InspireMD, Inc.
For the period ended Jun 30, 2026. Filed Aug 14, 2026.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Jun 30, 2026 · Filed Aug 14, 2026
NSPR$0.70+8.9%Stored close · as of Nov 6, 2026
What changed in Risk Factors?
Read the current filingPrevious report: 10-Q
Period ended 2026-03-31; filed 2026-05-07.
0001493152-26-021636
Item 1A. Risk FactorsCurrent report: 10-Q
Period ended 2026-06-30; filed 2026-08-14.
0001493152-26-038438
Item 1A. Risk FactorsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 30 previous paragraphs and 42 current paragraphs.
26 unchanged; 4 reworded; 12 added; 0 removed; 0 previous and 0 current paragraphs rearranged.
Tables are not compared: 2 previous and 2 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (12)
Current report
Nasdaq has established certain standards for the continued listing of a security on the Nasdaq Capital Market. The standards for continued listing include, among other things, that the minimum bid price for the listed securities not fall below $1.00 per share for a period of 30 consecutive trading days and that we maintain a minimum of $2,500,000 in stockholders’ equity and a market value of listed securities of at least $5 million.
Current report
On July 17, 2026, we received a notification letter, or the Notification Letter, from the Nasdaq Listing Qualifications notifying us that we are not in compliance with the minimum bid price requirements set forth in Nasdaq Listing Rule 5550(a)(2), or the Rule, for continued listing on The Nasdaq Capital Market. The Notification Letter provides that we have 180 calendar days, or until January 13, 2027, to regain compliance with the Rule. To regain compliance, the bid price of our common stock must have a closing bid price of at least $1.00 per share for a minimum of 10 consecutive business days. In the event we do not regain compliance by January 13, 2027, we may then be eligible for an additional 180 days if we meet the continued listing requirement for market value of publicly held shares and all other initial listing standards for The Nasdaq Capital Market, with the exception of the bid price requirement, and will need to provide written notice of our intention to cure the deficiency during the second compliance period. If we do not qualify for the second compliance period or fail to regain compliance during the second compliance period, then Nasdaq will notify us of its determination to delist our common stock, at which point we will have an opportunity to appeal the delisting determination to a Hearings Panel.
Current report
No assurance can be given that we will be able to regain compliance with the Rule. Failure to meet applicable Nasdaq continued listing standards could result in a delisting of our common stock. A delisting of our common stock from Nasdaq could materially reduce the liquidity of our common stock and result in a corresponding material reduction in the price of our common stock. In addition, delisting could harm our ability to raise capital through alternative financing sources on terms acceptable to us, or at all, and may result in the potential loss of confidence by investors, employees and fewer business development opportunities.
Current report
Our restructuring and the associated workforce reduction may not result in anticipated savings, could result in total costs and expenses that are greater than expected and could disrupt our business.
Current report
We have begun to implement a restructuring plan that includes a reduction in our workforce, and we expect to continue to implement this plan. We may incur additional expenses not currently contemplated due to events associated with the reduction in force, and our restructuring activities may subject us to reputational risks and litigation risks and expenses. We may not realize, in full or in part, the anticipated benefits, savings and improvements in our cost structure from our restructuring efforts due to unforeseen difficulties, delays or unexpected costs. If we are unable to realize the expected operational efficiencies and cost savings from the restructuring, our operating results and financial condition would be adversely affected. In addition, to the extent we do not realize such anticipated operational efficiencies, we may need to undertake additional workforce reductions or restructuring activities in the future.
Current report
Furthermore, our restructuring plan may be disruptive to our operations. For example, our workforce reductions could yield unanticipated consequences, such as attrition beyond planned staff reductions, increased difficulties in our day-to-day operations and reduced employee morale. The changes to our operations and the reduction in workforce may yield unintended consequences and costs, such as the loss of institutional knowledge and expertise, attrition beyond our intended reductions in force, and a reduction in morale among our remaining employees, all of which may have an adverse effect on our business, results of operations or financial condition. If employees who were not affected by the reductions in force seek alternative employment, this could result in our seeking contractor support at unplanned additional expense or harm our productivity. Any employee litigation related to the headcount reduction could be costly and prevent management from fully concentrating on the business.
Current report
Our workforce reductions could also harm our ability to attract and retain qualified management, scientific, technical, and manufacturing personnel who are critical to our business. For example, the workforce reduction may negatively impact our regulatory, technical operations, and commercial functions, which would have a negative impact on our ability to successfully develop, and ultimately, commercialize our products. We may also discover that the reductions in workforce could make it difficult for us to pursue new opportunities and initiatives and require us to hire qualified replacement personnel, which may require us to incur additional and unanticipated costs and expenses. Our future financial performance and our ability to develop our products or additional assets will depend, in part, on our ability to effectively manage any future growth or restructuring, as the case may be. Our failure to successfully accomplish any of the above activities and goals may have a material adverse impact on our business, results of operations and financial condition.
Current report
Changes in U.S. or international social, political, regulatory and economic conditions or in laws and policies governing trade, manufacturing, development and investment in the countries where we currently conduct our business could adversely affect our business, reputation, financial condition and results of operations. Changes or proposed changes in U.S. or other countries’ trade policies may result in restrictions and economic disincentives on international trade.
Current report
We currently manufacture, package and distribute all of our products, including CGuard Prime, which we commercially launched in July 2025 following FDA approval of the PMA in June 2025, at our own facility in Israel. To support our anticipated production growth following the commercialization of CGuard Prime, we have engaged Aptyx to expand our manufacturing capacity of CGuard Prime finished goods to full-scale production at their ISO Class 7 cleanroom facility in North Carolina. While we are in the process of establishing manufacturing operations in the United States with Aptyx, this transition will take time, and until it is operational, we expect to rely entirely on product shipments from Israel to the U.S. market.
Current report
The U.S. government has recently adopted, proposed and considered a variety of tariff measures and other trade restrictions affecting imports from numerous countries, and additional changes to U.S. trade policy remain under active consideration. The implementation, modification, suspension, expiration, extension or judicial review of existing or proposed tariffs and trade measures has created and may continue to create significant uncertainty for companies engaged in international manufacturing and cross-border commerce. In addition, new investigations under U.S. trade laws, changes to customs rules, import restrictions, sanctions or other trade-related measures could result in additional duties, restrictions or compliance obligations affecting imported products and components.
Current report
Because we currently manufacture our products in Israel and remain dependent on shipments from Israel to serve the U.S. market while we continue efforts to expand manufacturing capacity in the United States, changes in tariffs, customs duties, import regulations or other trade measures applicable to products imported into the United States could increase our costs, reduce our margins, disrupt our supply chain, adversely affect customer demand or require us to modify our manufacturing, sourcing or distribution strategies. We cannot predict the scope, duration or outcome of current or future trade actions, related legal challenges, or any retaliatory measures by affected countries. Any of these developments could have a material adverse effect on our business, financial condition and results of operations.
Current report
Tariffs, economic sanctions and other changes in U.S. trade policy have in the past and could in the future trigger retaliatory actions by affected countries, and certain foreign governments have instituted or are considering imposing retaliatory measures on certain U.S. goods. Further, any emerging protectionist or nationalist trends (whether regulatory- or consumer-driven) either in the United States or in other countries could affect the trade environment. Our business, like many other corporations, would be impacted by changes to the trade policies of the United States and foreign countries (including governmental action related to tariffs, international trade agreements, or economic sanctions). We cannot predict whether, and to what extent, trade policies will change in the future. If tariffs or other trade restrictions are imposed on products manufactured in Israel while we remain dependent on Israeli manufacturing, our cost of goods sold for the U.S. market may increase materially, which could negatively impact our gross margins and limit our pricing flexibility. Additionally, changes to trade agreements or customs regulations between the U.S. and Israel could increase lead times, introduce logistical complexities, or require modifications to our supply chain planning. These or similar trade-related developments may have a material adverse effect on our business, financial condition, and results of operations.
Reworded paragraphs (4)
Previous wording
The manufacturing and marketing of medical devices involves an inherent risk that our products may prove to be defective and cause a health risk even after regulatory clearances have been obtained. The FDA and similar governmental authorities in other countries have the authority to require the recall of commercialized products in the event of material regulatory deficiencies or defects in design or manufacture. Medical devices may also be modified after regulatory clearance is obtained to such an extent that additional regulatory clearance is necessary before the device can be further marketed. In these events, we may voluntarily implement a recall or market withdrawal or may be required to do so by a regulatory authority. For example, in May 2026, we announced a voluntary recall in the U.S. of CGuard Prime, initiated in consultation with the FDA. This decision followed our determination during controlled launch that the technical success of the delivery system during CAS procedures had not met performance expectations Such recall, and any recalls in the future, could result in significant current and future costs and other negative impacts associated with such recalls (including inventory write-off costs, refunds and other remediation costs), loss of revenues, sales or customers, potential actions by regulators or other governmental entities, potential claims and lawsuits by customers and patients (including class action product liability litigation), other operational impacts and consequences such as business disruption, loss of personnel and distraction of management or other key employees, the restatement of previously issued financial statements, inability to raise capital, as well as negative publicity and damage to our reputation, which could have a material adverse impact on our business, results of operations and financial condition.
Current wording
The manufacturing and marketing of medical devices involves an inherent risk that our products may prove to be defective and cause a health risk even after regulatory clearances have been obtained. The FDA and similar governmental authorities in other countries have the authority to require the recall of commercialized products in the event of material regulatory deficiencies or defects in design or manufacture. Medical devices may also be modified after regulatory clearance is obtained to such an extent that additional regulatory clearance is necessary before the device can be further marketed. In these events, we may voluntarily implement a recall or market withdrawal or may be required to do so by a regulatory authority. For example, in May 2026, we announced a voluntary recall in the U.S. of CGuard Prime, initiated in consultation with the FDA. This decision followed our determination during controlled launch that the technical success of the delivery system during CAS procedures had not met performance expectations. Such recall, and any recalls in the future, could result in significant current and future costs and other negative impacts associated with such recalls (including inventory write-off costs, refunds), loss of revenues, sales or customers, potential actions by regulators or other governmental entities, potential claims and lawsuits by customers and patients (including class action product liability litigation), other operational impacts and consequences such as business disruption, loss of personnel and distraction of management or other key employees, the restatement of previously issued financial statements, inability to raise capital, as well as negative publicity and damage to our reputation, which could have a material adverse impact on our business, results of operations and financial condition.
Previous wording
Defects or failures associated with our products has led to recalls, and could lead to additional recalls, safety alerts or litigation, as well as significant costs and negative publicity.
Current wording
Defects or failures associated with our products have led to recalls, and could lead to additional recalls, safety alerts or litigation, as well as significant costs and negative publicity.
Previous wording
For example, in May 2026, we announced a voluntary recall in the U.S. of CGuard Prime, initiated in consultation with the FDA. This decision followed our determination during controlled launch that the technical success of the delivery system during CAS procedures had not met performance expectations. Such recall, and any recalls in the future, could result in significant current and future costs and other negative impacts associated with such recalls (including inventory write-off costs, refunds and other remediation costs), loss of revenues, sales or customers, potential actions by regulators or other governmental entities, potential claims and lawsuits by customers and patients (including class action product liability litigation), other operational impacts and consequences such as business disruption, loss of personnel and distraction of management or other key employees, or the restatement of previously issued financial statements, inability to raise capital, as well as negative publicity and damage to our reputation, which could have a material adverse impact on our business, results of operations and financial condition.
Current wording
For example, in May 2026, we announced a voluntary recall in the U.S. of CGuard Prime, initiated in consultation with the FDA. This decision followed our determination during controlled launch that the technical success of the delivery system during CAS procedures had not met performance expectations. Such recall, and any recalls in the future, could result in significant current and future costs and other negative impacts associated with such recalls (including inventory write-off costs, refunds), loss of revenues, sales or customers, potential actions by regulators or other governmental entities, potential claims and lawsuits by customers and patients (including class action product liability litigation), other operational impacts and consequences such as business disruption, loss of personnel and distraction of management or other key employees, or the restatement of previously issued financial statements, inability to raise capital, as well as negative publicity and damage to our reputation, which could have a material adverse impact on our business, results of operations and financial condition.
Previous wording
Further, in April 2024 and October 2024, Iran launched a series of drone and missile strikes against Israel, to which Israel responded. In addition, in response to ongoing Iranian aggression and support of proxy attacks against Israel, on June 13, 2025, Israel conducted a series of preemptive defensive air strikes in Iran targeting Iran’s nuclear program and military commanders. While a ceasefire was reached in June 2025 following 12 days of hostilities, on February 28, 2026, the United States and Israel launched coordinated military strikes against Iran, including attacks on strategic military infrastructure and leadership targets, with the stated aim of degrading Iran’s capacity to conduct or support hostile operations against them. In response, Iran has fired missiles and drones toward population centers and military installations in Israel, Europe and neighboring countries in the Gulf region, and also launched counter-strikes against U.S. forces and allied bases throughout the Gulf region. While a temporary ceasefire agreed to between Iran and the U.S. on April 8, 2026 as part of ongoing negotiations for a permanent ceasefire agreement, the situation remains volatile and uncertain. Although the ceasefire has been subject to extensions and continued diplomatic engagement, it has reportedly been characterized by tensions, alleged violations and stalled negotiations. We cannot predict if and to what extent this ceasefire will remain in effect or upheld or whether hostilities may resume or further escalate. A broader regional conflict involving additional state and non-state actors remains a significant risk How long and how severe the conflicts in Gaza, Northern Israel, Lebanon, Iran or the broader region last and become is unknown at this time and any renewed or continued clash among Israel, Hamas, Hezbollah, Iran or other countries or militant groups in the region may escalate in the future into a greater regional conflict. Continued military escalation, retaliatory actions, or broader regional involvement may adversely affect economic conditions, disrupt markets, and create uncertainty that could negatively impact our business, financial condition and results of operations.
Current wording
Further, in April 2024 and October 2024, Iran launched a series of drone and missile strikes against Israel, to which Israel responded. In addition, in response to ongoing Iranian aggression and support of proxy attacks against Israel, on June 13, 2025, Israel conducted a series of preemptive defensive air strikes in Iran targeting Iran’s nuclear program and military commanders. While a ceasefire was reached in June 2025 following 12 days of hostilities, on February 28, 2026, the United States and Israel launched coordinated military strikes against Iran, including attacks on strategic military infrastructure and leadership targets, with the stated aim of degrading Iran’s capacity to conduct or support hostile operations against them. In response, Iran has fired missiles and drones toward population centers and military installations in Israel, Europe and neighboring countries in the Gulf region, and also launched counter-strikes against U.S. forces and allied bases throughout the Gulf region. Although the United States and Iran have announced ceasefire and de-escalation arrangements from time to time, including a memorandum of understanding entered into on June 17, 2026 that contemplates the termination of military operations on multiple fronts, hostilities have resumed and may continue or escalate. A broader regional conflict involving additional state and non-state actors remains a significant risk. How long and how severe the conflicts in Gaza, Northern Israel, Lebanon, Iran or the broader region last and become is unknown at this time and any renewed or continued clash among Israel, Hamas, Hezbollah, Iran or other countries or militant groups in the region may escalate in the future into a greater regional conflict. Continued military escalation, retaliatory actions, or broader regional involvement may adversely affect economic conditions, disrupt markets, and create uncertainty that could negatively impact our business, financial condition and results of operations.