Core Viewpoint - Lifeward Ltd. has received its first prior authorization from a UnitedHealthcare Medicare Advantage Plan for the ReWalk 7 Personal Exoskeleton, marking a significant step in expanding reimbursement pathways for advanced assistive technology for individuals with spinal cord injuries [1][2][3]. Company Summary - Lifeward is a global leader in innovative medical technology aimed at transforming the lives of individuals with physical limitations or disabilities, with a mission to drive innovation and deliver groundbreaking solutions [5]. - The company’s product portfolio includes the ReWalk Exoskeleton, AlterG Anti-Gravity System, ReStore Exo-Suit, and MyoCycle FES System, and it operates in the United States, Israel, and Germany [5]. Industry Summary - UnitedHealthcare's approval for the ReWalk 7 demonstrates a commitment to providing access to advanced assistive technology, enhancing mobility and quality of life for individuals with spinal cord injuries [2][3]. - The approval reflects a proactive approach in expanding reimbursement pathways, ensuring reliable access to personal exoskeletons as part of a comprehensive care strategy [3]. - The Centers for Medicare & Medicaid Services (CMS) implemented a reimbursement pathway for personal exoskeletons in 2024, leading to an acceleration in prior authorizations as payer adoption expands [4].

Core Insights - Lifeward Ltd. reported a record quarter for Medicare beneficiary placements, indicating strong commercial execution and operational improvements [3][9] - The company achieved a 16% year-over-year decrease in quarterly cash burn and a 27% decrease in quarterly Non-GAAP operating loss, reflecting ongoing efficiency initiatives [4][6] - Lifeward secured a $3.0 million loan agreement with Oramed Ltd. to support its operations and strategic initiatives [9][10] Financial Performance - Revenue for Q3 2025 was $6.2 million, a slight increase of approximately 1% from $6.1 million in Q3 2024, and an 8% increase from $5.7 million in Q2 2025 [4] - Revenue from traditional products, including ReWalk Personal exoskeletons, rose to $3.1 million, up 24% year-over-year, driven by Medicare-related sales [4] - Gross margin improved to 43.7% in Q3 2025, compared to 36.2% in Q3 2024, primarily due to lower production costs following the closure of the Fremont manufacturing facility [4][5] Operating Expenses and Losses - Total operating expenses in Q3 2025 were $5.9 million, up from $5.4 million in Q3 2024, but adjusted operating expenses decreased to $5.7 million from $6.7 million year-over-year [5] - The operating loss for Q3 2025 was $3.1 million, slightly improved from a loss of $3.2 million in Q3 2024, with adjusted operating loss decreasing to $3.0 million from $4.1 million [6] - Net loss for Q3 2025 was $3.2 million, or $0.20 per share, compared to a net loss of $3.1 million, or $0.35 per share, in Q3 2024 [7] Liquidity and Guidance - As of September 30, 2025, Lifeward had $2.0 million in unrestricted cash and cash equivalents, with cash used in operations improving to $3.8 million from $4.5 million in Q3 2024 [8] - The company reaffirmed its full-year 2025 guidance, expecting revenue in the range of $24 to $26 million and a projected non-GAAP net loss between $12 to $14 million [11]

Core Viewpoint - The recent ruling by an Administrative Law Judge establishes that the ReWalk Exoskeleton is a "reasonable and necessary" medical device for enabling paralyzed individuals to walk, paving the way for Medicare coverage and potentially broader commercial insurance access [1][2]. Group 1: Legal and Regulatory Developments - The ALJ ruling supports an appeal by a Medicare beneficiary for coverage of the ReWalk Exoskeleton, affirming its medical necessity for individuals with spinal cord injuries [1]. - This ruling builds on a prior decision by the Centers for Medicare & Medicaid Services (CMS) in April 2024, which finalized a reimbursement pathway for personal exoskeletons [2]. Group 2: Company Innovations and Products - The ReWalk Exoskeleton is noted as the only personal exoskeleton that allows paralyzed individuals to navigate stairs and curbs, in addition to walking in everyday environments [2]. - The latest model, ReWalk 7, received FDA clearance in March 2025 and is now commercially available in the United States [2]. Group 3: Company Mission and Vision - Lifeward aims to transform the lives of individuals with physical limitations through innovative medical technology, focusing on expanding data and programs for the paralyzed community [2][3]. - The company is committed to delivering groundbreaking solutions that empower individuals to regain mobility and improve their quality of life [3].

Core Insights - Lifeward Ltd. has received approval from a major U.S. health insurance company for the ReWalk 7 Personal Exoskeleton, marking a significant step in expanding access for individuals with spinal cord injuries (SCI) [1][2] - The approval follows the Centers for Medicare & Medicaid Services (CMS) establishing a reimbursement pathway for personal exoskeletons in 2024, which is expected to enhance access for Medicare beneficiaries, who represent about one-third of individuals living with SCI [2][3] Company Overview - Lifeward is a leader in innovative medical technology aimed at transforming the lives of individuals with physical limitations or disabilities, with a mission to drive innovation in rehabilitation and recovery [4] - The company has launched the ReWalk 7, a device designed to assist paralyzed individuals in standing, walking, and navigating everyday environments [3][4] Market Context - The decision by a major commercial health insurer to cover the ReWalk 7 is seen as a pivotal moment that could encourage other insurers to follow suit, thereby solidifying Lifeward's growth trajectory [2][3] - The ReWalk 7 received FDA clearance in March 2025 and was launched for sales in the U.S. on April 15, 2025, indicating a timely entry into the market [1][3]

Core Viewpoint - Lifeward Ltd. has launched the ReWalk 7 Personal Exoskeleton, enhancing the walking experience for individuals with spinal cord injuries through innovative features and improved user control [1][3]. Product Features - The ReWalk 7 includes customizable walking speeds, allowing users to transition smoothly between different environments [5]. - A new Crutch Control feature enables users to manage device functions such as standing, walking, and speed selection with ease [5]. - The introduction of a Wrist Control smartwatch and MyReWalk mobile app facilitates operation mode selection, goal setting, and usage tracking [5]. - Enhanced battery life and improved accessibility features allow users to walk longer distances and navigate stairs and curbs [5][6]. - A new handheld device for therapists improves training efficiency and safety during rehabilitation sessions [5][4]. Development and Feedback - The ReWalk 7 was developed over several years, incorporating feedback from over two dozen end users and physical therapists to optimize its functionality in real-world settings [3][4]. - Clinicians reported that the new features would enhance training sessions, while users expressed increased confidence and control with the updated crutch control unit [4]. Regulatory and Market Access - The ReWalk 7 received FDA clearance in March 2025, following previous advancements in technology and market access for the ReWalk product line [5]. - In 2024, the Centers for Medicare & Medicaid Services finalized a reimbursement pathway for personal exoskeleton use, expanding access for individuals with spinal cord injuries [6]. Company Overview - Lifeward Ltd. is dedicated to developing innovative medical technologies aimed at transforming the lives of individuals with physical limitations or disabilities [8]. - The company’s portfolio includes various products designed for rehabilitation and recovery, emphasizing its commitment to driving innovation in the medical technology sector [8].