Lifeward Ltd.

Square feet (approximate)

Hudson, Massachusetts · 16,335

Yokneam, Israel · 11,500

Berlin, Germany · 950

Total · 28,785

We believe our facilities are adequate and suitable for our current needs.

• Defects in our products or the software that drives them could adversely affect the results of our operations.
• If we are unable to leverage our sales, marketing, and training infrastructure we may fail to increase our sales.
• The potential health benefits of our ReWalk products have not been substantiated by long-term clinical data, which could limit sales of such products.
• We depend on third-party suppliers to manufacture our AlterG products and we rely on a limited number of third-party suppliers for certain components of our products.
• We operate in a competitive industry that is subject to rapid technological change, and we expect competition to increase.
• We utilize independent distributors for the ReWalk and AlterG products who are free to market other products that compete with ours.
• We may receive a significant number of warranty claims or our ReWalk, AlterG, or ReStore systems may require significant amounts of service after sale.
• We may not be able to enhance our exoskeleton product offerings through our research and development efforts.
• We may enter into collaborations, in-licensing arrangements, joint ventures, strategic alliances, business acquisitions or partnerships with third parties that may not result in the development of commercially viable products or the generation of significant future revenue.
• We may seek to grow our business through acquisitions of businesses, products or technologies, and the failure to manage acquisitions, or the failure to integrate them with our existing business, could have a material adverse effect on our business, financial condition, and operating results.
• Risks Related to Government Regulation
• Although the FDA granted Breakthrough Device Designation status to our ReBoot device, this designation does not guarantee regulatory clearance, or a speedier clearance timeline.
• U.S. healthcare reform measures and other potential legislative initiatives could adversely affect our business.
• Our devices are subject to the FDA’s regulations pertaining to marketing and promotional communications, among others. Failure to comply with such regulations may give rise to a number of potential FDA enforcement actions, any of which could have a material adverse effect on our business.
• We are subject to extensive governmental regulations relating to the manufacturing, labeling, and marketing of our products, and a failure to comply with such regulations could lead to withdrawal or recall of our products from the market.
• If we or our third-party manufacturers fail to comply with the FDA’s Quality Management System Regulation, or QMSR, our manufacturing operations could be interrupted.
• We are subject to various laws and regulations, including “fraud and abuse” laws and anti-bribery laws, which, if violated, could subject us to substantial penalties.
• If we are found to have violated laws protecting the confidentiality of patient health information, we could be subject to civil or criminal penalties, which could increase our liabilities and harm our reputation or our business.
• Our use of new and evolving technologies, such as artificial intelligence, may present risks and challenges that can impact our business, including by posing cybersecurity and other risks to our confidential and/or proprietary information, including personal information, and as a result we may be exposed to reputational harm and liability.
• Compliance with various regulations, including those related to our status as a U.S. public company and the manufacturing, labeling, and marketing of our products, may result in heightened general and administrative expenses and costs, divert management’s attention from revenue-generating activities and pose challenges for our management team, which has limited time, personnel and finances to devote to regulatory compliance.
• Risks Related to Our Intellectual Property and Information Technology
• We depend on computer and telecommunications systems we do not own or control and failures in our systems or a cybersecurity attack or incident relating to our IT systems or technology could significantly disrupt our business operations or result in sensitive customer information being compromised which would negatively materially affect our reputation and/or results of operations.
• Our success depends in part on our ability to obtain and maintain protection for the intellectual property relating to or incorporated into our products.
• We are not able to protect our intellectual property rights in all countries.
• We may be subject to patent infringement claims, which could result in substantial costs and liability and prevent us from commercializing our current and future products.
• We rely on trademark protection to distinguish our products from the products of our competitors.
• We may be subject to damages resulting from claims that our employees or we have wrongfully used or disclosed alleged trade secrets of their former employers.
• Risks Related to Ownership of Our Ordinary Shares
• Sales of a substantial number of ordinary shares by us or our large shareholders, certain of whom may have registration rights, or dilutive exercises of a substantial number of warrants by our warrant-holders could adversely affect the value of our ordinary shares.
• Future grants of ordinary shares under our equity incentive plans to our employees, non-employee directors and consultants, or sales by these individuals in the public market, could result in substantial dilution, thus decreasing the value of your investment in our ordinary shares, and certain grants may also require shareholder approval. In addition, stockholders will experience dilution upon the exercise of outstanding warrants.
• If we do not meet the expectations of equity research analysts, if any, if the equity analysts following our business do not continue to publish research or reports about our business, or if the analyst issues unfavorable commentary or a downgrade of the rating on our ordinary shares, the price of our ordinary shares could decline. Additionally, we may fail to meet publicly announced financial guidance or other expectations about our business, which could cause our ordinary shares to decline in value.
• We are a “smaller reporting company” and the reduced reporting requirements applicable to such companies may make our ordinary shares less attractive to investors.
• We are subject to ongoing costs and risks associated with determining whether our existing internal controls over financial reporting systems are compliant with Section 404 of the Sarbanes-Oxley Act, and if we fail to achieve and maintain adequate internal controls, it could have a material adverse effect on our stated results of operations and harm our reputation.
• U.S. holders of our ordinary shares may suffer adverse U.S. tax consequences if we are characterized as a passive foreign investment company, or a PFIC, under Section 1297(a) of the Code.
• The price of our ordinary shares may be volatile, and you may lose all or part of your investment.
• Our business could be negatively affected as a result of actions of activist shareholders, which could be disruptive and costly and may impact the trading value of our securities.
• Risks Related to Our Incorporation and Location in Israel
• Political, economic and military instability in Israel or the Middle East may adversely affect our business.
• Many of our employees and independent contractors who reside in Israel are required to perform military reserve duty, which may disrupt their work for us.
• 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.
• We may become subject to claims for remuneration or royalties for assigned service invention rights by our employees, which could result in litigation and adversely affect our business.
• Provisions of Israeli law and our Articles of Association may delay, prevent, or otherwise impede a merger with, or an acquisition of, us, even when the terms of such a transaction are favorable to us and our shareholders.
• It may be difficult to enforce a judgment of a U.S. court against us, our officers, and directors, to assert U.S. securities laws claims in Israel or to serve process on our officers and directors.
• Your rights and responsibilities as a shareholder will be governed by Israeli law, which differs in some material respects from the rights and responsibilities of shareholders of U.S. companies.
• Risks Related to the Oramed Transaction
• We will be subject to business uncertainties, including the risk of litigation, and contractual restrictions, prior to the closing of the Oramed Transaction and for a period of time thereafter, which may cause disruptions to our business and make it more difficult to maintain relationships with employees, suppliers or customers.
• Until the completion of the Oramed Transaction or the termination of the Share Purchase Agreement and Securities Purchase Agreement in accordance with their terms, we are prohibited from taking certain actions that might otherwise be beneficial to us and our shareholders.
• If the Oramed Transaction is consummated, Oramed will have significant control and influence over our company.
• The terms of the Securities Purchase Agreement, Notes and ancillary documentation require us to meet certain operating covenants and place restrictions on our operating and financial flexibility. If we raise additional capital through debt financing, the terms of any new debt could further restrict our ability to operate our business.
• There can be no assurances that Oratech’s proprietary POD™ technology will receive the necessary regulatory approvals.
• General Risks
• Exchange rate fluctuations between the U.S. dollar, the euro and the NIS may negatively affect our earnings.
• We are subject to certain regulatory regimes that may affect the way that we conduct business internationally, and our failure to comply with applicable laws and regulations could materially adversely affect our reputation and result in penalties and increased costs.
• Our business may be materially affected by changes to fiscal and tax policies. Potentially negative or unexpected tax consequences of these policies, or the uncertainty surrounding their potential effects, could adversely affect our results of operations and share price.
• Certain U.S. holders of our ordinary shares may suffer adverse U.S. tax consequences if we are characterized as a controlled foreign corporation, or a CFC, under Section 957 of the Code.
• If there are significant disruptions in our information technology systems, our business, financial condition, and operating results could be adversely affected.
• If we fail to properly manage our anticipated growth, our business could suffer.
• We are highly dependent on the knowledge and skills of our senior management, and if we are not successful in attracting and retaining highly qualified personnel, we may not be able to successfully implement our business strategy.
• Shutdowns of the U.S. federal government could materially impair our business and financial condition.