UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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Item 5.02 | Departure of Directors or Principal Officers; Election of Directors; Appointment of Principal Officers. |
On April 19, 2022, Non-Executive Director Louis Drapeau notified the Chair of the Board of Directors of AVITA Medical, Inc. (the “Company”) that due to changed personal circumstances, Mr. Drapeau is resigning from the Board of Directors. Such resignation is effective April 29, 2022. Mr. Drapeau’s pending resignation did not result from any disagreements between himself and the Company on any matter concerning its operations, policies, or practices. Non-Executive Director James Corbett will assume Mr. Drapeau’s former role as Chair of the Audit Committee.
Item 8.01. | Other Events |
On April 21, 2022, the Company issued a press release announcing the resignation of Mr. Drapeau as described in Item 5.02 above. A copy of the press release, which is attached hereto as Exhibit 99.1, is furnished pursuant to Items 8.01 and 9.01.
The information in this Item 8.01 and Item 9.01 below 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 |
Description | |
99.1 | Press Release, titled “Avita Medical, Inc. Announces Resignation of Louis Drapeau from Board of Directors” | |
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 21, 2022
AVITA MEDICAL, INC. | ||
By: | /s/ Donna Shiroma | |
Name: | Donna Shiroma | |
Title: | General Counsel |
Exhibit 99.1
Avita Medical, Inc. Announces Resignation of Louis Drapeau from Board of Directors
VALENCIA, Calif. 21 April 2022 and MELBOURNE, Australia, 22 April 2022 AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH) (Company), 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 Louis Drapeau has resigned, effective April 29, 2022, from the Companys Board of Directors. Mr. Drapeaus resignation is not because of a disagreement with the Company on any matter relating to the Companys operations, policies or practices. Rather, his resignation is due to personal reasons.
Mr. Drapeau has been a non-executive Director of AVITA Medical since January 2016 and served as Chair of the Audit Committee. As disclosed in the Company Form 10-KT dated March 1, 2022, Louis Drapeau had already stepped down as Chair of the Audit Committee and James Corbett was appointed Chair of the Audit Committee in his place as of February 23, 2022.
Lou Panaccio, Chairman of the Board, stated, We want to thank Louis for his time, dedication and contributions to AVITA Medical over the past six years. We appreciate his insights and dedication to the Company and wish him the best.
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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 Medicals patented and proprietary collection and application technology provides innovative treatment solutions derived from the regenerative properties of a patients own skin. The medical devices work by preparing a RES® REGENERATIVE EPIDERMAL SUSPENSION, an autologous suspension comprised of the patients skin cells necessary to regenerate natural healthy epidermis. This autologous suspension is then sprayed onto the areas of the patient requiring treatment.
AVITA Medicals 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 patients 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 USERECELL® 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 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.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This press release includes forward-looking statements. These forward-looking statements generally can be identified by the use of words such as anticipate, expect, intend, could, may, will, believe, estimate, look forward, forecast, goal, target, project, continue, outlook, guidance, future, other words of similar meaning and the use of future dates. Forward-looking statements in this press release include, but are not limited to, statements concerning, among other things, our ongoing clinical trials and product development activities, regulatory approval of our products, the potential for future growth in our business, and our ability to achieve our key strategic, operational and financial goal. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Each forward-looking statement contained in this press release is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statement. Applicable risks and uncertainties include, among others, the timing of regulatory approvals of our products; physician acceptance, endorsement, and use of our products; failure to achieve the anticipated benefits from approval of our products; the effect of regulatory actions; product liability claims; risks associated with international operations and expansion; and other business effects, including the effects of industry, economic or political conditions outside of the companys control. Investors should not place considerable reliance on the forward-looking statements contained in this press release. Investors are encouraged to read our publicly available filings for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this release, and we undertake no obligation to update or revise any of these statements.
This press release was authorized by the review committee of AVITA Medical, Inc.
AVITA Medical Inc, 28159 Avenue Stanford, Valencia, CA 91355
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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 20222204
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AVITA Medical Inc, 28159 Avenue Stanford, Valencia, CA 91355
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