InspireMD, Inc.

We took possession of Suite 215 on November 1, 2024, and Suite 280 on May 18, 2025, following the landlord’s completion of construction. The lease for the combined premises extends through September 30, 2030, and includes a five-year extension option in accordance with the terms of the lease.

We have provided a $500,000 security deposit under the lease, which is refundable in stages over the lease term, subject to our compliance with the lease. Pursuant to the lease, we paid a base rent of $22,911.75 per month during the first year of the Term, increasing on an incremental basis each subsequent year of the Term, which as of March 18, 2026 is $22,911.75. In addition to base rent, we are responsible for customary lease-related expenses, including taxes, operating costs, and utilities.

Israel

We also maintain a leased 1,830-square-meter office and manufacturing facility in Tel Aviv, Israel, where we produce and assemble our CGuard EPS and CGuard Prime products. The facility has capacity to manufacture approximately 5,500 products per quarter based on a single-shift schedule. We believe our current facility is sufficient to meet anticipated demand through additional staffing or the addition of a second production shift. The lease for this facility currently runs through December 31, 2028.

• We may not be able to achieve or maintain satisfactory pricing and margins for our products.
• We may become subject to claims by much larger and better capitalized competitors enforcing their intellectual property rights against us or seeking to invalidate our intellectual property or our rights thereto.
• Risks Related to our Clinical Trials and Regulatory Matters
• Completion of clinical trials for CGuard Prime 80 cm in TCAR procedures (C-GUARDIANS II), SwitchGuard NPS (C-GUARDIANS III), and any other investigational product candidates requires compliance with FDA IDE regulations, and failure to meet these requirements could materially harm our business.
• Clinical trials necessary to support regulatory submissions for our products, including the C-GUARDIANS II study evaluating the CGuard Prime 80 cm stent system for TCAR procedures and the C-GUARDIANS III study evaluating the SwitchGuard NPS, are often lengthy and difficult to conduct, and delays or failures in these trials could adversely affect our business.
• The results of our C-GUARDIANS II and C-GUARDIANS III trials, as well as any other clinical trials, may be insufficient to obtain regulatory approval for our products.
• Patients may discontinue their participation in our clinical studies, which may negatively impact the results of these studies and extend the timeline for completion of our development programs.
• Even if we obtain regulatory approvals, our products will be subject to ongoing regulatory review and if we fail to comply with continuing U.S. and applicable foreign regulations, we could lose those approvals and our business would be seriously harmed.
• Even if products we develop receive marketing approval, we or others may later discover that the product is less effective than previously believed or causes undesirable side effects that were not previously identified, which could compromise our ability or that of any collaborators to market the product, and could cause regulatory authorities to take certain regulatory actions.
• Our products may in the future be subject to product notifications, recalls, or voluntary market withdrawals that could harm our reputation, business and financial results.
• We have only limited experience in regulatory affairs, which may affect our ability, or the time required, to navigate complex regulatory requirements and obtain necessary regulatory approvals, if such approvals are received at all. Regulatory delays or denials may increase our costs, cause us to lose revenue and materially and adversely affect our results of operations and the value of our business.
• Even if our products are approved by regulatory authorities, if we or our suppliers fail to comply with ongoing regulatory requirements, or if we experience unanticipated problems with our products, these products could be subject to restrictions or withdrawal from the market.
• Failure to obtain regulatory approval in foreign jurisdictions will prevent us from marketing our products in such jurisdictions.
• We are subject to federal, state and foreign healthcare laws and regulations and implementation of, or changes to, such healthcare laws and regulations could adversely affect our business and results of operations.
• We may be subject, directly or indirectly, to applicable U.S. federal and state anti-kickback, false claims laws, physician payment transparency laws, fraud and abuse laws or similar healthcare and security laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm and diminished profits and future earnings.
• We may be exposed to product liability claims and insurance may not be sufficient to cover these claims.
• Even if one or more of our products are approved by the FDA, we may fail to obtain an adequate level of reimbursement for our products by third party payors, such that there may be no commercially viable markets for our products, or the markets may be much smaller than expected.
• In the United States and European Union, our business could be significantly and adversely affected by healthcare reform initiatives and/or other legislation or judicial interpretations of existing or future healthcare laws and/or regulations.
• Disruptions at the FDA and other government agencies caused by funding shortages or global health concerns could hinder their ability to hire, retain or deploy key leadership and other personnel, or otherwise prevent new or modified products from being developed, cleared or approved or commercialized in a timely manner or at all, which could negatively impact our business.
• If we are unable to obtain and maintain intellectual property protection covering our products, others may be able to make, use or sell our products, which would adversely affect our revenue.
• The failure to obtain or maintain patents, licensing agreements and other intellectual property rights that are sufficiently broad and protective could impact our ability to compete effectively.
• Intellectual property rights of third parties could adversely affect our ability to commercialize our products and services, and we might be required to litigate or obtain licenses from third parties in order to develop or market our products. Such litigation or licenses could be costly or not available on commercially reasonable terms.
• Patent policy and rule changes could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of any issued patents.
• We may be involved in lawsuits to protect or enforce our intellectual property, which could be expensive, time-consuming, and unsuccessful.
• We may not be able to protect our intellectual property rights throughout the world.
• Risks Related to Our Business and Operations
• CGuard EPS, CGuard Prime, and SwitchGuard NPS are complex medical devices that require training for qualified personnel.
• If we fail to maintain or establish reliable supply arrangements, or if we experience interruptions in the supply of key materials or components, our ability to manufacture and commercialize our products could be adversely affected.
• Our business is dependent upon the total market opportunity for CAS and our ability to penetrate it through continued adoption of CAS by hospitals and physicians.
• Adoption of CAS depends upon appropriate physician training, and inadequate training may lead to adverse patient outcomes, adversely affect adoption of CAS and adversely affect our business.
• The failure of third parties to meet their contractual, regulatory, and other obligations could adversely affect our business.
• We face manufacturing risks that could adversely affect our ability to manufacture products, reduce our gross margins and negatively affect our business and operating results.
• Our results of operations could be materially harmed if we are unable to accurately forecast customer demand for our products and manage our inventory.
• Our quarterly and annual results may fluctuate significantly and may not fully reflect the underlying performance of our business.
• Defects or failures associated with our products could lead to additional recalls, safety alerts or litigation, as well as significant costs and negative publicity.
• The use, misuse or off-label use of our products may result in injuries that lead to product liability suits, which could be costly to our business.
• We face risks associated with litigation and claims.
• Our business and operations would suffer in the event of computer system failures, cyber-attacks or deficiencies in our cyber-security.
• If we are unable to manage the anticipated growth of our business, our future revenue and operating results may be harmed.
• The loss of key members of our senior management team or our inability to attract and retain highly skilled scientists and laboratory and field personnel could adversely affect our business.
• We are an international business, and we are exposed to various global and local risks that could have a material adverse effect on our financial condition and results of operations.
• Our business, operating results and growth rates may be adversely affected by current or future unfavorable economic and market conditions and adverse developments with respect to financial institutions and associated liquidity risk.
• We are subject to financial reporting and other requirements that place significant demands on our resources.
• There are inherent limitations in all control systems, and misstatements due to error or fraud may occur and not be detected.
• Scrutiny of sustainability and environmental, social, and governance (“ESG”) initiatives could increase our costs or otherwise adversely impact our business.
• Increasing inflation could adversely affect our business, financial condition, results of operations or cash flows.
• Changes to trade policy, including tariff and customs regulations, or failure to comply with such regulations may have an adverse effect on our reputation, business, financial condition and results of operations.
• Changes in tax laws could have a material adverse effect on our business, cash flow, results of operations or financial conditions.
• Risks Related to Operating in Israel
• We anticipate being subject to fluctuations in currency exchange rates because we expect a substantial portion of our revenues will be generated in Euros and U.S. dollars, while a significant portion of our expenses will be incurred in New Israeli Shekels (“NIS”).
• If there are significant shifts in the political, economic and military conditions in Israel and its neighbors, it could have a material adverse effect on our business operations and ability to reach profitability.
• Under applicable U.S. and Israeli law, we may not be able to enforce covenants not to compete and therefore may be unable to prevent our competitors from benefiting from the expertise of some of our former employees. In addition, employees may be entitled to seek compensation for their inventions irrespective of their agreements with us, which in turn could affect our future profitability.
• 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.
• It may be difficult for investors in the United States to enforce any judgments obtained against us or some of our directors or officers.
• Risks Related to Our Common Stock, Preferred Stock and Warrants
• The market prices of our common stock are subject to fluctuation and have been and may continue to be volatile, which could result in substantial losses for investors.
• If we fail to maintain compliance with the Nasdaq minimum listing requirements, our common stock will be subject to delisting. Our ability to publicly or privately sell equity securities and the liquidity of our common stock could be adversely affected if our common stock delisted.
• Delaware law and our corporate charter and bylaws contain anti-takeover provisions that could delay or discourage takeover attempts that stockholders may consider favorable.
• We have a staggered board of directors, which could impede an attempt to acquire us or remove our management.
• As a former shell company, resales of shares of our restricted common stock in reliance on Rule 144 of the Securities Act are subject to the requirements of Rule 144(i).
• If securities and/or industry analysts fail to continue publishing research about our business, if they change their recommendations adversely, or if our results of operations do not meet their expectations, our stock price and trading volume could decline.
• Aspects of the tax treatment of the securities may be uncertain.