8-K

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): 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)	(Commission 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)

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:

☐ 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	Trading Symbol(s)	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

Exhibit No.	Description of Exhibit
99.1	June 2023 Expanded FDA Indication Update.
104	Cover Page Interactive Data File (embedded within the Inline XBRL document)

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: June 26, 2023
	AVITA MEDICAL, INC.
	By:	/s/ Donna Shiroma
	Name:	Donna Shiroma
	Title:	General Counsel

EX-99.1

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.

XML

Document and Entity Information	Jun. 26, 2023
Cover [Abstract]
Amendment Flag	false
Entity Central Index Key	0001762303
Document Type	8-K
Document Period End Date	Jun. 26, 2023
Entity Registrant Name	AVITA Medical, Inc.
Entity Incorporation State Country Code	DE
Entity File Number	001-39059
Entity Tax Identification Number	85-1021707
Entity Address, Address Line One	28159 Avenue Stanford
Entity Address, Address Line Two	Suite 220
Entity Address, City or Town	Valencia
Entity Address, State or Province	CA
Entity Address, Postal Zip Code	91355
City Area Code	661
Local Phone Number	367.9170
Written Communications	false
Soliciting Material	false
Pre Commencement Tender Offer	false
Pre Commencement Issuer Tender Offer	false
Security 12b Title	Common Stock, par value $0.0001 per share
Trading Symbol	RCEL
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	true
Entity Ex Transition Period	false