8-K
false 0001762303 0001762303 2022-04-28 2022-04-28

 

 

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): April 28, 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 April 28, 2022, AVITA Medical, Inc. (the “Company”) issued a press release announcing it will release its first quarter 2022 financial results on Thursday, May 12, 2022. In conjunction with the release, the Company plans to host a conference call and webcast that day at 4:30 p.m. Eastern Time to discuss its financial results and recent highlights. A copy of the Company’s press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

The information under Item 8.01 in this current report on Form 8-K and the related information in the exhibit attached hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, regardless of any general incorporation language in such filing.

 

Item 9.01

Financial Statements and Exhibits.

(d) Exhibits

 

Exhibit

    No.    

  

Description of Exhibit

99.1    Press release, titled “AVITA Medical to Announce First Quarter 2022 Financial Results”
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: April 29, 2022      
    AVITA MEDICAL, INC.
    By:  

/s/ Donna Shiroma

    Name:   Donna Shiroma
    Title:   General Counsel
EX-99.1

Exhibit 99.1

 

LOGO    ASX/News Release

AVITA Medical to Announce First Quarter 2022 Financial Results

Valencia, Calif., and MELBOURNE, Australia, April 28, 2022 (GLOBE NEWSWIRE) — AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH), a regenerative medicine company that is developing and commercializing a technology platform that enables point-of-care autologous skin restoration for multiple unmet needs, announced today that it will release its first quarter 2022 financial results on Thursday, May 12, 2022. In conjunction with such release, the Company plans to host a conference call and webcast that day at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time (Friday, May 13, 2022 at 6:30 a.m. Australian Eastern Standard Time) to discuss its financial results and recent highlights.

Interested parties may access the live call via telephone by dialing (833) 614-1538 for domestic callers or (706) 634-6548 for international callers, using conference ID: 7569924. The live webinar of the call may be accessed by visiting the Events section of the Company’s website at ir.avitamedical.com. A replay of the webinar will be available on the Company’s website shortly after the conclusion of the call.

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

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 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.

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. 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 (https://recellsystem.com/) for a full description of indications for use and important safety information including contraindications, warnings, and precautions.

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

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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.

FOR FURTHER INFORMATION:

 

U.S. Media

Sam Brown, Inc.

Christy Curran

Phone +1-615-414-8668

christycurran@sambrown.com

 

O.U.S. Media

Rudi Michelson

Phone +61 (0)3 9620 3333

Mobile +61 (0)411 402 737

rudim@monsoon.com.au

  

Investors

ICR Westwicke

Caroline Corner

Phone +1-415-202-5678

caroline.corner@westwicke.com

PR 20220426

# # #

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

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