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].