Lifeward (LFWD) risk factors, FY2025 10-K

Risks Related to Our Business and Our Industry

1. 01We have concluded that there is substantial doubt as to our ability to continue as a going concern
2. 02Global, regional, and local economic weakness and uncertainty could adversely affect our demand for our products and services and our business and financial performance32% rewritten
3. 03We may not fully realize the anticipated positive impacts to future financial results from our streamlining efforts37% rewritten
4. 04We may encounter difficulties in transitioning the manufacturing of our ReWalk products to our in-house manufacturerNew
5. 05We face economic and political risks associated with doing business in Taiwan, particularly due to the geopolitical tension between Taiwan and China, and in Russia that could negatively affect our business and hence the value of your investment
6. 06Our future growth and operating results will depend on our ability to develop, receive regulatory clearance for and commercialize new products and penetrate new product and geographic markets37% rewritten
7. 07The market for medical exoskeletons, including soft suit devices, remains relatively new and unproven, and important assumptions about the potential market for our current and future products may be inaccurate49% rewritten
8. 08Future products for those with paraplegia or other mobility impairments or spinal cord injuries may have the same or other restrictions30% rewritten
9. 09We expect that in the future a significant source of payment for ReWalk systems will be private insurance plans and managed care programs, government programs such as Medicare, the VHA, workers’ compensation plans, and other third-party payors37% rewritten
10. 10Defects in our products or the software that drives them could adversely affect the results of our operations
11. 11If we are unable to leverage our sales, marketing, and training infrastructure we may fail to increase our sales
12. 12The potential health benefits of our ReWalk products have not been substantiated by long-term clinical data, which could limit sales of such products
13. 13We 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 products43% rewritten
14. 14We operate in a competitive industry that is subject to rapid technological change, and we expect competition to increase
15. 15We utilize independent distributors for the ReWalk and AlterG products who are free to market other products that compete with ours
16. 16We may receive a significant number of warranty claims or our ReWalk, AlterG, or ReStore systems may require significant amounts of service after sale69% rewritten
17. 17We may not be able to enhance our exoskeleton product offerings through our research and development efforts
18. 18obtain the necessary regulatory clearances and approvals for proposed products
19. 19We 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
20. 20We 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 results20% rewritten
21. 21increased legal and accounting costs relating to the acquisitions or compliance with regulatory matters

Risks Related to Government Regulation

1. 22Although the FDA granted Breakthrough Device Designation status to our ReBoot device, this designation does not guarantee regulatory clearance, or a speedier clearance timeline
2. 23U.S. healthcare reform measures and other potential legislative initiatives could adversely affect our business26% rewritten
3. 24Our 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
4. 25We 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 market24% rewritten
5. 26If we or our third-party manufacturers fail to comply with the FDA’s Quality Management System Regulation, or QMSR, our manufacturing operations could be interrupted28% rewritten
6. 27pursuit of criminal prosecution
7. 28We 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
8. 29If 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

Risks Related to Our Intellectual Property and Information Technology

1. 30Our success depends in part on our ability to obtain and maintain protection for the intellectual property relating to or incorporated into our products
2. 31Our patents and proprietary technology and processes may not provide us with a competitive advantage
3. 32We are not able to protect our intellectual property rights in all countries
4. 33We 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
5. 34We rely on trademark protection to distinguish our products from the products of our competitors
6. 35We 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

1. 36Sales 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 shares50% rewritten
2. 37We are a “smaller reporting company” and the reduced reporting requirements applicable to such companies may make our ordinary shares less attractive to investors
3. 38The price of our ordinary shares may be volatile, and you may lose all or part of your investment
4. 39announcements regarding business acquisitions
5. 40Our 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 securities84% rewritten

Risks Related to Our Incorporation and Location in Israel

1. 41Political, economic and military instability in Israel or the Middle East may adversely affect our businessNew
2. 42Many of our employees and independent contractors who reside in Israel are required to perform military reserve duty, which may disrupt their work for us75% rewritten
3. 43Furthermore, the consideration available to our shareholders in a future transaction involving the transfer outside of Israel of technology or know-how developed with IIA funding (such as a merger or similar transaction) may be reduced by any amounts that we are required to pay to the IIA
4. 44We 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
5. 45Provisions 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
6. 46Your 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

1. 47Until 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 shareholdersNew
2. 48If the Oramed Transaction is consummated, Oramed will have significant control and influence over our companyNew
3. 49placing us at a competitive disadvantage compared to our competitors that have less debt or better debt servicing optionsNew
4. 50There can be no assurances that Oratech’s proprietary POD™ technology will receive the necessary regulatory approvalsNew

General Risks

1. 51Exchange rate fluctuations between the U.S. dollar, the euro and the NIS may negatively affect our earnings
2. 52Our operations also could be adversely affected if we are unable to effectively hedge against currency fluctuations in the future59% rewritten
3. 53We 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
4. 54Our 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
5. 55If there are significant disruptions in our information technology systems, our business, financial condition, and operating results could be adversely affected
6. 56If we fail to properly manage our anticipated growth, our business could suffer
7. 57We 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
8. 58Shutdowns of the U.S. federal government could materially impair our business and financial condition27% rewritten