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The Latest: Police believe gunman who killed UnitedHealthcare CEO has left New York CityEric Trump, the second son of former President Donald Trump, has recently made headlines for his bold statements regarding the future of banking in the United States. In a statement that has sparked both interest and controversy, Eric Trump proclaimed that traditional banks are outdated and that the United States must lead the way in embracing the wave of cryptocurrency. He further emphasized the importance of establishing a clear regulatory roadmap to guide the transition towards a more digital and decentralized financial system.
Former Red Sox exec weighs in on controversial Aroldis Chapman signing: ‘I guess enough time has passed’
Apple’s Abandoned Gamble: Inside the Scrapped iPhone Subscription Service
New collagen-based dermal matrix designed for tissue generation, complementary to RECELL and PermeaDerm Cohealyx expected to triple AVITA Medical’s addressable market in burns VALENCIA, Calif., Dec. 19, 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 granted 510(k) clearance for Cohealyx TM , a new collagen-based dermal matrix branded by AVITA Medical and co-developed with Regenity Biosciences. Cohealyx is designed for tissue integration and revascularization to facilitate wound healing, reduce treatment timelines, and improve patient outcomes in the treatment of full-thickness wounds. Burns and full-thickness wounds penetrate all layers of the skin, resulting in significant tissue loss and structural damage. Unlike superficial wounds, full-thickness wounds lack the cellular components and structural support necessary to regenerate missing tissue. Without timely surgical intervention, there is heightened risk of delayed closure, infection, and severe scarring. Dermal matrices are essential in two-stage procedures for treating these wounds, as they support tissue generation for successful skin graft take and improve healing outcomes. Cohealyx addresses this critical need in the treatment of full-thickness wounds with an advanced bovine collagen-based design engineered to facilitate cellular migration and blood vessel formation. Preclinical studies in porcine models demonstrated that Cohealyx generated robust tissue capable of consistently supporting a split-thickness skin graft in a two-stage procedure earlier than leading dermal matrices in the study. While animal model results do not necessarily translate to clinical results, this expedited timeline is anticipated to lead to quicker wound closure and streamlined clinician workflows, resulting in shorter hospital stays, reduced treatment costs, and better patient outcomes. These parameters will be evaluated in a clinical study. “Cohealyx is a strategic addition to our RECELL-centric portfolio, unlocking the powerful synergies of RECELL and Cohealyx to address full-thickness wounds,” said Jim Corbett, Chief Executive Officer of AVITA Medical. “This expansion to our product portfolio strengthens our ability to deliver superior patient outcomes and significantly expands our commercial potential in burns. By equipping clinicians with more comprehensive treatment options, we strengthen our competitive position, drive new growth opportunities, and further our commitment to advancing regenerative medicine.” Cohealyx strengthens AVITA Medical’s portfolio by expanding its capabilities in the treatment of full-thickness wounds. Offered alongside RECELL and PermeaDerm ® , Cohealyx enhances our comprehensive portfolio for addressing full-thickness wound care. This expanded portfolio is expected to triple AVITA Medical’s addressable market in burns, as dermal matrices are a critical component of the standard two-stage surgical procedure for definitive closure of these wounds. We also anticipate Cohealyx will generate significant revenue as we penetrate the full-thickness skin defect market. AVITA Medical plans to develop clinical data for Cohealyx in early 2025 to build on the preclinical success and support the product’s commercial launch. The post-market clinical study will assess Cohealyx’s performance in real-world settings, focusing on clinical efficacy and cost savings in the treatment of full-thickness wounds and burns. In the U.S., we expect to launch full commercialization efforts in the beginning of the second quarter of 2025. 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 . About Regenity Biosciences Regenity Biosciences, a Linden Capital Partners portfolio company, is a leading global developer and manufacturer of bioresorbable technologies to repair and regenerate natural tissue and bone for a variety of markets including dental, spine, orthopaedic, sports medicine, advanced wound, neurosurgery, ENT, and nerve repair. Founded in 1997, Regenity (formerly Collagen Matrix, Inc.) is headquartered in Paramus, New Jersey, with manufacturing locations in Oakland and Allendale, New Jersey and Groningen, the Netherlands. Regenity's product portfolio includes a variety of collagen-based and synthetic polymer solutions that support the company's platform for tissue and bone regeneration. Regenity develops proprietary products that are sold to OEM customers on either a contract or private label basis and offers partnership opportunities including contract product development and manufacturing services. For more information, please visit www.regenity.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.But any efforts to halt the policy would face steep legal hurdles. Birthright citizenship means anyone born in the United States automatically becomes an American citizen. It's been in place for decades and applies to children born to someone in the country illegally or in the U.S. on a tourist or student visa who plans to return to their home country. It's not the practice of every country, and Trump and his supporters have argued that the system is being abused and that there should be tougher standards for becoming an American citizen. But others say this is a right enshrined in the 14th Amendment to the Constitution, it would be extremely difficult to overturn and even if it's possible, it's a bad idea. Here's a look at birthright citizenship, what Trump has said about it and the prospects for ending it: During an interview Sunday on NBC’s “Meet the Press” Trump said he “absolutely” planned to halt birthright citizenship once in office. “We’re going to end that because it’s ridiculous,” he said. Trump and other opponents of birthright citizenship have argued that it creates an incentive for people to come to the U.S. illegally or take part in “birth tourism,” in which pregnant women enter the U.S. specifically to give birth so their children can have citizenship before returning to their home countries. “Simply crossing the border and having a child should not entitle anyone to citizenship,” said Eric Ruark, director of research for NumbersUSA, which argues for reducing immigration. The organization supports changes that would require at least one parent to be a permanent legal resident or a U.S. citizen for their children to automatically get citizenship. Others have argued that ending birthright citizenship would profoundly damage the country. “One of our big benefits is that people born here are citizens, are not an illegal underclass. There’s better assimilation and integration of immigrants and their children because of birthright citizenship,” said Alex Nowrasteh, vice president for economic and social policy studies at the pro-immigration Cato Institute. In 2019, the Migration Policy Institute estimated that 5.5 million children under age 18 lived with at least one parent in the country illegally in 2019, representing 7% of the U.S. child population. The vast majority of those children were U.S. citizens. The nonpartisan think tank said during Trump’s campaign for president in 2015 that the number of people in the country illegally would “balloon” if birthright citizenship were repealed, creating “a self-perpetuating class that would be excluded from social membership for generations.” In the aftermath of the Civil War, Congress ratified the 14th Amendment in July 1868. That amendment assured citizenship for all, including Black people. “All persons born or naturalized in the United States and subject to the jurisdiction thereof, are citizens of the United States and of the State wherein they reside,” the 14th Amendment says. “No State shall make or enforce any law which shall abridge the privileges or immunities of citizens of the United States.” But the 14th Amendment didn't always translate to everyone being afforded birthright citizenship. For example, it wasn't until 1924 that Congress finally granted citizenship to all Native Americans born in the U.S. A key case in the history of birthright citizenship came in 1898, when the U.S. Supreme Court ruled that Wong Kim Ark, born in San Francisco to Chinese immigrants, was a U.S. citizen because he was born in the states. The federal government had tried to deny him reentry into the county after a trip abroad on grounds he wasn’t a citizen under the Chinese Exclusion Act. But some have argued that the 1898 case clearly applied to children born of parents who are both legal immigrants to America but that it's less clear whether it applies to children born to parents without legal status or, for example, who come for a short-term like a tourist visa. “That is the leading case on this. In fact, it’s the only case on this,” said Andrew Arthur, a fellow at the Center for Immigration Studies, which supports immigration restrictions. “It’s a lot more of an open legal question than most people think.” Some proponents of immigration restrictions have argued the words “subject to the jurisdiction thereof” in the 14th Amendment allows the U.S. to deny citizenship to babies born to those in the country illegally. Trump himself used that language in his 2023 announcement that he would aim to end birthright citizenship if reelected. Trump wasn't clear in his Sunday interview how he aims to end birthright citizenship. Asked how he could get around the 14th Amendment with an executive action, Trump said: “Well, we’re going to have to get it changed. We’ll maybe have to go back to the people. But we have to end it.” Pressed further on whether he'd use an executive order, Trump said “if we can, through executive action." He gave a lot more details in a 2023 post on his campaign website . In it, he said he would issue an executive order the first day of his presidency, making it clear that federal agencies “require that at least one parent be a U.S. citizen or lawful permanent resident for their future children to become automatic U.S. citizens.” Trump wrote that the executive order would make clear that children of people in the U.S. illegally “should not be issued passports, Social Security numbers, or be eligible for certain taxpayer funded welfare benefits.” This would almost certainly end up in litigation. Nowrasteh from the Cato Institute said the law is clear that birthright citizenship can’t be ended by executive order but that Trump may be inclined to take a shot anyway through the courts. “I don’t take his statements very seriously. He has been saying things like this for almost a decade," Nowrasteh said. "He didn’t do anything to further this agenda when he was president before. The law and judges are near uniformly opposed to his legal theory that the children of illegal immigrants born in the United States are not citizens." Trump could steer Congress to pass a law to end birthright citizenship but would still face a legal challenge that it violates the Constitution. Associated Press reporter Elliot Spagat in San Diego contributed to this report.
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ORLANDO, Fla. , Dec. 19, 2024 /PRNewswire/ -- Security First Insurance, based in Florida , and Embark MGA, Florida insurance experts, join forces to launch a modern HO5 homeowners' insurance program designed exclusively for new home builders to have an affordable, turnkey insurance option for home buyers. This innovative homeowners' insurance solution combines enhanced coverage options tailored to the unique needs of Florida homeowners with the simplicity of embedding the insurance in the home-buying process. This solution comes at a crucial time for Florida builders. Recent surveys reveal that many prospective home buyers in Florida cite insurance as a major barrier to purchasing a home. To address this problem head-on, Security First will provide a new level of comprehensive protection to new home buyers in Florida , supported by Embark's expertise in custom insurance solutions and proprietary technology. The new HO5 policy comes with a broader scope of protection for new home buyers than the standard HO3 policy and streamlined claims processing. These HO5 policies are distinctive in the Builder channel because they provide "open-perils" coverage for both the home and personal belongings, and coverage for incidents that are often excluded from traditional policies, bringing extra reassurance to home buyers that their new investment will be well protected. "This partnership with Embark allows Security First to expand our reach into a new segment of Florida homeowners," said Bob Ketchum , SVP of Product and Underwriting. "We pride ourselves on innovative product design and exceptional service," continued Ketchum, "and promise to be there for our customers when they need us the most." Embark's commitment to providing modern, tech-driven insurance solutions in niche customer segments complements Security First's deep knowledge of the Florida market. Leveraging Embark's proprietary technology, insurance quotes are seamlessly integrated into the home-buying and mortgage qualification process. The system preloads builders' home inventory, community details, and model data, enabling accurate, bindable quotes without the need for lengthy applications. This streamlined approach electronically shares insurance information with builders' mortgage and title partners, reducing closing delays and eliminating much of the friction typically faced by consumers during the home-buying journey. Key Features of the Security First New Home Builder HO5 Policy: Open-Perils Coverage : Offers broad protection with fewer exclusions than standard homeowners' insurance policies. Service Line and Equipment Breakdown Coverage : These two valuable extra coverages are included in the product without an additional premium. Increased Personal Property Coverage : Higher limits for personal belongings, including high-value items. Streamlined Claims Process : A simplified and user-friendly experience for faster claims handling. Comprehensive Protection : Enhanced coverage for accidental damage and other risks not typically covered under HO3 policies. "We are thrilled to partner with Security First Insurance, a company that shares our commitment to innovation and delivering exceptional, customer-centric service," said Brian Crumbaker , EVP Distribution at Embark. "We look forward to supporting the unique needs of new home builders and their clients. This new embedded product stands out with its competitive pricing and broad coverage options, offering a superior solution in the Florida market." Media Contacts: Embark MGA Marc T. Murphy Jr. Director of Agency Operations and Marketing mmurphy@embarkgeneral.com 470-723-4241 Security First Insurance Wendy Maddalone Director of Marketing and Communications wendy.maddalone@securityfirstflorida.com 386-243-4707 About Embark MGA: Embark is a technology-driven insurance company focused on providing innovative and customer-friendly insurance solutions. Through its modern platform and product offerings, Embark simplifies the insurance experience, offering comprehensive protection tailored to today's consumer needs. About Security First Insurance: Security First Insurance is a leading provider of homeowners insurance in Florida , committed to safeguarding Florida families with tailored, reliable coverage. With deep expertise in the unique challenges Florida residents face, Security First delivers high-quality service and protection. About Our New Home Builder Program: Our New Home Builder Program offers new home builders, their distribution partners, and client's direct access to insurance products specifically designed for new homes. Exclusively available to our partners, this program simplifies the underwriting process by only using information about the house to issue policies that typically provide more flexibility than a standard homeowner's policy. View original content to download multimedia: https://www.prnewswire.com/news-releases/security-first-insurance-partners-with-embark-mga-to-enter-the-new-home-builder-insurance-channel-with-the-launch-of-an-innovative-ho5-product-in-florida-302336659.html SOURCE Embark General © 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Wallbox Receives Notice of Non-Compliance with NYSE Trading Share Price Listing RuleThe sudden change in tone from OpenAI has raised questions about the company's transparency and the reliability of its promises. Many are now questioning the integrity of Sora's development process and the validity of the claims made by OpenAI regarding its capabilities. The discrepancy between the hype surrounding Sora's launch and the reality of its performance has left a bitter taste in the mouths of those who had been eagerly anticipating its arrival.
As the country grapples with the implications of this verdict, one thing remains clear: the fight for justice and accountability is far from over. The verdict may have been delivered, but the conversation around police violence and systemic racism continues, and the demand for change grows stronger with each passing day. In the words of one protester outside the courthouse, "No justice, no peace."Biden officials, Republicans point fingers over exhausted disaster loans program
Trump has flip-flopped on abortion policy. His appointees may offer clues to what happens nextPicture This announce extra concert date ahead of huge Cork gig – and tickets go on sale this weekProZero is proud to announce the successful delivery of a 15m ProZero passenger vessel to Metro-Opus, a prominent provider of high-speed ferry services in Norway. After rigorous testing and certification processes, the state-of-the-art 15-meter passenger vessel has been approved for operations by the Norwegian Maritime Authority, marking a significant milestone for ProZero and Metro Opus. The vessel was formally handed over to Metro-Opus Project Manager Rasmus Husby Larsen by Jakob Frost, co-owner of the shipyard. The delivery ceremony underscored the collaboration and innovation that brought this unique vessel to fruition. Designed and built with ProZero’s modular construction approach, the vessel combines cutting-edge technology, universal design principles, and unparalleled efficiency. It is certified to accommodate 12 passengers, including wheelchair spaces, as well as cargo and crew. The vessel’s innovative hull design ensures low hydrodynamic resistance for enhanced fuel efficiency and exceptional stability in challenging weather conditions. Project Manager Rasmus Husby Larsen praised the partnership, stating: ”This vessel fully fulfills our trust in ProZero’s ability to deliver a robust, well-proven vessel tailored to our diverse requirements. Its performance, stability, and efficiency exceed our expectations and set a new benchmark for small vessel passenger transport in the Norwegian ferry market.” Jakob Frost, co-owner of the ProZero shipyard, expressed his excitement at the successful delivery: ”We are delighted to see this vessel ready to serve in Norway. This project represents ProZero’s commitment to innovation, quality, and customer-focused solutions. Working with Metro-Opus has been a rewarding experience, and we are proud to have met their high standards.” The Norwegian Maritime Authority’s approval further highlights the vessel’s compliance with stringent safety and operational regulations, ensuring reliability and safety for passengers and crew alike. Source: ProZero
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