SeaStar Medical Activates Sentara Norfolk General Hospital and Provides Enrollment Update in Adult AKI Pivotal Trial
03 Dezember 2024 - 2:30PM
SeaStar Medical Holding Corporation (Nasdaq: ICU), a
commercial-stage medical device company developing proprietary
solutions to reduce the consequences of hyperinflammation on vital
organs, announces the activation of Sentara Norfolk General
Hospital in Norfolk, Virginia as its thirteenth active site in its
NEUTRALIZE-AKI pivotal trial. The Company also reports the
enrollment of nine critically ill adult acute kidney injury (AKI)
patients in the trial during November, bringing total trial
enrollment to 65 subjects. The NEUTRALIZE-AKI trial is evaluating
the safety and efficacy of the Company’s proprietary therapeutic
Selective Cytopheretic Device (SCD) in 200 adult patients with AKI
in the intensive care unit (ICU) receiving continuous renal
replacement therapy (CRRT).
“We are thankful for the steady pace of site
activations and continued brisk enrollment with our recently
activated sites already contributing,” said Kevin Chung, MD, Chief
Medical Officer of SeaStar Medical. “The rate of enrollment has
increased significantly with nearly two times the number of
subjects enrolled in the first two months of the fourth quarter,
compared with the total number for each of the previous three
quarters of 2024. We are working to activate additional sites in
December, which will help us reach our enrollment milestones
sooner.”
“Previously completed pilot studies demonstrate
the SCD’s ability to save the lives of critically ill patients with
AKI and to eliminate dialysis dependence, with additional benefits
to the overall healthcare system,” said Eric Schlorff, SeaStar
Medical CEO. “Given the addressable adult AKI population of
approximately 210,000 patients in the U.S. each year, we estimate
annual peak sales of approximately $1 billion for the SCD in this
indication. AKI is only one of multiple high-value indications
where hyperinflammation plays a role and we have preliminary
evidence of effectiveness of the SCD in mitigating a variety of
illnesses. We plan to pursue cardiorenal syndrome as our next
clinical focus.”
SeaStar Medical’s SCD previously received U.S.
Food and Drug Administration (FDA) Breakthrough Device Designation
for adults with AKI, which is awarded to a therapy to treat a
serious or life-threatening condition with preliminary clinical
evidence indicating it may demonstrate substantial improvement over
available therapies on clinically significant endpoints. In July
2024, the Centers for Medicare & Medicaid Services granted
Category B coverage for certain expenses incurred by medical
centers when treating Medicare or Medicaid patients enrolled in
NEUTRALIZE-AKI.
NEUTRALIZE-AKI Pivotal
Trial
The NEUTRALIZE-AKI (NEUTRophil
and monocyte deActivation via
SeLective Cytopheretic Device – a
randomIZEd clinical trial in Acute Kidney Injury)
is expected to enroll up to 200 adults. The trial’s primary
endpoint is a composite of 90-day mortality or dialysis dependency
among patients treated with SCD in addition to CRRT as the standard
of care, compared with the control group receiving only CRRT
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.
Acute Kidney Injury (AKI) and
Hyperinflammation
AKI is characterized by a sudden and temporary
loss of kidney function and can be caused by a variety of
conditions such as COVID-19, sepsis, severe trauma and surgery. AKI
can cause hyperinflammation, which is the overproduction or
overactivity of inflammatory effector cells and other molecules
that can be toxic. Damage resulting from hyperinflammation in AKI
can progress to other organs, such as the heart or liver, and
potentially to multi-organ dysfunction or even failure that could
result in worse outcomes, including increased risk of death. Even
after resolution, these patients may face complications including
chronic kidney disease or end-stage renal disease requiring
dialysis. Hyperinflammation may also contribute to added healthcare
costs, such as prolonged ICU stays and increased reliance on
dialysis and mechanical ventilation.
Selective Cytopheretic
Device
The Selective Cytopheretic Device (SCD) is a
patented cell-directed extracorporeal device that employs
immunomodulating technology to selectively target proinflammatory
neutrophils and monocytes during CRRT and reduces the
hyperinflammatory milieu including the cytokine storm. Unlike
pathogen removal and other blood-purification tools, the SCD is
integrated with CRRT hemofiltration systems to selectively target
and transition proinflammatory monocytes to a reparative state and
promote activated neutrophils to be less inflammatory. This unique
immunomodulation approach may promote long-term organ recovery and
eliminate the need for future renal replacement treatment (RRT),
including dialysis.
The SCD has been awarded FDA Breakthrough Device
Designation in four indications:
- Cardiorenal Syndrome – Left
Ventricular Assist Device (CRS-LVAD)
- Adult Acute Kidney Injury
(AKI)
- Hepatorenal Syndrome (HRS)
- Chronic Dialysis
QUELIMMUNE™, the Company’s SCD-Pediatric device,
is being commercialized following FDA approval for children with
AKI and sepsis or septic condition weighing 10 kilograms or more
who are being treated in the ICU with RRT. QUELIMMUNE was approved
in February 2024 under a Humanitarian Device Exemption (HDE)
application, having met the applicable criteria with clinical
results showing safety and probable clinical benefit in a limited
population of critically ill children with AKI who have few
treatment options.
About SeaStar Medical
SeaStar 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 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 1995.
These forward-looking statements include, without limitation, the
ability of the SCD to treat patients with AKI and other diseases;
anticipated patient enrollment and the expansion of the clinical
trial sites; the number of patients and annual sales for the
addressable AKI market; the anticipated Medicare and Medicaid
reimbursement by CMS for patients enrolled in clinical trials;
planned future clinical trials; the expected regulatory approval
process and timeline for commercialization of our clinical
products; and the ability of SeaStar Medical to meet the expected
timeline. 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 current or future
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; (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 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:
Alliance Advisors IRJody Cain(310)
691-7100Jcain@allianceadvisors.com
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