FDA Grants Breakthrough Device Designation to SeaStar Medical’s Selective Cytopheretic Device for Cardiorenal Syndrome
September 29 2023 - 8:30AM
SeaStar Medical Holding Corporation (Nasdaq: ICU), a medical device
company developing proprietary solutions to reduce the consequences
of hyperinflammation on vital organs, announces receipt of U.S.
Food and Drug Administration (FDA) Breakthrough Device Designation
for its patented, first-in-class, cell-directed Selective
Cytopheretic Device (SCD) for use with patients in the hospital
intensive care unit (ICU) with acute or chronic systolic heart
failure and worsening renal function due to cardiorenal syndrome or
right ventricular dysfunction awaiting implantation of a left
ventricular assist device (LVAD). The Breakthrough Device
Designation is expected to expedite the clinical development and
regulatory review of the SCD for use in this patient population.
This is only the ninth Breakthrough Device Designation granted by
the FDA’s Center for Biologics Evaluation and Research (CBER) since
the program’s inception in 2015.
“Cardiorenal syndrome is seen in the most severe
cases of heart failure and is associated with a very poor
prognosis,” said Kevin Chung, MD, Chief Medical Officer of SeaStar
Medical. “The SCD is able to halt the downward spiral often
perpetuated by a hyperinflammatory state driven by the innate
immune system, giving these patients a fighting chance.”
In addition to preclinical data, SeaStar
Medical’s Breakthrough Device submission included a first-in-human
study under a National Institutes of Health (NIH) grant to the
University of Michigan under which a patient with severe chronic
heart failure who was ineligible for heart transplantation or LVAD
implantation was treated with the SCD. The patient achieved the
primary endpoint of a successful LVAD implantation and was
discharged to home. Additionally, the procedure was safe and there
were no SCD-related serious adverse events (SAEs), which is
consistent with the SCD’s record of no device-related SAEs across
multiple clinical trials in critically ill adults and children with
acute kidney injury (AKI) and multi-organ failure.
“We believe the SCD represents a novel,
innovative and transformative approach to treating
hyperinflammation in severely ill patients with chronic heart
failure. Receipt of Breakthrough Device Designation in adult AKI
previously and now in cardiorenal syndrome, coupled with highly
promising data from studies across multiple disease conditions,
strengthens our position that the SCD’s proprietary mechanism of
action of targeting dysregulated immune responses is
organ-agnostic, with potential applicability in multiple
high-value, unmet medical needs where hyperinflammation plays a
role,” said Eric Schlorff, SeaStar Medical CEO. “We plan to work in
partnership with the University of Michigan to conduct a larger
clinical study in the same patient population to gather additional
evidence to support the submission of a Premarket Approval (PMA)
application to the FDA.”
About Hyperinflammation
and the SCD
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. In
2022 the SCD received Breakthrough Device Designation for use in
adult acute kidney injury.
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
https://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 ability of SCD
to treat patients with cardiorenal syndrome and other diseases and
the ability to obtain regulatory approval of SCD under the
Breakthrough Device Designation. 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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