Elutia Inc. Files 8-K with Regulatory Updates

TL;DR

Elutia Inc. (ELUT) filed an 8-K on 6/17 for events on 6/14, covering Reg FD, other events, and financials.

AI Summary

Elutia Inc. filed an 8-K on June 17, 2024, reporting events that occurred on June 14, 2024. The filing includes information related to Regulation FD Disclosure, Other Events, and Financial Statements and Exhibits. The company, formerly known as Aziyo Biologics, Inc., is incorporated in Delaware and headquartered in Silver Spring, MD.

Why It Matters

This 8-K filing provides important updates and disclosures from Elutia Inc. to investors and the public regarding recent corporate events and financial information.

Risk Assessment

Risk Level: low — This filing is a routine 8-K report detailing corporate events and disclosures, not indicating immediate financial distress or significant operational changes.

Key Players & Entities

• ELUTIA INC. (company) — Registrant
• Aziyo Biologics, Inc. (company) — Former company name
• Delaware (jurisdiction) — State of incorporation
• Silver Spring, MD (location) — Principal executive offices location
• June 14, 2024 (date) — Date of earliest event reported
• June 17, 2024 (date) — Date of report

FAQ

Key Financial Figures

• $0.001 — hich registered Class A Common Stock, $0.001 par value per share ELUT The Nasdaq

Filing Documents

• tm2417396d1_8k.htm (8-K) — 32KB
• tm2417396d1_ex99-1.htm (EX-99.1) — 14KB
• tm2417396d1_ex99-1img01.jpg (GRAPHIC) — 16KB
• 0001104659-24-072044.txt ( ) — 245KB
• elut-20240614.xsd (EX-101.SCH) — 3KB
• elut-20240614_lab.xml (EX-101.LAB) — 33KB
• elut-20240614_pre.xml (EX-101.PRE) — 22KB
• tm2417396d1_8k_htm.xml (XML) — 4KB

01 Regulation FD Disclosure

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 CanGarooRM 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.

01 Other Information

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.

01 Financial Statements and Exhibits

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

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

View Full Filing

View this 8-K filing on SEC EDGAR