FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____ to ______ Commission File Number: 001-36612 ReWalk Robotics Ltd. UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 (Exact name of registrant as specified in charter) | Israel | Not applicable | | --- | --- | | ...

[General Information and Forward-Looking Statements](index=4&type=section&id=GENERAL%20AND%20WHERE%20YOU%20CAN%20FIND%20MORE%20INFORMATION) This section introduces ReWalk Robotics Ltd., defines report terms, outlines information sources, and highlights risks and uncertainties affecting future performance and the AlterG acquisition - Company website: www.rewalk.com. SEC filings are available for download, free of charge, on the company's website and the SEC's website (http://www.sec.gov)[11](index=11&type=chunk) - Forward-looking statements cover expectations regarding future growth, market acceptance, reimbursement from third-party payors (including CMS), Nasdaq compliance, the announced acquisition of AlterG, the impact of the COVID-19 pandemic, capital requirements, R&D, intellectual property protection, market conditions, and other factors discussed in the 'Risk Factors' section of the 2022 annual report on Form 10-K[12](index=12&type=chunk)[13](index=13&type=chunk)[16](index=16&type=chunk) [Part I - Financial Information](index=6&type=section&id=PART%20I%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements (Unaudited)](index=6&type=section&id=ITEM%201.%20FINANCIAL%20STATEMENTS%20(unaudited)) This section presents the unaudited condensed consolidated financial statements for ReWalk Robotics Ltd. and its subsidiaries, including balance sheets, statements of operations, changes in shareholders' equity, and cash flows, along with accompanying notes [Condensed Consolidated Balance Sheets](index=6&type=section&id=CONDENSED%20CONSOLIDATED%20BALANCE%20SHEETS%20-%20JUNE%2030%2C%202023%20AND%20DECEMBER%2031%2C%202022) The condensed consolidated balance sheets provide a snapshot of the company's assets, liabilities, and shareholders' equity at June 30, 2023, and December 31, 2022 Condensed Consolidated Balance Sheets (in thousands) | Metric | June 30, 2023 | December 31, 2022 | Change | | :-------------------------------- | :------------ | :---------------- | :----- | | Cash and cash equivalents | $58,184 | $67,896 | $(9,712) | | Total current assets | $63,842 | $72,510 | $(8,668) | | Total assets | $65,811 | $74,236 | $(8,425) | | Total current liabilities | $5,442 | $4,782 | $660 | | Total liabilities | $6,837 | $6,071 | $766 | | Total shareholders' equity | $58,974 | $68,165 | $(9,191) | [Condensed Consolidated Statements of Operations](index=8&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20OPERATIONS%20-%20THREE%20AND%20SIX%20MONTHS%20ENDED%20JUNE%2030%2C%202023%20AND%202022) The condensed consolidated statements of operations show the company's revenues, costs, and net loss for the three and six months ended June 30, 2023, compared to the same periods in 2022 Condensed Consolidated Statements of Operations (in thousands) | Metric | Q2 2023 | Q2 2022 | YoY Change (Q2) | 6M 2023 | 6M 2022 | YoY Change (6M) | | :-------------------------------- | :------ | :------ | :-------------- | :------ | :------ | :-------------- | | Revenues | $1,337 | $1,570 | $(233) | $2,567 | $2,446 | $121 | | Cost of revenues | $761 | $824 | $(63) | $1,420 | $1,435 | $(15) | | Gross profit | $576 | $746 | $(170) | $1,147 | $1,011 | $136 | | Operating expenses | $5,734 | $5,122 | $612 | $10,680 | $9,675 | $1,005 | | Operating loss | $(5,158) | $(4,376) | $(782) | $(9,533) | $(8,664) | $(869) | | Financial (expenses) income, net | $558 | $(44) | $602 | $636 | $(68) | $704 | | Net loss | $(4,642) | $(4,446) | $(196) | $(8,963) | $(8,796) | $(167) | | Net loss per ordinary share, basic and diluted | $(0.08) | $(0.07) | $(0.01) | $(0.15) | $(0.14) | $(0.01) | [Condensed Statements of Changes in Shareholders' Equity](index=9&type=section&id=CONDENSED%20STATEMENTS%20OF%20CHANGES%20IN%20SHAREHOLDERS'%20EQUITY%20-%20JUNE%2030%2C%202023%20AND%202022) The condensed statements of changes in shareholders' equity detail movements in share capital, additional paid-in capital, treasury shares, and accumulated deficit for the six months ended June 30, 2023, and 2022 Condensed Statements of Changes in Shareholders' Equity (in thousands) | Metric | June 30, 2023 | December 31, 2022 | Change | | :-------------------------- | :------------ | :---------------- | :----- | | Share capital | $4,435 | $4,489 | $(54) | | Additional paid-in capital | $280,455 | $279,857 | $598 | | Treasury Shares | $(3,203) | $(2,431) | $(772) | | Accumulated deficit | $(222,713) | $(213,750) | $(8,963) | | Total shareholders' equity | $58,974 | $68,165 | $(9,191) | - Net loss for the six months ended June 30, 2023, was **$(8,963) thousand**[25](index=25&type=chunk) - Share-based compensation for the six months ended June 30, 2023, was **$622 thousand**[25](index=25&type=chunk) - Treasury shares at cost increased by **$(772) thousand** for the six months ended June 30, 2023[25](index=25&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20CASH%20FLOWS%20-%20SIX%20MONTHS%20ENDED%20JUNE%2030%2C%202023%20AND%202022) The condensed consolidated statements of cash flows illustrate the cash generated from or used in operating, investing, and financing activities for the six months ended June 30, 2023, and 2022 Cash Flow Summary (in thousands) | Metric | 6M 2023 | 6M 2022 | YoY Change | | :------------------------------------ | :------ | :------ | :--------- | | Net cash used in operating activities | $(8,739) | $(9,377) | $638 | | Net cash used in investing activities | $0 | $(18) | $18 | | Net cash used in financing activities | $(986) | $0 | $(986) | | Decrease in cash, cash equivalents, and restricted cash | $(9,720) | $(9,559) | $(161) | | Cash, cash equivalents, and restricted cash at end of period | $58,835 | $79,491 | $(20,656) | - Net cash used in operating activities decreased by **$638 thousand**, primarily due to decreased insurance prepaid expenses and decreased inventory purchases, partially offset by acquisition costs[141](index=141&type=chunk)[142](index=142&type=chunk) - Net cash used in financing activities increased by **$986 thousand** due to the repurchase of ordinary shares under the repurchase program[141](index=141&type=chunk)[142](index=142&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=11&type=section&id=NOTES%20TO%20CONDENSED%20CONSOLIDATED%20FINANCIAL%20STATEMENTS) This comprehensive section provides detailed disclosures and explanations for the figures presented in the condensed consolidated financial statements [Note 1: General](index=11&type=section&id=NOTE%201%3A%20GENERAL) This note provides general information about ReWalk Robotics Ltd., including its incorporation details, wholly-owned subsidiaries, and core business as a medical device company - ReWalk Robotics Ltd. (RRL) was incorporated in Israel on June 20, 2001, with wholly-owned subsidiaries ReWalk Robotics, Inc. (RRI) in Delaware and ReWalk Robotics GMBH (RRG) in Germany[30](index=30&type=chunk) - The Company designs, develops, and commercializes innovative technologies for mobility and wellness in rehabilitation and daily life for individuals with neurological conditions, including SCI Products (ReWalk Personal and ReWalk Rehabilitation Exoskeleton devices) and the ReStore Exo-Suit[28](index=28&type=chunk)[30](index=30&type=chunk) - The Company is also the exclusive distributor of MYOLYN MyoCycle FES Pro/Home cycles in the U.S. The distribution agreement for MediTouch Tutor movement biofeedback systems was terminated as of January 31, 2023, due to unsatisfactory sales[28](index=28&type=chunk)[30](index=30&type=

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____ to ______ Commission File Number: 001-36612 ReWalk Robotics Ltd. (Exact name of registrant as specified in charter) | Israel | Not applicable | | --- | --- | | (St ...

ReWalk Robotics Ltd. (RWLK) Q4 2022 Earnings Conference Call February 23, 2023 8:30 AM ET Company Participants Mike Lawless - Chief Financial Officer Larry Jasinski - Chief Executive Officer Conference Call Participants Swayampakula Ramakanth - H.C. Wainwright Martin Pollack - KMTR Operator Good morning, everyone and welcome to the ReWalk Robotics Fourth Quarter Earnings Conference Call. All participants will be in a listen-only mode. [Operator Instructions] After today’s presentation, there will be an oppo ...

[Report Information](index=1&type=section&id=Report%20Information) [Form 10-K Filing Details](index=1&type=section&id=Form%2010-K%20Filing%20Details) This report is ReWalk Robotics Ltd.'s annual Form 10-K filing for the year ended December 31, 2022, with its shares traded on the Nasdaq Capital Market under the ticker RWLK - The company filed its annual report on Form 10-K for the year ended December 31, 2022[2](index=2&type=chunk) Company Securities Registered Information | Title of Each Class | Trading Symbol(s) | Name of Each Exchange on Which Registered | | :------------------ | :---------------- | :-------------------------------------- | | Ordinary Shares, par value NIS 0.25 per share | RWLK | Nasdaq Capital Market | [Registrant Status and Market Value](index=1&type=section&id=Registrant%20Status%20and%20Market%20Value) The company is classified as a non-accelerated filer and a smaller reporting company, with an aggregate market value of approximately **$58.5 million** of common stock held by non-affiliates as of June 30, 2022 - The company is classified as a non-accelerated filer and a smaller reporting company[9](index=9&type=chunk) - As of June 30, 2022, the aggregate market value of common stock held by non-affiliates was approximately **$58,466,801**[11](index=11&type=chunk) - As of February 23, 2023, the company had **59,480,132** ordinary shares outstanding[12](index=12&type=chunk) [Special Note Regarding Forward-Looking Statements and Risk Factors Summary](index=4&type=section&id=Special%20Note%20Regarding%20Forward-Looking%20Statements%20and%20Risk%20Factors%20Summary) [Forward-Looking Statements Disclaimer](index=4&type=section&id=Forward-Looking%20Statements%20Disclaimer) This report contains forward-looking statements based on management's beliefs and assumptions regarding future operating results, business strategies, and financing plans, which are subject to uncertainties that may cause actual results to differ materially - Forward-looking statements are based on management's beliefs and assumptions, covering future operating results, business strategies, financing plans, competitive position, industry environment, growth opportunities, and market opportunities[18](index=18&type=chunk) - Important factors may cause actual results, activity levels, performance, or achievements to differ materially from those expressed in forward-looking statements[18](index=18&type=chunk) - Investors should not place undue reliance on forward-looking statements, and the company undertakes no obligation to update any forward-looking statements after the report date[21](index=21&type=chunk)[22](index=22&type=chunk) [Key Risk Factors Summary](index=4&type=section&id=Key%20Risk%20Factors%20Summary) The company faces various key risks, including future growth, product market acceptance, third-party reimbursement, Nasdaq listing compliance, COVID-19 impact, funding needs, limited operating history, acquisition integration, clinical research, supply chain, product improvements, regulatory approvals, cybersecurity, intellectual property protection, and stock market volatility - Future growth, including the ability to increase sales in existing markets and expand into new ones - The ability to maintain and enhance product reputation and market acceptance - The ability to obtain third-party payer reimbursement or advance CMS coverage for products - The ability to regain and maintain compliance with Nasdaq Capital Market continued listing requirements - The adverse impact of the COVID-19 pandemic on business and operating results - Whether sufficient capital is available to meet future capital needs, which could impair efforts to develop and commercialize existing and new products - Limited operating history and the ability to leverage sales, marketing, and training infrastructure - The ability to achieve business growth through acquisitions of businesses, products, or technologies, and the risk of failed acquisition management or integration - Expectations regarding clinical research programs and clinical outcomes - The ability to obtain product components from third-party suppliers and ongoing support from product manufacturers - The ability to improve existing products and develop new ones - Compliance with medical device reporting regulations, reporting product-related side effects, which could lead to enforcement actions such as voluntary corrective actions or mandatory recalls - The ability to obtain and maintain regulatory approvals and comply with any post-market requirements - The risk of cybersecurity attacks or information technology system breaches severely disrupting business operations - The ability to maintain adequate intellectual property protection and avoid infringing on others' intellectual property - The impact of significant sales of company stock by certain shareholders on market price - The ability to effectively utilize proceeds from securities offerings - Significant dilution that may result from periodic issuances of ordinary shares - The impact of the market price of ordinary shares on whether the company is deemed a passive foreign investment company - Market and other conditions, including inflation or global instability, that could disrupt business operations or financial condition - Other factors discussed in "Part I. Item 1A. Risk Factors"[20](index=20&type=chunk)[24](index=24&type=chunk) [ITEM 1. BUSINESS](index=6&type=section&id=ITEM%201.%20BUSINESS) [Overview](index=6&type=section&id=Overview) ReWalk Robotics Ltd. is a medical device company focused on designing, developing, and commercializing innovative technologies to provide mobility and health support for individuals with neurological disorders, featuring ReWalk spinal cord injury exoskeletons, ReStore stroke rehabilitation soft exoskeletons, and MyoCycle FES Pro distribution - ReWalk Robotics Ltd. designs, develops, and commercializes innovative technologies aimed at providing mobility and health support for individuals with neurological disorders[25](index=25&type=chunk) - ReWalk Personal and ReWalk Rehabilitation exoskeleton devices: Used for spinal cord injury (SCI) patients, employing tilt-sensor technology, an onboard computer, and motion sensors to drive motorized legs, enabling paraplegic individuals to stand and walk - ReStore Exo-Suit device: A lightweight soft exoskeleton for rehabilitation of individuals with lower limb disability due to stroke, commercialization began in June 2019 - MyoCycle FES Pro cycling device: Exclusively distributed in the United States to rehabilitation clinics and Veterans Affairs (VA) hospitals - MediTouch Tutor motion biofeedback system: Previously an exclusive distribution product, the agreement was terminated on January 31, 2023, due to unsatisfactory sales performance - ReBoot: A research-stage personal soft exoskeleton for home and community use by post-stroke patients, which received FDA Breakthrough Device designation, but further investment was paused in 2023[25](index=25&type=chunk)[26](index=26&type=chunk)[27](index=27&type=chunk) - The company's primary markets are the United States and Europe, with direct sales operations in Germany and partnerships with distributors in other key countries[28](index=28&type=chunk) - Revenue sources include third-party payers (private and government payers) and self-pay individuals, with the company actively pursuing reimbursement and insurance coverage[29](index=29&type=chunk)[30](index=30&type=chunk)[31](index=31&type=chunk) [COVID-19 Pandemic Impact](index=7&type=section&id=COVID-19%20Pandemic%20Impact) The COVID-19 pandemic significantly disrupted the company's operations, causing global supply chain issues, hindering new customer acquisition, delaying product trials and training, and reducing product demand due to healthcare system staff shortages, with business not yet fully recovering to pre-pandemic levels - The pandemic caused significant disruptions to the global economy, capital markets, and the company's business[33](index=33&type=chunk) - Global suppliers, distributors, and manufacturing facilities were severely adversely affected by restrictive government and corporate measures[34](index=34&type=chunk) - Pandemic restrictions impacted the company's ability to identify new customers through trade shows, engage with existing customers, conduct product trials, deliver and service systems, and provide training for new patients and rehabilitation centers[34](index=34&type=chunk) - Staff shortages in the healthcare system led to decreased demand for spinal cord injury products[34](index=34&type=chunk) - Despite the lifting of restrictions, business has not fully recovered to pre-pandemic levels and is expected to continue to be adversely affected[34](index=34&type=chunk) [ReWalk Personal and ReWalk Rehabilitation Products](index=8&type=section&id=ReWalk%20Personal%20and%20ReWalk%20Rehabilitation%20Products) ReWalk Personal 6.0 and ReWalk Rehabilitation are robotic exoskeletons designed for paraplegic patients to restore standing and walking, utilizing tilt-sensor technology to provide a natural gait and demonstrating potential secondary health benefits, with approximately **20.2%** of **296,000** US spinal cord injury patients being potential candidates - ReWalk Personal 6.0: A battery-powered wearable exoskeleton that uses tilt-sensor technology, sensors, and a computer control system to drive knee and hip movement, allowing users to stand, walk, sit, and, depending on local regulations, ascend and descend stairs and curbs - ReWalk Rehabilitation: Composed of a Personal 6.0 unit and multi-size adjustable components, used by clinics for training and therapy for multiple patients, and also for evaluating a patient's future ability to use ReWalk Personal - ReWalk Personal 6.0 received CE Mark in Europe in late 2012 and FDA approval in the United States in June 2014 - Clinical studies indicate ReWalk Personal can provide functional walking speeds and have reported potential secondary health benefits, including pain reduction, improved bowel and bladder function, reduced spasticity, increased range of motion, improved sleep and reduced fatigue, increased oxygen intake and heart rate, and reduced hospitalizations - Approximately **296,000** individuals in the United States have spinal cord injuries, with about **17,900** new cases annually; based on FDA restrictions, approximately **20.2%** of spinal cord injury patients may be considered candidates for the ReWalk Personal exoskeleton[35](index=35&type=chunk)[36](index=36&type=chunk)[38](index=38&type=chunk)[41](index=41&type=chunk)[42](index=42&type=chunk)[43](index=43&type=chunk)[44](index=44&type=chunk)[46](index=46&type=chunk) [Overview of Spinal Cord Injury](index=9&type=section&id=Overview%20of%20Spinal%20Cord%20Injury) Spinal cord injury is a severe medical condition resulting from physical damage to spinal nerves, leading to functional loss such as mobility or sensation, categorized by completeness and level of injury - Spinal cord injury is a severe medical condition resulting from physical damage to spinal nerves, leading to loss of function such as mobility or sensation[39](index=39&type=chunk) - Complete injury: Patients experience a complete loss of sensation and voluntary movement below the level of injury - Incomplete injury: Some function is retained below the level of injury - Injury level classification: Cervical injuries result in tetraplegia (quadriplegia), thoracic injuries result in paraplegia (paralysis of the legs), lumbar injuries result in paraplegia, and sacral injuries primarily affect bowel and bladder function, as well as sexual function[39](index=39&type=chunk)[40](index=40&type=chunk) [Market Opportunity](index=10&type=section&id=Market%20Opportunity) Spinal cord injury patients face severe physical and psychological deterioration from prolonged bed rest, incurring high medical costs and reduced quality of life, with **296,000** patients in the US and **42,000** eligible veterans as of 2021 - Long-term bed rest for spinal cord injury patients can lead to severe physical and psychological deterioration, resulting in high medical costs and reduced quality of life[43](index=43&type=chunk) - The National Spinal Cord Injury Statistical Center (NSCISC) estimates that paraplegia-related complications cost approximately **$500,000** in the first year post-injury, with substantial lifetime costs[43](index=43&type=chunk) - As of 2021, there were **296,000** individuals with spinal cord injuries in the United States, with approximately **17,900** new cases annually; the Department of Veterans Affairs (VA) has about **42,000** eligible veteran patients[44](index=44&type=chunk) - Based on FDA restrictions, approximately **20.2%** of spinal cord injury patients may be considered candidates for the ReWalk Personal exoskeleton[46](index=46&type=chunk) [Sales and Marketing activities](index=10&type=section&id=Sales%20and%20Marketing%20activities) The company shifted its commercial focus from rehabilitation centers to direct promotion of ReWalk Personal exoskeletons to patients, physicians, and physical therapists, emphasizing medical necessity, while continuing to pursue reimbursement efforts and expand commercial coverage through direct sales and distributors - The company has shifted its commercialization focus from rehabilitation centers to directly promoting the ReWalk Personal exoskeleton to patients, physicians, and physical therapists, emphasizing its necessity as a medical intervention[47](index=47&type=chunk) - The company sells products directly in Germany and the United States, and primarily through distributors in other markets[48](index=48&type=chunk) ReWalk Device Deployment Numbers (units) | Device Type | As of December 31, 2022 | As of December 31, 2021 | | :------- | :----------------- | :----------------- | | ReWalk Rehabilitation | 128 | 121 | | ReWalk Personal | 572 | 533 | - The company plans to continue focusing on reimbursement efforts, handling insurance claims on a case-by-case basis, and investing in expanding commercial reimbursement coverage[49](index=49&type=chunk) [Third-Party Reimbursements](index=11&type=section&id=Third-Party%20Reimbursements) The company actively seeks third-party reimbursement for ReWalk products from the US Department of Veterans Affairs (VA) and German health insurance providers, with VA having a national policy and several German insurers offering coverage, while pursuing broader Medicare coverage in the US through case-by-case applications and CMS collaboration - In the United States, individuals typically obtain ReWalk Personal exoskeletons through third-party medical insurance (such as workers' compensation insurance, VA) or self-pay[52](index=52&type=chunk) - The VA issued a national policy in December 2014, covering assessment, training, and procurement of ReWalk Personal exoskeleton systems for eligible veterans; as of December 31, 2022, **34** devices have been deployed through the VA policy, and the VA contributed **14%** of total revenue in 2022[53](index=53&type=chunk) - The company is collaborating with CMS to clarify Medicare coverage categories for personal exoskeletons and obtained a unique code for the ReWalk Personal exoskeleton in July 2020[59](index=59&type=chunk) - In Germany, BARMER GEK and DGUV have indicated they will provide coverage for eligible users; the ReWalk Personal exoskeleton system has been listed in the German medical device directory, and several German statutory health insurance (SHI) and private health insurance (PHI) companies have signed agreements with the company[31](index=31&type=chunk)[64](index=64&type=chunk) - Italy's Ministry of Labor and Social Policies issued a policy in March 2018 to provide exoskeleton systems for eligible spinal cord injury patients, with **10** devices supplied through the Italian distributor[66](index=66&type=chunk) [United States](index=11&type=section&id=United%20States) In the US, the VA issued a national policy in 2014 covering ReWalk Personal systems for eligible veterans, contributing **14%** of 2022 revenue, while the company works with CMS for broader Medicare coverage amidst a lack of uniform commercial insurance policies - The VA issued a national policy in December 2014, covering assessment, training, and procurement of ReWalk Personal exoskeleton systems for eligible veterans; as of December 31, 2022, **34** devices have been deployed through the VA policy, and the VA contributed **14%** of total revenue in 2022[53](index=53&type=chunk) - Commercial insurance payers in the United States do not yet have a uniform medical technology coverage and reimbursement policy for electronic exoskeletons, but reimbursement can be obtained through case-by-case determinations[56](index=56&type=chunk) - As of December 31, 2022, **13** insurance coverage decision cases were pending in the United States[57](index=57&type=chunk) - The company is collaborating with CMS to seek national Medicare beneficiary category designation for the ReWalk Personal exoskeleton and obtained a unique code in July 2020[59](index=59&type=chunk)[60](index=60&type=chunk) [Europe](index=12&type=section&id=Europe) In Europe, German insurers BARMER and DGUV cover ReWalk systems, which are listed in the German medical device directory, and Italy's Ministry of Labor and Social Policies also provides coverage for eligible spinal cord injury patients - German insurance companies BARMER and DGUV have indicated they will provide coverage for ReWalk systems for eligible users[64](index=64&type=chunk) - The ReWalk Personal system has been listed in the German medical device directory, and German statutory health insurance (SHI) and private health insurance (PHI) companies have signed agreements with the company[64](index=64&type=chunk) - As of December 31, 2022, **47** insurance cases were pending in Germany[63](index=63&type=chunk) - Italy's Ministry of Labor and Social Policies issued a policy in March 2018 to provide exoskeleton systems for eligible spinal cord injury patients, with **10** devices supplied through the Italian distributor[66](index=66&type=chunk) [ReStore](index=13&type=section&id=ReStore) ReStore Exo-Suit is a lightweight soft exoskeleton for stroke rehabilitation, commercialized in 2019 after FDA and CE approvals, designed to improve walking speed and symmetry through flexible materials and sensors, with **33** units deployed by the end of 2022 - The ReStore Exo-Suit is a lightweight soft exoskeleton system, initially designed for rehabilitation of stroke patients, and began commercialization in June 2019 after receiving FDA approval and CE approval in May[68](index=68&type=chunk) - ReStore provides plantarflexion and dorsiflexion assistance to the patient's ankle joint through flexible materials, sensors, and powered assistance, aiming to improve walking speed and symmetry[70](index=70&type=chunk)[71](index=71&type=chunk) - The primary market for ReStore is rehabilitation clinics with stroke treatment programs, and the company focuses its commercial efforts in the United States and Europe[72](index=72&type=chunk) ReStore Device Deployment Numbers (units) | Year | Deployment Quantity | | :--- | :------- | | 2022 | 33 | | 2021 | 30 | [ReBoot](index=14&type=section&id=ReBoot) ReBoot is a research-stage personal soft exoskeleton for post-stroke home and community use, granted FDA Breakthrough Device designation in November 2021, but further investment was temporarily paused in 2023 pending evaluation of its clinical and commercial opportunities - ReBoot is a research-stage personal soft exoskeleton for home and community use by post-stroke patients, which received FDA Breakthrough Device designation in November 2021[27](index=27&type=chunk)[76](index=76&type=chunk) - ReBoot aims to provide walking assistance for individuals with impaired ankle function due to neurological injury (such as stroke), with an estimated market size of approximately **400,000** stroke patients annually requiring walking assistance[76](index=76&type=chunk) - In 2023, the company temporarily paused further investment in the ReBoot development pathway, pending further determination of its clinical and commercial opportunities[27](index=27&type=chunk)[76](index=76&type=chunk) [Competition](index=14&type=section&id=Competition) The medical exoskeleton market is highly competitive and rapidly evolving, with key rivals including Ekso Bionics and Cyberdyne, and ReWalk Personal's tilt-sensor technology and FDA personal use clearance, along with ReStore's natural gait assistance and cost-effectiveness, provide competitive advantages - The medical exoskeleton market is highly competitive and rapidly changing, with competition expected to intensify[77](index=77&type=chunk) - Key competitors: Ekso Bionics, Rex Bionics Pty, Cyberdyne, FREE Bionics, DIH, AlterG, Wandercraft, and Bioness - Alternative devices and therapies: Treadmill gait therapy, such as products offered by Hocoma, Tyromotion, AlterG, Aretech, and Reha Technology[78](index=78&type=chunk)[81](index=81&type=chunk) - Key competitive advantages of the ReWalk Personal device include tilt-sensor technology, a more natural gait, faster walking speed, self-weight support capability, and broad user specifications, and it was the first medical exoskeleton to receive FDA clearance for personal use[79](index=79&type=chunk) - Competitive advantages of the ReStore soft exoskeleton device include achieving a natural functional walking pattern through flexible materials, sensors, and powered assistance, and its lower cost and weight compared to rigid exoskeleton devices[80](index=80&type=chunk) [Community Engagement and Education](index=15&type=section&id=Community%20Engagement%20and%20Education) The company dedicates significant resources to engage and educate the spinal cord injury community, promoting the benefits of SCI products and ReStore devices through collaborations with hospitals, rehabilitation centers, key opinion leaders, and patient advocacy groups to advance exoskeleton technology adoption - The company is committed to interacting with and educating the spinal cord injury community, promoting the benefits of SCI products and ReStore devices[84](index=84&type=chunk) - Actively collaborates with hospitals, rehabilitation centers, and key opinion leaders, participating in research and development and clinical activities[84](index=84&type=chunk) - Several advocacy groups, including the United Spinal Association and the Dana and Christopher Reeves Foundation, have publicly endorsed the ReWalk Personal device[85](index=85&type=chunk) [Services and Customer Support](index=15&type=section&id=Services%20and%20Customer%20Support) The company operates support centers in Marlborough, US, and Berlin, Germany, providing comprehensive customer support and product services for North America and Europe through specialized technical staff, including training for healthcare providers and direct user assistance - The company operates support centers in Marlborough, United States, and Berlin, Germany, responsible for all customer support and product service functions in North America and Europe[86](index=86&type=chunk) - Provides training for healthcare providers and support for product users through specialized technical service personnel[86](index=86&type=chunk) [Research and Development](index=15&type=section&id=Research%20and%20Development) The company maintains a robust R&D program to support existing products and develop new ones, with primary activities in Yokneam, Israel, funded partly by the Israel Innovation Authority (IIA), and collaborations with the Human-Robot Interaction (HRI) Consortium and Harvard University to advance exoskeleton technology - The company is committed to investing in a robust research and development program to support existing product lines and develop new, complementary products[87](index=87&type=chunk) - The R&D team includes internal and external engineers, mechanics, researchers, as well as marketing, quality, manufacturing, regulatory, and clinical personnel - Primary R&D work is conducted at facilities in Yokneam, Israel - Product design improvements and expanded labeling work are underway for ReWalk Personal 6.0, with plans to introduce the ReWalk 7.0 next-generation device - Future medical indications that may be pursued include multiple sclerosis, cerebral palsy, Parkinson's disease, and assistance for the elderly[87](index=87&type=chunk)[88](index=88&type=chunk) - As of December 31, 2022, the company had received a total of **$2.3 million** in R&D funding from the Israel Innovation Authority (IIA)[89](index=89&type=chunk) [Research and Development Collaborations](index=16&type=section&id=Research%20and%20Development%20Collaborations) The company collaborates with the Human-Robot Interaction (HRI) Consortium to develop advanced social robotics and with Harvard University on lightweight soft exoskeleton technology for lower limb disabilities, securing exclusive licenses for related patents - On April 1, 2022, the company entered into an R&D collaboration agreement with the Human-Robot Interaction (HRI) Consortium (part of the Israel Innovation Authority MAGNET incentive program), aimed at developing advanced robotic technologies with social capabilities to improve human-robot interaction[90](index=90&type=chunk) - The HRI Consortium project budget is **NIS 57 million**, with **NIS 1.745 million** allocated to ReWalk-specific projects[90](index=90&type=chunk) - On May 16, 2016, the company entered into a research collaboration agreement and an exclusive license agreement with Harvard University to jointly develop lightweight soft exoskeleton system technology for lower limb disabilities, aimed at treating conditions such as stroke, multiple sclerosis, and mobility impairment in the elderly[91](index=91&type=chunk) - Under the Harvard license agreement, the company obtained a global, exclusive, royalty-bearing license to Harvard University's relevant patents and the right to license new inventions arising from the joint research collaboration[92](index=92&type=chunk) [Intellectual Property](index=16&type=section&id=Intellectual%20Property) The company protects its intellectual property through patents, trademarks, confidentiality agreements, and trade secret laws, holding **12** US patents, **19** non-US patents, and **11** pending applications as of December 31, 2022, with ReWalk and ReStore trademarks registered in multiple regions - The company protects its intellectual property through patents, trademarks, confidentiality agreements, and trade secret laws[95](index=95&type=chunk) - As of December 31, 2022, the company held **12** granted US patents and **19** granted non-US patents - The company has **11** pending patent applications in the United States, China, and Europe - Patents cover ReWalk's tilt-sensor technology and user-activated control methods - The ReWalk trademark is registered in the United States, Europe, Israel, and the United Kingdom - The ReStore trademark is registered in the United States, Europe, and the United Kingdom[97](index=97&type=chunk)[100](index=100&type=chunk) - Patent terms typically last **20 years** from the earliest filing date but may be slightly extended due to patent term adjustments[99](index=99&type=chunk) [Government Regulation](index=17&type=section&id=Government%20Regulation) The company's medical products and manufacturing are extensively regulated by agencies like the US FDA, EU MDR, and UKCA, covering product development, testing, manufacturing, labeling, marketing, and post-market surveillance, requiring compliance with pre-market and post-market requirements, as well as anti-kickback, false claims, and data privacy laws - The company's medical products and manufacturing operations are subject to extensive regulation by domestic and international agencies, including the U.S. FDA, EU MDR, and UKCA[102](index=102&type=chunk)[119](index=119&type=chunk)[121](index=121&type=chunk) - Regulation covers product development, testing, manufacturing, labeling, storage, installation, servicing, advertising, promotion, marketing, distribution, import, export, and market surveillance[102](index=102&type=chunk) - United States: Medical devices are classified into Class I, II, or III, requiring 510(k) pre-market notification, PMA approval, or a de novo classification order; ReWalk is classified as a Class II powered exoskeleton device and must comply with special controls; ReStore received 510(k) clearance - European Union: Medical devices are regulated by the EU Medical Device Regulation (MDR) 2017/745 and require CE marking - United Kingdom: Regulated by the Medical Devices Regulations 2002, with the CE Mark to be replaced by the UKCA Mark[103](index=103&type=chunk)[104](index=104&type=chunk)[106](index=106&type=chunk)[108](index=108&type=chunk)[109](index=109&type=chunk)[119](index=119&type=chunk)[120](index=120&type=chunk)[121](index=121&type=chunk) - Post-market regulatory requirements include establishing registration and device listings, quality assurance systems, labeling regulations, UDI requirements, medical device reporting, and corrective action reporting[112](index=112&type=chunk)[117](index=117&type=chunk) - The company must also comply with U.S. anti-kickback laws, false claims laws, HIPAA data privacy laws, and the Sunshine Act, among other healthcare fraud and abuse laws[124](index=124&type=chunk)[126](index=126&type=chunk)[129](index=129&type=chunk)[130](index=130&type=chunk)[131](index=131&type=chunk) - Healthcare reform measures, such as the Affordable Care Act (ACA), may impact medical product pricing and reimbursement, adversely affecting the company's business[144](index=144&type=chunk)[148](index=148&type=chunk) [U.S. Regulation](index=17&type=section&id=U.S.%20Regulation) US medical devices are regulated by the FDA, categorized into Class I, II, or III, requiring pre-market clearance (510(k), PMA, or de novo classification), with ReWalk classified as a Class II powered exoskeleton and ReStore receiving 510(k) clearance, all subject to post-market requirements - U.S. medical devices are regulated by the FDA, categorized into Class I, II, or III, requiring pre-market clearance through 510(k) notification, PMA approval, or a de novo classification order[103](index=103&type=chunk)[104](index=104&type=chunk)[106](index=106&type=chunk) - ReWalk received FDA "de novo" classification in June 2014, categorizing it as a Class II powered exoskeleton device subject to special controls[108](index=108&type=chunk) - ReStore received FDA 510(k) clearance in June 2019 for stroke patient rehabilitation[109](index=109&type=chunk) - Post-market regulatory requirements include compliance with Quality System Regulation (QSR), adverse event reporting, UDI requirements, and post-market surveillance[112](index=112&type=chunk)[114](index=114&type=chunk)[117](index=117&type=chunk) - The FDA confirmed in May 2022 that ReWalk had completed its 522 post-market study requirements[113](index=113&type=chunk) [Regulation outside of the U.S.](index=20&type=section&id=Regulation%20outside%20of%20the%20U.S.) Medical devices in the EU are regulated by the MDR 2017/745, requiring CE marking, while post-Brexit UK regulations (Medical Devices Regulations 2002) will replace CE with UKCA marking, and other jurisdictions have their own approval processes - Medical devices in the European Union are regulated by the EU Medical Device Regulation (MDR) 2017/745 and require CE marking[119](index=119&type=chunk)[120](index=120&type=chunk) - Following Brexit, medical devices in the United Kingdom are regulated by the Medical Devices Regulations 2002, and the CE Mark will be replaced by the UKCA Mark[121](index=121&type=chunk) - Sales in other jurisdictions require compliance with local government regulations and approval processes[122](index=122&type=chunk) [U.S. Anti-kickback, False Claims and Other Healthcare Fraud and Abuse Laws](index=20&type=section&id=U.S.%20Anti-kickback%2C%20False%20Claims%20and%20Other%20Healthcare%20Fraud%20and%20Abuse%20Laws) The company is subject to US anti-kickback, false claims, and healthcare fraud laws, including HIPAA and ACA, which prohibit inducements for product purchases, false claims to the government, and mandate reporting of payments to healthcare providers under the Sunshine Act, alongside data privacy regulations - Federal and state anti-kickback laws prohibit paying or receiving kickbacks to induce the purchase or recommendation of medical products and services[124](index=124&type=chunk) - The Civil False Claims Act (FCA) prohibits knowingly submitting false or fraudulent claims for payment to the federal government, which can result in treble damages and civil penalties[126](index=126&type=chunk) - Federal criminal statutes, including the Health Insurance Portability and Accountability Act (HIPAA) and the Affordable Care Act (ACA) amendments, prohibit healthcare fraud and abuse[129](index=129&type=chunk) - The Physician Payments Sunshine Act requires medical device manufacturers to annually report payments and other transfers of value made to healthcare providers[130](index=130&type=chunk) - The company is also subject to data privacy and security regulations, such as HIPAA, HITECH, GDPR, and CCPA[131](index=131&type=chunk)[261](index=261&type=chunk)[262](index=262&type=chunk) [Coverage and Reimbursement](index=22&type=section&id=Coverage%20and%20Reimbursement) Commercial success hinges on obtaining adequate coverage and reimbursement from government and private third-party payers, who increasingly restrict or regulate pricing, potentially limiting product access or requiring high co-payments, making favorable CMS coverage crucial for new product launches - The commercial success of products depends on government payers (Medicare, Medicaid), private health insurance companies, and other third-party payers providing coverage and establishing adequate reimbursement levels[136](index=136&type=chunk) - Government agencies and third-party payers are increasingly limiting or regulating the prices of medical products and services, which could result in average selling prices lower than anticipated[137](index=137&type=chunk) - Payers may restrict coverage for specific therapeutic products or require high co-payments to control costs[137](index=137&type=chunk)[142](index=142&type=chunk) - Obtaining favorable CMS coverage and reimbursement is often a critical issue for the successful launch of new products[140](index=140&type=chunk) [Healthcare Reform Measures](index=23&type=section&id=Healthcare%20Reform%20Measures) Healthcare reform measures in the US and abroad, such as the ACA and Budget Control Act of 2011, aim to control healthcare spending, potentially limiting government payments for medical products and services, restricting coverage and reimbursement, and reducing product demand - The United States and many foreign jurisdictions have enacted or proposed legislative and regulatory reforms to limit the growth of government healthcare spending[143](index=143&type=chunk) - The Patient Protection and Affordable Care Act (ACA) significantly altered healthcare financing and had a major impact on the pharmaceutical industry[144](index=144&type=chunk) - The Budget Control Act of 2011 resulted in a **2%** reduction in Medicare payments, and the Bipartisan Budget Act of 2018 extended this cut[146](index=146&type=chunk)[242](index=242&type=chunk) - Future healthcare reform measures may limit the amount governments pay for medical products and services, leading to restricted coverage and reimbursement, and reduced product demand[150](index=150&type=chunk) [Environmental Matters](index=24&type=section&id=Environmental%20Matters) The company adheres to environmental, health, and safety regulations concerning air and water emissions, chemical management, and waste disposal, with Israeli contract manufacturers requiring poison permits and EU products complying with WEEE and RoHS directives, affirming material compliance with applicable laws - The company complies with various environmental, health, and safety laws and regulations, including those concerning air emissions, water discharges, and the use, transportation, management, and disposal of chemicals and hazardous materials[151](index=151&type=chunk) - In Israel, contract manufacturers are required to obtain a poison permit under the Israeli Hazardous Substances Law[152](index=152&type=chunk) - In the EU market, electrical and electronic equipment must comply with the WEEE Directive (encouraging reuse and recycling) and the RoHS Directive (restricting the use of hazardous substances)[153](index=153&type=chunk) - The company believes it is in compliance with applicable environmental laws and regulations in all material respects[153](index=153&type=chunk) [Manufacturing](index=24&type=section&id=Manufacturing) The company contracts Sanmina Corporation to manufacture all its products, including ReWalk and ReStore, at its Ma'alot, Israel facility, enabling focus on technology development and commercialization with scalable production, while internally developing some software components and licensing others - The company contracts Sanmina Corporation to manufacture all its products, including ReWalk and ReStore, at its Ma'alot, Israel facility[154](index=154&type=chunk) - This contract manufacturing relationship allows the company to focus on technology development and commercialization, and provides scalable production capacity[155](index=155&type=chunk) - The company internally develops some software components and licenses other open-source software[156](index=156&type=chunk) - The company produces based on internal sales forecasts, aiming to deliver products within two weeks of receiving an order[156](index=156&type=chunk) [Suppliers](index=25&type=section&id=Suppliers) The company relies on Sanmina for most product components and raw materials, sourced globally, with some direct procurement; despite pandemic-driven electronic component price increases, current manufacturing and supply arrangements are deemed sufficient for foreseeable capacity needs - The company contracts Sanmina to procure all product components and raw materials, with some raw materials procured directly by the company[158](index=158&type=chunk) - Components and raw materials are sourced from suppliers in the United States, Europe, China, and Israel[158](index=158&type=chunk) - During the pandemic, prices for some electronic components increased[158](index=158&type=chunk) - The company believes its manufacturing and supply arrangements are sufficient to support foreseeable capacity needs[159](index=159&type=chunk) [Human Capital](index=25&type=section&id=Human%20Capital) As of December 31, 2022, the company employed **56** individuals primarily in sales, marketing, and R&D, adhering to local labor laws, offering competitive compensation and benefits, and fostering a diverse and inclusive work environment - As of December 31, 2022, the company had **56** employees (including full-time and hourly workers), with **24** in the United States, **17** in Israel, and **15** in Europe[159](index=159&type=chunk) - Most employees are engaged in sales and marketing activities[159](index=159&type=chunk) - The company complies with labor laws and regulations in the United States, Germany, and Israel, offering competitive compensation, bonuses, equity incentives, and comprehensive benefits programs[160](index=160&type=chunk)[161](index=161&type=chunk) - The company is committed to diversity and inclusion, encouraging different perspectives and striving to create an equal opportunity workplace[162](index=162&type=chunk) [Financial Information about Geographic Areas and Significant Customer Information](index=25&type=section&id=Financial%20Information%20about%20Geographic%20Areas%20and%20Significant%20Customer%20Information) In 2022, the company's total revenue was **$5.511 million**, an **8%** decrease from **$5.966 million** in 2021, with both the US and Europe being primary revenue sources experiencing declines, while Israel, Asia-Pacific, and Africa contributed smaller amounts Revenue by Customer Location (thousand dollars) | | 2022 | 2021 | | :--- | :--- | :--- | | Israel | 32 | — | | United States | 2,303 | 2,519 | | Europe | 3,057 | 3,381 | | Asia-Pacific | 115 | 60 | | Africa | 4 | 6 | | Total Revenue | 5,511 | 5,966 | - Total revenue in 2022 was **$5.511 million**, an **8%** decrease from 2021, primarily due to decreased U.S. rehabilitation equipment sales and unfavorable Euro to U.S. Dollar exchange rates[406](index=406&type=chunk) [ITEM 1A. RISK FACTORS](index=26&type=section&id=ITEM%201A.%20RISK%20FACTORS) [Risks Related to Our Business and Our Industry](index=26&type=section&id=Risks%20Related%20to%20Our%20Business%20and%20Our%20Industry) The company faces business and industry risks including global economic uncertainty, ongoing COVID-19 impacts, insufficient funding, Nasdaq delisting risk, new product development challenges, low market acceptance, reliance on a single manufacturer and limited suppliers, intense competition, non-exclusive distributors, high warranty claims, and inadequate R&D capabilities - Weak and uncertain global, regional, and local economic conditions could adversely affect demand for products and services and financial performance[166](index=166&type=chunk) - The COVID-19 pandemic has adversely affected, and may continue to adversely affect, business, operations, and financial results[168](index=168&type=chunk) - The company may not have sufficient capital to meet future operating needs or capital requirements, potentially necessitating dilutive equity or restrictive debt financing[172](index=172&type=chunk) - The company does not meet all Nasdaq Capital Market listing requirements, posing a risk of delisting[177](index=177&type=chunk) - Future growth and operating results depend on the ability to develop, obtain regulatory clearance for, and commercialize new products, as well as penetrate new markets[181](index=181&type=chunk) - The company relies on sales of ReWalk and ReStore systems and related service contracts and extended warranties, and may not achieve or maintain market acceptance[187](index=187&type=chunk) - The medical exoskeleton market is relatively new and unproven, and assumptions about the potential market may be inaccurate[190](index=190&type=chunk) - The company relies on a single third-party supplier (Sanmina) for product manufacturing and a limited number of third-party suppliers for certain components, posing risks of supply chain disruptions and operational challenges[216](index=216&type=chunk)[218](index=218&type=chunk) - The industry in which the company operates is highly competitive and rapidly changing, with competition expected to intensify[221](index=221&type=chunk) - The independent distributors utilized by the company may sell competing products[225](index=225&type=chunk) - The company may receive a significant number of warranty claims or ReWalk and ReStore systems may require substantial after-sales service[226](index=226&type=chunk) - The company may not be able to enhance its product offerings through research and development efforts[227](index=227&type=chunk) [Risks Related to Government Regulation](index=38&type=section&id=Risks%20Related%20to%20Government%20Regulation) The company faces government regulatory risks such as US healthcare reform, no guaranteed fast FDA approval for breakthrough devices, marketing compliance, manufacturing and labeling regulations, QSR compliance, anti-fraud and anti-bribery laws, patient health information confidentiality, and the compliance costs and management challenges of being a US public company and medical device manufacturer - FDA Breakthrough Device designation does not guarantee regulatory clearance or a faster clearance timeline[235](index=235&type=chunk) - U.S. healthcare reform measures and other potential legislative initiatives could adversely affect the company's business[238](index=238&type=chunk) - The company's devices are subject to FDA marketing and promotional communication regulations, and non-compliance could lead to enforcement actions[244](index=244&type=chunk) - The company is subject to extensive government regulations concerning the manufacturing, labeling, and marketing of its products, and non-compliance could lead to product withdrawals or recalls[246](index=246&type=chunk) - Failure by the company or its third-party manufacturer to comply with FDA's Quality System Regulation (QSR) could lead to disruptions in manufacturing operations[255](index=255&type=chunk) - The company is subject to various laws and regulations, including "fraud and abuse" laws and anti-bribery laws, and violations could result in substantial penalties[257](index=257&type=chunk) - If the company is found to be in violation of laws protecting the confidentiality of patient health information, it could face civil or criminal penalties[261](index=261&type=chunk) - Compliance with various regulations as a U.S. public company and medical device manufacturer could lead to increased administrative expenses, management distraction, and compliance challenges[264](index=264&type=chunk) [Risks Related to Our Intellectual Property and Information Technology](index=43&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property%20and%20Information%20Technology) The company's success relies partly on intellectual property protection but faces risks from patent validity uncertainty, high litigation costs, trade secret disclosure, IT system failures, and cybersecurity attacks, potentially leading to loss of competitive advantage, legal liabilities, and business disruptions - The company relies on computer and telecommunications systems that it does not own or control, and system failures or cybersecurity attacks could severely disrupt business operations or lead to the disclosure of sensitive customer information[269](index=269&type=chunk) - The company's success is partly dependent on obtaining and maintaining protection for intellectual property related to its products[274](index=274&type=chunk) - The patent landscape for robotic and exoskeleton inventions is highly uncertain, and patent laws and interpretations may change, potentially weakening patent value or narrowing the scope of protection[275](index=275&type=chunk) - Intellectual property litigation can be time-consuming and expensive, potentially leading to patent invalidation or narrow interpretation[276](index=276&type=chunk) - The company relies on trademark protection to distinguish its products, but trademarks may be challenged or infringed upon[289](index=289&type=chunk) - The company may face claims from employees or other companies regarding the improper use or disclosure of former employers' trade secrets[290](index=290&type=chunk) [Risks Related to Ownership of Our Ordinary Shares](index=46&type=section&id=Risks%20Related%20to%20Ownership%20of%20Our%20Ordinary%20Shares) Ownership of the company's ordinary shares carries multiple risks, including potential dilution from large stock sales or warrant exercises, future equity incentive plans, failure to meet analyst expectations, reduced investor appeal as a 'smaller reporting company,' internal control compliance costs, adverse tax consequences if deemed a PFIC, and stock price volatility - Significant sales of ordinary shares by the company or major shareholders, or large exercises of warrants by holders, could adversely affect the value of ordinary shares[291](index=291&type=chunk) - Future grants of ordinary shares to employees, non-employee directors, and consultants under equity incentive plans, or sales of shares by these individuals in the open market, could result in substantial dilution[295](index=295&type=chunk) - If the company fails to meet the expectations of equity research analysts, or if analysts cease publishing research reports or issue unfavorable comments, the stock price could decline[297](index=297&type=chunk) - The company's status as a "smaller reporting company" and its simplified reporting requirements may reduce the attractiveness of its ordinary shares to investors[300](index=300&type=chunk) - The company faces ongoing costs and risks in determining whether its existing internal control over financial reporting system complies with Section 404 of the Sarbanes-Oxley Act, and failure to maintain adequate internal controls could materially adversely affect financial performance and reputation[302](index=302&type=chunk) - If the company is deemed a passive foreign investment company (PFIC), U.S. holders of ordinary shares may face adverse U.S. tax consequences[306](index=306&type=chunk) - The price of the company's ordinary shares may fluctuate, and investors could lose all or part of their investment[313](index=313&type=chunk) [Risks Related to Our Incorporation and Location in Israel](index=50&type=section&id=Risks%20Related%20to%20Our%20Incorporation%20and%20Location%20in%20Israel) The company's Israeli operations face risks from political and military instability, employee military service, boycotts, termination of tax benefits, government funding restrictions on technology transfer, and employee invention claims, while Israeli law and articles of association may hinder M&A, and US court judgments may be difficult to enforce - The company's technology development and quality headquarters, as well as its contract manufacturer's facilities, are located in Israel; therefore, economic restrictions and political and military instability in Israel could adversely affect the company's business[315](index=315&type=chunk) - Military service obligations for Israeli citizens could disrupt the operations of the company and its contract manufacturer[318](index=318&type=chunk) - Boycotts against Israel could adversely affect the sales of the company's products[319](index=319&type=chunk) - Tax benefits available to the company require meeting various conditions and may be terminated or reduced in the future, increasing costs and taxes[320](index=320&type=chunk) - The company has received funding from the Israeli government for its R&D activities, and the terms of these grants restrict the company's ability to manufacture products or transfer technology outside of Israel, or may require penalty payments if the company is sold[321](index=321&type=chunk) - The company may face claims from employees regarding their rights to compensation or royalties for service inventions[325](index=325&type=chunk) - Provisions of Israeli law and the company's articles of association may delay, prevent, or otherwise hinder mergers or acquisitions of the company[326](index=326&type=chunk) - Judgments rendered against the company, its officers, and directors in U.S. courts may be difficult to enforce in Israel, or it may be difficult to assert U.S. securities law claims or serve process in Israel[333](index=333&type=chunk) [General Risks](index=54&type=section&id=General%20Risks) The company faces profitability risks from currency exchange rate fluctuations (USD, EUR, NIS), changes in international trade and anti-bribery laws, fiscal and tax policy adjustments, IT system disruptions, and challenges in managing growth, while also being highly dependent on senior management and potentially impacted by US federal government shutdowns - Fluctuations in exchange rates between the U.S. Dollar, Euro, and New Israeli Shekel could adversely affect the company's profitability[339](index=339&type=chunk) - The company is subject to various regulatory regimes that may affect international operations, and failure to comply with applicable laws and regulations could harm its reputation and lead to fines and increased costs[344](index=344&type=chunk) - Changes in fiscal and tax policies could have a significant impact on the company's business and result in potential negative or unexpected tax consequences[346](index=346&type=chunk) - If the company is deemed a controlled foreign corporation (CFC), U.S. holders of ordinary shares may face adverse U.S. tax consequences[348](index=348&type=chunk) - Significant disruptions to information technology systems could adversely affect the company's business, financial condition, and results of operations[350](index=350&type=chunk) - If the company fails to properly manage anticipated growth, its business could be harmed[352](index=352&type=chunk) - The company is highly dependent on the knowledge and skills of its senior management, and failure to attract and retain highly qualified personnel may prevent successful implementation of business strategies[353](index=353&type=chunk) - A U.S. federal government shutdown could severely harm the company's business and financial condition[355](index=355&type=chunk) [ITEM 1B. UNRESOLVED STAFF COMMENTS](index=57&type=section&id=ITEM%201B.%20UNRESOLVED%20STAFF%20COMMENTS) There are no unresolved staff comments in this report - There are no unresolved staff comments in this report[356](index=356&type=chunk) [ITEM 2. PROPERTIES](index=57&type=section&id=ITEM%202.%20PROPERTIES) The company's headquarters are in Yokneam, Israel, with US operations in Marlborough and European operations in Berlin, Germany; all facilities are leased, totaling approximately **24,297 square feet**, and are considered sufficient for current needs - The company's headquarters are located in Yokneam, Israel, its U.S. headquarters in Marlborough, Massachusetts, and its European headquarters in Berlin, Germany - All facilities are leased, and the company does not own any real estate - The company believes its facilities are sufficient to meet current needs[357](index=357&type=chunk)[358](index=358&type=chunk) Leased Property Area (approximate, square feet) | Location | Area (square feet) | | :--- | :--------------- | | Marlborough, Massachusetts | 11,850 | | Yokneam, Israel | 11,500 | | Berlin, Germany | 947 | | Total | 24,297 | [ITEM 3. LEGAL PROCEEDINGS](index=57&type=section&id=ITEM%203.%20LEGAL%20PROCEEDINGS) The company is occasionally involved in various legal claims, lawsuits, and regulatory investigations arising in the ordinary course of business, for which it accrues losses when probable and estimable, but does not believe any pending or threatened matters will materially adversely affect its consolidated operating results, liquidity, or financial condition - The company is occasionally involved in various legal claims, lawsuits, and regulatory investigations, most of which arise in the ordinary course of business[359](index=359&type=chunk) - The company accrues for losses when they are probable and the amount can be reasonably estimated[359](index=359&type=chunk) - The company does not believe that any pending or threatened legal matters will have a material adverse effect on its consolidated operating results, liquidity, or financial condition[360](index=360&type=chunk) [ITEM 4. MINE SAFETY DISCLOSURES](index=57&type=section&id=ITEM%204.%20MINE%20SAFETY%20DISCLOSURES) Not applicable - Not applicable[362](index=362&type=chunk) [ITEM 5. MARKET FOR REGISTRANT'S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES](index=58&type=section&id=ITEM%205.%20MARKET%20FOR%20REGISTRANT%27S%20COMMON%20EQUITY%2C%20RELATED%20STOCKHOLDER%20MATTERS%20AND%20ISSUER%20PURCHASES%20OF%20EQUITY%20SECURITIES) [Market Information](index=58&type=section&id=Market%20Information) The company's ordinary shares began trading on the Nasdaq Global Market on September 12, 2014, transferred to the Nasdaq Capital Market on May 25, 2017, and had approximately **278,511** registered shareholders as of February 23, 2023 - The company's ordinary shares began trading on the Nasdaq Global Market on September 12, 2014, and transferred to the Nasdaq Capital Market on May 25, 2017[365](index=365&type=chunk) - As of February 23, 2023, the company had approximately **278,511** registered shareholders[365](index=365&type=chunk) [Dividend Policy](index=58&type=section&id=Dividend%20Policy) The company has never declared or paid cash dividends and does not anticipate doing so in the foreseeable future, planning to retain future earnings to fund operations and business expansion, with dividend distributions restricted by Israeli law to retained earnings or court approval - The company has never declared or paid any cash dividends and does not expect to do so in the foreseeable future[366](index=366&type=chunk) - The company plans to retain any future earnings to fund operations and business expansion[366](index=366&type=chunk) - Dividend distributions are restricted by Israeli law, allowing distribution only from retained earnings or with Israeli court permission[366](index=366&type=chunk) [Israeli Taxes Applicable to U.S. Holders](index=58&type=section&id=Israeli%20Taxes%20Applicable%20to%20U.S.%20Holders) Non-Israeli residents selling shares in Israeli public companies are generally exempt from Israeli capital gains tax under certain conditions, while dividends paid to non-Israeli residents are typically subject to **25%** or **30%** Israeli income tax, potentially reduced by tax treaties, with US residents possibly eligible for federal income tax credits - Capital gains derived by non-Israeli residents from the sale of shares in Israeli public companies are generally exempt from Israeli tax, provided certain conditions are met, such as the shares not being held through a permanent establishment in Israel[367](index=367&type=chunk) - Dividends paid to non-Israeli residents are generally subject to Israeli income tax at a rate of **25%** or **30%**, with the specific tax rate potentially reduced by applicable tax treaties[371](index=371&type=chunk) - Under the U.S.-Israel tax treaty, dividends paid to U.S. residents are subject to a maximum Israeli withholding tax rate of **25%**, which may be reduced to **15%** or **12.5%** in certain circumstances[371](index=371&type=chunk) - U.S. residents may be entitled to a U.S. federal income tax credit after paying Israeli withholding tax[371](index=371&type=chunk) - Israeli individuals with annual income exceeding a certain threshold (**NIS 663,240** in 2022) are subject to an additional **3%** tax[372](index=372&type=chunk) [Recent Sales of Unregistered Equity Securities](index=59&type=section&id=Recent%20Sales%20of%20Unregistered%20Equity%20Securities) All sales of unregistered equity securities during the reporting period have been disclosed in Form 8-K or Form 10-Q quarterly reports - All sales of unregistered equity securities during the reporting period have been disclosed in Form 8-K or Form 10-Q quarterly reports[373](index=373&type=chunk) [Purchases of Equity Securities by the Issuer and Affiliated Purchasers](index=59&type=section&id=Purchases%20of%20Equity%20Securities%20by%20the%20Issuer%20and%20Affiliated%20Purchasers) The company initiated a stock repurchase program in June 2022, with board approval to repurchase up to **$8 million** of ordinary shares, extended by an additional **$5.8 million** in December 2022, resulting in the repurchase of approximately **2.9 million** ordinary shares for a total cost of **$2.6 million** as of December 31, 2022 - The company initiated a stock repurchase program in June 2022, with the Board of Directors approving the repurchase of up to **$8 million** of ordinary shares, and further approving an extension of the repurchase program by an additional **$5.8 million** in December 2022[374](index=374&type=chunk)[376](index=376&type=chunk)[459](index=459&type=chunk)[460](index=460&type=chunk) Q4 2022 Stock Repurchase Activity (thousand dollars) | Period | Total Number of Shares Purchased | Average Price Paid Per Share | Total Number of Shares Purchased as Part of a Publicly Announced Plan | Maximum Value of Shares That May Yet Be Purchased Under the Plan | | :----------------------- | :----------------------------- | :--------------------------- | :----------------------------------------------------------------- | :------------------------------------------------------------- | | October 1 - October 30, 2022 | 529,319 | $0.90 | 529,319 | $7,330 | | November 1 - November 30, 2022 | 1,056,776 | $0.94 | 1,056,776 | $6,317 | | December 1 - December 31, 2022 | 1,162,484 | $0.80 | 1,162,484 | $5,358 | | Quarter Total | 2,748,579 | $0.87 | 2,748,579 | $5,358 | - As of December 31, 2022, the company had repurchased approximately **2.9 million** ordinary shares at a total cost of **$2.6 million**[462](index=462&type=chunk) - Between January 1 and January 20, 2023, the company repurchased an additional **730,350** ordinary shares under the repurchase program for a total consideration of **$628,477**[376](index=376&type=chunk) [ITEM 6. [RESERVED]](index=60&type=section&id=ITEM%206.%20%5BRESERVED%5D) This item is reserved and contains no content [ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS](index=60&type=section&id=ITEM%207.%20MANAGEMENT%27S%20DISCUSSION%20AND%20ANALYSIS%20OF%20FINANCIAL%20CONDITION%20AND%20RESULTS%20OF%20OPERATIONS) [Overview](index=60&type=section&id=Overview) The company is a medical device firm developing mobility and health technologies for neurological disorders, featuring ReWalk SCI exoskeletons, ReStore stroke exoskeletons, and MyoCycle distribution, primarily targeting US and European markets with revenue from third-party payers and self-pay individuals, while ReBoot soft exoskeleton development is paused - The company designs, develops, and commercializes innovative technologies aimed at providing rehabilitation and daily living mobility and health support for individuals with neurological disorders[379](index=379&type=chunk) - Primary products: ReWalk Personal and ReWalk Rehabilitation exoskeleton devices (for spinal cord injury), ReStore Exo-Suit device (for stroke rehabilitation) - Distributed products: MYOLYN MyoCycle FES Pro cycling device (exclusive U.S. distribution), MediTouch Tutor motion biofeedback system (distribution terminated) - Products in development: ReBoot (personal soft exoskeleton for post-stroke home and community use), which received FDA Breakthrough Device designation, but further investment was paused in 2023[379](index=379&type=chunk)[380](index=380&type=chunk)[381](index=381&type=chunk) - Primary markets are the United States and Europe, with revenue derived from third-party payers (including private and government payers) and self-pay individuals[382](index=382&type=chunk)[383](index=383&type=chunk) - The company is actively pursuing coverage and reimbursement from Medicare and German health insurance[385](index=385&type=chunk)[386](index=386&type=chunk) [Components of Our Statements of Operations](index=61&type=section&id=Components%20of%20Our%20Statements%20of%20Operations) This section details the company's statement of operations components, including revenue from product sales, leases, service contracts, and extended warranties, cost of revenue and gross profit, operating expenses (R&D, S&M, G&A), net financial expenses (income), income taxes, and government grants - Revenue primarily derives from sales and leases of ReWalk Personal and ReWalk Rehabilitation exoskeleton devices, sales of ReStore exoskeleton devices, sales of distributed products, and related extended service contracts - Revenue sources include third-party payers (private and government employers, institutions) and self-pay individuals, with third-party payers expected to become an increasingly important revenue source - Cost of revenue primarily includes the cost of systems procured from outsourced manufacturer Sanmina, internal personnel costs, manufacturing and inventory management, training and inspection, warranty and service activities, freight, and inventory impairment provisions - Gross profit and gross margin are affected by product sales volume, pricing, product mix, and fluctuations in cost of revenue, and are expected to expand in the future with revenue growth and economies of scale - Research and development expenses primarily include personnel costs, materials, consulting fees, clinical research, regulatory filings, and patent costs, net of R&D grants received - Sales and marketing expenses primarily include personnel costs related to sales, marketing, and reimbursement, travel, advertising, trade shows, lobbying, and public relations activities - General and administrative expenses primarily include administrative, finance, and management personnel costs, professional service fees, and insurance premiums - Net financial expenses (income) include b

Financial Data and Key Metrics Changes - ReWalk reported revenues for Q3 2022 of $886,000, a decrease from $2 million in Q3 2021, and for the nine months ended September 30, 2022, revenues were $3.3 million compared to $4.7 million in the same period of the previous year [18][19] - The gross margin for Q3 2022 was 25%, down from 58% in the prior year's quarter, primarily due to fixed production costs and rising production costs [23] - The net loss for Q3 2022 was $5.5 million or $0.09 per share, compared to a net loss of $2.7 million or $0.06 per share in Q3 2021 [27] Business Line Data and Key Metrics Changes - Sales of ReWalk exoskeleton units were adversely affected by the timing of coverage decisions by insurers and delays in training schedules [19] - In Q3 2022, ReWalk generated approximately $250,000 from the sale of MYOLYN MyoCycles, marking the highest quarterly performance for this product line [20] - The current pipeline of active rentals consists of 26 cases, with a total of 74 cases in process, including 56 in Germany and 18 in the U.S. [22] Market Data and Key Metrics Changes - The U.S. and German markets were almost fully open, allowing for training and placement for home systems, which is expected to improve sales cycles [29] - The capital budgets for clinic-based products are constrained, leading to delays in some planned purchases [30] Company Strategy and Development Direction - The company is focused on establishing coverage for exoskeletons through public and private insurance, with submissions to Medicare administrative contractors (MACs) underway [9][11] - ReWalk is pursuing additional commercial product lines to leverage its organizational structure and achieve profitability [32] - The company aims to submit two FDA device applications for improved ReWalk designs, with the first submission made in June 2022 and the second expected in Q1 2023 [36] Management's Comments on Operating Environment and Future Outlook - Management indicated that the timing of reimbursement decisions has delayed revenue growth expectations for 2022, but many deferred cases are anticipated to conclude in Q4 [31] - The company remains focused on execution to enhance shareholder value and improve patient outcomes [38] Other Important Information - ReWalk's operating expenses for Q3 2022 were $5.7 million, up from $3.8 million in the prior year's quarter, driven by increased R&D and sales and marketing expenses [24][25] - The company ended the quarter with $74 million in cash and cash equivalents and no debt, indicating a strong balance sheet [27][28] Q&A Session Summary - There were no questions during the Q&A session, and the operator concluded the conference call [40][41]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____ to ______ Commission File Number: 001-36612 ReWalk Robotics Ltd. (Exact name of registrant as specified in charter) | Israel | Not applicable | | --- | --- | | ...

ReWalk Robotics Ltd. (RWLK) Q2 2022 Earnings Conference Call August 9, 2022 8:30 AM ET Company Participants Almog Adar - Director of Finance Larry Jasinski - CEO Conference Call Participants Swayampakula Ramakanth - H.C. Wainwright & Co Martin Pollack - KMTR Holdings Operator Welcome to the Second Quarter 2022 ReWalk Robotics Ltd. Earnings Conference Call. My name is Richard and I will be your operator for today’s call. At this time all participants are in a listen-only mode. Later, we will conduct a questi ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2022 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____ to ______ Commission File Number: 001-36612 ReWalk Robotics Ltd. (Exact name of registrant as specified in charter) | Israel | Not applicable | | --- | --- | | (Sta ...

ReWalk Robotics Ltd. (RWLK) Q1 2022 Earnings Conference Call May 13, 2022 4:30 PM ET Company Participants Almog Adar - Director of Finance Larry Jasinski - CEO Conference Call Participants Martin Pollack - KMTR Holdings Operator Good day, and thank you for standing by. Welcome to the Q1 2022 ReWalk Robotics Ltd. Earnings Conference Call. At this time all participants are in a listen-only mode. After the speakers’ presentation there will be a question-and-answer session. [Operator Instructions] Please be ad ...