FDA Issues Approvable Letter for SeaStar Medical’s Selective Cytopheretic Device for Pediatric Patients
October 30 2023 - 8:00AM
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 that the U.S. Food and Drug
Administration’s (FDA) Center for Biologics Evaluation and Research
(CBER) has issued an Approvable Letter for the company’s
proprietary Selective Cytopheretic Device Pediatric (SCD-PED) 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). As announced in early October 2023, SeaStar Medical
expected the FDA to issue this approvable letter within a month of
such announcement.
The issuance by the FDA of an Approvable Letter
is a standard step in the approval process of a Humanitarian Device
Exemption (HDE) application. The Approvable Letter indicates that
SeaStar Medical’s HDE application substantially meets the
requirements for an Approval Order and outlines remaining
administrative steps that must be finalized before the HDE can be
active for commercialization. For the SCD-PED, these include
revisions to product labeling and minor modifications to the
post-approval study plan. SeaStar Medical intends to work
diligently with the FDA to complete these action items in the
coming weeks and expects to commence commercialization of the SCD
by the end of 2023 or the first quarter of 2024.
“Receipt of this Approvable Letter is a major
accomplishment indicating that the FDA supports our application and
acknowledges the potential of our device to save lives and
eliminate dialysis dependency in critically ill children with AKI
and sepsis,” said Kevin Chung, MD, Chief Medical Officer of SeaStar
Medical. “We intend to work closely with the FDA to complete the
final steps outlined in the Letter and anticipate the much-needed
availability of the product in pediatric intensive care units by
early next year.”
“We are well on our way to commercializing
SeaStar Medical’s Selective Cytopheretic Device (SCD) in the first
of what we believe will be multiple high-value indications where
dysregulated inflammation plays a role,” said Eric Schlorff,
SeaStar Medical Chief Executive Officer. “Our pivotal trial in
critically ill adults with AKI is progressing well with the goal of
the SCD becoming the standard of care for AKI in the ICU. In
addition to adult AKI, we have recently received Breakthrough
Device Designations for the SCD in both cardiorenal syndrome and
hepatorenal syndrome, which should expedite the clinical
development and regulatory review of the SCD for use in these
indications.”
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. 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.
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
can 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 pro-inflammatory 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 ability of SCD to treat patients
with AKI and other diseases; the expected regulatory approval
process and timeline for commercialization; 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
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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