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VALENCIA, Calif., Dec. 23, 2024 (GLOBE NEWSWIRE) -- AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH), a commercial-stage regenerative medicine company focused on first-in-class devices for wound care management and skin restoration, today announced that the U.S. Food and Drug Administration (FDA) has approved its premarket approval (PMA) supplement for RECELL GO® mini. As a line extension of the RECELL GO system, the RECELL GO mini disposable cartridge is designed specifically to treat smaller wounds up to 480 square centimeters, compared to the standard RECELL GO disposable cartridge, which treats an area of 1,920 square centimeters. RECELL GO mini addresses a critical need in the full-thickness skin defect market, which includes a high volume of smaller wounds. As part of the RECELL GO platform, RECELL GO mini uses the same multi-use processing device as the standard disposable cartridge but features a modified cartridge optimized for smaller skin samples that reduces resource use and minimizes waste. This design provides an entry point for clinicians who may not have previously used the RECELL GO platform for smaller wounds, enabling broader accessibility and use in trauma and burn centers. “The FDA approval of RECELL GO mini strengthens our ability to provide clinicians with fit-for-purpose solutions that meet the diverse needs of patients with full-thickness wounds,” said Jim Corbett, Chief Executive Officer of AVITA Medical. “By introducing a treatment option specifically for smaller wounds, we are expanding the accessibility of RECELL to a wider range of patients. We believe this addition will drive greater adoption across trauma centers, where smaller wounds are common, and support our broader growth strategy.” The company expects RECELL GO mini to serve as a growth driver within the broader RECELL GO platform, further advancing AVITA Medical’s strategy to expand its impact on patient care. Rollout will begin with trauma and burn centers that currently treat smaller wounds during the first quarter of 2025. The PMA supplement follows the original PMA of RECELL Autologous Cell Harvesting Device and subsequent PMA supplements. About AVITA Medical, Inc. AVITA Medical is a commercial-stage regenerative medicine company transforming the standard of care in wound care management and skin restoration with innovative devices. At the forefront of our platform is the RECELL System, approved by the FDA for the treatment of thermal burn wounds and full-thickness skin defects, and for repigmentation of stable depigmented vitiligo lesions. RECELL harnesses the regenerative properties of a patient’s own skin to create Spray-On SkinTM Cells, delivering a transformative solution at the point-of-care. This breakthrough technology serves as the catalyst for a new treatment paradigm enabling improved clinical outcomes. In the United States, AVITA Medical also holds the exclusive rights to market, sell, and distribute PermeaDerm®, a biosynthetic wound matrix, and Cohealyx, an AVITA Medical-branded collagen-based dermal matrix. In international markets, the RECELL System is approved to promote skin healing in a wide range of applications including burns, full-thickness skin defects, and vitiligo. The RECELL System, excluding RECELL GOTM, is TGA-registered in Australia, has received CE mark approval in Europe, and has PMDA approval in Japan. To learn more, visit www.avitamedical.com . Forward-Looking Statements Th is press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are subject to significant risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Forward-looking statements generally may be identified by the use of words such as “anticipate,” “expect,” “intend,” “could,” “would,” “may,” “will,” “believe,” “continue,” “estimate,” “look forward,” “forecast,” “goal,” “target,” “project,” “outlook,” “guidance,” “future,” and similar words or expressions, and the use of future dates. Forward-looking statements include, but are not limited to, statements relating to the timing and realization of regulatory approvals of our products; physician acceptance, endorsement, and use of our products; anticipated market share growth and revenue generation from certain 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, as well as other economic or political conditions outside of the Company’s control. These statements are made as of the date of this release, and the Company undertakes no obligation to publicly update or revise any of these statements, except as required by law. For additional information and other important factors that may cause actual results to differ materially from forward-looking statements, please see the “Risk Factors” section of the Company’s latest Annual Report on Form 10-K and other publicly available filings for a discussion of these and other risks and uncertainties. Authorized for release by the Chief Financial Officer of AVITA Medical, Inc. A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/b6b7df71-e67c-4a6e-847c-bdcca54fad27 Investor & Media Contact: Jessica Ekeberg Phone +1-661-904-9269 investor@avitamedical.com media@avitamedical.com3 Key Developments in the Russia-Ukraine War in 2024
SAN DIEGO , Dec. 23, 2024 /PRNewswire/ -- CreateAI Holdings Inc., formerly TuSimple Holdings Inc. (OTCMKTS: TSPH) ("CreateAI" or the "Company"), a global artificial intelligence technology company, today announced shareholder voting results for its annual meeting of stockholders held on December 20, 2024 (the "Annual Meeting"). As of October 28, 2024 , the record date for the Annual Meeting, there were a total of 232,618,399 shares of common stock outstanding and entitled to vote at the Annual Meeting, comprised of 208,618,399 shares of Class A Common Stock (each with one vote per share) and 24,000,000 shares of Class B Common Stock (each with ten votes per share). At the Annual Meeting, holders of 207,347,538 shares of common stock, representing 423,347,538 votes, entitled to vote at the meeting were represented in person or by proxy and, therefore, a quorum constituted of the majority of the voting power of the shares of common stock issued and outstanding and entitled to vote at the Annual Meeting was present. The following is a brief description of each matter voted upon at the 2024 Annual Meeting and the numbers of votes cast for, withheld, or against, the number of abstentions, and the number of broker non-votes with respect to each other, as applicable. 1. Election of six nominees to serve on the Board of Directors (the "Board") for a term which will expire at the 2025 annual meeting of stockholders, or, if Proposal Two is adopted, to hold office until the annual meeting of stockholders in accordance with the class of director to which each nominee will be assigned. The following six directors were elected by the votes as indicated below. For Withheld Broker Non-Votes Cheng Lu 208,949,915 164,765,019 1 49,632,604 Mo Chen 208,946,146 164,768,788 1 49,632,604 James Lu 209,109,928 164,605,006 1 49,632,604 Zhen Tao 209,158,316 164,556,618 1 49,632,604 Albert Schultz 348,895,019 1 24,819,915 49,632,604 Jianan Hao 209,021,652 164,693,282 1 49,632,604 The totals above include the 240,000,000 votes represented by the Class B shares of Common Stock. 12,000,000 shares of Class B Common Stock (representing 120,000,00 votes) were voted "FOR" and 12,000,000 shares of Class B Common stock (representing 120,000,00 votes) were voted "WITHHELD" for each of the Directors other than Albert Schultz . All shares of Class B Common Stock were voted "FOR" the election of Albert Schultz . Excluding the 240,000,000 votes from the 24,000,000 shares of Class B Common Stock from the totals above, the 183,347,538 shares of Class A Common Stock were voted as indicated below. For Withheld Broker Non-Votes Cheng Lu 88,949,915 44,765,019 49,632,604 Mo Chen 88,946,146 44,768,788 49,632,604 James Lu 89,109,928 44,605,006 49,632,604 Zhen Tao 89,158,316 44,556,618 49,632,604 Albert Schultz 108,895,019 24,819,915 49,632,604 Jianan Hao 89,021,652 44,693,282 49,632,604 2. Amendment to the Company's Restated Certificate of Incorporation to classify the Board of Directors into three classes, with directors in each class to serve staggered three-year terms. Pursuant to the Restated Certificate of Incorporation, Proposal Two must receive the affirmative vote of the holders of at least a majority of the voting power of all of the then-outstanding shares of the capital stock of the Company entitled to vote generally in the election of directors, voting together as a single class, since directors representing two-thirds (2/3) of the total number of authorized directors have already approved. The amendment was not approved 2 by the votes as indicated below: For Against 1 Abstain Broker Non-Votes 208,955,668 164,659,652 99,614 49,632,604 Because Proposal Two was not approved, the six directors elected pursuant to Proposal One will serve on the Board for a term which will expire at the 2025 annual meeting of stockholders. 3. Ratification of the appointment of UHY LLP as the Company's independent registered public accounting firm for the fiscal year ending December 31, 2024 . The selection was ratified by the votes as indicated below: For Against 1 Abstain Broker Non-Votes 255,504,371 155,923,768 11,919,399 - Note 1: Includes 120,000,000 votes of the 12,000,000 shares of Class B Common Stock held by White Marble LLC and White Marble International Limited (together, the "White Marble Entities") controlled by Dr. Xiaodi Hou . Note 2: The White Marble Entities have filed an action in the Delaware Court of Chancery seeking a declaratory judgment that the voting agreement between White Marble and Mo Chen is invalid and White Marble, not Mo Chen , controls the vote. White Marble LLC v. Chen , C.A. No. 2024-1208-PAF (Del. Ch.) On December 13, 2024 , the Court entered an order that allows the Company to hold the vote on Proposal Two, and ordered that if Proposal Two is not approved at the Annual Meeting but the Court determines in the Action that Mo Chen , not the White Marble Entities, control how the White Marble Entities' Shares are voted, then the White Marble Entities' shares shall be deemed to have been voted in favor of Proposal Two at the Annual Meeting and that such vote shall stand. The vote totals above include the votes of the shares held by the White Marble Entities as voted by the White Marble Entities. If the shares held by the White Marble entities reflected in the totals above are deemed to have been voted in favor of Proposal Two, the Proposal will have passed. Accordingly, if the Court rules in Mo Chen's favor, Proposal Two will be deemed to have passed and the Company would be permitted to amend its Certificate of Incorporation to implement Proposal Two and each of the directors elected pursuant to Proposal One will serve on the Board until the annual meeting of stockholders in accordance with the class of director to which each nominee is assigned. About CreateAI CreateAI (formerly TuSimple) is a global artificial intelligence company with offices in US, China , and Japan . The company is pioneering the future of digital entertainment content production, seamlessly blending cutting-edge generative AI technology with the creativity of world-class talent. Our mission is to redefine the boundaries of what's possible in digital storytelling by developing immersive, captivating, and visually stunning experiences that resonate with audiences on a global scale. Investor Relations Contact: ICR for CreateAI CreateAI.IR@icrinc.com View original content to download multimedia: https://www.prnewswire.com/news-releases/createai-announces-results-of-2024-annual-meeting-of-stockholders-302338618.html SOURCE CreateAI Holdings Inc