UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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Date of Report (Date of earliest event reported): September 24, 2025 |
SeaStar Medical Holding Corporation
(Exact name of Registrant as Specified in Its Charter)
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Delaware |
001-39927 |
85-3681132 |
(State or Other Jurisdiction
of Incorporation) |
(Commission File Number) |
(IRS Employer
Identification No.) |
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3513 Brighton Blvd, Suite 410 |
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Denver, Colorado |
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80216 |
(Address of Principal Executive Offices) |
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(Zip Code) |
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Registrant’s Telephone Number, Including Area Code: 844 427-8100 |
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
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Title of each class
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Trading
Symbol(s) |
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Name of each exchange on which registered
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Common Stock par value $0.0001 per share |
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ICU |
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The Nasdaq Stock Market LLC |
Warrants, each whole warrant exercisable for one share of Common Stock for $11.50 per share |
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ICUCW |
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The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 8.01 Other Events
On September 24, 2025, SeaStar Medical Holding Corp. (the "Company"), issued a press release announcing that the independent Data Safety Monitoring Review Board (the "DSMB") has recommended the continuation of the NEUTRALIZE-AKI pivotal trial of the Selective Cytopheretic Device ("SCD") therapy in adult patients with acute kidney injury ("AKI") requiring continuous renal replacement therapy ("CRRT"). The DSMB notes that there were zero device-related safety issues. It also recommended an increase in the total patient enrollment in the trial to 339 patients to meet the original powering assumptions of the statistical analysis plan for the trial.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
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Exhibit No. |
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Description |
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99.1 |
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Press Release dated September 24, 2025 |
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104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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SeaStar Medical Holding Corporation |
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By: |
/s/ Eric Schlorff |
Date: |
September 24, 2025 |
Name: |
Eric Schlorff |
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Title: |
Chief Executive Officer |
