0001193125-22-281300.txt : 20221109 0001193125-22-281300.hdr.sgml : 20221109 20221109165404 ACCESSION NUMBER: 0001193125-22-281300 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 14 CONFORMED PERIOD OF REPORT: 20221103 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20221109 DATE AS OF CHANGE: 20221109 FILER: COMPANY DATA: COMPANY CONFORMED NAME: AVITA Medical, Inc. CENTRAL INDEX KEY: 0001762303 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] IRS NUMBER: 202578762 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-39059 FILM NUMBER: 221373436 BUSINESS ADDRESS: STREET 1: 28159 AVENUE STANFORD STREET 2: SUITE 220 CITY: VALENCIA STATE: CA ZIP: 91355 BUSINESS PHONE: 661-568-1317 MAIL ADDRESS: STREET 1: 28159 AVENUE STANFORD STREET 2: SUITE 220 CITY: VALENCIA STATE: CA ZIP: 91355 FORMER COMPANY: FORMER CONFORMED NAME: Avita Therapeutics, Inc. DATE OF NAME CHANGE: 20200630 FORMER COMPANY: FORMER CONFORMED NAME: Avita Medical, Ltd. DATE OF NAME CHANGE: 20181218 8-K 1 d421402d8k.htm 8-K 8-K
false 0001762303 0001762303 2022-11-03 2022-11-03

 

 

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): November 3, 2022

 

 

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 8.01.

Other Events.

On November 3, 2022, AVITA Medical, Inc. (“the Company”) issued a press release announcing that the Food and Drug Administration granted the RECELL System designations as a Breakthrough Device for its proposed soft tissue repair indication as well as its vitiligo indication. A copy of the press release is attached hereto as Exhibit 99.1.

The information under this Item 8.01 and in Item 9.01 below are 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

99.1    AVITA Medical Announces FDA Breakthrough Device Designations for the RECELL® System

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: November 9, 2022

 

AVITA MEDICAL, INC.
By:  

/s/ Donna Shiroma

Name:   Donna Shiroma
Title:   General Counsel
 EX-99.1 2 d421402dex991.htm EX-99.1 EX-99.1

Exhibit 99.1

 

LOGO    ASX/News Release                

AVITA Medical Announces FDA Breakthrough Device Designations for the RECELL® System

Valencia, Calif., November 3, 2022 and MELBOURNE, Australia, November 4 2022 (GLOBE NEWSWIRE)

— AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH), a regenerative medicine company leading the development and commercialization of first-in-class devices and autologous cellular therapies for skin restoration, announced today that the Food and Drug Administration (FDA) granted the RECELL System designations as a Breakthrough Device for its proposed soft tissue repair indication as well as its vitiligo indication.

The goal of the FDA Breakthrough Devices Program is to provide patients and health care providers with timely access to new medical devices and technologies by expediting the development, assessment, and review of devices that provide more effective treatment of life-threatening or irreversibly debilitating diseases or conditions. Under the program, AVITA Medical will receive prioritized review and interactive communication with the FDA throughout the premarket review phase.

“We are pleased that the FDA has recognized the therapeutic potential of our RECELL System for our proposed soft tissue repair and vitiligo indications with the Breakthrough Device designations,” said Jim Corbett, AVITA Medical Chief Executive Officer. “We are hopeful that the designations will help ensure timely patient access to RECELL as therapeutic treatments for both soft tissue repair and vitiligo, and we look forward to interacting with the agency in its review of RECELL for these proposed indications.”

AVITA Medical’s clinical trial in soft tissue repair has been funded in part with Federal funds from the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201500028C.

Authorized for release by the Chief Financial Officer of AVITA Medical, Inc.

ABOUT AVITA MEDICAL, INC.

AVITA Medical is a regenerative medicine company leading the development and commercialization of devices and autologous cellular therapies for skin restoration. The RECELL® System technology platform, approved by the FDA for the treatment of acute thermal burns in both adults and children, harnesses the regenerative properties of a patient’s own skin to create Spray-On Skin™ cells. Delivered at the point-of-care, RECELL enables improved clinical outcomes and validated cost savings. RECELL is the catalyst of a new treatment paradigm and AVITA Medical is leveraging its proven and differentiated capabilities to develop first-in-class cellular therapies for multiple indications, including soft tissue repair and repigmentation of stable vitiligo lesions.

 

AVITA Medical, Inc. | 28159 Avenue Stanford, Suite 220 Valencia, CA 91355

Page 1

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 approved for acute partial-thickness thermal burn wounds in patients 18 years of age and older or application in combination with meshed autografting for acute full-thickness thermal burn wounds in pediatric and adult patients. In February 2022, the FDA reviewed and approved the PMA supplement for RECELL Autologous Cell Harvesting Device, an enhanced RECELL System aimed at providing clinicians a more efficient user experience and simplified workflow.

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 15,000 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 (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 approved under the RECELL System brand to promote skin healing in a wide range of applications including burns, soft tissue repair, vitiligo, and aesthetics. The RECELL System is TGA-registered in Australia, received CE-mark approval in Europe and has PMDA approval in Japan. To learn more, visit www.avitamedical.com.

FOR FURTHER INFORMATION:

 

Investors & Media

AVITA Medical, Inc.

Jessica Ekeberg

Phone +1-661-904-9269

investor@avitamedical.com

media@avitamedical.com

 

PR 20221020

# # #

 

AVITA Medical, Inc. | 28159 Avenue Stanford, Suite 220 Valencia, CA 91355

Page 2

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Document and Entity Information
Nov. 03, 2022
Cover [Abstract]  
Amendment Flag false
Entity Central Index Key 0001762303
Document Type 8-K
Document Period End Date Nov. 03, 2022
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
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