What the changes say
- The risk section is dominated by the recent US commercial launch of CGuard Prime and upcoming trials for SwitchGuard NPS.
- Increased disclosures focus on US sales execution, clinical trial compliance, single-source component vulnerabilities, and Israeli operational dependencies.
What changed since the prior 10-K
New
- NewRisk Related to Commercialization of Our Products
We have only recently transitioned to a commercial stage medical device company in the United States, which may make it difficult for analysts and investors to evaluate the success of our business to date and to assess our future viability
The company recently launched CGuard Prime in the United States in July 2025 following FDA approval, leaving limited operating history for investors to evaluate future success.
- NewRisk Related to Commercialization of Our Products
If our direct sales organization and distribution capabilities fail, or are otherwise unsuccessful, it would materially adversely impact the commercialization of CGuard Prime in the United States, impact our ability to generate revenue and harm our business
Revenue growth relies heavily on successful commercialization of CGuard Prime and obtaining FDA approval for SwitchGuard.
- NewRisk Related to Commercialization of Our Products
We may not be able to achieve or maintain satisfactory pricing and margins for our products
Price competition and payer reimbursement declines for carotid artery stenting could erode gross margins and harm the business.
- NewRisks 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 for CGuard Prime 80 cm and SwitchGuard NPS must comply with FDA IDE regulations and Good Clinical Practice requirements.
- NewRisks Related to Our Business and Operations
CGuard EPS, CGuard Prime, and SwitchGuard NPS are complex medical devices that require training for qualified personnel
Misuse of complex medical devices like CGuard EPS, CGuard Prime, and SwitchGuard NPS could cause adverse medical consequences and product liability litigation.
- NewRisks Related to Our Business and Operations
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
The company relies on single-source suppliers for critical components, such as polymer fiber mesh, with inventory for PET resin secured only through early 2028.
- NewRisks Related to Our Business and Operations
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
Future growth depends on physician awareness and the total addressable market size for carotid artery stenting procedures.
- NewRisks Related to Our Business and Operations
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
Inadequate physician training and improper technique during carotid artery stenting can lead to adverse patient outcomes and limit product adoption.
- NewRisks Related to Our Business and Operations
Our results of operations could be materially harmed if we are unable to accurately forecast customer demand for our products and manage our inventory
Inaccurate forecasting of customer demand or inventory needs could disrupt manufacturing operations and harm financial results.
- NewRisks Related to Our Business and Operations
Our quarterly and annual results may fluctuate significantly and may not fully reflect the underlying performance of our business
Quarterly and annual financial results may fluctuate significantly, making period-to-period comparisons unreliable indicators of underlying performance.
- NewRisks Related to Our Business and Operations
Defects or failures associated with our products could lead to additional recalls, safety alerts or litigation, as well as significant costs and negative publicity
Design flaws, manufacturing defects, or component failures could lead to product recalls, safety alerts, or litigation.
- NewRisks Related to Our Business and Operations
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
Off-label use of CGuard Prime by physicians can result in severe adverse events such as stroke and myocardial infarction, triggering product liability claims.
- NewRisks Related to Our Business and Operations
If we are unable to manage the anticipated growth of our business, our future revenue and operating results may be harmed
- NewRisks Related to Our Business and Operations
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
- NewRisks Related to Our Business and Operations
Changes in tax laws could have a material adverse effect on our business, cash flow, results of operations or financial conditions
- NewRisks Related to Our Common Stock, Preferred Stock and Warrants
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
Dropped
- DroppedRisk Related to Commercialization of Our Products
Although we met the primary endpoint in our C-GUARDIANS trial of the CGuard Carotid Stent System, the results may not be sufficient to support FDA approval
- DroppedRisk Related to Commercialization of Our Products
We plan on self-commercializing CGuard Prime in the U.S. if we receive FDA approval and historically have no experience selling, marketing or distributing products in the U.S
- DroppedRisk Related to Commercialization of Our Products
If we are unable to establish our own manufacturing, sales, marketing and distribution capabilities or enter into successful arrangements with third parties to perform these services, any future product revenues and our profitability, may be materially adversely affected
- DroppedRisk Related to Commercialization of Our Products
CGuard and Switch Guard are complex medical devices that requires training for qualified personal
Discussed whether C-GUARDIANS trial results would suffice for FDA approval.
- DroppedRisk Related to Commercialization of Our Products
We depend on outside suppliers for certain raw materials. These raw materials or components may not always be available at our standards or on acceptable terms, if at all, and we may be unable to locate alternative suppliers or produce necessary materials or components on our own
- DroppedRisk Related to Commercialization of Our Products
In addition, we will be required to obtain prior regulatory approval from the FDA or foreign regulatory authorities to use different suppliers or components that may not be as safe or as effective. As a result, regulatory approval of our products may not be received on a timely basis or at all
- DroppedRisks Related to Our Common Stock, Preferred Stock and Warrants
In addition, the securities markets have from time to time experienced significant price and volume fluctuations that are unrelated to the operating performance of particular companies. These market fluctuations may also significantly affect the market prices of our common stock
Covered plans to self-commercialize CGuard Prime in the U.S. without prior domestic experience.
Reworded
- 84% rewrittenRisks 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”)
Added specific 2025 revenue currency breakdown (39% USD, 61% other primarily Euros) and detailed USD/NIS and EUR/NIS exchange rate exposure.
- 68% rewrittenRisks Related to Our Business and Operations
Scrutiny of sustainability and environmental, social, and governance (“ESG”) initiatives could increase our costs or otherwise adversely impact our business
Added nuance that ESG scrutiny may come from stakeholders both supporting and opposing initiatives, adding compliance complexity.
- 60% rewrittenRisks Related to our Clinical Trials and Regulatory Matters
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
Updated healthcare policy text to specifically reference President Trump reducing HHS, FDA, and CMS employees and modifying the Affordable Care Act.
- 60% rewrittenRisks Related to our Clinical Trials and Regulatory Matters
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
Retained clinical trial patient discontinuation and enrollment risks with minor stylistic updates.
- 59% rewrittenRisks Related to Operating in Israel
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
Expanded regional conflict risks in Israel to explicitly name terrorist organizations Iran, Hamas, and Hezbollah.
Was: 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 relationships and profitability
- 49% rewrittenRisks Related to our Clinical Trials and Regulatory Matters
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
Maintained ongoing regulatory review and FDA inspection risks for approved products.
- 35% rewrittenRisk Related to Commercialization of Our Products
We operate in an intensely competitive and rapidly changing business environment, and there is a substantial risk our products could become obsolete or uncompetitive
Updated competitive landscape references to specify SwitchGuard NPS and CGuard Prime competing against Silk Road Medical (acquired by Boston Scientific).
- 32% rewrittenRisks Related to Our Financial Condition
We will need to raise additional capital to meet our business requirements in the future, and such capital raising may be costly or difficult to obtain and could dilute our stockholders’ ownership interests
Cleaned up bullet points regarding future capital raising needs for U.S. commercialization and product development.
- 30% rewrittenRisks 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
- 27% rewrittenRisks Related to Our Financial Condition
We have a history of net losses and may experience future losses
- 21% rewrittenRisks Related to our Clinical Trials and Regulatory Matters
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
Was: The results of our C-GUARDIANS trial as well as any other clinical trials may be insufficient to obtain regulatory approval for our products
All 58 risk factors
Headings as the filing states them, in filing order.
Risks Related to Our Financial Condition
- 01We have a history of net losses and may experience future losses27% rewritten
- 02We will need to raise additional capital to meet our business requirements in the future, and such capital raising may be costly or difficult to obtain and could dilute our stockholders’ ownership interests32% rewritten
- 03Any additional capital raised through the sale of equity or equity-backed securities may dilute our stockholders’ ownership percentages and could also result in a decrease in the market value of our equity securities
Risk Related to Commercialization of Our Products
- 04We have only recently transitioned to a commercial stage medical device company in the United States, which may make it difficult for analysts and investors to evaluate the success of our business to date and to assess our future viabilityNew
- 05If our direct sales organization and distribution capabilities fail, or are otherwise unsuccessful, it would materially adversely impact the commercialization of CGuard Prime in the United States, impact our ability to generate revenue and harm our businessNew
- 06We operate in an intensely competitive and rapidly changing business environment, and there is a substantial risk our products could become obsolete or uncompetitive35% rewritten
- 07We may not be able to achieve or maintain satisfactory pricing and margins for our productsNew
- 08We 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
- 09Completion 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 New
- 10The 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 products21% rewritten
- 11Patients 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 programs60% rewritten
- 12Even 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 harmed49% rewritten
- 13Our products may in the future be subject to product notifications, recalls, or voluntary market withdrawals that could harm our reputation, business and financial results
- 14Even 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
- 15Failure to obtain regulatory approval in foreign jurisdictions will prevent us from marketing our products in such jurisdictions
- 16We 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
- 17We may be exposed to product liability claims and insurance may not be sufficient to cover these claims
- 18Even 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
- 19In 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 regulations60% rewritten
- 20If 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
- 21The 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
- 22It is also possible that others may obtain issued patents that could prevent us from commercializing our products or require us to obtain licenses requiring the payment of significant fees or royalties in order to enable us to conduct our business
- 23Patent 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
- 24We may be involved in lawsuits to protect or enforce our intellectual property, which could be expensive, time-consuming, and unsuccessful
- 25A company may attempt to commercialize competing products utilizing our proprietary design, trademarks or tradenames in foreign countries where we do not have sufficient patent protection and where legal recourse may be limited. This may have a significant commercial impact on our foreign business operations
Risks Related to Our Business and Operations
- 26CGuard EPS, CGuard Prime, and SwitchGuard NPS are complex medical devices that require training for qualified personnelNew
- 27If 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 affectedNew
- 28Our business is dependent upon the total market opportunity for CAS and our ability to penetrate it through continued adoption of CAS by hospitals and physiciansNew
- 29Adoption 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 businessNew
- 30The failure of third parties to meet their contractual, regulatory, and other obligations could adversely affect our business
- 31We face manufacturing risks that could adversely affect our ability to manufacture products, reduce our gross margins and negatively affect our business and operating results
- 32Our results of operations could be materially harmed if we are unable to accurately forecast customer demand for our products and manage our inventoryNew
- 33Our quarterly and annual results may fluctuate significantly and may not fully reflect the underlying performance of our businessNew
- 34Defects or failures associated with our products could lead to additional recalls, safety alerts or litigation, as well as significant costs and negative publicityNew
- 35The 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 businessNew
- 36We face risks associated with litigation and claims
- 37Our business and operations would suffer in the event of computer system failures, cyber-attacks or deficiencies in our cyber-security
- 38If we are unable to manage the anticipated growth of our business, our future revenue and operating results may be harmedNew
- 39The 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
- 40We 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
- 41Our 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
- 42We are subject to financial reporting and other requirements that place significant demands on our resources
- 43There are inherent limitations in all control systems, and misstatements due to error or fraud may occur and not be detected
- 44Scrutiny of sustainability and environmental, social, and governance (“ESG”) initiatives could increase our costs or otherwise adversely impact our business68% rewritten
- 45Increasing inflation could adversely affect our business, financial condition, results of operations or cash flows
- 46Changes 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 operationsNew
- 47Changes in tax laws could have a material adverse effect on our business, cash flow, results of operations or financial conditionsNew
Risks Related to Operating in Israel
- 48We 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”)84% rewritten
- 49If 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 profitability59% rewritten
- 50We 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
- 51It 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
- 52The 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 investors30% rewritten
- 53If 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 delistedNew
- 54Delaware law and our corporate charter and bylaws contain anti-takeover provisions that could delay or discourage takeover attempts that stockholders may consider favorable
- 55We have a staggered board of directors, which could impede an attempt to acquire us or remove our management
- 56As 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)
- 57If 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
- 58Aspects of the tax treatment of the securities may be uncertain
Other InspireMD 10-Ks
- FY2024 10-K risk factors49 risks
InspireMD reports recurring net losses, including $32.0 million for 2024, and holds an accumulated deficit of $254 million. The company relies heavily on the success, FDA approval, and self-commercialization of the CGuard Prime carotid stent system. Operations in Israel expose the company to regional geopolitical conflicts and currency exchange risks.
Filed Mar 12, 2025
About this page
The headings are the filing's own. The one-line readings and the overview are automated and can be wrong: read Item 1A of the 10-K for the exact wording.