InspireMD, Inc.

Current report

We have only recently transitioned to a commercial stage medical device company in the United States, which may make it difficult for you to evaluate the success of our business to date and to assess our future viability.

Current report

We only recently launched the CGuard Prime Carotid Stent System in the United States following FDA approval in June 2025. Consequently, any predictions you make about our future success or viability may not be as accurate as they could be if we had more experience commercializing the CGuard Prime Carotid Stent System in the United States. To be profitable, we will need to successfully transition our focus to expand our commercialization capabilities through our direct sales organization and build our distribution capabilities to support the commercial launch of the CGuard Prime carotid stent system in the United State. Ultimately, we may not be successful in such a transition.

Current report

CGuard Prime has been commercially launched in the United States and we have limited experience selling, marketing or distributing products in the U.S. The timing of uptake and distribution efforts are unpredictable and there is a risk that we may not achieve and sustain commercial success for the CGuard Prime.

Current report

In July 2025, we announced the official commercial launch of CGuard Prime in the U.S. following FDA approval in June 2025, and we are currently executing on an independent commercialization plan for CGuard Prime in the U.S. As part of our plan, we have, and continue, to build out sales, marketing and distribution capabilities and engaged with a contract manufacturer. Historically, prior to the commencement of our commercialization activities in the U.S., we did not have experience in manufacturing, selling, marketing or distributing products in the U.S. To be able to successfully commercialize CGuard Prime, if at all, we may need to further develop our existing manufacturing, sales, marketing and distribution capabilities, which is expensive and time-consuming, or enter into arrangements with third parties to perform these services.

Current report

There are risks involved in establishing our own sales, marketing and distribution capabilities and partnering with a third party manufacturer. We must commit significant financial and managerial resources to develop a marketing and sales force with technical expertise and with supporting distribution capabilities. Factors that may inhibit our efforts to commercialize our products directly and without strategic partners include:

Current report

We are continuing to expand our commercialization capabilities and to build our distribution capabilities to support the commercialization of the CGuard Prime carotid stent system. We expect that it will take time for this team to generate significant sales momentum, if it does so at all. We may not be successful in recruiting and retaining the manufacturing, sales and marketing personnel necessary to sell CGuard Prime, and we may not be successful in marketing CGuard Prime, which would have a material adverse effect on our business, financial condition and results of operations.

Current report

In addition, other factors that have and may continue to inhibit our efforts to successfully commercialize CGuard Prime in the United States include our ability to access key health care decision makers, price CGuard Prime at a sufficient price point to ensure an adequate and attractive level of profitability, and maintain sufficient financial resources to cover the costs and expenses associated with creating and sustaining a capable sales and marketing organization and related commercial infrastructure. If we are not successful in setting our marketing, pricing and reimbursement strategies, recruiting and maintaining effective sales and marketing personnel or building and maintaining the infrastructure to support commercial operations in the United States and elsewhere, we will have difficulty successfully commercializing CGuard Prime in the U.S. market, which would adversely affect our business and financial condition.

Current report

If we are unable to establish and maintain our own manufacturing, sales, marketing and distribution capabilities or enter into successful arrangements with third parties to perform these services, our future product revenues and profitability may be materially adversely affected. If we are not successful in commercializing CGuard Prime in the United States, we may be required to collaborate or partner with a third-party medical device or biotechnology company with existing products. To the extent we collaborate or partner, the financial value will be shared with another party and we will need to establish and maintain a successful collaboration arrangement, and we may not be able to enter into these arrangements on acceptable terms or in a timely manner in order to establish CGuard Prime in the U.S. market. To the extent that we enter into co-promotion or other arrangements, any revenues we receive will depend upon the efforts of third parties, which may not be successful and are only partially in our control. In that event, our product revenues may be lower than if we marketed and sold our products directly with the highest priority, and we may be required to reduce or eliminate much of our commercial infrastructure and personnel as a result of such collaboration or partnership.

Current report

CGuard Prime, or any other product candidate that may receive marketing approval in the future, may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success and the market opportunity for CGuard Prime or any other product candidate may be smaller than our estimates.

Current report

CGuard Prime, or any other product candidate that may be approved in the future by the appropriate regulatory authorities for marketing and sale, may fail to gain sufficient market acceptance by physicians, patients, third-party payors and others in the medical community. Physicians are often reluctant to switch their patients from existing medical devices even when new and potentially more effective or convenient products enter the market.

Current report

Efforts to educate the medical community and third-party payors on the benefits of CGuard Prime over its competition have required significant resources and may not ultimately be successful. If CGuard Prime, or any other product candidate that may be approved in the future for marketing and sale in the future, does not achieve an adequate level of market acceptance, we may not generate significant revenues and we may not become profitable. The degree of market acceptance of CGuard Prime, or any other product candidate that may be approved in the future, will depend on a number of factors, including:

Current report

● the advantages of the product compared to competitive products;

Current report

● the number of competitors approved for similar uses;

Current report

● the relative promotional effort and marketing success of us as compared with our competitors;

Current report

● how the product is positioned in physician treatment guidelines and pathways;

Current report

● the efficacy and safety of the product;

Current report

● the product’s tolerability, consistency of performance, convenience and ease of administration compared to alternative product;

Current report

● the willingness of the target patient population to try, and of physicians to utilize, the product;

Current report

● limitations or warnings, including use restrictions, contained in the product’s approved labeling;

Current report

● the timing of market introduction of our approved products as well as competitive products;

Current report

● potential product liability claims;

Current report

● changes in the standard of care for the targeted indications of the product; and

Current report

● availability and amount of coverage and reimbursement from government payors, managed care plans and other third-party payors.

Current report

In addition, the potential market opportunities for CGuard Prime and any other product are difficult to estimate precisely. Our estimates of the potential market opportunities are predicated on many assumptions, including industry knowledge and publications, third-party research reports and other surveys. While we believe that our internal assumptions are reasonable, these assumptions involve the exercise of significant judgment on the part of our management, are inherently uncertain and the reasonableness of these assumptions has not been assessed by an independent source. If any of the assumptions prove to be inaccurate, the actual markets for our therapeutic candidate could be smaller than our estimates of the potential market opportunities.

Current report

If the commercial launch of CGuard Prime in the United States for which we established a direct sales organization and distribution capabilities is not successful for any reason, we could incur substantial costs and our investment in our direct sales organization and distribution capabilities would be lost if we cannot retain or reassign our sales, marketing, market access and medical affairs personnel.

Current report

To achieve commercial success for CGuard Prime in the United States, we have expended and anticipate that we will continue to expend significant resources to support our direct sales organization and distribution capabilities. There are risks involved with establishing our own sales, marketing, distribution, training and support capabilities. For example, recruiting and training sales and marketing personnel is expensive and time consuming and could delay our ability to focus on other priorities. If the commercial launch of CGuard Prime in the United States is not successful for any reason, this would be costly, and our investment would be lost if we cannot retain or reassign our sales, marketing, market access and medical affairs personnel or terminate on favorable terms any agreements entered into with third parties to support our commercialization efforts.

Current report

Factors that may inhibit or limit our efforts to commercialize CGuard Prime in the United States on our own include:

Current report

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.

Current report

In October 2023, Hamas terrorists infiltrated Israel’s southern border from the Gaza Strip and conducted a series of attacks on civilian and military targets. Hamas also launched extensive rocket attacks on Israeli population and industrial centers located along Israel’s border with the Gaza Strip and in other areas within the State of Israel. These attacks resulted in extensive deaths, injuries and kidnapping of civilians and soldiers. Following the attack, Israel’s security cabinet declared war against Hamas and a military campaign against these terrorist organizations commenced in parallel to their continued rocket and terror attacks. In January 2025, Israel and Hamas entered into a ceasefire agreement, which remained in effect until March 18, 2025, when hostilities resumed. As of October 9, 2025, Israel and Hamas entered into a renewed ceasefire agreement calling for a permanent end of the war. However, there are no assurances that such as agreement will hold. While the conflict has created heightened security concerns, disruptions to business operations, and economic instability, the ceasefire may contribute to improved regional stability. However, the security situation remains fluid, and any renewed military actions, restrictions, or government-imposed measures could adversely affect our operations, supply chains, and financial condition.

Current report

While the intensity and duration of the security situation in Israel have been difficult to predict, as were the economic implications on our business and operations and on Israel’s economy in general, the ceasefire marks a potential shift towards stability in the region. If sustained, this could reduce the risk of disruptions to our business and the Israeli economy in general. However, if the war is renewed or expands to other fronts, such as Lebanon, Syria and the West Bank, our operations may be harmed.

Previous report

Item 1A. Risk Factors

Previous report

The intensity and duration of Israel’s current war is difficult to predict at this stage, as are such war’s economic implications on the Company’s business and operations and on Israel’s economy in general. If the ceasefires declared collapse or a new war commences or hostilities expand to other fronts, our operations may be adversely affected.

Previous report

Item 3. Defaults Upon Senior Securities

Previous report

Item 4. Mine Safety Disclosures

Current report — wording carried from elsewhere

In October 2024, we established our global headquarters in Miami, Florida to support the U.S. commercial launch of the CGuard Prime carotid stent system. During 2024, we started the build-out of the infrastructure for commercial operations in the U.S. designed to support the commercialization of the CGuard Prime carotid stent system. In addition, to support our anticipated production growth in connection with the commercialization of the CGuard Prime carotid stent system, we have engaged Aptyx Interventional Systems (“Aptyx”), a contract manufacturer that is a developer and manufacturer of complex components and devices for the life sciences, to transfer the manufacturing of CGuard Prime finished goods to full-scale production at their ISO Class 7 cleanroom facility in North Carolina.