UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

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): March 1, 2021

AVITA Medical, Inc.

(Exact name of registrant as specified in its charter)

N/A

(Former name or former address, if changed since last report)

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:

Securities registered pursuant to Section 12(b) of the Act:

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 or Rule 12b-2 of the Securities Exchange Act of 1934. 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 March 1, 2021, AVITA Medical, Inc., a Delaware corporation (the “Company”) issued a press release announcing the successful closing of an underwritten registered public offering of its shares of common stock, the details of which were previously released to the market on February 24, 2021 and provided on a separate Form 8-K filed by the Company on March 1, 2021. A copy of the Company’s press release is attached as Exhibit 99.1 and is incorporated by reference herein.

Additionally, on March 1, 2021, the Company made an announcement on the Australian Securities Exchange (the “ASX”) pursuant to section 708A(5)(e) of the Corporations Act 2001 (Cth), as modified by Australian Securities and Investment Commission Class Order 14/827. A copy of the Company’s ASX announcement is attached as Exhibit 99.2 and is incorporated by reference herein.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

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.

Date: March 3, 2021

Exhibit 99.1

AVITA MEDICAL, INC. ANNOUNCES CLOSING OF OFFERING OF 3,214,250 SHARES OF COMMON STOCK

VALENCIA, CA, March 1, 2021 and MELBOURNE, Australia, March 2, 2021 – AVITA Medical, Inc. (Nasdaq: RCEL; ASX: AVH) (“AVITA Medical”), a regenerative medicine company that is developing and commercializing a technology platform that enables point-of-care autologous skin restoration for multiple unmet needs, today announced the successful closing of an underwritten registered public offering of its shares of common stock, the details of which were released to the market on February 24, 2021 (United States) / February 25, 2021 (Australia).

AVITA Medical has issued 3,214,250 shares of common stock at the offering price of US$21.50 per share. This amount includes 419,250 shares of common stock issued upon the exercise in full by the underwriters of their option to purchase additional shares. The gross proceeds from the offering are approximately US$69.1 million, before deducting underwriting discounts and commissions and estimated offering expenses.

AVITA Medical expects to use the net proceeds from the offering to fund its product development pipeline, to pursue approvals of its products for additional indications and for general corporate purposes, which may include licensing arrangements.

Piper Sandler & Co. and Cowen and Company, LLC acted as joint book-running managers for the offering. BTIG, LLC acted as lead manager and Lake Street Capital Markets, LLC acted as co-manager for the offering.

The offering was made pursuant to a shelf registration statement on Form S-3 (File No. 333-249419) that was previously filed with the Securities and Exchange Commission (the “SEC”) on October 9, 2020 and declared effective on October 16, 2020 and that was also publicly released on the Australian Securities Exchange (“ASX”). The final prospectus supplement relating to and describing the terms of the offering was filed with the SEC and released on the ASX on February 25, 2021 (in the United States) / March 1, 2021 (in Australia). A copy of these documents may be obtained by visiting EDGAR on the SEC’s website at www.sec.gov or by contacting Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, Minnesota 55402, by e-mail at prospectus@psc.com, or by phone at (800) 747-3924, or Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attention: Prospectus Department, by telephone at (833) 297-2926 or by email at PostSaleManualRequests@broadridge.com.

This announcement shall not constitute an offer to sell, or the solicitation of an offer to buy, nor may there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About AVITA Medical, Inc.:

AVITA Medical is a regenerative medicine company with a technology platform positioned to address unmet medical needs in burns, chronic wounds, and aesthetics indications. AVITA Medical’s proprietary collection and application technology provides innovative treatment solutions derived from the regenerative properties of a patient’s own skin. The medical devices work by preparing a RES^® REGENERATIVE EPIDERMAL SUSPENSION, an autologous suspension comprised of the patient’s skin cells necessary to regenerate natural healthy epidermis. This autologous suspension is then sprayed onto the areas of the patient requiring treatment.

AVITA Medical’s first U.S. product, the RECELL^® System, was approved by the U.S. Food and Drug Administration (FDA) in September 2018. The RECELL System is indicated for use in the treatment of acute thermal burns in patients 18 years and older. The RECELL System is used to prepare Spray-On Skin^™ Cells using a small amount of a patient’s own skin, providing a new way to treat severe burns, while significantly reducing the amount of donor skin required. The RECELL System is designed to be used at the point of care alone or in combination with autografts depending on the depth of the burn injury. Compelling data from randomized, controlled clinical trials conducted at major U.S. burn centers and real-world use in more than 10,000 patients globally, reinforce that the RECELL System is a significant advancement over the current standard of care for burn patients and offers benefits in clinical outcomes and cost savings. Healthcare professionals should read the INSTRUCTIONS FOR USE—RECELL^® Autologous Cell Harvesting Device for a full description of indications for use and important safety information including contraindications, warnings and precautions.

In international markets, our products are marketed under the RECELL System brand to promote skin healing in a wide range of applications including burns, chronic wounds and aesthetics. The RECELL System is TGA-registered in Australia and received CE-mark approval in Europe.

Forward-Looking Statements:

This announcement contains “forward-looking statements” within the meaning of Section 27A of the Private Securities Litigation Reform Act of 1995. Although the forward-looking statements in this announcement reflect the good faith judgment of management, forward-looking statements are inherently subject to known and unknown risks and uncertainties that may cause actual results to be materially different from those discussed in these forward-looking statements. Readers are urged to carefully review and consider the various disclosures made by AVITA Medical in the reports it has filed with the SEC, including the “Risk Factors” section of the Company’s Annual Report 10-K for the year ended June 30, 2020 for a description of the risks that may affect its business, financial condition, results of operation and cash flows. If one or more of these risks or uncertainties materialize, or if the underlying assumptions prove incorrect, AVITA Medical’s actual results may vary materially from those expected or projected. Readers are urged not to place undue reliance on these forward-looking statements, which speak only as of the date of this announcement. AVITA Medical assumes no obligation to update any forward-looking statements in order to reflect any event or circumstance that may arise after the date of this announcement, except as required by law.

For Further Information:

PR 20210301B.

Exhibit 99.2

AVITA MEDICAL, INC. (ASX:AVH)

Cleansing Notice under section 708A(5)(e) of the Corporations Act 2001 (Cth)

Valencia, Calif., USA 1 March 2021 and Melbourne, Australia, 2 March 2021: On 1 March 2021 (United States) / 2 March 2021 (Australia), AVITA Medical, Inc. (Company) issued a total of 3,214,250 fully paid shares of common stock in the Company (New Securities) at an issue price of US$21.50 per share of common stock, the terms of which were announced to the market on 24 February 2021 (United States) / 25 February 2021 (Australia).

The New Securities will be quoted on NASDAQ, but may be converted into CHESS Depositary Interests (CDIs) in the Company quoted on ASX at any time by the relevant holder(s) (with five CDIs being equivalent to one share of common stock). The Company seeks to rely on an exemption under section 708A of the Corporations Act 2001 (Cth) (Corporations Act) with respect to the sale of any CDIs which are issued on conversion of the New Securities (in the instance that such conversion occurs).

The Company gives this notice under section 708A(5)(e) of the Corporations Act as modified by ASIC Class Order 14/827.

The New Securities were issued without disclosure to investors under Part 6D.2 of the Corporations Act.

As at the date of this notice, the Company has complied with:

As at the date of this notice, there is no information that is ‘excluded information’ within the meaning of section 708A(7) and section 708A(8) of the Corporations Act.

Authorised for release by the General Counsel of the Company.

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ABOUT THE AVITA GROUP

The AVITA group is a regenerative medicine group of companies with a technology platform positioned to address unmet medical needs in burns, chronic wounds, and aesthetics indications. The AVITA group’s patented and proprietary collection and application technology provides innovative treatment solutions derived from the regenerative properties of a patient’s own skin. The medical devices work by preparing a RES^® REGENERATIVE EPIDERMAL SUSPENSION, an autologous suspension comprised of the patient’s skin cells necessary to regenerate natural healthy epidermis. This autologous suspension is then sprayed onto the areas of the patient requiring treatment.

The AVITA group’s first U.S. product, the RECELL^® System, was approved by the U.S. Food and Drug Administration (FDA) in September 2018. The RECELL System is indicated for use in the treatment of acute thermal burns in patients 18 years and older. The RECELL System is used to prepare Spray-On Skin^™ Cells using a small amount of a patient’s own skin, providing a new way to treat severe burns, while significantly reducing the amount of donor skin required. The RECELL System is designed to be used at the point of care alone or in combination with autografts depending on the depth of the burn injury. Compelling data from randomized, controlled clinical trials conducted at major U.S. burn centers and real-world use in more than 8,000 patients globally, reinforce that the

AVITA Medical, Inc. Suite 220, 28159 Avenue Stanford, Valencia, California 91355 United States of America

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RECELL System is a significant advancement over the current standard of care for burn patients and offers benefits in clinical outcomes and cost savings. Healthcare professionals should read the INSTRUCTIONS FOR USE - RECELL^® Autologous Cell Harvesting Device (https://recellsystem.com/) for a full description of indications for use and important safety information including contraindications, warnings and precautions.

In international markets, our products are marketed under the RECELL System brand to promote skin healing in a wide range of applications including burns, chronic wounds and aesthetics. The RECELL System is TGA-registered in Australia and received CE-mark approval in Europe.

To learn more, visit www.avitamedical.com.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This announcement includes forward-looking statements. These forward-looking statements generally can be identified by the use of words such as “anticipate,” “expect,” “intend,” “could,” “may,” “will,” “believe,” “estimate,” “look forward,” “forecast,” “goal,” “target,” “project,” “continue,” “outlook,” “guidance,” “future,” other words of similar meaning and the use of future dates. Forward-looking statements in this announcement include, but are not limited to, statements concerning, among other things, our ongoing clinical trials and product development activities, regulatory approval of our products, the potential for future growth in our business, and our ability to achieve our key strategic, operational and financial goals. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Each forward- looking statement contained in this announcement is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statement. Applicable risks and uncertainties include, among others, the timing of regulatory approvals of our products; physician acceptance, endorsement, and use of our products; failure to achieve the anticipated benefits from approval of our products; the effect of regulatory actions; product liability claims; risks associated with international operations and expansion; and other business effects, including the effects of industry, economic or political conditions outside of the Company’s control. Investors should not place considerable reliance on the forward-looking statements contained in this announcement. Investors are encouraged to read our publicly available filings for a discussion of these and other risks and uncertainties. The forward- looking statements in this announcement speak only as of the date of this announcement, and we undertake no obligation to update or revise any of these statements.

FOR FURTHER INFORMATION:

PR 20210301A

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AVITA Medical, Inc. Suite 220, 28159 Avenue Stanford, Valencia, California 91355 United States of America

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