# EDGAR Filing Document

**Accession Number:** 0001831868
**File Stem:** 0000950170-25-093142
**Filing Date:** 2025-7
**Character Count:** 16547
**Document Hash:** c420e9351039d32213e9cc60d9f41f08
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0000950170-25-093142.hdr.sgml**: 20250702

**ACCESSION NUMBER**: 0000950170-25-093142

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 12

**CONFORMED PERIOD OF REPORT**: 20250701

**ITEM INFORMATION**: Regulation FD Disclosure

**ITEM INFORMATION**: Other Events

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20250702

**DATE AS OF CHANGE**: 20250702

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** SeaStar Medical Holding Corp
- **CENTRAL INDEX KEY:** 0001831868
- **STANDARD INDUSTRIAL CLASSIFICATION:** SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841]
- **ORGANIZATION NAME:** 08 Industrial Applications and Services
- **EIN:** 853681132
- **STATE OF INCORPORATION:** CO
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-39927
- **FILM NUMBER:** 251102251

**BUSINESS ADDRESS:**
- **STREET 1:** 3513 BRIGHTON BLVD
- **STREET 2:** SUITE 410
- **CITY:** DENVER
- **STATE:** CO
- **ZIP:** 80216
- **BUSINESS PHONE:** 844-427-8100

**MAIL ADDRESS:**
- **STREET 1:** 3513 BRIGHTON BLVD
- **STREET 2:** SUITE 410
- **CITY:** DENVER
- **STATE:** CO
- **ZIP:** 80216

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** LMF Acquisition Opportunities Inc
- **DATE OF NAME CHANGE:** 20201109

?xml version='1.0' encoding='ASCII'? 8-K

**UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549**

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## **FORM** 8-K

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**CURRENT REPORT**

**Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934**

**Date of Report (Date of earliest event reported):** July 01, 2025<br>

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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<br>of Incorporation)** | **(Commission File Number)** | **(IRS Employer<br>Identification No.)** |
| 3513 Brighton Blvd,<br>Suite 410 |  |  |
| Denver**,** Colorado |  | 80216 |
| **(Address of Principal Executive Offices)** |  | **(Zip Code)** |

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**Registrant's Telephone Number, Including Area Code:** 844 427-8100<br>

**(Former Name or Former Address, if Changed Since Last Report)**

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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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| | | |
|:---|:---|:---|
| **<br>Title of each class** | **Trading<br>Symbol(s)** | **<br>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 |

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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. ☐

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**Item 7.01 Regulation FD Disclosure.**

*Press Release*

On July 2, 2025, SeaStar Medical Holding Corporation (the "Company") issued a press release announcing that the Company had received confirmation from the Nasdaq that the Company evidenced compliance with the $2.5 million Minimum Stockholders' Equity Requirement. A copy of such press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is hereby incorporated by reference herein.

**Item 8.01 Other Events**

The Company has confirmed in a letter dated July 1, 2025, that the Company has regained compliance with Nasdaq's minimum stockholders' equity requirement under Nasdaq Listing Rule 5550(b)(1) (the "Minimum Stockholders' Equity Requirement"). Nasdaq noted in its letter that to maintain compliance, the Company will have to raise additional funds, otherwise the Company will be below the Minimum Stockholders' Equity Requirement by the end of July.

As previously disclosed by the Company in a Current Report on Form 8-K filed on March 11, 2025, the Company received a decision letter from the Nasdaq Hearings Panel (the "Panel"), granting the Company's request to continue its listing on Nasdaq, subject to certain conditions. The Panel's decision provided the Company with an exception until June 22, 2025, to demonstrate compliance with the Minimum Stockholders' Equity Requirement for continued listing set forth in Nasdaq Listing Rule 5550(b).

Pursuant to Nasdaq Listing Rule 5815(d)(4)(B), the Company will be subject to a Mandatory Panel Monitor until July 1, 2026. If, within that one-year monitoring period, the Nasdaq Listing Qualifications staff (the "Staff") finds the Company again out of compliance with the Minimum Stockholders' Equity Requirement, notwithstanding Nasdaq Listing Rule 5810(c)(2), the Company would not be permitted to provide the Staff with a plan of compliance with respect to that deficiency and the Staff would not be permitted to grant additional time for the Company to regain compliance with respect to that deficiency, nor would the Company be afforded an applicable cure or compliance period pursuant to Nasdaq Listing Rule 5810(c)(3). Instead, the Staff would issue a "Delist Determination Letter" and the Company would have an opportunity to request a new hearing with the initial Panel or a newly convened Hearings Panel if the initial Panel is unavailable.

**Item 9.01 Financial Statements and Exhibits**

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| | |
|:---|:---|
| **<u>Exhibit No.</u>**  | **<u>Description</u>** |
| 99.1 | [<u>Press Release dated July 2, 2025</u>](icu-ex99_1.htm) |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). |

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**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 |
|  |  | By: | /s/ Eric Schlorff |
| Date: | July 2, 2025 | Name: | Eric Schlorff |
|  |  | Title: | Chief Executive Officer |

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## Exhibit 99.1

**Exhibit 99.1**

![img257978346_0.jpg](img257978346_0.jpg)

**SeaStar Medical Announces Positive Nasdaq Listing Determination** 

**DENVER, CO., JULY 2, 2025 –** SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage healthcare company focused on transforming treatments for critically ill patients facing organ failure and potential loss of life,announced today that it has received confirmation from The Nasdaq Stock Market that the Company has evidenced compliance with the minimum $2.5 million stockholders' equity requirement and all other applicable criteria for continued listing on The Nasdaq Capital Market. Accordingly, the previously disclosed listing matter has been closed.

"We are very pleased to have this hurdle behind us and can now turn our full attention to commercializing QUELIMMUNE and our clinical development of potential organ-sparing and life-saving therapies for critically ill adult patients," stated Eric Schloff, CEO of SeaStar Medical. "We will continue our diligent effort to manage our capital and create additional value to our stakeholders through expanded adoption of QUELIMMUNE and successful execution of our Selective Cytopheretic Device (SCD) therapy in our NEUTRALIZE-AKI pivotal trial in adult patient with Acute Kidney Injury (AKI) receiving continuous renal replacement therapy (CRRT)."

**About Acute Kidney Injury (AKI) and Hyperinflammation** 

**AKI is characterized by a sudden and temporary loss of kidney function and can be caused by a variety of conditions such as sepsis, severe trauma, surgery and COVID-19. AKI can cause destructive hyperinflammation, which is the overproduction or overactivity of inflammatory effector cells and other molecules that can be toxic. Damage resulting from this destructive hyperinflammation in AKI can progress to other organs, such as the heart or liver, and potentially to multi-organ dysfunction or even failure that could result in worse outcomes, including increased risk of death. Even after resolution, these patients may face complications including chronic kidney disease or end-stage renal disease (ESRD) requiring dialysis. Extreme hyperinflammation may also contribute to added healthcare costs, such as prolonged ICU stays and increased reliance on dialysis and mechanical ventilation.** 

**About QUELIMMUNE** 

The QUELIMMUNE™ therapy is being commercialized for children with AKI and sepsis or septic condition weighing 10 kilograms or more who are on antibiotics and being treated in the ICU with Renal Replacement Therapy (RRT). It was approved in February 2024 under a Humanitarian Device Exemption application. Data from two clinical studies of the QUELIMMUNE therapy, published in <u>Kidney Medicine</u>, showed a 77% survival rate in patient treated with QUELIMMUNE versus standard of care, representing an approximate 50% reduction in loss of life compared to historical data in this patient population. No dialysis was required for survivors and 87.5% of survivors had normal kidney function at Day 60 after ICU discharge.

In January 2025, SeaStar Medical was awarded the 2025 Corporate Innovator Award by the National Kidney Foundation for its significant contribution to improving the lives of pediatric patients with AKI based on the approval and introduction of the QUELIMMUNE therapy.

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**About the NEUTRALIZE-AKI Pivotal Trial** 

The <u>NEUTRALIZE-AKI</u> (NEUTRophil and monocyte deActivation via SeLective Cytopheretic Device – a randomIZEd clinical trial in Acute Kidney Injury) pivotal trial is evaluating the safety and efficacy of the SCD therapy in 200 adults with AKI in the ICU receiving CRRT. The trial's primary endpoint is a composite of 90-day mortality or dialysis dependency of patients treated with the SCD therapy in addition to CRRT as the standard of care, compared with the control group receiving only CRRT standard of care. Secondary endpoints include mortality at 28 days, ICU-free days in the first 28 days, major adverse kidney events at Day 90 and dialysis dependency at one year. The study will also include subgroup analyses to explore the effectiveness of the SCD therapy in AKI patients with sepsis and acute respiratory distress syndrome.

**About the SeaStar Medical Selective Cytopheretic Device Therapy** 

The Selective Cytopheretic Device (SCD) therapy is designed as a disease-modifying device that neutralizes over-active immune cells and stops the cytokine storm that yields destructive hyperinflammation and creates a cascade of events that wreak havoc in the patient's body. The SCD therapy has broad applications in multiple acute and chronic kidney and cardiovascular diseases, representing patients who today have no FDA-approved options for treating their disease. Unlike pathogen removal and other blood-purification tools, the SCD therapy is integrated with an existing continuous renal replacement therapy (CRRT) hemofiltration system to selectively target and transition proinflammatory monocytes to a reparative state and promote activated neutrophils to be less inflammatory. This unique immunomodulation approach may promote long-term organ recovery, eliminate the need for future RRT, including dialysis, and prevent loss of life.

**About SeaStar Medical**

SeaStar Medical is a commercial-stage healthcare company focused on transforming treatments for critically ill patients facing organ failure and potential loss of life. SeaStar's first commercial product, QUELIMMUNE (SCD-PED), was approved in 2024 by the U.S. Food and Drug Administration (FDA). It is the only FDA approved product for the ultra-rare condition of life-threatening acute kidney injury (AKI) due to sepsis or a septic condition in critically ill pediatric patients. SeaStar's Selective Cytopheretic Device (SCD) therapy has been awarded Breakthrough Device Designation for four therapeutic indications by the FDA, enabling the potential for a speedier pathway to approval and preferable reimbursement dynamics at commercial launch. The company is currently conducting a pivotal trial of its SCD therapy in adult patients with AKI requiring continuous renal replacement therapy, a life-threatening condition with no effective treatment options that impacts over 200,000 adults in the U.S. annually.

For more information visit <u>www.seastarmedical.com</u> or visit us on <u>LinkedIn</u> or <u>X</u>.

**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 managing our capital in the future; the expanded adoption of QUELIMMUNE; anticipated patient enrollment and the expansion of the clinical trial sites; the ability of SCD to treat patients with AKI and other diseases; the expected regulatory approval process and timeline for commercialization; and the ability of SeaStar Medical to meet the expected timeline. 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

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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 risk that SeaStar Medical may not be able to obtain regulatory approval of its SCD product candidates; (ii) the risk that SeaStar Medical may not be able to raise sufficient capital to fund its operations, including current or future clinical trials; (iii) 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, (iv) the risk that SeaStar Medical may never achieve or sustain profitability; (v) the risk that SeaStar Medical may not be able to secure additional financing on acceptable terms; (vi) the risk that third-party suppliers and manufacturers are not able to fully and timely meet their obligations, (vii) the risk of product liability or regulatory lawsuits or proceedings relating to SeaStar Medical's products and services, (viii) the risk that SeaStar Medical is unable to secure or protect its intellectual property, and (ix) other risks and uncertainties indicated from time to time in SeaStar Medical's Annual Report on Form 10-K, including those under the "Risk Factors" section therein and in SeaStar Medical's other filings with the SEC. The foregoing list of factors is not exhaustive. 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 do not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise.

Contact:

<u>IR@SEASTARMED.COM</u>

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