UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
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FORM
CURRENT REPORT
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| Item 7.01 | Regulation FD Disclosure. |
On June 17, 2024, Elutia Inc. (the “Company”) published a press release announcing that the U.S. Food and Drug Administration (“FDA”) had cleared its antibiotic-eluting bioenvelope, EluPro® (referred to as CanGaroo®RM in development). A copy of the press release is furnished as Exhibit 99.1 hereto.
The information in this Item 7.01 of this Current Report on Form 8-K (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of Section 18, nor shall it be deemed to be incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.
| Item 8.01 | Other Information. |
On June 14, 2024, the Company received written notice from the FDA that it had reviewed the Company’s premarket notification report filed under Section 510(k) of the Federal Food, Drug and Cosmetic Act of 2022 (the “Act”) related to the EluPro® antibacterial envelope device, that the FDA had determined “substantial equivalence” with respect to such device, and that such device may be marketed subject to the general controls provisions of the Act.
| Item 9.01 | Financial Statements and Exhibits. |
| (d) | Exhibits. |
| Exhibit No. | Exhibit Description | |
| 99.1 | Press Release of the Company dated June 17, 2024 | |
| 104 | Cover Page Interactive Data File (formatted as 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.
| ELUTIA INC. | ||
| Date: June 17, 2024 | By: | /s/ Matthew Ferguson |
| Matthew Ferguson | ||
| Chief Financial Officer | ||