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Business Wire
an hour ago
- Business Wire
Mauna Kea Technologies Enters Australian Market with Endotherapeutics Partnership
PARIS & BOSTON--(BUSINESS WIRE)--Regulatory News: Mauna Kea Technologies (Euronext Growth: ALMKT), inventor of Cellvizio®, the multidisciplinary probe and needle-based confocal laser endomicroscopy (p/nCLE) platform, today announces its entry into the Australian market by signing a new exclusive distribution agreement with Endotherapeutics Pty Ltd, a leading Australia-based distributor of cutting-edge medical devices, to bring the Cellvizio platform to Australian physicians. This strategic expansion comes as Mauna Kea experiences growing momentum for its CellTolerance application, prompting the company to open new geographic markets with strong growth potential. The three-year agreement grants Endotherapeutics the exclusive rights to distribute and promote the Cellvizio platform in Australia. As part of the market entry, a submission for Therapeutic Goods Administration (TGA) approval for the latest generation of Cellvizio products is underway. Mauna Kea Technologies has already been granted TGA clearance in the past and does not anticipate any hurdles in obtaining it again. The partnership will leverage the upcoming launch of the CellTolerance program with Professor Gerald Holtmann, MD, PhD, MBA, a leading Australian physician at Princess Alexandra Hospital in Brisbane, who is planning to acquire one Cellvizio for food intolerance applications. 'This technology brings hope of change for millions of patients suffering from food-related IBS symptoms,' commented Professor Holtmann. 'Cellvizio is truly unique in its ability to help identify the root causes of patient symptoms, enabling the creation of tailored diets. My entire team is excited to explore its full potential and improve the lives of our patients.' 'We're very pleased to partner with Mauna Kea Technologies to introduce Cellvizio to the vibrant Australian GI market,' stated Rob Curtin, Business Manager for GI at Endotherapeutics. 'The potential for Cellvizio and its key indications, particularly pancreatic cyst characterization and food intolerance detection is very significant.' Sacha Loiseau, Chairman and CEO of Mauna Kea Technologies, added: "We are thrilled to partner with Endotherapeutics, a premier distributor of cutting-edge medical devices and a trusted partner with deep roots in the Australian healthcare system. This partnership marks a key milestone in our international expansion strategy. As we see good momentum in the adoption of our platform, particularly for CellTolerance, we are taking key initiatives to expand our market reach in territories with strong growth potential.' *** About Endotherapeutics Pty Ltd Endotherapeutics is a leading Healthcare Technologies distributor serving customers across Australia and New Zealand, headquartered in Sydney, Australia. Endotherapeutics' mission is to improve healthcare and achieves this by supplying innovative healthcare solutions with the highest levels of service and support. To find out more, visit About Mauna Kea Technologies Mauna Kea Technologies is a global medical device company that manufactures and sells Cellvizio®, the real-time in vivo cellular imaging platform. This technology uniquely delivers in vivo cellular visualization which enables physicians to monitor the progression of disease over time, assess point-in-time reactions as they happen in real time, classify indeterminate areas of concern, and guide surgical interventions. The Cellvizio® platform is used globally across a wide range of medical specialties and is making a transformative change in the way physicians diagnose and treat patients. For more information, visit Disclaimer This press release contains forward-looking statements about Mauna Kea Technologies and its business. All statements other than statements of historical fact included in this press release, including, but not limited to, statements regarding Mauna Kea Technologies' financial condition, business, strategies, plans and objectives for future operations are forward-looking statements. Mauna Kea Technologies believes that these forward-looking statements are based on reasonable assumptions. However, no assurance can be given that the expectations expressed in these forward-looking statements will be achieved. These forward-looking statements are subject to numerous risks and uncertainties, including those described in Chapter 2 of Mauna Kea Technologies' 2024 Annual Report filed with the Autorité des marchés financiers (AMF) on April 30, 2025, which is available on the Company's website ( as well as the risks associated with changes in economic conditions, financial markets and the markets in which Mauna Kea Technologies operates. The forward-looking statements contained in this press release are also subject to risks that are unknown to Mauna Kea Technologies or that Mauna Kea Technologies does not currently consider material. The occurrence of some or all of these risks could cause the actual results, financial condition, performance or achievements of Mauna Kea Technologies to differ materially from those expressed in the forward-looking statements. This press release and the information contained herein do not constitute an offer to sell or subscribe for, or the solicitation of an order to buy or subscribe for, shares of Mauna Kea Technologies in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. The distribution of this press release may be restricted in certain jurisdictions by local law. Persons into whose possession this document comes are required to comply with all local regulations applicable to this document.


Newsweek
an hour ago
- Newsweek
List of Places Where Tesla Faces Legal Action Over Self-Driving Cars
Based on facts, either observed and verified firsthand by the reporter, or reported and verified from knowledgeable sources. Newsweek AI is in beta. Translations may contain inaccuracies—please refer to the original content. Tesla, headed by CEO Elon Musk, has come under increasing legal scrutiny worldwide over its self-driving technology, with lawsuits and regulatory actions unfolding in France, Australia, Florida, and California. Many of the cases share a common theme of criticizing Tesla's advertising, with lawyers saying that the company's claims of "autonomous vehicles" fail to live up to reality. Newsweek contacted Tesla for more information on the legal action via email. The Context Tesla's global sales have struggled in 2025, with developing foreign competition further threatening its leading position in key markets, and backlash against CEO Elon Musk's role in President Donald Trump's administration resulting in protests and boycotts of the company's vehicles. The legal challenges across the world mean Tesla has further issues to deal with, despite Musk's departure from the White House. France In France, the government has ordered Tesla to fix a series of violations over deceptive business practices, with the company facing daily fines of $58,000 if it fails to comply. French regulators determined that Tesla's "autonomous driving" features do not meet the standard implied by the company's marketing, and said that the company misled buyers by overstating the power of its autonomous driving technology. A Tesla electric car retail store and company brand logo sign at night, Wuhan, China, May 2nd 2024. A Tesla electric car retail store and company brand logo sign at night, Wuhan, China, May 2nd 2024. Getty Images Australia Thousands of Australian Tesla owners have joined a class action alleging "phantom braking" and misleading claims about the vehicles' capabilities and performance. Plaintiffs describe repeated, sudden, and unexplained braking events while using Tesla's Autopilot system, with some incidents leading to collisions or dangerous situations. "Drivers have reported feeling completely terrified when their vehicles have braked suddenly and it has led in some cases to collisions," said class action lawyer Rebecca Jancauskas in an interview in June. "We've had many reports of people who registered for this class action, telling us that they've been driving with their hands on the vehicle, fully alert, and these issues have occurred nonetheless." Florida In Miami, Florida, a federal jury trial is underway following a fatal 2019 crash involving a Tesla Model S using its Autopilot system. Plaintiffs claim Tesla exaggerated the abilities of its self-driving features, encouraging drivers—like George McGee, who admitted distraction at the wheel—to become over-reliant on the technology. The crash led to the death of Naibel Benavides Leon and severe injury to her companion. George McGee said in court, "I trusted the technology too much," acknowledging he took his attention off the road because of his confidence in the autopilot. The trial, overseen by U.S. District Judge Beth Bloom, is expected to set a precedent for how driver-assistance technologies are marketed and what obligations manufacturers bear. California The California Department of Motor Vehicles has filed a lawsuit seeking to halt Tesla sales and manufacturing in the state for at least 30 days. The Department accuses Tesla of making false and misleading claims about its autopilot and full self-driving capabilities, alleging the features are advertised as being more autonomous than they actually are. Attorney General Rob Bonta said in a statement, "These labels and descriptions represent specifically that respondent [Tesla]'s vehicles will operate as autonomous vehicles, which they could not and cannot do". What Happens Next The outcomes of these legal actions may have wide-reaching implications for Tesla and the broader self-driving automotive sector. In California, the DMV's lawsuit could result in a month-long suspension of Tesla's sales and manufacturing, potentially influencing how all automakers market advanced driver assistance systems.


Business Wire
5 hours ago
- Business Wire
HanesBrands Provides Details for Second-Quarter 2025 Earnings Announcement and Investor Conference Call
WINSTON-SALEM, N.C.--(BUSINESS WIRE)--HanesBrands Inc. (NYSE: HBI) today provided details for its second-quarter 2025 investor conference call at 8:30 a.m. ET Thursday, August 7, 2025. Prior to the conference call that day, HanesBrands will issue a news release disclosing financial results for the quarter ended June 28, 2025. Conference Call Details To participate via telephone, please register in advance by clicking here or using this link: After registering, all telephone participants will receive a confirmation email with instructions to join the conference call, including the dial-in number, a unique passcode, and a registrant ID for access. While not mandatory, joining 10 minutes before the event is recommended for a seamless experience. The conference call webcast, featuring prepared remarks followed by a Q&A session, will be available in the Investors section of the HanesBrands corporate website at The call is expected to conclude by 9:30 a.m. ET. A replay of the conference call will be available online. The archived webcast can be accessed after the call in the Investors section of the HanesBrands corporate website or directly via this link: About HanesBrands HanesBrands (NYSE: HBI), the No. 1 seller of innerwear, is a socially responsible global leader in everyday iconic apparel with a mission to create a more comfortable world for every body. The company owns a portfolio of some of the world's most recognized apparel brands including Hanes, the leading basic apparel brand in the U.S.; Bonds, an Australian staple since 1915 that is setting new standards for design and innovation; Maidenform, America's number one shapewear brand; and Bali, America's number one national bra brand. HanesBrands owns the majority of its worldwide manufacturing facilities and has built a strong reputation for workplace quality, ethical business practices, and reducing environmental impact.