SeaStar Medical Holding Corporation (Nasdaq:ICU), (“SeaStar
Medical” or the “Company”), a medical technology company developing
proprietary solutions to reduce the consequences of
hyperinflammation on vital organs, today announced the appointment
of Thomas R. Mullen as Vice President of Operations and Product
Development. Mr. Mullen is a proven medical device professional
with 30 years of experience leading business operations,
manufacturing, engineering, product development and regulatory
remediation.
“SeaStar Medical has continued to evolve and
remains on a trajectory of growth including near-term potential for
commercialization. As we continue our preparations for success in
treating both acute and chronic illnesses through advanced product
offerings, we believe Tom’s extensive experience and expertise will
be invaluable. We have had the pleasure of working with Tom since
2020 and during that time he has, among other things, ensured that
our business objectives and agency regulations were met. As we
continue to progress, we are pleased to welcome him as VP,
Operations and Product Development, and look forward to continuing
to leverage the leadership and skills he has amassed over the
course of his career,” commented Eric Schlorff, Chief Executive
Officer of SeaStar Medical.
Since 1993, Mr. Mullen has led Mullen Business
Development, a manufacturing, engineering and operations consulting
firm. Since its founding, he has served as a consultant to several
medical device organizations from startup to Fortune 500 to
establish and execute strategies, budgets and plans, as well as
develop products, processes and operational systems. Mr. Mullen has
served as a consultant to SeaStar Medical since 2020, during which
time he oversaw contract manufacturing activities, assisted with
agency submissions and provided remediation of compliance
documentation. During his consulting career, Mr. Mullen has managed
the relocation of multiple manufacturing lines from the U.S. to
Mexico, completed successful external ISO and FDA audits, and has
written and sourced compliance documentation for product
development and design control. Prior to his consultancy with
SeaStar Medical, he oversaw the manufacturing, engineering, and
project management for an implantable tissue heart patch,
qualification of aseptic processing, biocompatibility analyses, and
sterilization validation for new products.
Additional career highlights include Managing
Partner at 2MB2 Ventures, Director of Operations at WalkMed
Infusion, Director of Manufacturing Engineering at Colorado
MedTech, Principal Engineer/Project Manager at Medtronic Perfusion
Systems, Business Development and Finance Acquisition at Standard
Infusion, and several positions held at COBE Cardiovascular
including District Sales Manager, Senior Production Manager and
Senior Manufacturing Engineer.
Mr. Mullen added, “This is an exciting time for
SeaStar Medical. Having worked with the team over the past few
years, I believe SeaStar Medical has a proprietary solution with a
potential life-saving therapy for critically and chronically ill
patients. I am proud to be a part of the efforts to reduce the
consequences of hyperinflammation on vital organs and look forward
to working more closely with the team and positioning the Company
for potential commercialization.”
As VP, Operations and Product Development, Mr.
Mullen will oversee the development and advancement of the
Company’s Selective Cytopheretic Device (SCD), a patented
cell-directed extracorporeal therapy that works with continuous
kidney replacement therapy (CKRT) systems to selectively target and
reduce the inflammatory effects of activated neutrophils while
transitioning pro-inflammatory monocytes to promote reparative
processes. The SCD is currently being evaluated by the FDA for a
Humanitarian Device Exemption (HDE) marketing approval for use in
children (>20 kgs) with acute kidney injury (AKI). The Company
expects the FDA to complete a substantive review of its HDE
application during the first quarter of 2023, with a potential
commercial launch expected in the second quarter of 2023.
About SeaStar Medical Holding
Corporation
Denver-based SeaStar Medical (Nasdaq: ICU) is a
medical technology company that is focusing on 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. It is developing and commercializing
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 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 timing of
regulatory approval of its products and other corporate milestones,
the ability of SCD to treat patients with AKI, and the potential
benefits of SCD to treat 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 inability to
recognize the anticipated benefits of the business combination with
LMAO, which may be affected by, among other things, competition and
the ability of the post-combination company to grow and manage
growth profitability and retain its key employees, (ii) costs
related to the business combination, (iii) the outcome of any legal
proceedings that may be instituted against SeaStar Medical
following the business combination, (x) the ability to maintain the
listing of its securities on NASDAQ, (iv) the ability to implement
business plans, forecasts, and other expectations after the
completion of the proposed business combination, and identify and
realize additional opportunities, (v) the risk of downturns and the
possibility of rapid change in the highly competitive industry in
which SeaStar Medical operates, (vi) 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, (vii) the risk that SeaStar Medical may never achieve
or sustain profitability; (viii) the risk that SeaStar Medical may
need to raise additional capital to execute its business plan,
which many not be available on acceptable terms or at all; (ix) the
risk that third-parties suppliers and manufacturers are not able to
fully and timely meet their obligations, (x) the risk of product
liability or regulatory lawsuits or proceedings relating to SeaStar
Medical’s products and services, (xi) the risk that SeaStar Medical
is unable to secure or protect its intellectual property, and
(xiii) other risks and uncertainties indicated from time to time in
SeaStar Medical’s registration statement on Form S-4, as amended
(File No. 333-264993), 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.
Media Contact:
PSC ConsultingPatty Caballero(973)
348-5055patty@pscconsulting.net
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