Latest news with #ReWalk
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]
Yahoo
15-04-2025
- Business
- Yahoo
Lifeward Launches Sales of the ReWalk 7 Personal Exoskeleton in U.S. Market
MARLBOROUGH, Mass. and YOKNEAM ILLIT, Israel, April 15, 2025 (GLOBE NEWSWIRE) -- Seventh generation of industry-leading personal exoskeleton is now available nationwide for individuals with spinal cord injury New and improved features streamline user experience for greater control, engagement, and confidence during walking in everyday environments 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 U.S. national launch of the ReWalk 7 Personal Exoskeleton, the next generation of its groundbreaking personal exoskeleton technology. The Company will now begin sales of ReWalk 7, which includes innovative new and enhanced features such as cloud connectivity and customizable walking speeds, to provide a more functional and personalized walking experience for individuals with spinal cord injury ('SCI').'The ReWalk 7 was developed over several years, integrating advanced technological innovations with feedback from clinicians and patients to build upon the ReWalk's world-class reputation for industry leadership,' said Larry Jasinski, CEO of Lifeward. 'The result is a device that is optimized for real-world use, with an unmatched user experience and freedom of movement. We are thrilled to be able to provide paralyzed individuals across the country with a new option for integrating walking to everyday life.' As part of the FDA clearance process, Lifeward worked with more than two dozen end users and physical therapists, respectively, to gather critical feedback on the impact of the device in both the rehabilitative and real-world settings. 'The feedback we received from clinicians and ReWalkers was invaluable,' said Jill Butler, PT, DPT, NCS, Director of Clinical Development for Lifeward and the Primary Investigator for usability testing. 'Therapists felt that the handheld device will make training sessions much easier and more efficient, and ReWalk users were excited about the enhanced level of confidence and control they felt using the new crutch control unit. This feedback helped us to optimize the ReWalk to maximize success in real-world environments.' Advancements of the ReWalk 7 include: Smoother Movement: Users can select from two customizable walking speeds, allowing for seamless transitions between indoor and outdoor walking environments. More Control: Crutch Control puts device control at the user's fingertips, allowing them to stand, walk, select speeds, and stop—all at the touch of a button. Smarter Walking: New Wrist Control smartwatch and MyReWalk mobile app make it easy for users to select operation modes, set goals and track their usage. More Accessibility: Users have the freedom to walk longer and more often with an improved battery and seamless activation of stairs and curbs. Improved Training: The all-new therapist handheld device and click-to-stop control allows for safer, more effective progression to optimal gait patterns. The ReWalk 7 received FDA clearance in March 2025, building upon two other recent major advancements in technology and market access for the ReWalk product line. First, in 2023, Lifeward added the innovative capability for the ReWalk 6.0 system to allow users to navigate stairs and curbs, thereby enabling users' access to a wider array of everyday environments. Second, in 2024, the Centers for Medicare & Medicaid Services ('CMS') finalized a Medicare reimbursement pathway for personal exoskeleton use, further expanding access to the ReWalk Exoskeleton for more individuals living with SCI. The ReWalk 7 is now available for purchase in the U.S. for personal use, as well as in the clinical setting. For more information, 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: media@ Lifeward Investor Contact:Mike LawlessChief Financial OfficerLifeward Ltd.E: ir@ A photo accompanying this announcement is available at A video accompanying this announcement is available at This press release was published by a CLEAR® Verified in to access your portfolio
NBC Sports
27-03-2025
- Sport
- NBC Sports
Former NFL safety Matt Stevens dies at 51
Matt Stevens, a safety on the Patriots' 2001 Super Bowl XXXVI championship team, died March 20, the team announced Thursday. Stevens was 51. Stevens entered the NFL as a third-round pick of the Bills in 1996. He played eight seasons, spending time in Buffalo, New England, Philadelphia, Washington and Houston. In the Patriots' 2001 championship season, Stevens appeared in all but one game and totaled 43 tackles in 15 regular-season games. He added six more tackles in the three playoff victories, including the Super Bowl XXXVI victory over the Rams. Stevens appeared in 108 games, recording 301 tackles, 13 interceptions and a sack. In 2007, Stevens was involved in a motorcycle accident that injured his spinal cord, leaving him paralyzed from the waist down. He participated in clinical trials for the ReWalk device in 2011, a wearable exoskeleton that enabled him to regain mobility with the assistance of special leg braces. The Patriots said in a statement that, 'Matt Stevens's legacy is marked by his contributions to professional football, his determination to overcome personal adversity, and the inspiration he provided to many through his resilience and dedication.'
Yahoo
08-03-2025
- Business
- Yahoo
Lifeward Ltd (LFWD) Q4 2024 Earnings Call Highlights: Record Revenue and Strategic Growth ...
Q4 2024 Revenue: $7.5 million, up from $6.9 million in Q4 2023. Full Year 2024 Revenue: $25.7 million, an 85% increase from 2023. AlterG Product Revenue: $5.5 million in Q4 2024, highest since acquisition in August 2023. ReWalk Product Revenue: $2.0 million in Q4 2024. Gross Margin (GAAP): 24.4% in Q4 2024, down from 35.5% in Q4 2023. Adjusted Gross Margin (Non-GAAP): 45.4% in Q4 2024, compared to 46.9% in Q4 2023. Operating Expenses (GAAP): $17.1 million in Q4 2024, up from $8.6 million in Q4 2023. Adjusted Operating Expenses (Non-GAAP): $6.7 million in Q4 2024, down from $7.0 million in Q4 2023. Operating Loss (GAAP): $15.2 million in Q4 2024, compared to $6.7 million in Q4 2023. Adjusted Operating Loss (Non-GAAP): $3.3 million in Q4 2024, improved from $3.8 million in Q4 2023. Cash and Equivalents: $6.7 million at year-end 2024, with no debt. 2025 Revenue Guidance: $28 million to $30 million. 2025 Adjusted Gross Margin Guidance: 47% to 49%. 2025 Non-GAAP Operating Expenses Guidance: $22 million to $23 million. 2025 Non-GAAP Operating Loss Guidance: $7 million to $9 million. Warning! GuruFocus has detected 6 Warning Signs with LFWD. Release Date: March 07, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Lifeward Ltd (NASDAQ:LFWD) achieved record revenue of $7.5 million in Q4 2024, marking the highest quarterly revenue in the company's history. The company reported an 85% increase in full-year revenue for 2024, reaching $25.7 million, demonstrating significant business scaling. Lifeward Ltd (NASDAQ:LFWD) has established a Sustainable Growth Plan aimed at reducing costs and improving operating efficiency. The company has expanded its distribution agreement with MYOLYN, allowing for greater market penetration, particularly in the home market. Lifeward Ltd (NASDAQ:LFWD) has secured a meaningful contract with BARMER in Germany, setting a standard for providing exoskeletons. The ReWalk sales were below expectations due to delays and attrition in Medicare cases, impacting revenue predictability. GAAP gross margin decreased to 24.4% in Q4 2024 from 35.5% in Q4 2023, primarily due to restructuring charges. The company recorded a $9.8 million impairment charge on intangible assets, affecting GAAP operating expenses. Lifeward Ltd (NASDAQ:LFWD) received a going concern qualification from auditors, reflecting concerns about the adequacy of its balance sheet. The company experienced patient attrition and deferrals in the ReWalk product line, affecting sales cycles and revenue. Q: For the 2025 guidance, how do you see the growth of each component? Is the guidance generally more conservative? A: Mike Lawless, CFO: The guidance reflects growth across our three major product lines: ReWalk, AlterG, and MyoCycles. MyoCycles, being the smallest contributor, will likely show the biggest percentage growth due to an expanded distribution agreement. We expect growth in all three lines, focusing on more profitable and efficient growth. Q: What impact will the CoreLife partnership have on the workers' compensation segment? A: Larry Jasinski, CEO: The CoreLife partnership provides us with a larger conduit into the workers' compensation market, which is about 6% of all spinal cord injuries. CoreLife can process these efficiently, reducing our expenses and ensuring timely payments. Q: Will the next-gen ReWalk be introduced this year? A: Larry Jasinski, CEO: Yes, we anticipate the next-gen ReWalk will be on the market this year. The product has completed all testing, and we expect FDA clearance in the first half of the year. Q: How much of the recent announcements, like CoreLife and MyoCycle, are factored into the revenue guidance? A: Larry Jasinski, CEO: We have factored them in conservatively. CoreLife is a new arrangement, but it has good growth potential. The expanded MyoCycle agreement allows us to sell directly to home users, which is a larger market. Q: What are the learnings from the Medicare reimbursement cycle, and how does it affect discussions with private payers? A: Mike Lawless, CFO: The Medicare cycle has been longer than expected, but it provides a baseline for private payers. We anticipate CMS will become more efficient, and the commercial side seems to have a shorter path. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus. Sign in to access your portfolio
