UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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| 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 | |||||
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.