SeaStar Medical Holding Corp

This Annual Report on Form 10-K (this “Annual Report”) contains statements that are forward-looking and as such are not historical facts. These statements are based on the beliefs and assumptions of management. Although we believe that our plans, intentions, and expectations reflected in or suggested by these forward-looking statements are reasonable, we cannot assure you that we will achieve or realize these plans, intentions, or expectations. Forward-looking statements are inherently subject to risks, uncertainties, and assumptions. Generally, statements that are not historical facts, including statements concerning the our possible or assumed future actions, business strategies, events, or results of operations, are forward-looking statements. In some instances, these statements may be preceded by, followed by or include the words “believes,” “estimates,” “expects,” “projects,” “forecasts,” “may,” “will,” “should,” “seeks,” “plans,” “scheduled,” “anticipates” or “intends” or the negatives of these terms or variations of them or similar terminology.

Forward-looking statements are not guarantees of performance. You should not put undue reliance on these statements which speak only as of the date hereof. You should understand that the following important factors, among others, could affect our future results and could cause those results or other outcomes to differ materially from those expressed or implied in our forward-looking statements:

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our plans to conduct further clinical trials and anticipated enrollment, clinical sites, completion, results, and timing thereof;

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our plans and expected timeline related to our products, including timing of commercial launch, or developing new products, to address additional indications or to obtain regulatory approvals or clearances or otherwise;

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the expected use of our products by clinicians, including market awareness, acceptance and adoption of our products, and anticipated utilization of our products;

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our expectations regarding the number of procedures that will be performed with our products, the number of clinicians we expect to train, and the number of our sales territories;

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our ability to obtain, maintain, and expand regulatory clearances for our current products and any new products we create;

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our expectations regarding government and third-party payer coverage and reimbursement;

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our ability to obtain an adequate supply of materials and components for our products from our third-party suppliers, most of whom are single-source suppliers;

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our ability to manufacture sufficient quantities of our products with sufficient quality and the sufficiency of our current manufacturing capabilities;

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our ability to obtain and maintain intellectual property protection for our products and our business;

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our ability to expand our business into new geographic markets and the anticipated timing thereof;

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our compliance with extensive Nasdaq and SEC requirements and government laws, rules and regulations both in the United States and internationally;

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our expectations regarding operating trends, future financial performance and expense management and our estimates of our future expenses, ongoing losses, future revenue, capital requirements and our need for, or ability to obtain, additional financing;

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our ability to identify and develop new and planned products and/or acquire new products;

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our experience with inflationary and price pressures and increased labor costs and labor and staffing shortages as a result of general macroeconomic factors;

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developments and projections relating to our market opportunity and penetration, competitors, or our industry;

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our intended use of net proceeds from our public offerings.

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our ability to obtain funding or raise capital for its operations and future growth;

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any delays or challenges in obtaining FDA approval of our SCD product candidates;

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economic downturns and the possibility of rapid change in the highly competitive industry in which our operates;

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the ability to develop and commercialize its products or services following regulatory approval of our product candidates;

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the failure of third-party suppliers and manufacturers to fully and timely meet their obligations;

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product liability or regulatory lawsuits or proceedings relating to our products and services;

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inability to secure or protect its intellectual property;

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dispute or deterioration of relationship with our major partners and collaborators;

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the ability to maintain the listing of its Common Stock on Nasdaq;

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delays associated with government and other grant funding;

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the ability to recognize the anticipated benefits of the Business Combination, which may be affected by, among other things, competition, and the ability of our to grow and manage growth profitably; and

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other risks and uncertainties indicated in this Annual Report, including those under “Risk Factors” herein, and other filings that have been made or will be made with the SEC.

These and other factors that could cause actual results to differ from those implied by the forward-looking statements in this Annual Report are more fully described in the “Risk Factors” section. The risks described in “Risk Factors” are not exhaustive. New risk factors emerge from time to time, and it is not possible for us to predict all such risk factors, nor can we assess the impact of all such risk factors on our business or the extent to which any factor or combination of factors may cause actual results to differ materially from those contained in any forward-looking statements. All forward-looking statements attributable to us or persons acting on its behalf are expressly qualified in their entirety by the foregoing cautionary statements. We undertake no obligations to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Part I