SeaStar Medical (NASDAQ: ICU) trial to expand after clean safety readout

Rhea-AI Filing Summary

SeaStar Medical Holding Corporation reported that an independent Data Safety Monitoring Review Board recommended continuing its NEUTRALIZE-AKI pivotal trial of the Selective Cytopheretic Device in adults with acute kidney injury requiring continuous renal replacement therapy. The board cited zero device-related safety issues and advised increasing total trial enrollment to 339 patients to meet the original statistical powering assumptions.

Positive

• Independent board backs trial continuation with clean safety: The Data Safety Monitoring Review Board recommended continuing the NEUTRALIZE-AKI pivotal trial and reported zero device-related safety issues for the Selective Cytopheretic Device in a critically ill acute kidney injury population.
• Trial enrollment expanded to support robust statistics: Recommended total enrollment was increased to 339 patients to meet the original powering assumptions of the statistical analysis plan, which can strengthen the eventual efficacy and safety dataset for regulatory evaluation.

Negative

• None.

Insights

Clinical trial and biotech risk analyst

Clean safety and larger pivotal trial may strengthen SCD data.

The independent monitoring board recommended continuing SeaStar Medical’s NEUTRALIZE-AKI pivotal trial of its Selective Cytopheretic Device in adults with acute kidney injury on continuous renal replacement therapy. It specifically noted zero device-related safety issues, an important signal in a critically ill population.

The board also recommended increasing total enrollment to 339 patients to meet the original powering assumptions of the statistical plan. A larger, properly powered study can provide more robust evidence on efficacy and safety, which is typically required for regulatory review of pivotal data.

Future updates on enrollment progress, interim efficacy outcomes, and any subsequent recommendations from the monitoring board or regulators will be key to understanding how this pivotal program for acute kidney injury progresses toward potential approval decisions.

8-K Event Classification

2 items: 8.01, 9.01

2 items

Item 8.01 Other Events Other

Voluntary disclosure of events the company deems important to shareholders but not covered by other items.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, and exhibit attachments filed with this report.

Understanding 8-K Material Events →

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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

Date of Report (Date of earliest event reported): September 24, 2025

SeaStar Medical Holding Corporation

(Exact name of Registrant as Specified in Its Charter)

Delaware			001-39927	85-3681132
(State or Other Jurisdiction of Incorporation)			(Commission File Number)	(IRS Employer Identification No.)
3513 Brighton Blvd, Suite 410
Denver, Colorado				80216
(Address of Principal Executive Offices)				(Zip Code)

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:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock par value $0.0001 per share		ICU		The Nasdaq Stock Market LLC
Warrants, each whole warrant exercisable for one share of Common Stock for $11.50 per share		ICUCW		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

Exhibit No.		Description
99.1		Press Release dated September 24, 2025
104		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.

			SeaStar Medical Holding Corporation
		By:	/s/ Eric Schlorff
Date:	September 24, 2025	Name:	Eric Schlorff
		Title:	Chief Executive Officer

FAQ

What did SeaStar Medical (ICU) disclose about its NEUTRALIZE-AKI trial?

SeaStar Medical reported that an independent monitoring board recommended continuing the NEUTRALIZE-AKI pivotal trial of its Selective Cytopheretic Device in adults with acute kidney injury on continuous renal replacement therapy, confirming zero device-related safety issues and advising an increase in total patient enrollment.

How many patients will SeaStar Medicals NEUTRALIZE-AKI trial now enroll?

The independent Data Safety Monitoring Review Board recommended increasing NEUTRALIZE-AKI trial enrollment to 339 patients. This higher enrollment level is intended to meet the original powering assumptions of the trials statistical analysis plan, helping generate more robust efficacy and safety data.

What safety findings were reported for SeaStar Medicals Selective Cytopheretic Device?

The monitoring board noted zero device-related safety issues for SeaStar Medicals Selective Cytopheretic Device in the NEUTRALIZE-AKI pivotal trial. This safety outcome is important because the therapy is being studied in adult patients with acute kidney injury who require continuous renal replacement therapy.

What is the NEUTRALIZE-AKI pivotal trial described by SeaStar Medical (ICU)?

The NEUTRALIZE-AKI trial is a pivotal study evaluating SeaStar Medicals Selective Cytopheretic Device therapy in adult patients with acute kidney injury needing continuous renal replacement therapy. An independent board recently recommended its continuation and expansion to 339 patients to satisfy original statistical powering assumptions.

Why did SeaStar Medical issue an 8-K about the NEUTRALIZE-AKI trial?

SeaStar Medical filed an 8-K to report a press release stating that the independent Data Safety Monitoring Review Board recommended continuing its NEUTRALIZE-AKI pivotal trial, found zero device-related safety issues, and advised increasing enrollment to 339 patients to meet the trials planned statistical power.