UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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| Item 7.01. | Regulation FD Disclosure. |
On February 14, 2023, SeaStar Medical Holding Corporation (the “Company”) announced that it will hold a conference call to discuss business updates including the recent FDA approval to conduct a pivotal trial evaluating the effectiveness of its Selective Cytopheretic Device (SCD) in reducing hyperinflammation in adults with acute kidney injury (AKI) and an update regarding the Humanitarian Device Exemption (HDE) submission for market approval for use of the SCD for critically ill children with AKI on Wednesday, February 15, 2023 4:00 p.m. ET / 1:00 p.m. PT. A copy of the presentation slide deck that was presented is being furnished as Exhibit 99.1 to this report on Form 8-K. The recorded webcast of the presentation may be accessed by visiting the Investors Events & Presentations section of the Company’s website at https://investors.seastarmedical.com/events-and-presentations/default.aspx.
The information in this Item 7.01 and Exhibit 99.1 attached hereto is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section. It may only be incorporated by reference in another filing under the Exchange Act or the Securities Act of 1933, as amended, if such subsequent filing specifically references the information furnished pursuant to Item 7.01 and Exhibit 99.1 of this Current Report on Form 8-K.
| Item 8.01. | Other Events. |
On February 14, 2023, the Company issued a press release announcing a business update and the recent FDA approval to conduct a pivotal trial. A copy of this press release is being filed herewith as Exhibit 99.2 to this Current Report on Form 8-K.
Additionally, on February 15, 2023, the Company issued a press release announcing details of its pivotal NEUTRALIZE-AKI study evaluating the safety and efficacy of its Selective Cytopheretic Device (SCD) in adults with acute kidney injury (AKI) requiring continuous kidney replacement therapy (CKRT). A copy of this press release is being filed herewith as Exhibit 99.3 to this Current Report on Form 8-K.
| Item 9.01. | Financial Statements and Exhibits. |
(d) Exhibits
| Exhibit No. |
Description | |
| 99.1 | Presentation distributed by SeaStar Medical Holding Corporation dated February 15, 2023, furnished hereto. | |
| 99.2 | Press Release issued by SeaStar Medical Holding Corporation dated February 14, 2023. | |
| 99.3 | Press Release issued by SeaStar Medical Holding Corporation dated February 15, 2023. | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | |
SIGNATURE
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 | ||||||
| Date: February 15, 2023 | By: | /s/ Eric Schlorff | ||||
| Eric Schlorff | ||||||
| Chief Executive Officer | ||||||