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Business Upturn
24-06-2025
- Business
- Business Upturn
Administrative Law Judge Determines ReWalk Personal Exoskeleton is 'Reasonable and Necessary' for Medicare Beneficiary
MARLBOROUGH, Mass. and YOKNEAM ILLIT, Israel, June 24, 2025 (GLOBE NEWSWIRE) — Lifeward Ltd., (Nasdaq: LFWD) ('Lifeward' or the 'Company'), a global leader in innovative medical technology to transform the lives of people with physical limitations or disabilities, today announced the recent ruling by an Administrative Law Judge ('ALJ') in favor of an appeal by a Medicare beneficiary that their ReWalk Personal Exoskeleton shall be covered and reimbursed by Medicare as a 'reasonable and necessary' medical device that enables walking after spinal cord injury ('SCI'). The ruling establishes a legal basis that the ReWalk system constitutes a reasonable and necessary medical intervention for paralyzed individuals. 'The clinical basis for a reasonable and necessary definition of the ReWalk technology is supported by the scientific literature regarding the health benefits of being able to ambulate in everyday life,' said Keith Rose, M.D., Vice President, Medical Affairs of Lifeward. 'Our focus is to work with clinicians in expanding the data and programs to broaden utilization for the health and well-being of the paralyzed community.' 'This ruling is a meaningful step in establishing a legal precedent of access for those who can benefit from being able to walk in everyday life once again,' said Mark Grant, CEO of Lifeward. 'By reinforcing that personal exoskeletons are a reasonable and necessary intervention for people living with spinal cord injury, this ruling not only clarifies access for Medicare beneficiaries, but also paves the way for broader coverage through commercial payors, ultimately expanding access for the entire paralyzed community.' The ALJ ruling builds upon the April 2024 decision by the Centers for Medicare & Medicaid Services ('CMS') to finalize a Medicare reimbursement pathway for personal exoskeleton use, further expanding access to the ReWalk Exoskeleton for more individuals living with SCI. The ReWalk Exoskeleton is the only personal exoskeleton that enables paralyzed individuals to navigate stairs and curbs , in addition to walking in everyday environments. The latest ReWalk innovation, the ReWalk 7, received FDA clearance in March 2025 and is commercially available in the United States. To learn more about the ReWalk 7 Personal Exoskeleton, please visit About Lifeward Lifeward designs, develops, and commercializes life-changing solutions that span the continuum of care in physical rehabilitation and recovery, delivering proven functional and health benefits in clinical settings as well as in the home and community. Our mission at Lifeward is to relentlessly drive innovation to change the lives of individuals with physical limitations or disabilities. We are committed to delivering groundbreaking solutions that empower individuals to do what they love. The Lifeward portfolio features innovative products including the ReWalk Exoskeleton, the AlterG Anti-Gravity System, the ReStore Exo-Suit, and the MyoCycle FES System. Founded in 2001, Lifeward has operations in the United States, Israel, and Germany. Lifeward®, ReWalk®, ReStore®, and Alter G® are registered trademarks of Lifeward Ltd. and/or its affiliates. Forward-Looking Statements In addition to historical information, this press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, Section 27A of the U.S. Securities Act of 1933, and Section 21E of the U.S. Securities Exchange Act of 1934. Such forward-looking statements may include projections regarding the Company's future performance and other statements that are not statements of historical fact and, in some cases, may be identified by words like 'anticipate,' 'assume,' 'believe,' 'continue,' 'could,' 'estimate,' 'expect,' 'intend,' 'may,' 'plan,' 'potential,' 'predict,' 'project,' 'future,' 'will,' 'should,' 'would,' 'seek' and similar terms or phrases. The forward-looking statements contained in this press release are based on management's current expectations, which are subject to uncertainty, risks and changes in circumstances that are difficult to predict and many of which are outside of the Company's control. Important factors that could cause the Company's actual results to differ materially from those indicated in the forward-looking statements include, among others: the acceptance of the ReWalk 7 Personal Exoskeleton by healthcare professionals and patients; uncertainties associated with future clinical trials and the clinical development process, the product development process and FDA regulatory submission review and approval process; the Company's ability to have sufficient funds to meet certain future capital requirements, which could impair the Company's efforts to develop and commercialize existing and new products; the Company's ability to maintain and grow its reputation and the market acceptance of its products; the Company's ability to achieve reimbursement from third-party payors, including CMS, for its products; the Company's limited operating history and its ability to leverage its sales, marketing and training infrastructure; the Company's expectations as to its clinical research program and clinical results; the Company's expectations regarding future growth, including its ability to increase sales in its existing geographic markets and expand to new markets; the Company's ability to obtain certain components of its products from third-party suppliers and its continued access to its product manufacturers; the Company's ability to navigate any difficulties associated with moving production of its AlterG Anti-Gravity Systems to a contract manufacturer; the Company's ability to improve its products and develop new products; the Company's compliance with medical device reporting regulations to report adverse events involving the Company's products, which could result in voluntary corrective actions or enforcement actions such as mandatory recalls, and the potential impact of such adverse events on the Company's ability to market and sell its products; the Company's ability to gain and maintain regulatory approvals; the Company's ability to maintain adequate protection of its intellectual property and to avoid violation of the intellectual property rights of others; the risk of a cybersecurity attack or breach of the Company's IT systems significantly disrupting its business operations; the Company's ability to use effectively the proceeds of its offerings of securities; and other factors discussed under the heading 'Risk Factors' in the Company's annual report on Form 10-K, as amended, for the year ended December 31, 2024 filed with the SEC and other documents subsequently filed with or furnished to the SEC. Any forward-looking statement made in this press release speaks only as of the date hereof. Factors or events that could cause the Company's actual results to differ from the statements contained herein may emerge from time to time, and it is not possible for the Company to predict all of them. Except as required by law, the Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise. Lifeward Media Relations: Kathleen O'DonnellVice President, Marketing & New Business DevelopmentLifeward Ltd. E: [email protected]
Associated Press
08-06-2025
- Politics
- Associated Press
DEA's Marijuana Defiance Deepens: Rogue Bureaucrats Undermine DOJ, Supreme Court, and Rule of Law
Terrance Cole's First Test: Will He Restore DEA Diversion To Legitimacy As the DEA Diversion spirals into constitutional crisis, all eyes now turn to incoming Administrator Terrance Cole. With the Supreme Court, DOJ, and Congress aligned on the illegality of the agency's ALJ system, Cole faces a clear mandate: dismantle the DEA's kangaroo court framework, remove corrupt leadership like Thomas Prevoznik, Matthew Strait and attorney Aarathi Haig, restore sound marijuana policy and return the agency to the rule of law. His next moves will determine whether the DEA Diversion can be salvaged-or whether it must be restructured from the ground up. WASHINGTON, DC / ACCESS Newswire / June 8, 2025 / While the Department of Justice has publicly withdrawn its defense of DEA unconstitutional administrative law judges (ALJs), the Drug Enforcement Administration (DEA) continues to flout executive orders, Supreme Court precedent, and congressional intent-all while using tainted legal proceedings to obstruct cannabis science and protect entrenched interests. This brazen defiance is no longer theoretical-it is operational. The DEA is actively weaponizing a judicial system that the U.S. Supreme Court has declared unconstitutional in Axon v. FTC and Jarkesy v. SEC. Despite Attorney General Pam Bondi's directive that the DOJ will no longer defend this structure, the DEA marches forward, conducting hearings before ALJs who cannot be removed by the President-an arrangement that violates the Appointments Clause and undermines the separation of powers. The DOJ Says It's Over-The DEA Didn't Get the Memo In direct contradiction to Bondi's notice to Congress-including Judiciary Committee leaders like Senator Chuck Grassley-DEA officials have scheduled yet another ALJ hearing against MMJ BioPharma Cultivation, a federally compliant research firm seeking to advance treatments for Multiple Sclerosis and Huntington's Disease. This is not just bureaucratic overreach-it's deliberate sabotage. Worse, the DEA is exploiting the legal ambiguity around 'harm' to sidestep accountability. By claiming that MMJ and similar companies must first suffer irreparable injury before federal courts can intervene, the agency is playing a dangerous game-daring businesses to be destroyed before they can challenge illegal proceedings. 'The DEA's abuse of the harm requirement is nothing short of gaslighting,' said MMJ CEO Duane Boise. 'They tell us to wait for damage, then slam the door shut when that damage arrives.' The Real Harm Is Institutional The true injury here isn't just to MMJ or its scientists-it's to the American system of checks and balances. When an executive agency refuses to comply with a Supreme Court ruling and ignores its own Justice Department's constitutional analysis, it becomes something far more dangerous: an unelected, unaccountable power unto itself. The Architects of Obstruction: Prevoznik, Strait, and Haig DEA bureaucrats Thomas Prevoznik, Matthew Strait, and Aarathi Haig have emerged as the chief engineers of this lawless agenda. Haig, already under fire for her ineligibility to practice law in New Jersey due to bar compliance failures, remains the lead attorney against MMJ. Her continued participation not only violates 28 U.S.C. § 530B but further erodes the integrity of the agency's actions. Prevoznik and Strait, meanwhile, continue to stall legitimate cannabis research applications while ignoring illegal THC imports and exports. This two-tiered system punishes innovators and protects political allies. Congress Must Step In-or Be Complicit Lawmakers must recognize that the DEA is no longer just dragging its feet-it is actively resisting constitutional order. That resistance demands immediate action: If Congress fails to act, it will confirm what many Americans already suspect-that federal agencies like the DEA can operate beyond the law, without consequence, and without oversight. The Rule of Law Is Not Optional The DEA's refusal to follow the Supreme Court and its own Department of Justice is a constitutional crisis in real time. It is not just an affront to MMJ-it is a betrayal of every American who believes in due process, scientific integrity, and accountable government. If the DEA cannot respect the law, then the law must be used to dismantle the DEA. MMJ is represented by attorney Megan Sheehan. CONTACT: Madison Hisey [email protected] 203-231-8583 SOURCE: MMJ International Holdings press release
Yahoo
04-06-2025
- Business
- Yahoo
An early Joby Aviation backer might soon be its biggest distributor in Saudi Arabia
Joby Aviation has reached a tentative deal with investor and Saudi Arabian conglomerate Abdul Latif Jameel (ALJ) to distribute up to 200 electric aircraft valued at about $1 billion over the coming years. If finalized, the partnership could provide Joby with a fast path to monetizing its electric vertical takeoff and landing vehicles in Saudi Arabia. 'A question that folks have asked is, how are you going to monetize, and how quickly is that going to happen?' Paul Sciarra, the executive chairman of Joby's board who's most known for co-founding Pinterest, told TechCrunch. 'And I think what this shows is that with direct sales, there is a way to get to scale earlier for lower cost by thinking about distributor partners in given geographies. And this is the first of what we hope are a number of announcements on that front.' The two companies on Tuesday signed a memorandum of understanding (MoU) to explore a distribution agreement. And while an MoU is not exactly a signed and sealed deal, sources familiar with the agreement say they'll be able to share more concrete details later this year. The deal would be among the first instances of an eVTOL startup landing a distributor partner for their aircraft. Joby also plans to own and operate its own aircraft in the U.S. and other markets, and partner with airlines and other carriers in countries like Japan. Sciarra said ALJ is an ideal partner for a number of reasons, including the fact that the company's relationship with Toyota — which just closed the first $250 million tranche of its total $500 million investment into Joby — runs deep. ALJ became the exclusive distributor of Toyota in Saudi Arabia in 1955 and grew to be one of the world's largest independent Toyota and Lexus distributors. ALJ also participated in Joby's 2020 Toyota-led Series C funding round. Beyond their mutual ties, Sciarra says ALJ has 'a lot of the infrastructure on the ground, not only for the sales process, but also for the support, pilot training, and maintenance.' 'That's all going to be critical to actually making sure that the sales are not just cut, but are successful over the long arc,' Sciarra told TechCrunch. He noted that as an 80-year-old network of diversified businesses, ALJ is also close with the Saudi Arabian government and a number of potential customers, including restoration and tourism projects like the Red Sea Project and the AlUla Project. Despite the promising partnership in Saudi Arabia, Joby's go-to-market strategy will still be to launch in Dubai next year, with a U.S. market to follow. 'What this shows is how we deepen the funnel beyond some of the initial markets,' Sciarra said. 'And this sort of structure, where we find the right local partner that can help us sell and support, is going to be a way that we get to geographies that may not be first on our list, but allow us to monetize them more quickly.' Joby's deal with AFJ comes amid unprecedented levels of cooperation between the U.S. government and Saudi Arabia in the realms of AI, technology infrastructure, and energy. Last month, Saudi Arabian firm DataVolt agreed to invest $20 billion in AI data centers and energy infrastructure in the U.S., and American tech giants like Google, Oracle, Salesforce, AMD, and Uber have pledged $80 billion toward transformative technologies in both countries, according to the White House.
TechCrunch
03-06-2025
- Business
- TechCrunch
An early Joby Aviation backer might soon be its biggest distributor in Saudi Arabia
Joby Aviation has reached a tentative deal with investor and Saudi Arabian conglomerate Abdul Latif Jameel (ALJ) to distribute up to 200 electric aircraft valued at about $1 billion over the coming years. If finalized, the partnership could provide Joby with a fast path to monetizing its electric vertical takeoff and landing vehicles in Saudi Arabia. 'A question that folks have asked is, how are you going to monetize, and how quickly is that going to happen?' Paul Sciarra, the executive chairman of Joby's board who's most known for co-founding Pinterest, told TechCrunch. 'And I think what this shows is that with direct sales, there is a way to get to scale earlier for lower cost by thinking about distributor partners in given geographies. And this is the first of what we hope are a number of announcements on that front.' The two companies signed a Memorandum of Understanding to explore a distribution agreement Tuesday. And while an MoU is not exactly a signed and sealed deal, sources familiar with the agreement say they'll be able to share more concrete details later this year. The deal would be among the first instances of an eVTOL startup landing a distributor partner for their aircraft. Joby also plans to own and operate its own aircraft in the U.S. and other markets, and partner with airlines and other carriers in countries like Japan. Paul Sciarra, executive chairman of Joby's board and co-founder of Pinterest, said ALJ is an ideal partner for a number of reasons. First, the company's relationship with Toyota – which just closed the first $250 million tranche of its total $500 million investment into Joby – runs deep. ALJ became the exclusive distributor of Toyota in Saudi Arabia in 1955 and grew to be one of the world's largest independent Toyota and Lexus distributors. ALJ also participated in Joby's 2020 Toyota-led Series C funding round. Beyond their mutual ties, Sciarra says ALJ has 'a lot of the infrastructure on the ground, not only for the sales process, but also for the support, pilot training, and maintenance.' Techcrunch event Save now through June 4 for TechCrunch Sessions: AI Save $300 on your ticket to TC Sessions: AI—and get 50% off a second. Hear from leaders at OpenAI, Anthropic, Khosla Ventures, and more during a full day of expert insights, hands-on workshops, and high-impact networking. These low-rate deals disappear when the doors open on June 5. Exhibit at TechCrunch Sessions: AI Secure your spot at TC Sessions: AI and show 1,200+ decision-makers what you've built — without the big spend. Available through May 9 or while tables last. Berkeley, CA | REGISTER NOW 'That's all going to be critical to actually making sure that the sales are not just cut, but are successful over the long arc,' Sciarra told TechCrunch. He noted that as an 80-year-old network of diversified businesses, ALJ is also close with the Saudi Arabian government as well as a number of potential customers, including restoration and tourism projects like the Red Sea Project and the AlUla Project. Despite the promising partnership in Saudi Arabia, Joby's go-to-market strategy will still be to launch in Dubai next year, with a U.S. market to follow. 'What this shows is how we deepen the funnel beyond some of the initial markets,' Sciarra said. 'And this sort of structure, where we find the right local partner that can help us sell and support, is going to be a way that we get to geographies that may not be first on our list, but allow us to monetize them more quickly.' Joby's deal with AFJ comes amid unprecedented levels of cooperation between the U.S. government and Saudi Arabia in the realms of AI, technology infrastructure, and energy. Last month, Saudi Arabian firm DataVolt agreed to invest $20 billion in AI data centers and energy infrastructure in the U.S., and American tech giants like Google, Oracle, Salesforce, AMD, and Uber have pledged $80 billion toward transformative technologies in both countries, according to the White House.
Yahoo
04-05-2025
- Business
- Yahoo
DEA Diversion in Cannabis Chaos: MMJ Urges Terrance Cole, President Trump DEA Nominee to Dismantle Biden Era Cannabis Obstructors
Message to President Trump's Appointee: Terrance Cole Must Act on Cannabis Scientific Reform. "Mr. Cole has a historic opportunity to lead with integrity, science, and constitutional fidelity," said Boise. "He must put an end to this unlawful administrative hearing, root out DEA institutional marijuana bias, and restore lawful science-based regulatory practices." WASHINGTON, DC / / May 4, 2025 / MMJ BioPharma Cultivation announced it will file an emergency motion and lawsuit in the U.S. District Court for the District of Rhode Island following a controversial ruling by DEA Administrative Law Judge (ALJ) Teresa Wallbaum. Judge Wallbaum recently issued a ruling to vacate a previously granted stay-clearing the path for a DEA ALJ hearing before what MMJ asserts is a constitutionally defective tribunal. Judge Wallbaum retired immediately after issuing the ruling. The company's forthcoming legal action seeks to block the DEA's internal administrative hearing process, which MMJ argues violates the Supreme Court's landmark ruling in Axon Enterprise, Inc. v. FTC, and inflicts irreparable harm on its constitutional rights and medical mission. MMJ Direct Challenge to DEA Overreach The Axon decision, issued by the Supreme Court in 2023, affirmed that entities subject to unconstitutional agency proceedings can challenge them in federal court before being forced through the flawed administrative process. MMJ contends that the DEA's ALJ system, where judges are insulated from presidential oversight, runs afoul of Article II of the Constitution. "We are not just challenging DEA policy; we are defending the rule of law," said Duane Boise, CEO of MMJ BioPharma Cultivation. "The DEA cannot ignore Supreme Court precedent and funnel applicants into hearings that are constitutionally invalid." From Regulatory Delay to Constitutional Injury MMJ's application to grow pharmaceutical-grade marijuana for FDA-sanctioned clinical trials was filed in 2018. Since then, the company has: Built and passed inspection of a DEA-compliant facility Received a DEA Schedule I analytical registration Filed two FDA Investigational New Drug (IND) applications Been awarded FDA Orphan Drug Designation for Huntington's Disease Despite these milestones and the 60-day processing deadline set by the Medical Marijuana and Cannabidiol Research Expansion Act (MCREA), MMJ has waited over 2,300 days. "The damage done by these delays is not just procedural-it's personal," Boise added. "Patients living with Huntington's and MS deserve answers and access, not bureaucratic purgatory." Biden's Failed Cast of Characters: Milgram, Garland, Thomas Prevoznik, Matthew Strait For years, DEA Administrator Anne Milgram, Attorney General Merrick Garland, and the broader Biden administration have stood idle-overseeing a federal agency that continues to delay and deny legitimate medical cannabis research. Despite bipartisan legislation and judicial precedent, no meaningful reform has occurred. "The Biden administration had every opportunity to fix this. Instead, they turned a blind eye to patients and the Constitution," said Boise. Message to President Trump's Appointee: Terrance Cole Must Act Now, all eyes turn to Terrance Cole, President Trump's nominee for DEA Administrator, who MMJ urges to dismantle the obstructionist legacy left behind by the Biden-era leadership. "Mr. Cole has a historic opportunity to lead with integrity, science, and constitutional fidelity," said Boise. "He must put an end to this unlawful administrative hearing, root out DEA institutional bias, and restore lawful science-based regulatory practices." MMJ emphasized that Cole's leadership can mark a turning point: not just for the agency, but for tens of thousands of patients across the country. "This is about reclaiming the DEA from the grip of politics and putting patients first," Boise added. "Terrance Cole can either reform the agency-or risk continuing the shameful legacy of his predecessors." Federal Court Relief Sought MMJ's legal filing will request: A preliminary and permanent injunction halting the ALJ proceeding A declaration that the DEA's ALJ process violates the Constitution Expedited federal review in accordance with the Axon precedent "We are not seeking special treatment," Boise concluded. "We are demanding a fair, lawful process-something every American is entitled to. The DEA must be held accountable." MMJ is Represented by Attorney Megan Sheahan and Associates CONTACT:Madison Hiseymhisey@ SOURCE: MMJ International Holdings View the original press release on ACCESS Newswire
