SeaStar Medical Holding Corporation filed SEC Form 8-K: Other Events, Financial Statements and Exhibits
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
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Securities registered pursuant to Section 12(b) of the Act:
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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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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 |