Case Series of Three Critically Ill Children with Acute Kidney Injury Safely Treated with SeaStar Medical’s Selective Cytopheretic Device Published in the Journal Blood Purification

Rhea-AI Summary

SeaStar Medical announces successful treatment of critically ill children with its Selective Cytopheretic Device for children (SCD-PED)

Positive

• All three children showed gradual improvement and near normalization of kidney function at 60-day follow up
• Immunomodulatory treatment with the SCD-PED was associated with improvements in multisystem disease of STEC-HUS-induced AKI
• Favorable experience with the SCD-PED for critically ill children with AKI is highly encouraging

Negative

• None.

DENVER, Aug. 29, 2023 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, announces the publication of a case series of three critically ill children with Shiga-toxin-associated hemolytic uremic syndrome (STEC-HUS), a severe cause of acute kidney injury (AKI), who were safely treated with SeaStar Medical’s Selective Cytopheretic Device for children (SCD-PED).

All three children were in the ICU at two different hospitals and treated with continuous kidney replacement therapy (CKRT). Each show gradual improvement following treatment with the SCD-PED and normalization or near normalization of kidney function at 60-day follow up. The article, “Hemolytic Uremic Syndrome-Induced Acute Kidney Injury Treated via Immunomodulation with the Selective Cytopheretic Device: Cases of STEC-HUS Treated with Immunomodulation via SCD CRRT Filter,” (H. Rhodes Hambrick, et al.) was published in the peer-reviewed journal Blood Purification. An abstract of the article is available here.

“Although most critically ill children with STEC-HUS-associated AKI with multiorgan failure recover kidney function, about 5% die and 30% develop chronic renal morbidity,” said Stuart Goldstein, MD, Director of the Center for Acute Care Nephrology at Cincinnati Children’s Hospital and senior author of the paper. “HUS pathophysiology includes activated neutrophils damaging vascular endothelial cells. We found that immunomodulatory treatment with the SCD-PED in these three cases was associated with improvements in multisystem disease of STEC-HUS-induced AKI and was well-tolerated without any device-related adverse events.”

“The continued observation of favorable experience with the SCD-PED for critically ill children with AKI is highly encouraging,” said Kevin Chung, MD, Chief Medical Officer of SeaStar Medical. “We are working diligently to make this potentially life-saving therapy more broadly available to critically ill children with AKI and achieving our corporate goal of improving patient outcomes and saving lives.”

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 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.

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 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 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) future capital requirements and sources and uses of cash, (iii) the ability to obtain funding or raise capital for its operations and future growth, (iv) the ability to maintain the listing of its securities on Nasdaq, (v) any delays or challenges in obtaining FDA approval Company’s SCD product candidates, (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 in SeaStar Medical’s Annual Report on Form 10-K, including those under “Risk Factors” section therein, and other filings that have been made or will be made with the SEC. These 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:

LHA Investor Relations
Jody Cain
(310) 691-7100
Jcain@lhai.com

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