Avita Medical Inc. filed SEC Form 8-K: Entry into a Material Definitive Agreement, Regulation FD Disclosure, Financial Statements and Exhibits
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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Item 1.01 Entry into a Material Definitive Agreement.
Contract Manufacturing Agreement
On March 17, 2025, AVITA Medical Americas, LLC (“AVITA Medical”), a wholly-owned subsidiary of AVITA Medical, Inc. (the “Company”), entered into a contract manufacturing agreement (the “Manufacturing Agreement”) with Stedical Scientific, Inc. (“Stedical Scientific”) to manufacture PermeaDerm® Biosynthetic Wound Matrix (“PermeaDerm”) in the United States. PermeaDerm is cleared by the Food and Drug Administration as a transparent biosynthetic wound matrix for use in the treatment of a variety of wound types until healing is achieved.
Under the terms of the Manufacturing Agreement, AVITA Medical will manufacture PermeaDerm in the United States for the purposes of (i) sale in the United States under the terms of the existing Distribution Agreement (defined below) and (ii) sale to Stedical Scientific for sale or distribution outside the United States. The term of the Manufacturing Agreement is ten years.
Amendment Two to the Exclusive Distribution Agreement
On March 17, 2025, AVITA Medical and Stedical Scientific entered into an Amendment Two (the “Amendment”) of their existing exclusive distribution agreement under which AVITA Medical distributes PermeaDerm in the United States (the “Distribution Agreement”).
Under the terms of the Amendment, AVITA Medical's share of revenue from PermeaDerm sales increases from 50% to 60% and Stedical Scientific becomes eligible for certain milestone payments conditioned upon AVITA Medical's achievement of specified sales targets. The Amendment revises the initial term of the Distribution Agreement to ten years from the date of the Amendment.
Item 7.01. Regulation FD.
On March 17, 2025, the Company issued a press release announcing the entry into the Manufacturing Agreement and the Amendment. A copy of the press release is attached to this Current Report on Form 8-K as Exhibit 99.1.
The information under Item 7.01 and Exhibit 99.1 is being furnished and shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and shall not be deemed incorporated by reference into any filing made under the Securities Act of 1933 (except as expressly set forth by specific reference in such filing).
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
Exhibit No. |
Description of Exhibit |
10.1 |
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10.2 |
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99.1 |
AVITA Medical Announces Exclusive Manufacturing and Distribution Agreements with Stedical Scientific |
104 |
Cover Page Interactive Data File (embedded within the 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.
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AVITA Medical, Inc |
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Date: |
March 17, 2025 |
By: |
/s/ David O'Toole |
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David O'Toole |