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2025-01-24
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.comLeBron James is going to have to make room for the NFL. Wednesday's doubleheader on Netflix set records as the most-streamed NFL games in U.S. history, with numbers nearly five times more than the NBA. The averaged 24.3 million while averaged 24.1 according to early viewer figures released by Nielsen on Thursday. Nielsen also said there were 65 million U.S. viewers who tuned in for at least one minute of one of the two games. The NBA's five-game slate averaged about 5.25 million viewers per game across ABC, ESPN and its platforms, according to the league and Nielsen. “I love the NFL,” James said in his televised postgame interview Wednesday night. “But Christmas is our day.” While the NBA's Christmas lineup has its best viewer numbers in five years, the NFL has made Christmas one of its tentpole events during the regular season, joining Kickoff Weekend and Thanksgiving. “The numbers speak for themselves and LeBron can have his own view, and I’m sure more people will look at that because of this," said Hans Schroeder, the executive vice president of NFL Media. "But, you know, we’re focused on the NFL and we’re thrilled with the results this year with the Christmas on Netflix and we’re excited to continue to build that over the next couple of years.” Both NFL games surpassed the previous mark of 23 million for last season’s AFC wild-card game between the Miami Dolphins and Chiefs on Peacock. Viewership for Ravens-Texans peaked with the Beyoncé Bowl. The 20-minute halftime performance averaged over 27 million viewers. The viewer figures include the audience on Netflix, mobile viewership on NFL+ and those who tuned in on CBS stations in Pittsburgh, Kansas City, Baltimore and Houston. Global ratings and final U.S. numbers are expected to be available on Tuesday. The NFL's Christmas numbers decreased from last season, but not at the rate that usually happens when something goes from broadcast to streaming. Last year’s three games averaged 28.68 million viewers. The early afternoon contest between the Las Vegas Raiders and Chiefs led the way, averaging 29.48 million on CBS. Once global and Netflix's first-party data is released, both Christmas games should surpass 30 million. The NBA's lineup saw an 84% rise over 2023. One reason for the increase is that all five games were on ABC, compared to two last year. The Los Angeles Lakers’ 115-113 victory over the Golden State Warriors — a game pitting Olympic teammates LeBron James and Stephen Curry — averaged 7.76 million viewers and peaked with about 8.32 million viewers toward the end of the contest, the league said. Those numbers represent the most-watched NBA regular season game in five years. The NBA said all five Christmas games on its schedule — San Antonio at New York in Victor Wembanyama's holiday debut, Minnesota at Dallas, Philadelphia at Boston, Denver at Phoenix and Lakers-Warriors — saw year-over-year viewership increases. Wednesday's numbers pushed NBA viewership for the season across ESPN platforms to up 4% over last season. The league also saw more than 500 million video views on its social media platforms Wednesday, a new record. For the NBA, those are all good signs amid cries that NBA viewership is hurting. “Ratings are down a bit at beginning of the season. But cable television viewership is down double digits so far this year versus last year," NBA Commissioner Adam Silver said earlier this month. “You know, we’re almost at the inflection point where people are watching more programing on streaming than they are on traditional television. And it’s a reason why for our new television deals, which we enter into next year, every game is going to be available on a streaming service.” Part of that new package of television deals that the NBA is entering into next season also increases the number of regular season games broadcast on television from 15 to 75. ___ AP NBA:slot machine number

PHILADELPHIA (AP) — The Philadelphia Phillies and right-handed pitcher Joe Ross finalized a one-year contract on Monday. The 31-year-old Ross made 10 starts and 25 total appearances for the Milwaukee Brewers last season. He went 3-6 with a 3.77 ERA. Selected by the San Diego Padres in the first round of the 2011 amateur draft, the 6-foot-4 Ross has pitched in 123 career games across seven seasons with the Washington Nationals and Brewers. In his career, he has combined for a 4.19 ERA with 469 strikeouts to 170 walks. He's 29-34 with a 4.19 career ERA. Ross is the latest in an offseason of minor moves for the NL East champs. The Phillies acquired left-hander Jesús Luzardo from the Miami Marlins and signed free-agent outfielder Max Kepler to a $10 million, one-year deal. AP MLB: https://apnews.com/hub/MLB Copyright 2024 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed without permission. Get local news delivered to your inbox!PHILADELPHIA and PERTH, Australia , Dec. 23, 2024 /PRNewswire/ -- Arcadium Lithium plc (NYSE: ALTM, ASX: LTM, "Arcadium Lithium"), a leading global lithium chemicals producer, today announced that it has obtained all requisite shareholder approvals in connection with the proposed acquisition by Rio Tinto previously announced on October 9 , 2024. "Today's vote of support by our shareholders confirms our shared belief that with Rio Tinto, we will be a stronger global leader in lithium chemicals production. Together, we enhance our capabilities to successfully develop and operate our assets while supporting the clean energy transition. We are confident that this transaction will provide future benefit to our customers, employees and the communities in which we operate, and I am excited by the path ahead," said Paul Graves , president and chief executive officer of Arcadium Lithium. The final voting results of Arcadium Lithium's special meetings will be filed with the Securities and Exchange Commission in a Form 8-K and will also be available at https://ir.arcadiumlithium.com . Regulatory Update As of this release, merger control clearance has been satisfied or waived in Australia , Canada , China , the United Kingdom and the United States (Hart-Scott-Rodino Antitrust Improvements Act of 1976). Additionally, investment screening approval has been satisfied in the United Kingdom . The proposed transaction is still expected to close in mid-2025, subject to the receipt of remaining regulatory approvals and other closing conditions. Arcadium Lithium Contacts Investors: Daniel Rosen +1 215 299 6208 daniel.rosen@arcadiumlithium.com Phoebe Lee +61 413 557 780 phoebe.lee@arcadiumlithium.com Media: Karen Vizental +54 9 114 414 4702 karen.vizental@arcadiumlithium.com About Arcadium Lithium Arcadium Lithium is a leading global lithium chemicals producer committed to safely and responsibly harnessing the power of lithium to improve people's lives and accelerate the transition to a clean energy future. We collaborate with our customers to drive innovation and power a more sustainable world in which lithium enables exciting possibilities for renewable energy, electric transportation and modern life. Arcadium Lithium is vertically integrated, with industry-leading capabilities across lithium extraction processes, including hard-rock mining, conventional brine extraction and direct lithium extraction (DLE), and in lithium chemicals manufacturing for high performance applications. We have operations around the world, with facilities and projects in Argentina , Australia , Canada , China , Japan , the United Kingdom and the United States . For more information, please visit us at www.ArcadiumLithium.com . Important Information and Legal Disclaimer: Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995: Certain statements in this news release are forward-looking statements. In some cases, we have identified forward-looking statements by such words or phrases as "will likely result," "is confident that," "expect," "expects," "should," "could," "may," "will continue to," "believe," "believes," "anticipates," "predicts," "forecasts," "estimates," "projects," "potential," "intends" or similar expressions identifying "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including the negative of those words and phrases. Such forward-looking statements are based on our current views and assumptions regarding future events, future business conditions and the outlook for Arcadium Lithium based on currently available information. There are important factors that could cause Arcadium Lithium's actual results, level of activity, performance or achievements to differ materially from the results, level of activity, performance or achievements expressed or implied by the forward-looking statements, including the completion of the transaction on anticipated terms and timing, including obtaining required regulatory approvals, and the satisfaction of other conditions to the completion of the transaction; potential litigation relating to the transaction that could be instituted by or against Arcadium Lithium or its affiliates, directors or officers, including the effects of any outcomes related thereto; the risk that disruptions from the transaction will harm Arcadium Lithium's business, including current plans and operations; the ability of Arcadium Lithium to retain and hire key personnel; potential adverse reactions or changes to business or governmental relationships resulting from the announcement or completion of the transaction; certain restrictions during the pendency of the transaction that may impact Arcadium Lithium's ability to pursue certain business opportunities or strategic transactions; significant transaction costs associated with the transaction; the possibility that the transaction may be more expensive to complete than anticipated, including as a result of unexpected factors or events; the occurrence of any event, change or other circumstance that could give rise to the termination of the transaction, including in circumstances requiring Arcadium Lithium to pay a termination fee or other expenses; competitive responses to the transaction; the supply and demand in the market for our products as well as pricing for lithium and high-performance lithium compounds; our ability to realize the anticipated benefits of the integration of the businesses of Livent and Allkem or of any future acquisitions; our ability to acquire or develop additional reserves that are economically viable; the existence, availability and profitability of mineral resources and mineral and ore reserves; the success of our production expansion efforts, research and development efforts and the development of our facilities; our ability to retain existing customers; the competition that we face in our business; the development and adoption of new battery technologies; additional funding or capital that may be required for our operations and expansion plans; political, financial and operational risks that our lithium extraction and production operations, particularly in Argentina , expose us to; physical and other risks that our operations and suppliers are subject to; our ability to satisfy customer qualification processes or customer or government quality standards; global economic conditions, including inflation, fluctuations in the price of energy and certain raw materials; the ability of our joint ventures, affiliated entities and contract manufacturers to operate according to their business plans and to fulfill their obligations; severe weather events and the effects of climate change; extensive and dynamic environmental and other laws and regulations; our ability to obtain and comply with required licenses, permits and other approvals; and other factors described under the caption entitled "Risk Factors" in Arcadium Lithium's 2023 Form 10-K filed with the SEC on February 29, 2024 , as well as Arcadium Lithium's other SEC filings and public communications. Although Arcadium Lithium believes the expectations reflected in the forward-looking statements are reasonable, Arcadium Lithium cannot guarantee future results, level of activity, performance or achievements. Moreover, neither Arcadium Lithium nor any other person assumes responsibility for the accuracy and completeness of any of these forward-looking statements. Arcadium Lithium is under no duty to update any of these forward-looking statements after the date of this news release to conform its prior statements to actual results or revised expectations . View original content to download multimedia: https://www.prnewswire.com/news-releases/arcadium-lithium-announces-shareholder-approval-of-proposed-rio-tinto-transaction-and-provides-regulatory-update-302338409.html SOURCE Arcadium Lithium PLC

JERUSALEM — A new round of Israeli airstrikes in Yemen on Thursday targeted the Houthi rebel-held capital and multiple ports, while the World Health Organization's director-general said the bombardment occurred nearby as he prepared to board a flight in Sanaa, with a crew member injured. "The air traffic control tower, the departure lounge — just a few meters from where we were — and the runway were damaged," Tedros Adhanom Ghebreyesus said on the social media platform X. He added that he and U.N. colleagues were safe. "We will need to wait for the damage to the airport to be repaired before we can leave," he said, without mentioning the source of the bombardment. U.N. spokesperson Stephanie Tremblay later said the injured person was with the U.N. Humanitarian Air Service. The Israeli strikes followed several days of Houthi launches setting off sirens in Israel. The Israeli military said it attacked infrastructure used by the Iran-backed Houthis at the international airport in Sanaa and ports in Hodeida, Al-Salif and Ras Qantib, along with power stations, asserting they were used to smuggle in Iranian weapons and for the entry of senior Iranian officials. Israel's military didn't immediately respond to questions about Tedros' post but issued a statement saying it had "capabilities to strike very far from Israel's territory — precisely, powerfully, and repetitively." The strikes, carried out over 1,000 miles from Jerusalem, came a day after Israeli Prime Minister Benjamin Netanyahu said "the Houthis, too, will learn what Hamas and Hezbollah and Assad's regime and others learned" as his military has battled those more powerful proxies of Iran. The Houthi-controlled satellite channel al-Masirah reported multiple deaths. Iran's foreign ministry condemned the strikes. The U.S. military also has targeted the Houthis in recent days. The U.N. has noted that the targeted ports are important entryways for humanitarian aid for Yemen, the poorest Arab nation that plunged into a civil war in 2014. Over the weekend, 16 people were wounded when a Houthi missile hit a playground in the Israeli city of Tel Aviv, while other missiles and drones have been shot down. Last week, Israeli jets struck Sanaa and Hodeida, killing nine people, calling it a response to previous Houthi attacks. The Houthis also have been targeting shipping on the Red Sea corridor, calling it solidarity with Palestinians in Gaza. The U.N. Security Council has scheduled an emergency meeting Monday in response to an Israeli request that the council condemn the Houthi attacks and Iran for supplying them weapons. 5 journalists are killed in Gaza Meanwhile, an Israeli strike killed five Palestinian journalists outside a hospital in Gaza overnight, the territory's Health Ministry said. The Israeli military said all were militants posing as reporters. The strike hit a car outside Al-Awda Hospital in the built-up Nuseirat refugee camp in central Gaza. The journalists were working for local news outlet Al-Quds Today, a television channel affiliated with the Islamic Jihad militant group. Islamic Jihad is a smaller and more extreme ally of Hamas and took part in the Oct. 7, 2023 attack in southern Israel that ignited the war. Israel's military identified four of the men as combat propagandists and said that intelligence, including a list of Islamic Jihad operatives found by soldiers in Gaza, had confirmed that all five were affiliated with the group. Hamas, Islamic Jihad and other Palestinian militant groups operate political, media and charitable operations in addition to their armed wings. Associated Press footage showed the incinerated shell of a van, with press markings visible on the back doors. Sobbing young men attended the funeral. The bodies were wrapped in shrouds, with blue press vests draped over them. The Committee to Protect Journalists says more than 130 Palestinian reporters have been killed since the start of the war. Israel hasn't allowed foreign reporters to enter Gaza except on military embeds. Israel has banned the pan-Arab Al Jazeera network and accused six of its Gaza reporters of being militants. The Qatar-based broadcaster denies the allegations and accuses Israel of trying to silence its war coverage, which has focused heavily on civilian casualties from Israeli military operations. The toll continues to mount in Gaza Separately, Israel's military said a 35-year-old reserve soldier was killed during fighting in central Gaza. A total of 389 soldiers have been killed in Gaza since the start of the ground operation. The war began when Hamas-led militants stormed across the border, killing around 1,200 people, mostly civilians, and abducting around 250. About 100 hostages are still inside Gaza, at least a third believed to be dead. Israel's air and ground offensive has killed more than 45,000 Palestinians, according to the Health Ministry. It says more than half the fatalities have been women and children, but doesn't say how many of the dead were fighters. Israel says it has killed more than 17,000 militants, without providing evidence. The offensive has caused widespread destruction and hunger and driven around 90% of the population of 2.3 million from their homes. Hundreds of thousands are packed into squalid tent camps along the coast, with little protection from the cold, wet winter. Also Thursday, people mourned eight Palestinians killed by Israeli military operations in and around the city of Tulkarem in the occupied West Bank on Tuesday, according to the Palestinian Health Ministry. The Israeli military said that it opened fire after militants attacked soldiers, and it was aware of uninvolved civilians who were harmed in the raid.LEWISTON, N.Y. (AP) — Jaeden Marshall scored 21 points as Niagara beat Le Moyne 88-69 on Sunday. Marshall shot 5 for 8 (4 for 6 from 3-point range) and 7 of 8 from the free-throw line for the Purple Eagles (6-7). Justice Smith added 15 points while going 6 of 12 from the floor, including 1 for 3 from 3-point range, and 2 for 3 from the line and had five rebounds. Zion Russell shot 4 for 7, including 3 for 3 from beyond the arc to finish with 11 points. AJ Dancier finished with 17 points and four steals for the Dolphins (5-10). Le Moyne also got 11 points and 10 rebounds from Ocypher Owens. Dwayne Koroma had nine points and six rebounds. The Associated Press created this story using technology provided by Data Skrive and data from Sportradar .Altercation erupts at high-level meeting of Russia-dominated economic union

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