SeaStar Medical Holding Corporation (Nasdaq: ICU) (SeaStar Medical)
and Nuwellis, Inc. (Nasdaq: NUWE) (Nuwellis) announce an
exclusive U.S. license and distribution agreement by Nuwellis of
SeaStar Medical’s Selective Cytopheretic Device (SCD) for the
treatment of acute kidney injury (AKI) in children. Nuwellis will
market and distribute the SCD through its direct salesforce to
nephrologists and intensive care physicians who are trained in
pediatric extracorporeal therapy. SeaStar Medical expects the U.S.
Food and Drug Administration (FDA) to complete a substantive review
of a Humanitarian Device Exemption (HDE) for the use of SCD in
children (>20 kg.) with AKI during the first quarter of 2023,
with a potential commercial introduction in the second quarter of
2023.
SCD is a patented, cell-directed extracorporeal
therapy that selectively targets the most activated
pro-inflammatory neutrophils and monocytes to stop the cytokine
storm that frequently causes organ failure and possible death in
critically ill patients. The therapy works with CKRT to target and
neutralize pro-inflammatory neutrophils and monocytes, allowing the
body to return to homeostasis. Clinical studies have demonstrated
SCD’s potential to eliminate dialysis dependency, shorten ICU time
and restore the lives of critically ill patients.1,2,3
“Nuwellis’ established relationships with
pediatric nephrology and intensive care key opinion leaders make
them the ideal marketing partner for SCD in this indication,” said
Eric Schlorff, Chief Executive Officer of SeaStar Medical. “With
Nuwellis, we have a proven, efficient means to reach our target
customers while allowing SeaStar Medical to advance additional
indications including a planned pivotal clinical trial in the adult
acute kidney injury population, which we expect to initiate during
the first quarter of 2023.”
“We share a commitment with SeaStar Medical to
bring potentially lifesaving therapies to children undergoing CKRT
therapy,” said Nestor Jaramillo, Jr., President and CEO of
Nuwellis. “To this end, we are also currently developing a new,
fully integrated pediatric CKRT device designed to
provide care for small babies and children under 20 kg., and we
remain committed to developing and bringing to market safe
innovations to address these critical unmet needs. As with fluid
overload, critical care clinicians face an uphill battle to save
pediatric patients from potentially deadly hyperinflammation. SCD’s
unique approach has shown a significant impact on saving lives and
reducing hospital stays.”
Each year in the U.S. approximately 4,000
children with AKI require CKRT and those patient profiles are
associated with high mortality. The mortality rate in children with
AKI requiring CKRT is approximately 50 percent. Children who
survive an AKI episode are at risk for long-term conditions,
including chronic kidney disease (CKD).1
About NuwellisNuwellis, Inc. is
a medical technology company dedicated to transforming the lives of
patients suffering from fluid overload through science,
collaboration and innovation. The Company is focused on
commercializing the Aquadex SmartFlow® system for ultrafiltration
therapy. Nuwellis is headquartered in Minneapolis, with a wholly
owned subsidiary in Ireland. For more information
visit www.nuwellis.com or visit us
on LinkedIn.
About SeaStar Medical Holding
CorporationSeaStar Medical is a medical technology company
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. The
Company 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.
Nuwellis Forward-Looking
StatementsCertain statements in this release may be
considered forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995, including without
limitation, statements regarding the new market opportunities and
anticipated growth in 2022 and beyond. 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 risks and uncertainties. Many factors
could cause actual future events to differ materially from the
forward-looking statements in this release, including, without
limitation, those risks associated with our ability to execute on
our commercialization strategy, the impact of the COVID-19
pandemic, the possibility that we may be unable to raise sufficient
funds necessary for our anticipated operations, our post-market
clinical data collection activities, benefits of our products to
patients, our expectations with respect to product development and
commercialization efforts, our ability to increase market and
physician acceptance of our products, potentially competitive
product offerings, intellectual property protection, our ability to
integrate acquired businesses, our expectations regarding
anticipated synergies with and benefits from acquired businesses,
and other risks and uncertainties described in our filings with the
SEC. Forward-looking statements speak only as of the date when
made. Nuwellis does not assume any obligation to publicly update or
revise any forward-looking statements, whether due to new
information, future events or otherwise.
SeaStar Medical 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 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, (iv) the ability to maintain
the listing of its securities on NASDAQ, (v) the ability to
implement business plans, forecasts, and other expectations after
the completion of the business combination, and identify and
realize additional opportunities, (vi) the risk of downturns and
the possibility of rapid change in the highly competitive industry
in which SeaStar Medical operates, (vii) 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, (viii) the risk that SeaStar Medical may never achieve
or sustain profitability; (ix) the risk that SeaStar Medical may
need to raise additional capital to execute its business plan,
which may not be available on acceptable terms or at all; (x) the
risk that third-parties suppliers and manufacturers are not able to
fully and timely meet their obligations, (xi) the risk of product
liability or regulatory lawsuits or proceedings relating to SeaStar
Medical’s products and services, (xii) 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.
1. Goldstein, Stuart L., et al. “Use of the Selective
Cytopheretic Device in Critically Ill Children.” Kidney
International Reports, vol. 6, no. 3, 18 Dec. 2020, pp. 775–784.,
https://doi.org/10.1016/j.ekir.2020.12.010. 2. Tumlin, James
A., et al. “A Multi-Center, Randomized, Controlled, Pivotal Study
to Assess the Safety and Efficacy of a Selective Cytopheretic
Device in Patients with Acute Kidney Injury.” PLOS ONE, vol.
10, no. 8, 2015,
https://doi.org/10.1371/journal.pone.0132482. 3. Yessayan,
Lenar T., et al. “Extracorporeal Immunomodulation Treatment and
Clinical Outcomes in ICU COVID-19 Patients.” Critical Care
Explorations, vol. 4, no. 5, 19 May 2022,
https://doi.org/10.1097/cce.0000000000000694.
SeaStar Medical Contacts
Media:
PSC Consulting
Patty Caballero
(973) 348-5055
patty@pscconsulting.net
Investors:
LHA Investor Relations
Jody Cain
(310) 691-7100
Jcain@lhai.com
Nuwellis Contacts
Media:
Annika Parrish
Health+Commerce
annika@healthandcommerce.com
Investors:
Gilmartin Group
Vivian Cervantes
ir@nuwellis.com
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