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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 Skin TM 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 GO TM , 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-bdcca54fad27Actress Angelina Jolie ’s recent appearances on the red carpet for her Maria Callas biopic have sparked widespread concern among fans . The Hollywood longtimer is being called out for her noticeably slim frame and prominent veins. While fans and critics alike have praised her portrayal of the legendary opera singer , the conversation about her talent has been overshadowed by growing worries about her health. Angelina Jolie smiles while shopping after Brad Pitt case takes alarming turn Brad Pitt's girlfriend plans his 61st birthday celebration despite family feud Social media has been full of comments, with users sharing extreme and unhealthy dieting methods inspired by Jolie’s appearance . The Times of India stated: "One user reportedly asked how to achieve a ‘bulging vein’ look, while another suggested avoiding hydration and reducing body fat to make veins more visible." “Others praised the appearance, calling it ‘sexy’ and ‘impressive,’” the outlet stated. Jolie’s biopic, which debuted on Netflix on December 11, has been celebrated for her “stunning portrayal of Maria Callas,” with audiences applauding her ability to bring the opera legend’s life and struggles to the screen. Despite this praise, her recent red-carpet appearances have triggered what outlets have called an “unsettling trend” of fans obsessing over her look. DON'T MISS: Brad Pitt’s ‘body double’ jailed for 'stealthing’ rape charge among other crimes [REVEALED] Angelina Jolie 'blocking' ex Brad from third marriage as he celebrates birthday [INSIGHT] Angelina Jolie is 'often alone' and hasn't 'figured out' how to live life [LATEST] “Concerns about her health have started stealing the spotlight,” one observer noted, as fans speculate whether the stress of her “ messy divorce battle with Brad Pitt ” is taking a toll. This speculation is nothing new, as Jolie’s slim frame and visible veins “have often been a subject of public speculation,” with rumors suggesting stress-related health issues linked to her personal life . Though Jolie appeared radiant on the red carpet, “observers noted that Jolie appeared frail and unwell at some events.”BluSky Carbon Announces Extension of Strategic Marketing Agreement
NonePresident Sarhad Chamber of Commerce and Industry (SCCI), Fazal Moqeem Khan has termed the China-Pakistan Economic Corridor (CPEC) a game-changer for the economic and social development of Pakistan. Emphasizing its importance, he urged the government to allocate all necessary resources for the successful implementation of the project. Fazal Moqeem Khan expressed these views during his visit to the China Window, a Chinese cultural and information center in Peshawar. He was accompanied by the Chamber’s Senior Vice President Abdul Jalil Jan, Vice President Shahryar Khan, and Executive Committee Members Mujeeb-ur-Rehman and Ishtiaq Ahmed. During his visit, Fazal Moqeem Khan toured the various galleries at China Window, recorded his impressions in the guest book, and signed the Friendship Wall. Mr Khan described CPEC as a cornerstone of Pakistan’s economic growth, offering unprecedented opportunities for trade, infrastructure development, and regional connectivity. He praised the initiative for fostering industrialization, creating employment, and strengthening ties between Pakistan and China. “The China-Pakistan Economic Corridor is not just a project; it is a gateway to prosperity. It has the potential to turn Pakistan into a hub of economic activity and bring significant benefits to the region,” he said. He stressed the need to expedite work on CPEC, highlighting that trade activities under the project would boost the national economy, generate employment opportunities, and pave the way for Pakistan’s development. He further remarked that the friendship between Pakistan and China is recognized worldwide, and CPEC stands as a remarkable symbol of this bond. He called for efforts to remove obstacles hindering the project’s progress, ensuring its timely completion. Fazal Moqeem Khan also assured that the business community is fully committed to supporting the success of CPEC, expressing confidence that the project will usher in a new era of development and prosperity, particularly in Khyber Pakhtunkhwa. The SCCI delegation lauded China Window as a significant hub of Pak-China friendship in Peshawar. They praised its role in fostering bilateral ties and promoting a positive image of Pakistan-China relations. Earlier, a Memorandum of Understanding (MoU) was signed between the Sarhad Chamber of Commerce and Industry Peshawar and China Window. Under this agreement, both organizations will collaborate to strengthen Pak-China relations and raise awareness about CPEC through various events and initiatives.
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