LFWD 10-K & 10-Q changes, risk factors and insider trading

As of December 31, 2024,2025, we had an accumulated deficit in the total amount of approximately $264.8$284.7 million and anticipate further losses in the development of our business. Those factors raise substantial doubt about our ability to continue as a going concern. Our ability to continue as a going concern depends upon our obtaining the necessary financing to meet our obligations and timely repay our liabilities arising from normal business operations. The financial statements have been prepared assuming that we will continue to operate as a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. Management concluded that substantial doubt about our ability to continue as a going concern exists as of the date of the issuance of these financial statements. Our auditors also included an explanatory paragraph to their audit opinion relating to our accompanying consolidated financial statements for the fiscal year ended December 31, 20242025 regarding the substantial doubt about our ability to continue as a going concern. If we are unable to secure additional capital, including through the closing of the Oramed transaction and by other means, we may be required to take additional measures to reduce costs in order to conserve our cash in amounts sufficient to sustain operations and meet our obligations. If we become insolvent, investors in our securities may lose the entire value of their investment in our business. The accompanying financial statements do not include any adjustments that may be necessary should we be unable to continue as a going concern, and it is not possible for us to predict at this time the potential success of our business.

We intend to finance our business by close management of our operating expenses until we reach profitable operation using existing cash on hand, issuances of equity and/or debt securities, and other future public or private issuances of securities, cash exercised of outstanding warrants, or through a combination of the foregoing, though we may also consider additional capital raising alternatives, such as entering into a credit facility, if the foregoing alternatives are not available to us or unavailable on reasonable terms. We had cash and cash equivalents of $6.7$2.2 million as of December 31, 2024, and raised approximately $5.0 million in January 2025 through a registered direct offering of our ordinary shares.2025. However, we will need to seek additional sources of financing if we require more funds than anticipated during the next 12 months or in later periods.

We may also need to pursue additional strategic transactions, such as joint ventures, in-licensing transactions, or the sale of our business, or all, or substantially all, of our assets if our financial stability is uncertain, and we are unable to raise additional capital effectively. These strategic transactions have in the past and could in the future require significant management attention, disrupt our business, adversely affect our financial results, be unsuccessful or fail to achieve the desired results.

We began streamlining our U.S. operations, including closing two U.S. facilities to complete the integration following the acquisition of AlterG. As a result of the organizational changes, we reduced our total headcount by greater than 35% since the closing of the AlterG acquisition. Key functions located at the affected facilities were integrated into the operations of the Marlborough, Massachusetts facility, and manufacturing of the AlterG Anti-Gravity Systems was assumed by Cirtronics Corporation, a nationally recognized contract manufacturer specializing in the manufacture of precision medical devices and instrumentation. Further, in the second quarter of 2025, we transitioned the manufacturing of our ReWalk products to our in-house manufacturer in an effort to reduce costs and provide us with more control over product quality. As a result, we terminated our agreement with Sanmina Corporation, an international contract manufacturer that manufactured our ReWalk products at its facility in Israel since 2013 and sourced the components and raw materials necessary for manufacturing. We estimate expect that such consolidation willmay save our company approximately $3 million inreduce operating expenses and improve gross margins whenonce the full impact of these measures is achieved,realized, which we expectbelieve tomay contribute to our goal of reducing costs and achieving profitability. Our ability to achieve the anticipated cost savings and other benefits from such streamlining efforts is subject to many estimates and assumptions and may vary materially based on factors such as market conditions and the effect of of our streamlining efforts on our work force. These estimates and assumptions are subject to significant economic, competitive and other uncertainties, some of which are beyond our control. We cannot assure that we will fully realize the anticipated positive impacts to future financial results from our current or future streamlining efforts. If our estimates and assumptions are incorrect or if other unforeseen events occur, we may not achieve the cost savings expected from such streamlining, and our business, financial condition and results of operations could be materially adversely affected.

Currently, we rely on third party suppliers in Taiwan for a portion of the components we use in our AlterG products. Accordingly, our business, financial condition and results of operations and the market price of our securities may be affected by changes in governmental policies, taxation, growth rate, inflation rate or interest rates and by social instability and diplomatic and social developments in or affecting Taiwan. In particular,addition, changes in international trade policies, including the uniquepotential political statusimposition of Taiwantariffs, andexport itscontrols internalor politicalother movementtrade causerestrictions sustainedaffecting tensiongoods betweenmanufactured in ChinaTaiwan, andcould Taiwan.increase Pastour developmentscosts relatedor todisrupt the interactionssupply betweenof Chinacomponents and Taiwan, especiallyused in relation to trade activities such as bans on exports of goods from time to time, have on occasions depressed the transactions and business operations of certain Taiwanese companies and overall economic environment. We cannot predict whether there will be escalation of the tensions between China and Taiwan, which would lead to new bans or tariffs on exports or even conflict. Any conflict which threatens the military, political or economic stability in Taiwan could have a material adverse effect on our currentAlterG or future business and financial conditions and results of operations.products.

We are currently engaged in research and development efforts to address the needs of patients with mobility impairments besides paraplegia, such as stroke, and, in the future, we may engage in efforts to address these needs in patients with other conditions such as multiple sclerosis, cerebral palsy, Parkinson’s disease and elderly assistance. In 2019, we commercialized ourthe firstReStore productExo-Suit for stroke patients,rehabilitation. theWhile ReStorewe Exo-Suit.previously Wemarketed continuethis to sell the ReStoreproduct in themultiple US butmarkets, we ceased sales in the EUEuropean Union in May 2024.2024 and the product currently represents a limited portion of our business. For more information, see “Part, Item 1. Business—ReStore Products” above. While our Collaboration Agreement with Harvard for the design, research and develop lightweight exoskeleton system technologies for lower limb disabilities intended to treat stroke, multiple sclerosis, mobility limitations for the elderly and other medical applications successfully concluded on March 31, 2022, Harvard has licensed to us certain of its intellectual property relating to lightweight exoskeleton system technologies for lower limb disabilities. We are obligated to use commercially reasonable efforts to develop products under the license in accordance with an agreed-upon development plan and to introduce and market such products commercially.

WeOur expectfuture thatgrowth awill portiondepend on our ability to expand the adoption of our revenueexisting willReWalk beand derived,AlterG inproduct thelines nextand fewto years,successfully fromdevelop theand ReStore Exo-Suit product, othercommercialize new products utilizing DAP,and and, in later years, if we choose to advance the current designs, from other potential new products, such as ReBoot, a home use device for stroke patients, or new products aimed attechnologies addressing mobility other medical indications which affect the ability to walk, including multiple sclerosis, cerebral palsy, Parkinson’s disease and elderly assistance.impairments. As such, our future results will depend on our ability to successfully develop and commercialize such new products and to penetrate ourtargeted targeted rehabilitation and mobility markets with our existing ReStoreand productfuture in larger scale than we have done to date.products. We cannot ensure that we will be able to introduce new products, products currently under development or products contemplated for future development for additional indications in a timely manner, or at all, as it depends on our available resources to fund such projects, as well as our ability to conduct clinical trials and testing. While we receivedhave governmentalpreviously obtained regulatory clearance tofor marketcertain of our ReStore product on the anticipated timetable in 2019,products, obtaining clearance for any other products we may develop could be an extensive, costly, and time-consuming process, which could delay any planned commercialization timelines. For more information on the clearance processes for our products, see “Part I, Item 1. Business—Government Regulation” above.

While our new products currently under development will share some aspects of the core technology platform of our current products, their design features and components may differ from our current products. Accordingly, these products will also be subject to the risks described in the risk factor immediately below entitled “We rely primarily on sales of our ReWalk Personal Exoskeletons, AlterG Anti-Gravity systems, and ReStoreMyoCycle Exo-SuitsFES cycles and related service contracts and extended warranties for our revenue. We may not be able to achieve or maintain market acceptance of our ReWalk, AlterG, or ReStore products, or to generate sufficient sufficient revenue from these current and future products to sustain our operations.” To the extent we are unable to successfully develop and commercialize products beyond our existing commercial product portfolio, we will not meet our operating and financial objectives.

We rely primarily on sales of our ReWalk Personal Exoskeletons, AlterG Anti-Gravity systems, and MyoCycle FES cycles and related service contracts and extended warranties for our revenue. We may not be able to achieve or maintain market acceptance of our ReWalk, AlterG, or MyoCycle products or to generate sufficient revenue from these current and future products to sustain our operations.

We currently rely, and expect in the future to rely, on sales of our ReWalk Personal Exoskeletons, AlterG Anti-Gravity systems, MyoCycle FES cycles, and related consumables, services, and extended warranties for our revenue. WeIn began2019, marketingwe commercialized the ReStore lightweight soft exo-suit infor 2019stroke rehabilitation in the United States and the European E.U.Union (following the receipt of FDA clearance and CE mark ) to support mobility for individuals suffering from other lower limb disabilities.mark. We ceased sales of the ReStore in the EUEuropean Union in May 2024.2024, and the product currently represents a limited portion of our overall business. Several factors could negatively affect our ability to achieve and maintain market acceptance of our ReWalk, AlterG, or ReStore systems, which could in turn materially impair our business, financial condition, and operating results, as follows:

We obtained FDA de novo authorization for our ReWalk Personal Exoskeleton device in June 2014. FDA subsequently cleared 510(k) premarket notifications for modifications to the ReWalk, including for use of the ReWalk on curbs and stairs. In March 2025, the FDA granted 510(k) clearance for our ReWalk 7 next-generation personal exoskeleton system. This marketing authorization permits us to market the device for use by individuals with spinal cord injury at levels T7 to L5 to perform ambulatory functions in home and community settings with supervision of a specially certified companion, and for use by individuals in rehabilitation institutions with spinal cord injury at levels T4 to T6. We obtained FDA clearance for our ReStore system in June 2019. This clearance2019, which permits us to market the device to be used toin assist ambulatory functions in rehabilitation institutions under the supervision of a trained therapist to assist ambulatory functions for peopleindividuals with hemiplegia or hemiparesis due to stroke who canare able to ambulate at least 1.5 meters (5 feet) with no more than minimal to moderate assistance. levelsWhile the ReStore system remains cleared by the FDA, the product currently represents a limited portion of assistance.our business.

The NSCISC estimates according to its 2024 SCI Data Sheet that there are 305,000308,000 people in the United States living with SCI, with an annual incidence of approximately 18,000 new cases per year. Based on information from the 2023 annual report published by the NSCISC, 40% of the total U.S. population of SCI patients suffered injuries between levels T4 and L5. Four published ReWalk trials with respect to such eligible SCI patients had an aggregate screening acceptance rate of 50% considering all current FDA limitations, resulting in an estimated 20% of the total population of SCI patients being qualified candidates for current ReWalk products under its medical labeling criteria. There may be other permanent or short-term factors that affect the market size such as the ability to participate in the training program, the ability to use the device in the user’s current home environment as well as available companion support. With regardsrespect to our ReStore product for stroke rehabilitation, as the indicationdevice ofis indicated for use is currently in rehabilitation clinics our target market is based onunder the numbersupervision of currenttrained and futuretherapists. clinics who treat stroke patients. AlthoughWhile there are thousands ofnumerous inpatient, outpatient and rehabilitation clinics providing therapy in the U.S.United forStates example,that wetreat stroke patients, the ReStore product currently see that onlyrepresents a limited portion of theour clinics have decided to include ReStore in their stroke rehab program.business. For more information onregarding our expectationsproduct regardingportfolio theseand plans,market opportunities, see “Part I, Item 1. Business—Our future growthReWalk Personal and operatingReWalk resultsRehabilitation willProducts—Market depend on our ability to develop, receive regulatory clearance for and commercialize new products and penetrate new product and geographic markets” below.Opportunity. For more information regarding the potential market for future products, including our lightweight soft suit exoskeleton, see “Part I, Item 1. Business—ReWalk Personal and ReWalk Rehabilitation Products—Market Opportunity” above.

We may fail to secure or maintain adequate insurance coverage or reimbursement for our products by third-party payors, which risk may be heightened if insurers find the products to be investigational or experimental or if new government regulations change existing reimbursement policies. Additionally, such coverage or reimbursement, even if maintained, may not produce revenue that areis high enough to allow us to sell our products profitably.

Generally,In the United States, generally, private insurance companies in the United States do not cover or provide reimbursement for any medical exoskeleton products for personal use, including ReWalk Personal Exoskeleton, and may ultimately provide no coverage at all. Additionally, there is limited clinical data related to the ReWalk and ReStore systems, and third-party payors may consider use of them to be experimental and therefore refuse to cover any or all of them. Additionally, the majority of independent medical review decisions to date made following the denial of ReWalk coverage have determined that ReWalk is experimental and/or investigational, citing a lack of clinical data.

As described above, in the United States, many private third-party payors use coverage decisions and payment amounts determined by CMS as guidelines in setting their coverage and reimbursement policies. In July 2020, CMS issued a Healthcare Common Procedure Coding System Level II Code for ReWalk Personal Exoskeleton. These codes are used to identify medical products and supplies and to facilitate insurance claim submissions and processing for these items. On November 1, 2023, CMS issued Calendar Year 2024 Home Health Prospective Payment System Rule CMS-1780,Rule, which explicitly included exoskeletons within a Medicare brace benefit category, effective January 1, 2024. On April 11, 2024, CMS revised its April 2024 DMEPOS Fee Schedule to include a final lump-sum Medicare purchase fee schedule amount for personal exoskeletons (HCPCS code K1007) with an established rate of $91,032.$91,032, Theand finalunder the January 2026 DMEPOS fee schedule, the maximum ceiling amount for HCPCS code K1007 is $114,097, effective January 1, 2026. CMS established the initial payment determinationamount was made by CMS by applyingthrough a “gapgap-filling filling”methodology process, which was used in light of CMS determining that the code describingbecause the technology haslacked noa fee scheduleschedule-based pricing history and CMS concluded that lower extremitylower-extremity exoskeletons incorporatecould “revolutionary features” that cannotnot be adequately described byby, or considered comparable to any otherto, existing codecodes or combinationcombinations of codes. As part of gap-filling, CMS utilizes verifiable supplier or commercial pricing information and adjusts this pricing information according to a deflation and update factor methodology. In applying this formula to the K1007 code describing the ReWalk Personal Exoskeleton, CMS says that it calculated this final payment amount by averaging pricing information for exoskeleton devices from Lifeward and other manufacturers.

However, even with a positive coverage and reimbursement response from CMS regarding a product of ours, future action by CMS or other government agencies may diminish possible payments to physicians, outpatient centers and/or hospitals that purchase our products for use by their patients and possible payments to individuals who purchase the ReWalk Personal Exoskeleton for their own use. Additionally, a decision by CMS to provide reimbursement could influence other payors, including private insurers. IfThe existence of a HCPCS code, a Medicare benefit category, or a fee schedule amount does not guarantee favorable claim determinations, adequate payment levels, broad beneficiary access, or adoption by commercial payors, and if CMS declinesor toits providecontractors forimpose restrictive reimbursementspayment, ofdocumentation, or coverage conditions, our products or if its reimbursement price is lower than that of other payors, our products may not be reimbursed at a cost-effective level or at all. Those private third-party payors that do not follow the Medicare guidelines may adopt different coverage and reimbursement policies for purchase of our products or their use in a hospital or rehabilitative setting. In addition, we expect that the purchase of ReWalk Rehabilitation Exoskeleton systems and the ReStore system, as it is currently being sold for use in rehabilitative settings, will require the approval of senior management at hospitals or rehabilitation facilities, inclusion in the hospitals’ or rehabilitation facilities’ budget process for capital expenditures, and in the case of ReWalk Personal Exoskeleton, fundraising, and financial planning or assistance.

The design, manufacture and marketing of our products involve certain inherent risks. Manufacturing or design defects, unanticipated use of ReWalk, ReStore, or AlterG, or inadequate disclosure of risks relating to the use of our products can lead to injury or other adverse events. In addition, because the manufacturing of some of our products is outsourced to Sanmina,Cirtronics, the original equipment manufacturer of such products, we may not be aware of manufacturing defects that could occur. Such adverse events could lead to recalls or safety alerts relating to those products (either voluntary or required by the FDA or similar governmental authorities in other countries), and could result, in certain cases, in the removal of our products from the market. A recall could result in significant costs. To the extent any manufacturing defect occurs, our agreement with Sanmina Cirtronics contains a limitation on Sanmina’sCirtronics’s liability, and therefore we could be required to incur the majority of related costs. Product defects or recalls could also result in our inability to profitably grow our business due to parts shortages, increased field service demand, and inventory shortages, and the resulting negative publicity, customer dissatisfaction, damage to our reputation or, in some circumstances, delays in new product clearances or approvals.

When an exoskeleton is used by a paralyzed individual to walk, the individual relies completely on the exoskeleton to hold him or her upright. Between 2013 and 2021, we submitted medical device reports (“MDRs”) to the FDA (and equivalent authorities outside of the United States) relating to reports of falls and fractures of individuals using the ReWalk Personal Exoskeleton system. We conducted a voluntary correction related to certain use instructions in the device’s labeling, which the FDA classified as a Class II recall. The recall was closed in November 2019, and the FDA cleared our 510(k) containing revised instructions for use in May 2020. Since that time, we have submitted seveneight further MDRs.

In addition, our products incorporate sophisticated computer software and hardware. Complex software frequently contains errors, especially when first introduced. Our software may experience errors or performance problems in the future. If any part of our product’s hardware or software were to fail, the user could experience death or serious injury. For example, in 2021 ReWalk submitted medical device reportsMDRs to the FDA and medical device vigilance reports to the European regulatory authorities and initiated a correction in response to two complaints regarding battery thermal runaway events. The correction that includes clarification of previous instructions and additional information on battery operation and storage is closed in Europe and in the United States. ReWalk has separately initiated a design project to improve power management and battery operation during charge and discharge, and this projectdesign remainsimprovement was released in process.the ReWalk 7 Personal Exoskeleton. Additionally, users may not use or maintain our products in accordance with safety, storage, and training protocols, which could enhance the risk of death or injury. Any such occurrence could cause delay in market acceptance of our products, damage to our reputation, the need for additional regulatory filings, product recalls, increased service and warranty costs, product liability claims, and loss of revenue relating to hardware or software defects.

We depend on third-party suppliers to manufacture our ReWalk and AlterG products and we rely on a limited number of third-party suppliers for certain components of our products.

We have contracted with Sanmina and Cirtronics, each a well-established contract manufacturer with expertise in the medical device industry, for the manufacture of all our ReWalk and ReStore systems and our AlterG products, respectively,products and the sourcing of all of our components and raw materials for those products. We may terminate our relationship with Cirtronics through notice at least one year prior to the expiration of the initial term or renewal term of the contract. We may terminate our relationship with Sanmina at any time upon written notice. Either we, on the one hand, or Sanmina or Cirtronics, on the other hand, may terminate the respective relationship in the event of a material breach, subject to a 30-day cure period in the case of Sanmina or a 45-day period in the case of Cirtronics.period. For our business strategy to be successful, Cirtronics each of Sanmina and AlterG must be able to manufacture our products in sufficient quantities, in compliance with regulatory requirements and quality control standards, in accordance with agreed upon specifications, at acceptable costs and quality levels, and on a timely basis. Increases in our product sales, whether forecasted or unanticipated, could strain the ability of Sanmina or Cirtronics to manufacture an increasingly large supply of our current or future products in a manner that meets these various requirements. In addition, although we are not restricted from engaging an alternative manufacturer, and potentially have the capabilities to manufacture our products in-house, the process of moving our manufacturing activities would be time consuming and costly, and may limit our ability to meet our sales commitments, which could harm our reputation and could have a material adverse effect on our business. In the second quarter of 2025, we transitioned the manufacturing of our ReWalk products to our in-house manufacturer in an effort to reduce costs and provide us with more control over product quality. As a result, we terminated our agreement with Sanmina Corporation, an international contract manufacturer that manufactured our ReWalk products at its facility in Israel since 2013 and sourced the components and raw materials necessary for manufacturing. Moreover, the failure of either of Sanmina or Cirtronics to comply with applicable regulatory requirements could expose us to regulatory action including warning letters, product recalls, termination of distribution, product seizures or civil penalties.

We also rely on third-party suppliers, many of which contract directly with Sanmina and Cirtronics, to supply certain components of our products, and in some cases, we purchase these components ourselves. Neither Lifeward, Sanmina, Lifeward nor Cirtronics has long-term supply agreements with most of the suppliers and, in many cases, make purchases on a purchase order basis and our ability to secure adequate quantities of such products may be limited. Suppliers may encounter problems that limit their ability to manufacture components for our products, including financial difficulties or damage to their manufacturing equipment or facilities. If If Lifeward, Sanmina,Lifeward or Cirtronics fails to obtain sufficient quantities of high-quality components to meet demand on a timely basis, we could lose customer orders, our reputation may be harmed, and our business could suffer.

Our results of operations and liquidity could be adversely impacted by supply chain disruptions and operational challenges faced by our manufacturer or suppliers. Each of Sanmina and Cirtronics generally uses a small number of suppliers for the ReWalk products and the AlterG products, respectively.products. Depending on a limited number of suppliers exposes us to risks, including limited control over pricing, availability, quality, and delivery schedules. Such risks were heightened in light of the interruptions in supply chains and distribution networks related to the COVID-19 pandemic. For example, as a result of the COVID-19 pandemic, several components, mainly electronic parts, experienced price increases. If any one or more of our suppliers ceases to provide sufficient quantities of components in a timely manner or on acceptable terms, we, Sanmina,we or Cirtronics would have to seek alternative sources of supply or accept price increase increases as we saw during the pandemic. It may be difficult to engage additional or replacement suppliers in a timely manner. Failure of these suppliers to deliver products at the level our business requires would limit our ability to meet our sales commitments, which could harm our reputation and could have a material adverse effect on our business. The ability of these suppliers to perform is largely outside of our control. We, Sanmina,We or Cirtronics may also may have difficulty obtaining similar components from other acceptable suppliers, which could require Sanmina, Cirtronics, or us to cease using the components, seek alternative components or technologies and we could be forced to modify our products to incorporate alternative components or technologies, which could result in a requirement to seek additional regulatory clearances or approvals. Any disruption of this nature or increased expenses could harm our commercialization efforts and adversely affect our operating results.

Sanmina’s manufacturing and assembly of our ReWalk products pursuant to our specifications is conducted at a single facility in Ma’alot, Israel, and, starting in January 2025, Cirtronics’Cirtronics manufacturing and assembly of our AlterG products pursuant to our specifications is conducted at a single facility in Milford, New Hampshire. Accordingly, we are highly dependent on the uninterrupted and efficient operation of these facilities. If operations at either of these facilities were to be disrupted as a result of acts of war or terrorism, equipment failures, earthquakes and other natural disasters, fires, accidents, work stoppages, power outages, or other reasons such as a local shutdown as we experienced during the COVID-19 pandemic, our business, financial condition and results of operations could be materially adversely affected. In particular, Sanmina’s facility is located in the north of Israel within range of rockets that have from time to time been fired into the country during armed conflicts with Hezbollah and other armed groups in Lebanon, Syria or other countries in the region. For more information, see the risk factor below entitled “Risks Related to Our Incorporation and Location in Israel - Conditions in Israel, including Israel’s wars against Hamas and other terrorist organizations in the Gaza Strip and against Hezbollah on Israel’s northern border, may materially and adversely affect our business and results of operations.” Although our manufacturing and assembly operations could be transferred elsewhere, either in-house or to to alternative Sanmina or Cirtronics facilities, the process of relocating these operations would cause delays in production. Lost sales or increased costs that we may experience during the disruption, or a forced relocation, of operations may not be recoverable under our insurance policies, and longer-term business disruptions could result in a loss of customers. If this were to occur, our business, financial condition and operations could be materially negatively impacted. Additionally, our reliance on Sanmina and Cirtronics as a contract manufacturersmanufacturer or any other contract manufacturer makes us vulnerable to possible capacity constraints and reduced control over component availability, delivery schedules, manufacturing yields and costs.

We utilize independent distributors for the ReWalk and ReStoreAlterG products who are free to market other products that compete with ours.

While we expect that the percentage of our sales generated from independent distributors will decrease over time as we continue to focus our resources on achieving reimbursement within our direct markets in the United States and Europe, we believe that independent distributors of the ReWalk or ReStoreAlterG products will continue to be an important distribution channel for us in the future. None of our independent distributors has been required to sell our products exclusively. Our agreements with these distributors generally have one-year initial terms and automatic renewals for an additional year. If any of our key independent distributors of the ReWalk or ReStoreAlterG products were to cease to distribute our products, our sales could be adversely affected. In such a situation, we may need to seek alternative independent distributors or increase our reliance on our other independent distributors or our direct sales representatives, which may not prevent our sales from being adversely affected. Additionally, to the extent that we enter into additional arrangements with independent distributors to perform sales, marketing, or distribution services, the terms of the arrangements could cause our product margins to be lower than if we directly marketed and sold our products.

Sales of ReWalk systems generally include a five-year warranty for parts and services, other than for normal wear and tear. However, systems sold to customers reimbursed through CMS programs are typically provided with a two-year warranty. Some of our active devices were delivered prior to 2019 withincluded a two-year warrantywarranty, so we provideand these customers withhave the option to purchase an extended warranty for up to an additional three years. Our ReStore product offering includes a two-year warranty for parts and services.services, Theand AlterG Anti-Gravity systems are sold with a one-year factory warranty covering parts and services. If warranty claims, product returnsreturns, or warrantyservice claims are significant orrequirements exceed our expectations, we couldmay incur unanticipated expenditurescosts for parts and services, which could havematerially aadversely material adverse effect onaffect our operating results.

In order to increase our sales and our market share in the exoskeleton market, we are working to enhance and broaden our research and development efforts and product offerings in response to the evolving demands of people with paraplegia, paralysis, other medical conditions and healthcare providers, as well as competitive technologies. We are also currently involved in ongoing research and development efforts directed to the needs of patients with other mobility impairments, such as stroke, and began commercializing our ReStore product for stroke patients in 2019. We continue tocurrently market the device in the U.S.United States (EUon a limited basis, and sales in the European Union ceased in May 2024).2024. Depending on our future resources and business focus, we plan to address these needs in patients with other conditions or devices for stroke patients to be used at home, improving our current products, or developing products to address additional medical conditions such as multiple sclerosis, Parkinson’s disease or cerebral palsy and support elderly assistance. We may decide to invest our business development resources in partnerships, licensing agreements, business acquisition and other ways that will provide us new product offerings without significant research and development activities. We may not be successful in developing, obtaining regulatory approval for, or marketing our currently proposed products, or our approved products for additional indications, products proposed to be created in the future or products that will be available for us through business acquisitions. In addition, notwithstanding our market research efforts, our future products may not be accepted by consumers, their caregivers, healthcare providers or third-party payors who reimburse consumers for our products. The success of any proposed product offerings will depend on numerous factors, including our ability to:

From time to time, we may consider opportunities to acquire or license other products or technologies that may enhance our product platform or or technology, expand the breadth of our markets or customer base, or advance our business strategies. For example, as discussed above in “Part I. Item 1. Business - Overview”, on August 11, 2023, we completed the acquisition of AlterG which became an indirect and wholly-owned subsidiary of the Company.Company, and on February 19, 2026, we entered into an Intellectual Property Assignment and Technology Transfer Agreement with Skelable Ltd. to acquire certain assets, including certain intellectual property and related technology assets. Potential acquisitions involve numerous risks, including:

Recent political changes Changes in the United States could result in significant changes in,federal and uncertainty with respect to,state legislation, regulation, global trade, reimbursement policy, enforcement priorities, and government policy that could substantially impact our business and the medical device industry generally. Certain proposals, if enacted into law, could impose limitations on the prices we will be able to charge for our ReWalk system or any products we may develop and offer in the future, or the amounts of reimbursement available for such products from governmental agencies or third-party payors. Additionally, any reduction in reimbursement from Medicare or other government-funded federal programs, including the VHA, or state healthcare programs could lead to a similar reduction in payments from private commercial payors. The FDA’s policies may also change, and additional government regulations may be issued that could prevent, limit, or delay regulatory approval of our future products, or impose more stringent product labeling and post-marketing testing and other requirements.

We expect that changes or additions to the Medicare and Medicaid programs, changes allowing the federal government to directly negotiate drug pricesprograms and changes stemming from other healthcare reform measures, especially with regard to healthcare access, financing or other legislation in individual states, could have a material adverse effect on the healthcare industry industry.and on coverage, reimbursement, purchasing decisions, capital budgets, and demand for our products.

The Budget Control Act of 2011, among other things, created the Joint Select Committee on Deficit Reduction to recommend proposals in spending reductions to Congress. The Joint Select Committee did not achieve its targeted deficit reduction of an amount greater than $1.2 trillion for the fiscal years 2012 through 2021, triggering the legislation’s automatic reductions to several government programs. These reductions included aggregate reductions to Medicare payments to healthcare providers of up to 2% per fiscal year. The Bipartisan Budget Act of 2018 retained the federal budget “sequestration” Medicare payment reductions of 2% and extended it through 2031. Under the Consolidated Appropriations Acts of 2023 and 2024, the Medicare sequester percentage in FY2032 is scheduled to be 2% from April 1, 2032, through September 30, 2032, and 0% for October 1, 2032,2032 through March 31, 2032,2033, unless congressional action is taken. On January 2, 2013, the American Taxpayer Relief Act was signed into law, which, among other things, reduced Medicare payments to several types of providers, including hospitals, imaging centers, and cancer treatment centers, and increased the statute of limitations period for the government to recover overpayments to providers from three to five years. The 2022 Inflation Reduction Act, among other things, directs CMS to engage in price-capped negotiation for certain drugs and biologics that CMS reimburses under Medicare Part B and Part D, penalizes drug manufacturers that increase prices of Medicare Part B and Part D drugs at a rate greater than the rate of inflation, and redesigns the Part D drug benefit, effective in 2025.

Our products are regulated as medical devices in the United States under the Federal Food Drug, and Cosmetic Act, (“FFDCA”) as implemented and enforced by the FDA. Under the FFDCA, medical devices are classified into one of three classes (Class I, Class II or Class III) depending on the degree of risk associated with the medical device, what is known about the type of device, and the extent of control needed to provide reasonable assurance of safety and effectiveness. Classification of a device is important because the class to which a device is assigned determines, among other things, the necessity and type of FDA review required prior to marketing the device. For more information, see “Part I, Item 1. Business-Government Regulation” above.

In June 2014, the FDA granted our request for “de novo” classification, which provides a route to market for medical devices that are low to moderate risk, but are not substantially equivalent to a predicate device, and classified ReWalk as Class II powered exoskeleton device subject to certain special controls. In March 2023 the FDA granted 510(k) clearance for the ReWalk Personal Exoskeleton with stair and curb functionality, which adds usage on stairs and curbs to the indication for use for the device in the U.S. In March 2025 we received 510(k) clearance from FDA for the ReWalk 7 Personal Exoskeleton, a next-generation ReWalk model. The ReWalk is intended to enable individuals with spinal cord injuries to perform ambulatory functions under supervision of a specially trained companion, indoor and inside rehabilitation institutions.outdoor. The special controls established in the de novo order for all powered exoskeletons include the following: clinical testing to demonstrate safe and effective use considering the level of supervision necessary and the use environment; non-clinical safety and performance testing, including durability testing to demonstrate that the device performs as intended under anticipated conditions of use; a training program; and labeling related to device use and user training. In order for us to market ReWalk, we must comply with both general controls, including controls related to quality, facility registration, reporting of adverse events and labeling, and the special controls established for the device. Failure to comply with these requirements could lead to an FDA enforcement action, which would have a material adverse effect on our business.

In the E.U. we are subject to regulations and standards regulating the design, manufacture, clinical trials, labeling and adverse event (i.e., vigilance) reporting for medical devices. The Medical Devices Regulation (EU) 2017/745 (MDR) became fully applicable on May 26, 2021, repealing and replacing the pre-existing E.U. Medical Devices Directive 93/42/EEC.EEC, MDD. Devices that comply with the requirements of the MDR, subject to certain transitional provisions that allow continued compliance of certain products to the Directive,MDD, are entitled to bear the CE mark, indicating that the device conforms to the essential requirements of the MDR and, accordingly, can be commercially distributed throughout the European Economic Area (i.e., the E.U. Member States plus Norway, Iceland, and Lichtenstein). We comply with the E.U. requirements and have received the CE mark for our allReStore device under the MDD and because the ReStore was not planned for MDR conformity, we ceased sales of the ReStore in the E.U. in May 2024. For our ReWalk Systems, we received MDR certification for the ReWalk 7 Personal Exoskeleton device in September 2025. Prior models of our ReWalk systemssystem includingare CE marked under the ReStoreMDD deviceand whichcontinue areto distributedbe placed on the EU market in compliance with the E.U.MDR transitional provisions. As compared with the Directive,MDD, the MDR includes additional premarket and post-market requirements, as well as potential product reclassifications and more stringent commercialization requirements that could adversely affect our CE mark. Failure to comply with these new requirements could lead to substantial penalties, including fines, revocation or suspension of the CE mark and criminal sanctions. Because the ReStore was not planned for MDR conformity, we ceased sales of the ReStore in the EU in May 2024.

Following the introduction of a product,product to a particular market, the competent governmental agencies in that market (and/or Notified Bodies in the E.U.) will periodically inspect our manufacturing processes and quality controls, and we are under a continuing obligation to ensure that all applicable regulatory requirements continue to be met. The process of complying with the applicable good manufacturing practices, adverse event reporting and other requirements can be costly and time consuming, and could delay or prevent the production, manufacturing, or sale of our devices. In addition, if we fail to comply with applicable regulatory requirements, it could result in fines, closure of manufacturing sites, seizures or recalls of products and damage to our reputation, as well as enforcement actions against us. For example, the FDA could request that we recall our ReWalk Personal Exoskeleton or ReStore device in case of product defects or require us to conduct post-market surveillance studies. If we fail to recall the device and/or conduct requested post-market surveillance studies to FDA’s satisfaction, we could be subject to FDA enforcement action.

In addition, governmental agencies may impose new requirements regarding registration or labeling that may require us to modify or re-register our our products or otherwise impact our ability to market our products in those countries, such as the May 2021 Medical Device Regulation changes in the European Union.countries. The process of complying with these governmental regulations can be costly and time consuming,time-consuming, and could delay or prevent the production, manufacturing, or sale of our products.

If we or our third-party manufacturers fail to comply with the FDA’s Quality Management System Regulation, or QSR,QMSR, our manufacturing operations could be interrupted.

We and our contract manufacturers, Sanmina and Cirtronics, are required to comply with the FDA’s QSRQMSR which covers the methods and documentation of the design, testing, production, control, quality assurance, labeling, packaging, sterilization, storage, and shipping of our products. InThe QMSR became effective in February 2024,2026 and amended the FDAQSR. issuedThe theQMSR Quality Management System Regulation Final Rule to amend the QSR, incorporatingincorporates by reference the international standard for medical device quality management systems set by the International Organization for Standardization (ISO), ISO 13485:2016. The rule will become effective on February 2, 2026. Until then, manufacturers are required to comply with the QSR. We, Sanmina, Cirtronics and our suppliers are also subject to the regulations of foreign jurisdictions regarding the manufacturing process if we or our distributors market our products abroad. We actively maintain compliance with the FDA’s QSR,QMSR, and the European Union’s Quality Management Systems requirements, ISO 13485:2016. We continue to monitor our quality management to maintain our overall level of compliance. Our facilities are subject to periodic and unannounced inspection by U.S. and foreign regulatory agencies to audit compliance with the QSRQMSR and comparable foreign regulations. If our facilities or those of Sanmina of Cirtronics or our suppliers are found to be in violation of applicable laws and regulations, or if we, Sanmina, Cirtronics or our suppliers fail to take satisfactory corrective action in response to an adverse inspection, the regulatory authority could take enforcement action, including any of the following sanctions:

The FCPA applies to U.S. companies, including companies like ours that are issuers of a class of securities registered under the Exchange Act. The FCPA and other global and local anti-bribery laws which apply to various aspects of our operations generally prohibit companies and their directors, officers, employees, agents, and other intermediaries from, directly or indirectly, authorizing, promising, offering, providing, or making improper payments or giving anything else of value to government officials for the purpose of obtaining or retaining an unfair business advantage. The FCPA also requires issuers to make and keep books and records that accurately and fairly reflect the transactions of the corporation and to devise and maintain an adequate system of internal accounting controls.controls sufficient to assure management’s control, authority, and responsibility over the company's assets. In various jurisdictions, our operations require us and third parties acting on our behalf to routinely interact with government officials, including medical personnel who may be considered government officials for purposes of these laws because they are employees of state-owned or controlled facilities.laws. Other applicable anti-bribery laws, including the U. K. Bribery Act, also prohibit improper payments to private parties and prohibit the receipt of improper payments. Our policies mandate compliance with applicable anti-bribery laws and prohibit our employees and third parties we engage from offering, making or receiving corrupt payments. We have also implemented a robustan anti-corruption compliance program to mitigate the risk of violations of anti-bribery laws relating to our international operations. However, our program cannot eliminate all risk that unauthorized improper acts have been or will be committed by our employeesemployees, agents, or agents.other third parties acting on our behalf. Violations of anti-bribery laws, or allegations of such violations, could result in civil or criminal sanctions or other adverse adverse consequences, including disruption of our business and harming our financial condition, results of operations, cash flows and reputation.

There are a number of federal, state and foreign laws protecting the confidentiality of certain patient health information, including patient records, and restricting the use and disclosure of that protected information. In particular, the U.S. Department of Health and Human Services, or HHS, promulgated patient privacy rules under HIPAA. These privacy rules protect medical records and other personal health information by limiting their use and disclosure, giving individuals the right to access, amend and seek accounting of their own health information and limiting most use and disclosures of health information to the minimum amount reasonably necessary to accomplish the intended purpose. Additionally, the E.U. General Data Protection Regulation (the “EU GDPR”) and the E.U. Member State laws, imposesalong with the data protection laws in the United Kingdom (as specified below), impose more stringent data protection requirements and provides for penalties for noncompliance. Additionally, if we or any of our service providers are found to be in violation of the promulgated patient privacy rules under HIPAA orHIPAA, the EU GDPR andGDPR, E.U. Member State laws, or UK data protection laws, we could be subject to civil or criminal penalties, which could be substantial and could increase our liabilities, harm our reputation and have a material adverse effect on our business, financial condition and operating results.

Furthermore, in the EEA, the NIS 2 Directive (“NIS 2”) is replacing the cybersecurity legal framework under the current NIS framework, aiming to ensure a high level of cybersecurity in the region. NIS 2 brings new medium and large organisationsorganizations providing services in the EEA within scope of the legal framework. It extends to additional sectors and expands the list of in-scope healthcare organisations,organizations, including to certain providers engaged in research and development of medicinal products. The new regime imposes direct obligations on management in respect of an in-scope organization's compliance with NIS 2, requires covered organisationsorganizations to put in place certain cyber risk management measures, strengthens incident reporting requirements and provides supervisory authorities with a greater oversight. The majority of obligations will come into force when national legislation implementing NIS 2 becomes effective in the relevant EU Member State. EU Member States had until 17 October 2024 to transpose NIS 2 into national legislation, although many countries have still not completed the transposition. As such, the cybersecurity regulatory landscape in the EU is currently fragmented and uncertain. To the extent we are subject to NIS 2, we will require additional investment of our resources in compliance programs. Under NIS 2 companies may be subject to administrative fines of up to the higher amount of €10 million or 2% of worldwide turnover.

We may useintegrate and integrateuse artificial intelligence into(“AI”) in our products, operations and business processes. For example, we have developed a prototype with integrated advanced sensing technologies and AI to enable autonomous decision making. Use of this technology presents risks and challenges that could affect our business.business If we enable or use solutions that draw controversy due to perceived or actual negative societal impact,and we may experience brand or reputational harm, competitive harm or legal liability.

Likewise, in the U.S., several states, including Colorado and California, passed laws that are in effect or will take effect in 2026, to regulate various uses of artificial intelligence, including to make consequential decisions. In addition, various federal regulators have issued guidance and focused enforcement efforts on the use of AI in regulated sectors. The U.S. Food and Drug Administration,FDA, for example, issued guidance on the use of artificial intelligence in medical devices, requiring detailed risk management and review processes to obtain approvals. IfOur wedevelopment develop orand use of AI systems governed by these laws or regulations, weregulations will need to meet higher standards of data quality, transparency, monitoring and human oversight, and we would need to adhere to specific and potentially burdensome and costly ethical, accountability, and administrative requirements, with the potential for significant enforcement or litigation in the event of any perceived non-compliance. We cannot predict the ultimate content, timing, or effect of any new regulatory requirements or guidance, and failure to obtain or maintain required regulatory clearances or approvals, or to comply with applicable regulatory requirements, could result in enforcement actions, injunctions, civil or criminal penalties, and may materially adversely affect our ability to commercialize AI-enabled products and our financial condition and results of operations.

The rapid evolution of artificial intelligence will require the application of significant resources to design, develop, test and maintain such systems to help ensure that artificial intelligence is implemented in accordance with applicable law and regulation and in a socially responsible manner and to minimize any real or perceived unintended harmful impacts. TheFurthermore, useour of certainexisting competitors and emerging players may outpace us in implementing advanced artificial intelligence technologies canthat also give rise to intellectual property risks, including by disclosing or otherwise compromising our confidential or proprietary intellectual property, or by undermining our ability to assert or defend ownership rights in intellectual property createdcomply with theevolving assistanceregulatory of artificial intelligence tools.standards.

We are a medical device company that designs, develops, and commercializes life-changing solutions that span the continuum of care in physical rehabilitation and recovery, delivering proven functional and health benefits in clinical settings as well as in the home and community. Our initial product offerings were the ReWalk Personal and ReWalk Rehabilitation Exoskeleton devices for individuals with spinal cord injury (“SCI Products”). These devices are robotic exoskeletons that are designed for individuals with paraplegia that use our patented tilt-sensor technology and an onboard computer and motion sensors to drive motorized legs that power movement. These SCI Products allow individuals with spinal cord injury (“SCI”) the ability to stand and walk again during everyday activities at home or in the community. In March 2023, we received clearance of our premarket notification (“510(k)”) from the U.S. Food and Drug Administration (“FDA”) for the ReWalk Personal Exoskeleton with stair and curb functionality, which adds usage on stairs and curbs to the indication for use for the device in the U.S. The clearance permits U.S. customers to participate in more walking activities in real-world environments in their daily lives where stairs or curbs may have previously limited them when using the exoskeleton for its intended, FDA-indicated uses. This feature has been available in Europe since initial CE Clearance, and real-world data from a cohort of 47 European users throughout a period of over seven years consisting of over 18,000 stair stepssteps, waswere collected to demonstrate the safety and efficacy of this feature and support the FDA submission. In JuneMarch 2024,2025, we submitted to the FDA areceived 510(k) premarketclearance notificationfrom the U.S. Food and Drug Administration (“FDA”) for the ReWalk 7 Personal Exoskeleton device, a next-generation ReWalk model, and such 510(k) is pending FDA review.model.

We have sought to expand our product offerings beyond the SCI Products through internal development, distribution agreements, and acquisitions. We have developed our ReStore Exo-Suit device, which we began commercializing in June 2019 (we ceased sales in the EU in May 2024).2019. The ReStore is a powered, lightweight soft exo-suit intended for use during the rehabilitation of individuals with lower limb disabilities due to stroke. Sales of the device in the European Union ceased in May 2024. In the second quarter of 2020, we finalizedsigned andan movedagreement to implement two separate agreements to distribute additional product lines in the United States, one of which we later discontinued. We arebecome the exclusive distributor of the MYOLYN MyoCycle FES Pro cycles to U.S. rehabilitation clinics and for the MyoCycle Home cycles available to U.S. veterans through the Veterans Health Administration (“VHA”) hospitals. We continue to distribute these products; however, our distribution rights are no longer exclusive.

In August 2023, we made our first acquisition to supplement our internal growth when we acquired AlterG, a leading provider of Anti-Gravity systems for use in physical and neurological rehabilitation. We paid a cash purchase price of approximately $19 million at closingclosing. andThe purchase agreement also provided for the potential of additional cash earnout payments may be paid based upon a percentage ofon AlterG’s revenue growth over the two years following the closing.closing; however, no earnout payments were earned. The AlterG Anti-Gravity systems use patented, National Aeronautics and Space Administration (“NASA”) derived differential air pressure (“DAP”) technology to reduce the effects of gravity and allow patients to rehabilitate with finely calibrated support and reduced pain. AlterG Anti-Gravity systems are utilized in over 4,0006,000 facilities globally in more than 40 countries. We will continue to evaluate other products for distribution or acquisition that can broaden our product offerings further to help individuals with neurological injury and disability.

In March 2025, we announced an agreement to increase our penetration of SCI Products into the workers’ compensation market in whichwith CorLife, LLC., a Delaware limited liability company (“CorLife”) and a division of Numotion, the nation’s leading and largest provider of products and services that provide mobility, health and personal independence.independence, to increase our penetration of SCI Products into the workers’ compensation market. Pursuant to the agreement, CorLife became the exclusive distributor for the ReWalk Personal Exoskeleton for individuals with workers’ compensation claims. The agreement leverages CorLife’s extensive network of credentialed providers and experts to include the ReWalk Personal Exoskeleton among the services and equipment they provide to thousands of injured workers each year. Under the agreement, the CorLife reimbursement team manages all workers’ compensation claims submissions for the ReWalk Personal Exoskeleton. We believe this agreement will build awareness of the benefits of the ReWalk Personal Exoskeleton among individuals with workers’ compensation coverage and gain us access to the resources of CorLife to facilitate efficient processing of claims.

Our principal markets are primarily in the United States and Europe with some lesser sales in Asia, the Middle East and South America. We sell our products primarily directly in the United States, through a combination of direct sales and distributors (depending on the product line) in Germany and Canada, and primarily through distributors in other markets. In markets where we sell direct to consumers, we have established relationships with clinics and rehabilitation centers, professional and college sports teams, and individuals and organizations in the SCI community, and in markets where we do not sell direct to consumers, our distributors maintain these relationships. We have primary offices in Yokneam, Israel, Marlborough,Hudson, Massachusetts, and Berlin, Germany. We also had offices in Fremont, California and Queens, New York where we ceased operations as of December 31, 2024.

We have in the past generated and expect to generate in the future revenue from a combination of clinics and rehabilitation centers, commercial distributors, third-party payors (including private and government payors), professional and college sports teams, and self-pay individuals. While a broad uniform policy of coverage and reimbursement by third-party commercial payors currently does not exist in the United States for exoskeleton technologies such as the ReWalk Personal Exoskeleton, we are pursuing various paths of reimbursement and support fundraising efforts by institutions and clinics,reimbursement, such as the VHA policy that was issued in December 2015 for the evaluation, training, and procurement of ReWalk Personal Exoskeleton systems for all qualifying veterans living with SCI across the United States.

We have also been pursuing updatesengaged with the CMS to clarifyregarding the Medicare coverage category (i.e., benefit category)framework applicable forto personal exoskeletons. In 2022,2024, the National Spinal Cord Injury Statistical Center (“NSCISC”), which maintains the world’s largest database on spinal cord injury research, reported that CMS is the primary payor for approximately 57% of the SCI population whichthat areis at least five years post their injury date,post-injury, with Medicare representing a majority of this percentage. In July 2020, following a successful submission and hearing process, a code was issued for ReWalk Personal Exoskeleton, which may be used for purposes of claim submission to Medicare, Medicaid, and other payors.

On November 1, 2023, CMS released the Calendar Year 2024 Home Health Prospective Payment System Final Rule, CMS-1780-F (“Final Rule”), which was adopted through the notice and comment rulemaking process. The Final Rule includes a policy confirming that personal exoskeletons are included in the Medicare brace benefit category, as of January 1, 2024. Medicare personal exoskeleton claims with dates of service on or after January 1, 2024 that are billed using HCPCS code K1007 are assigned to the brace benefit category. CMS reimburses items classified under the brace benefit category using a lump sumlump-sum payment methodology.

On April 11, 2024, CMS revised its April 2024 Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (“DMEPOS”) Fee Schedule to include a final lump-sum Medicare purchase fee schedule amount for personal exoskeletons (HCPCS code K1007) with an established rate of $91,032. TheCMS finaldetermined this payment determinationrate was made by CMS by applyingusing a “gap fillinggap-filling” process,methodology, which wasis usedapplied inwhen light of CMS determining that the code describing thea technology has no prior fee schedule pricing history and that lower extremity exoskeletons incorporate “revolutionary features” that cannot be described by or considered comparable to any other existing code or combination of codes. As part of gap-filling, CMS utilizes verifiable supplier or commercial pricing information and adjusts this pricing information according to a deflation and update factor methodology.history. In applying this formula toestablishing the K1007 code describing the ReWalk Personal Exoskeleton, CMS says that it calculated this final payment amount byfor averagingHCPCS code K1007, CMS considered available pricing information for exoskeleton devices from Lifeward and other manufacturers.

We currently rely, and in the future will rely, on sales of our ReWalk Personal Exoskeletons, AlterG Anti-Gravity systems, MyoCycle FES cycles, and related consumables, services, and extended warranties for our revenue. Our revenue is derived from a combination of third-party payors, including private and government employers, institutions, and self-payors. Payments for our products by third party payors have been made primarily through case-by-case determinations. Third-party payors include, without limitation, private insurance plans, workers’ compensation programs, managed care organizations, and government programs including the VHA and Medicare. We expect that third-party payors will be an increasingly important source of revenue in the future as we increase the volume of sales of ReWalk Personal systems to Medicare-eligible beneficiaries following establishment of a benefit category and pricing. In December 2015, the VHA issued a national policy for the evaluation, training, and procurement of ReWalk Personal Exoskeleton systems for all qualifying veterans across the United States. The VHA policy is the first national coverage policy in the United States for qualifying individuals who have suffered spinal cord injury.

For our AlterG systems, ReWalk, which we manufacturedbegan manufacturing at our facility in Fremont,Yokneam, CaliforniaIsrael untilin DecemberApril 31,2024,2025, cost of revenue consists primarily of raw materials, direct labor, including wages and related benefits for employees directly engaged in the manufacturing process, as well as indirect labor, labor and other factory overhead costs such as rent and utilities. In addition, cost of revenue also includes field service costs, shipping expenses and reserves for warranty and inventory condition.

For our certainAlterG productssystems, thatwhich we distributed,manufactured suchat asour thefacility MyoCyclein andFremont, MeditouchCalifornia productuntil lines,December 31, 2024, cost of revenue consists primarily of completeraw systemsmaterials, purchaseddirect fromlabor, theindirect manufacturers.labor, and other factory overhead costs such as rent and utilities. In addition, the cost of revenue also includes field service costscosts, shipping expenses, and shippingreserves expenses.for warranty and inventory condition.

Our gross profit and gross margin (defined as gross profit as a percentage of revenue) are influenced by a number of factors, including the volume and price of our products sold, fluctuations in the mix of products sold, and variability in our cost of revenue. We expect that gross profit and gross margin will expand in the future as we increase our revenue volumes and realize operating efficiencies associated with greater scale which will reduce the cost of revenue as a percentage of revenue.

Research and development expenses, net consist primarily of salaries and related personnel costs including share-based compensation, supplies, materials, and consulting expenses associated with to product design and development, clinical studies, regulatory submissions, patent costs, sponsored research and other related activities. We expense all research and development expenses as they are incurred.

Our sales and marketing expenses consist primarily of salaries and related personnel costs including share-based compensation for sales, sales support, marketing, and reimbursement relatedand market access activities, travel, marketing, advertisement,advertising, tradeshows and conferences, lobbying, and public relations activities.

Financial (Expeses) Expenses (Income),Income, Net

Financial income and expenses consist primarily of bank commissions, foreign exchange gains and losses, interest income earned on investments in short-term shortdeposits, terminterest depositsexpense on our outstanding borrowings, and royaltychanges income.in the fair value of derivative liabilities associated with our loan arrangements.

Interest income consists of interest earned on our cash and cash equivalent balances. Interest expense consists primarily of interest accrued on,on our outstanding borrowings and certain other costs associated with respect to anysuch indebtedness. Changes in the fair value of derivative liabilities reflect the periodic remeasurement of derivatives embedded in or associated with our loan agreements. Foreign currency exchange changes reflect gains or losses related to transactions denominated in currencies other than the U.S. dollar.

Our taxable income generated outside of Israel will be subject to the regularapplicable corporate tax raterates in the applicablethose jurisdictions. As a result, Accordingly, our effective tax rate will bedepend a function ofon the relativegeographic proportiondistribution of our taxable income that is generated in those locations compared to our overall net income.

From our inception through December 31, 2024,2025, we have received a total ofapproximately $2.8 million in funding from the IIA, $1.6 million of which are royalty-bearing grants, $400 thousand were received in consideration for an investment in our preferred shares while $806 thousand was received without future obligation. Of the royalty-bearing grants received, we have paid royalties to the IIA in the total amount of $114$117 thousand. The agreements with IIA require us to pay royalties at a rate of 3% on sales of certain systems and related services up to the total amount of funding received for the development of these systems, linked to the dollar, and bearing interest at an annual rate of SOFRPR applicable to dollar deposits. If we transfer IIA-supported technology or know-how outside of Israel, we will be liable for additional payments to IIA depending upon the value of the transferred technology or know-how, the amount of IIA support, the time of completion of the IIA-supported research project and other factors. As of December 31, 2024, the aggregate contingent liability to the IIA was $1.6 million. For more information, see “Part I, Item 1A. Risk Factors-We have received Israeli government grants for certain of our research and development activities and we may receive additional grants in the future. The terms of those grants restrict our ability to manufacture products or transfer technologies outside of Israel and we may be required to pay penalties in such cases or upon the sale of our company.”

In March 2026, we closed the previously announced acquisition of all of the outstanding equity interests of Oratech.Oratech from Oramed. In connection with the transaction, we will develop ORMD-0801, an oral protein delivery technology. We are advancing preparations for a planned Phase 2 trial for ORMD-0801.

FirstSecond Quarter 2026 Business Highlights

Results of Operations for the Three Months Ended March 31, 2026 and March 31, 2025 Our operating results for the three and six months ended MarchJune 31,30, 2026, as compared to the same period in 2025, are presented below. The results set forth below are not necessarily indicative of the results to be expected in future periods.

Three and Six Months Ended MarchJune 31,30, 2026 Compared to Three and Six Months Ended MarchJune 31,30, 2025

Our revenue for the three and six months ended MarchJune 31,30, 2026 and 2025 was as follows (in thousands):

Revenue was $3.9$6.6 million during the three months ended MarchJune 31,30, 2026, aan decreaseincrease of $1.1$0.9 million, or 22%,16%, compared to the three months ended MarchJune 31,30, 2025. The decreaseincrease was primarily attributabledriven toby a decrease inhigher AlterG revenue of approximately $1.3$0.8 million, mainlyprimarily duereflecting to lowerhigher unit shipments in the U.S.U.S., together with increased service revenue and internationallyimproved resultingaverage fromselling timingprices. issuesThis associatedincrease withalso workingreflected capitalhigher constraintsReWalk impactingrevenue, sourcingprimarily driven by stronger sales in Europe, and supply chain activities. The decline was partially offset by increased ReWalkCMS revenue.

Our gross profit for the three and six months ended MarchJune 31,30, 2026 and 2025 was as follows (in thousands):

Gross profit was $1.3$2.7 million, or 34.2%40.9% of revenue, for the three months ended MarchJune 31,30, 2026, compared to $2.1$2.5 million, or 42.2%43.9% of revenue, for the three months ended MarchJune 31,30, 2025. The decrease in gross margin was primarily attributable to lower sales volumes and the resulting lower absorption of fixed manufacturing overhead, as well as higher tariffs andadverse foreign exchange rate fluctuations.fluctuations, revenue sharing expense related to Oramed transaction and higher tariffs.

We expect gross profit and gross margin to improve over time as higher revenue volumes increase,improve the absorption of fixed manufacturing overhead isand absorbed over a larger revenue base, andas we continue to realize operational efficiencies and cost reduction initiatives.

Our research and development expenses, net, for the three and six months ended MarchJune 31,30, 2026 and 2025 were as follows (in thousands):

Research and development expenses were $5.8$1.8 million for the three months ended MarchJune 31,30, 2026, an increase of $4.9$1.0 million, compared to the three months ended MarchJune 31,30, 2025. The increase was primarily attributable to aapproximately one-time$0.7 acquired IPR&D chargemillion of approximatelyclinical $4.9trial millionand CRO service costs related to the Oratech clinical trial, together with higher development costs related to the AlterG project and development activities associated with the Skelable technology following its acquisition.

Our sales and marketing expenses for the three and six months ended MarchJune 31,30, 2026 and 2025 were as follows (in thousands):

Sales and marketing expenses were $3.3$3.5 million for the three months ended MarchJune 31,30, 2026, a decrease of $0.6$0.3 million, or 15%,7%, compared to the three months ended MarchJune 31,30, 2025. The decrease was primarily reflectsattributable improvedto productivityreduced spending on commercial and efficiencyreimbursement-related inactivities, marketinglower personnel-related expenses, and sales operations, as well as lower reimbursementspending andon marketingtrade consultant expenses.shows.

Our general and administrative expenses for the three and six months ended MarchJune 31,30, 2026 and 2025 were as follows (in thousands):

General and administrative expenses were $2.6$1.6 million for the three months ended MarchJune 31,30, 2026, ana increasedecrease of $0.3$0.2 million, or 16%,9%, compared to the same period in 2025. The increasedecrease was primarily attributable to approximatelylower $0.6personnel-related millioncosts and professional services expenses and the absence of one-timebad professionaldebt andexpense legalrecognized expensesin the prior-year period, partially offset by the absence of a benefit related to the strategicelimination transaction and related financing activities. Excluding these expenses, general and administrative expenses decreased compared toof the sameearnout periodliability in 2025.the prior-year period.

Our financial expense (income), net, for the three and six months ended MarchJune 31,30, 2026 and 2025 were as follows (in thousands):

Financial expense (income), net, increased by $0.5$7.4 million, for the three months ended MarchJune 31,30, 2026, compared to the three months ended MarchJune 31,30, 2025. The increase was primarily attributable to interestnon-cash expensefair recognizedvalue changes in connectionwarrant and derivative liabilities associated with the convertibleCompany's notefinancing transaction,transactions partially offset byand the fairOratech value change of a derivative component,acquisition, as well as lower interest incomeexpense duerelated to reducedthe cashCompany's balancesconvertible and unfavorable foreign currency exchange rate fluctuations.notes.

Our income tax for the three and six months ended MarchJune 31,30, 2026 and 2025 was as follows (in thousands):

Income taxes decreasedincreased by $5$10 thousand, for the three months ended MarchJune 31,30, 2026, compared to the three months ended MarchJune 31,30, 2025, primarily due to lowerhigher taxable income in onea foreign jurisdiction.

As of MarchJune 31,30, 2026, we had cash and cash equivalents of $11.4$9.4 million. We had an accumulated deficit in the total amount of $295.5$307.1 million as of MarchJune 31,30, 2026 and further losses are anticipated in the development of our business. Those factors raise substantial doubt about our ability to continue as a going concern. The ability to continue as a going concern is dependent upon us obtaining the necessary financing to meet our obligations and repay our liabilities arising from normal business operations when they come due.

The accompanying unaudited condensed consolidated financial statements have been prepared assuming we will continue as a going concern, which contemplates the realization of assets and liabilities and commitments in the normal course of business. The consolidated financial statements for the three and six months ended MarchJune 31,30, 2026 do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classification of liabilities that may result from uncertainty related to our ability to continue as a going concern.

In connection with the transaction, we received bridge financing from Oramed. On November 14, 2025, we entered into a Secured Promissory Note (the “Original Note ”) with Oramed Ltd., pursuant to which we issued to Oramed Ltd. a secured promissory note in the principal amount of $3.0 million. The loan bears interest at a rate of 15% per annum, is secured by a lien on our cash, and matures on May 14, 2026.

Cash Flows for the ThreeSix Months Ended MarchJune 31,30, 2026 and 2025 (in thousands):

Net cash used in operating activities decreasedincreased by $1.8$0.3 million, or 33%,3%, for the threesix months ended MarchJune 31,30, 2026, compared to the threesix months ended MarchJune 31,30, 2025. The decrease wasincrease primarily attributablereflected tochanges improvedin working capitalcapital, managementincluding higher trade receivables and higherprepaid cashexpenses collectionsand fromother customers,assets, partially offset by increasedhigher inventorytrade levels.payables and other liabilities.

Net Cash provided by (used in) Investing Activities

Net cash provided by investing activityactivities increased by $6.5 million, primarily due to cash acquired in connection with the Oratech acquisition.

Net cash provided by financing activities increased by $2.0$2.7 million for the threesix months ended MarchJune 31,30, 2026, compared to the threesix months ended MarchJune 31,30, 2025. Financing activities during the 2026 period primarily reflected proceeds from the OramedCompany's financing transactions, including the issuance of additional convertible notenotes transaction,and cash received in connection with the June Securities Purchase Agreement prior to its closing on July 6, 2026, while the comparable prior-year period primarily reflected proceeds from the Company’sCompany's Januaryregistered 2025direct offering, at-the-market offering, and public offering.

Set forth below is a summary of our contractual obligations as of MarchJune 31,30, 2026.

We calculated the payments due under our operating lease obligation for our Israeli office that are to be paid in NIS at a rate of exchange of NIS 3.1652.979: $1.00, and the payments due under our operating lease obligation for our German subsidiary that are to be paid in euros at a rate of exchange of €1.00: $1.148, both of$1.00 which were the applicable exchange rates as of MarchJune 31,30, 2026 .

We had no off-balance sheet arrangements or guarantees of third-party obligations as of MarchJune 31,30, 2026.