UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
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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): December 9, 2024
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ARTIVION, INC.
(Exact name of registrant as specified in its charter)
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| | | | | | | | |
| Delaware | 1-13165 | 59-2417093 |
(State or Other Jurisdiction
of Incorporation) | (Commission File Number) | (IRS Employer Identification No.) |
| | | | | | | | |
| 1655 Roberts Boulevard, N.W., Kennesaw, Georgia | | 30144 |
| (Address of principal executive office) | | (Zip Code) |
Registrant’s telephone number, including area code: (770) 419-3355
___________________________________________________________________________________
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 (see General Instruction A.2. below):
| | | | | |
| ☐ | 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, $0.01 par value | AORT | NYSE |
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 December 9, 2024, Artivion, Inc. (“Artivion”) issued a press release announcing that the U.S. Food and Drug Administration granted a Humanitarian Device Exemption for use of Artivion’s AMDS Hybrid Prosthesis (“AMDS”) in acute DeBakey Type I dissections in the presence of malperfusion. The AMDS is the world’s first aortic arch remodeling device for use in the treatment of acute DeBakey Type I aortic dissections. The full text of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
Item 9.01(d) Exhibits
(d)Exhibits.
| | | | | |
| Exhibit Number | Description |
| Press Release dated December 9, 2024. |
| 104 | Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101). |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, Artivion, Inc. has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Date: December 9, 2024
| | | | | | | | |
| ARTIVION, INC. |
| | |
| By: | /s/ Lance A. Berry |
| Name: | Lance A. Berry |
| Title: | Chief Financial Officer and Executive Vice President, Finance |
