidney injury (AKI) programs it is
developing with its patented, first-to-market, cell-directed
Selective Cytopheretic Device (SCD) extracorporeal therapy in
critically ill patients with AKI.
“We now have 21 subjects enrolled across five
clinical sites in our NEUTRALIZE-AKI pivotal clinical trial, which
is intended to evaluate the safety and efficacy of our SCD in adult
AKI patients. Additional sites are progressing through the site
activation and contract completion process,” said Kevin Chung, MD,
Chief Medical Officer of SeaStar Medical. “We expect the pace of
enrollment will accelerate as more medical centers come onboard. We
anticipate conducting an interim analysis once we have reached our
90-day primary endpoint in 100 enrolled subjects, which we expect
to reach in the second half of 2024.”
The NEUTRALIZE-AKI (NEUTRophil and monocyte
deActivation via SeLective Cytopheretic Device – a randomiZEd
clinical trial in Acute Kidney Injury) pivotal trial is expected to
enroll up to 200 adults. The trial’s primary endpoint is a
composite of 90-day mortality or dialysis dependency of patients
treated with SCD in addition to continuous kidney replacement
therapy (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. More information on the trial
is available here.
In February 2024 the U.S. Food and Drug
Administration (FDA) granted a Humanitarian Device Exemption (HDE)
Approval Order to the Quelimmune™ pediatric device for use in
children weighing 10 kilograms or more with AKI due to sepsis or a
septic condition requiring kidney replacement therapy (KRT).
“Interactions with several key target hospitals
are underway with plans to expand the commercial rollout with
Nuwellis, Inc. during the second quarter,” said Eric Schlorff, CEO
of SeaStar Medical. “As our therapeutic device is approved under an
HDE, each hospital is required to secure institutional review board
approval prior to purchasing the device for use in patients. We
view Quelimmune as a tremendous win for children with AKI requiring
CKRT given clinical results from our AKI pediatric trials that
showed a 77% survival rate and no dialysis dependency at 60 days in
those subjects, as well as for the healthcare system given the
average cost of dialysis for a single patient with AKI who develops
chronic kidney disease is about $100,000 annually.”
SeaStar Medical estimates the eligible
population for its Quelimmune pediatric device to be approximately
4,000 children annually with AKI. About 20% of the top 50
children’s hospitals already have direct experience with the SCD.
Pediatric patients undergoing treatment with the SCD are expected
to require, on average, seven SCD units, with the disposable device
being changed once every 24 hours. With the Approval Order, SeaStar
Medical can build Quelimmune Clinical Kits into inventory in
parallel to the hospital approvals process.
The FDA’s HDE Approval Order was based on a
pooled analysis from two non-controlled studies, SCD-PED-01 (funded
by the FDA Office of Orphan Products Development) and SCD-PED-02.
These studies showed that pediatric patients weighing ≥10kg with
AKI requiring CKRT treated with the Quelimmune pediatric device had
no device-related serious adverse events or device-related
infections, a 77% survival rate, and no dialysis dependency at Day
60. The SCD-PED-01 (weight range ≥15 kg) and SCD-PED-02 (weight
range ≥10 kg) studies demonstrated 75% and 83% survival rates,
respectively.
SeaStar Medical also announces that its
executive management team plans to hold a business update
conference call in April to discuss progress with its AKI programs
and opportunities in other indications, and to answer questions.
Details regarding this call will be made available in the coming
weeks.
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
patented cell-directed extracorporeal device that employs
immunomodulating technology to selectively target proinflammatory
neutrophils and monocytes during CKRT 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 SCD is integrated with CKRT hemofiltration systems to
selectively target and transition proinflammatory monocytes to a
reparative state and promote activated neutrophils to be less
inflammatory. The 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 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.
Quelimmune is the official brand name for the Selective
Cytopheretic Device in pediatrics that has received FDA HDE
Approval based on safety and probable efficacy.
About SeaStar MedicalSeaStar
Medical 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. 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
X.
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, the SCD’s ability to treat
hyperinflammation and the expected results of clinical trials and
studies. 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 Relations Jody Cain (310)
691-7100 Jcain@lhai.com
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