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's collaboration with Beilinson Hospital represents a significant advancement in the adoption of exoskeleton technology in Israel, particularly for rehabilitation of soldiers injured in combat [1][3]. Company Overview - Lifeward Ltd. is a global leader in innovative medical technology, focusing on transforming the lives of individuals with physical limitations or disabilities [4]. - The company offers a range of products, including the ReWalk Exoskeleton, designed to aid in physical rehabilitation and recovery [4]. Key Developments - An Israeli soldier, paralyzed in both legs due to injuries sustained in the current war, has successfully completed training with the ReWalk Personal Exoskeleton, marking a historic first for injured soldiers in Israel [1][2]. - The soldier emphasized the life-changing impact of the ReWalk device, advocating for its approval for all paralyzed individuals [2]. Rehabilitation Insights - Dr. Yaron Watts from Beilinson Hospital described the use of the ReWalk during rehabilitation as a "precedent-setting historic event," highlighting its importance for other wounded soldiers [2][3]. - The Israeli Rehabilitation Department is now evaluating the safety and effectiveness of the ReWalk for other paralyzed veterans following the soldier's successful experience [3]. Future Implications - Lifeward's CEO, Larry Jasinski, expressed the company's commitment to expanding access to the ReWalk for eligible users, particularly for military personnel injured in combat [4].

Core Viewpoint - Lifeward Ltd. has launched the ReWalk 7 Personal Exoskeleton in the U.S., enhancing assistive technology for individuals with spinal cord injuries, showcasing the company's leadership and technological advancements in the industry [1][2][5]. Product Launch and Market Impact - The ReWalk 7 received FDA clearance in March 2025 and follows the ReWalk 6.0 system, which improved user capabilities for navigating stairs and curbs [2]. - The introduction of a Medicare reimbursement pathway in 2024 has facilitated broader market access for the ReWalk 7, supporting Lifeward's mission to empower the spinal cord injury community [2][5]. Technological Enhancements - The ReWalk 7 features cloud connectivity for data-driven updates, two customizable walking speeds, and a new crutch control unit for enhanced user control [7]. - Complementary devices, including a wrist control smartwatch and a mobile application, simplify mode selection and progress tracking, integrating the device into daily routines [7]. User-Centric Development - Lifeward collaborated with over two dozen end users and physical therapists to gather feedback, leading to improvements in training efficiency and safety [9]. - The development process included the introduction of a therapist handheld device for better session control, resulting in a device that enhances user confidence and control [9]. Financial Performance - Following the launch announcement, LFWD's shares increased by 1.4% on April 15, although the company has experienced an 18% decline in shares year-to-date, compared to an 11.1% decline in the industry and an 8.4% drop in the S&P 500 Index [4].

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].

Core Insights - Lifeward Ltd. has received FDA 510(k) clearance for its ReWalk 7 Exoskeleton, a significant advancement for individuals with spinal cord injuries, enhancing user experience and mobility outcomes [1][2][4] Company Developments - The FDA clearance is a milestone that reinforces Lifeward's leadership in the medical exoskeleton market, positioning the company for expansion and continued innovation [2][4] - The ReWalk 7 is the seventh generation of Lifeward's exoskeleton technology, designed to improve the quality of life for users by enabling independent standing and walking [6][9] - Lifeward's market capitalization currently stands at $16.1 million, with an expected earnings growth of 91.4% for the current year compared to the industry's 15% growth [5] Market Performance - Following the announcement of the ReWalk 7, Lifeward's shares fell by 5.6%, closing at $1.51, and have decreased by 52.2% over the past six months, contrasting with the industry's 8.4% growth [3] - The anticipated commercial rollout of the ReWalk 7 is expected to strengthen Lifeward's competitive edge and revenue streams [9] Strategic Partnerships - Lifeward has expanded its partnership with MYOLYN, Inc. to enhance access to the MyoCycle Functional Electrical Stimulation Cycling Therapy System, broadening distribution rights and referral sales for home-based therapy [10]

Core Insights - Lifeward Ltd. has received 510(k) FDA clearance for its latest personal exoskeleton device, the ReWalk 7, which is designed for individuals with spinal cord injury (SCI) [1][2] - The ReWalk 7 features new enhancements and upgrades, continuing Lifeward's commitment to providing advanced exoskeleton technology [2] - The company plans to begin sales of the ReWalk 7 in the United States as soon as it becomes available [3] Company Developments - Lifeward has a history of innovation, having previously received FDA clearance for the ReWalk 6.0 in 2023, which allowed use on stairs and curbs, and a national reimbursement policy from CMS in 2024 for eligible beneficiaries [2] - The company was the first to receive FDA clearance for an exoskeleton medical device for individuals with SCI in 2014 [2] - Lifeward's mission is to drive innovation in medical technology to improve the lives of individuals with physical limitations or disabilities [3] Product Portfolio - Lifeward's product offerings include the ReWalk Exoskeleton, AlterG Anti-Gravity System, ReStore Exo-Suit, and MyoCycle FES System, all aimed at enhancing rehabilitation and recovery [3]

Financial Data and Key Metrics Changes - Lifeward reported record revenue of $7.5 million in Q4 2024, compared to $6.9 million in Q4 2023, marking an increase of approximately 8.7% [17] - For the full year 2024, revenue reached $25.7 million, an 85% increase from the previous year, representing the highest annual revenue performance in the company's history [17] - GAAP gross margin for Q4 2024 was 24.4%, down from 35.5% in Q4 2023, primarily due to restructuring charges [23] - Non-GAAP adjusted gross margin was 45.4% in Q4 2024, slightly below the 46.9% in Q4 2023 [24] - GAAP operating loss for Q4 2024 was $15.2 million, compared to a loss of $6.7 million in the prior year [26] - Non-GAAP adjusted operating loss improved to $3.3 million in Q4 2024 from $3.8 million in Q4 2023 [27] Business Line Data and Key Metrics Changes - Revenue from traditional products and services, including ReWalk's exoskeletons and Myocycles, was $2.0 million in Q4 2024, while AlterG products generated $5.5 million, the highest quarterly revenue since acquisition [18] - ReWalk sales were below expectations due to delays in Medicare cases, but a growing volume of qualified leads is anticipated to improve predictability in future performance [18][20] - AlterG systems ended Q4 2024 with a backlog of 25 orders, indicating a seasonal decline but an expected 20% revenue growth in Q1 2025 compared to Q1 2024 [22] Market Data and Key Metrics Changes - The company has over 110 qualified candidates for future ReWalk claim submissions in the U.S. and 44 cases in Germany [20] - Active rentals for ReWalk systems consist of 27 cases, with 24 in Germany and 3 in the U.S. [21] - The workers' compensation market represents about 6% of all spinal cord injuries, a segment previously limited for the company but now accessible through the CorLife partnership [52] Company Strategy and Development Direction - Lifeward aims to maintain reasonable growth while reducing quarterly operating losses, targeting a loss at or below $1 million in Q4 2025 [11] - The company is focusing on higher-margin opportunities and operational efficiencies, including a sustainable growth plan to reduce costs [13][29] - Lifeward plans to expand its market access through partnerships, including a new agreement with CorLife for workers' compensation and an expanded distribution agreement with MYOLYN [38][39] Management's Comments on Operating Environment and Future Outlook - Management views 2024 as a year of meaningful achievements, establishing long-term access to technologies and launching a pathway toward profitability [9] - The company anticipates full-year revenue for 2025 in the range of $28 million to $30 million, with adjusted gross margins between 47% to 49% [30] - Management expressed confidence in the sustainable growth plan, which aims to balance top-line growth with spending discipline [91] Other Important Information - The company ended 2024 with $6.7 million in cash and equivalents and no debt, raising an additional $5 million in January 2025 [27][28] - Lifeward received a going concern qualification from auditors, prompting actions to address balance sheet adequacy [28] Q&A Session Summary Question: How does the company see the growth of each component in the 2025 guidance? - Management indicated that the guidance reflects growth across all three major product lines: ReWalk, AlterG, and MyoCycles, with MyoCycles expected to show the biggest percentage growth due to an expanded distribution agreement [47][49] Question: What impact will the CorLife partnership have on the workers' compensation segment? - The CorLife partnership is expected to provide a larger conduit into the workers' compensation market, allowing for efficient processing and quicker payment cycles [51][52] Question: Will the next-generation ReWalk be introduced this year? - Management confirmed that the next-generation ReWalk is expected to be on the market by mid-2025, pending FDA clearance [54] Question: How are recent announcements factored into revenue guidance? - Management stated that recent partnerships have been factored into the revenue guidance conservatively, with expectations for growth in both CorLife and MYOLYN agreements [57][58] Question: What are the common reasons for patient attrition in ReWalk? - Patient attrition was attributed to seasonal factors and deferrals rather than losses, with management noting that these are common in the patient population [66][67] Question: What are the learnings from Medicare reimbursements? - The reimbursement cycle with Medicare has been longer than expected, but management anticipates it will shorten as they gain more experience [72][74] Question: Is the focus on workers' compensation a reaction to federal government policies? - Management clarified that the focus on workers' compensation is driven by opportunity rather than a reaction to government policies [77]

Lifeward (LFWD) Q4 2024 Earnings Call March 07, 2025 04:52 PM ET Company Participants Mike Lawless - CFOLarry Jasinski - CEOBen Haynor - Managing Director Conference Call Participants Yale Jen - Senior Managing Director & Senior Biotech AnalystRamakanth Swayampakula - Managing Director & Senior Research Analyst Operator Good day, and welcome to the Life Learning Fourth Quarter twenty twenty four Earnings Conference Call. All participants will be in listen only mode. After today's presentation, there will be ...

Acquisition and Market Strategy - The company acquired AlterG for approximately $19 million, with potential additional payments based on revenue growth over the next two years[34] - The company has ceased sales of the ReStore Exo-Suit in the EU as of May 2024, indicating a strategic shift in market focus[33] - The company is working to secure formal operating contracts with additional SHIs to establish processes for obtaining ReWalk exoskeletons for beneficiaries[42] - The company has distribution agreements in several European countries, with ongoing efforts to secure broader reimbursement coverage from various insurers[69] - The company has rebranded under the name Lifeward to emphasize its commitment to innovative technologies for rehabilitation[92] Product Development and Regulatory Compliance - The company is in the research stage of the ReBoot device, which received Breakthrough Device Designation from the FDA, but further investment is currently on hold[36] - The company has submitted a premarket notification for its 7th generation ReWalk design, currently pending FDA review[48] - The company is working on product design improvements and expanded labeling for the ReWalk Personal Exoskeleton, with plans to launch following regulatory clearance[106] - The company is currently reviewing its application for MDR assessment of the ReWalk 7 Personal Exoskeleton, submitted in August 2024[139] - The company has received a Notified Body Certificate of Conformity under the previous Medical Devices Directive (MDD) for its ReWalk systems, allowing continued market presence in the EU during the transition to the new Medical Devices Regulation (MDR)[139] Market Opportunities and Coverage - Approximately 57% of the spinal cord injury population is covered by Medicare, which represents a significant market opportunity for the company's products[39] - The final lump-sum Medicare purchase fee for personal exoskeletons (HCPCS code K1007) is established at $91,032 as per the revised DMEPOS Fee Schedule by CMS[67] - In Germany, agreements with various SHIs, including BARMER and DGUV, have been formalized to provide coverage for ReWalk exoskeletons to eligible users[42] - As of February 2025, approximately 45% of the 70 million people in Germany covered by Statutory Health Insurance have defined reimbursement processes for personal exoskeletons[71] - The VHA accounted for 4.5% of total revenue for the year ended December 31, 2024, with 49 units placed under the VHA policy[60] Financial Performance - Total revenue for 2024 reached $25.663 million, a 85.5% increase from $13.854 million in 2023[181] - Revenue from the United States was $14.425 million in 2024, up 89.5% from $7.636 million in 2023[181] - Revenue from Europe increased to $9.546 million in 2024, a 89.1% rise from $5.044 million in 2023[181] - The company had 80 employees as of December 31, 2024, with the majority engaged in sales and marketing activities[177] Research and Development - The company continues to support clinical research and academic publications to strengthen the case for insurance coverage of its products[70] - The ReStore Exo-Suit technology was developed in collaboration with Harvard University, focusing on improving walking for stroke survivors[85] - The stroke incidence rate in the United States is approximately 800,000 per year, with 80% of survivors experiencing some form of lower limb disability, creating a significant market for ReStore[89] - The AlterG Anti-Gravity system is designed to support rehabilitation for lower extremity injuries, with a potential market of approximately 1,180 certified inpatient rehabilitation facilities in the U.S.[81] Legal and Regulatory Risks - The civil False Claims Act (FCA) can impose treble damages and civil penalties for false claims, potentially aggregating into millions of dollars[145] - The company may face penalties for violations of healthcare laws, including exclusion from federal healthcare programs and significant civil monetary penalties[152] - The commercial success of product candidates depends on adequate coverage and reimbursement from governmental and private payors[154] - Government authorities and third-party payors are increasingly regulating the price of medical products, leading to lower average selling prices[156] Manufacturing and Supply Chain - The company relies on Sanmina Corporation and Cirtronics Corporation for manufacturing, with contracts allowing termination under specific conditions[172][173] - The company has not experienced significant volatility in component prices, although temporary increases were noted during the COVID-19 pandemic[175] Innovation and Patents - The company holds 12 issued patents in the United States and 24 issued patents outside the United States for its ReWalk product line as of December 31, 2024[117] - The company has 28 issued patents in the United States and 9 issued patents outside the United States for its DAP and AlterG technology as of December 31, 2024[117] Employee and Organizational Commitment - The company maintains a commitment to diversity and inclusion across its organizational structure[180]

Lifeward (LFWD) came out with a quarterly loss of $0.38 per share versus the Zacks Consensus Estimate of a loss of $0.20. This compares to loss of $0.35 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -90%. A quarter ago, it was expected that this maker of wearable robotic exoskeletons that help paralyzed patients walk would post a loss of $0.27 per share when it actually produced a loss of $0.45, delivering a surprise of -66. ...