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Washington, D.C. 20549







Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): June 26, 2023



AVITA Medical, Inc.

(Exact name of registrant as specified in its charter)




Delaware   001-39059   85-1021707

(State or other jurisdiction

of incorporation)



File Number)


(IRS Employer

Identification No.)


28159 Avenue Stanford, Suite 220, Valencia, CA 91355   661.367.9170
(Address of principal executive offices, including Zip Code)   (Registrant’s telephone number, including area code)


(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:


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





Name of each exchange

on which registered

Common Stock, par value $0.0001 per share   RCEL   The Nasdaq Stock Market LLC

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 7.01

Regulation FD Disclosure.

AVITA Medical, Inc. (the “Company”) is furnishing herewith certain information regarding market size for the Company’s RECELL System following recent FDA approval of its use to treat full thickness skin defects. By furnishing this information, the Company is not undertaking to update this disclosure periodically or at all, and no assurance can be given that the Company will choose to provide any such update in the future.

The information under this 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 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



Description of Exhibit

99.1    June 2023 Expanded FDA Indication Update.
104    Cover Page Interactive Data File (embedded within the Inline XBRL document)


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: June 26, 2023      

/s/ Donna Shiroma

    Name:   Donna Shiroma
    Title:   General Counsel

Exhibit 99.1 Full-Thickness Skin Defects (“FTSD”) Market Sizing – June 2023 Update Market Size Additional Market Opportunity (1) (1) Prior to FDA Approval with FDA Approved Expanded Indication of FTSD Traumatic Wounds Traumatic Wounds Surgical Wounds Data • Degloving (Open Wounds) 99,000 • Gun Shot Wounds • Muscle-only Flap pending Data • Crush 2,000 • Traumatic Hematoma • Laparotomy pending • Abrasion 5,000 • Abdominoplasty Dehiscence • Laceration 10,000 • Hidradenitis Suppurativa • Puncture 2,000 Chronic Wounds Surgical Excision – Cancer Surgical Wounds • DFU 21,000 • Cancer Excision 136,000 • Necrotizing Fasciitis 2,000 • VLU 42,000 • Amputation 6,000 • Non - Pressure Ulcers 51,000 • Fasciotomy 1,000 • Pressure Ulcers 14,000 ~127,000 Eligible Procedures > 264,000 Eligible Procedures Total Market Opportunity of Traumatic, Surgical, Cancer Excision & Chronic Wounds ~391,000 Annual Eligible Procedures (1) Market size derived from third-party claims reports and internal analysis based on skin graft CPT codes tied to diagnosis code of specified wound types. © 2023 AVITA Medical. All Rights Reserved.