v3.26.1
DESCRIPTION OF BUSINESS
 6 Months Ended
Jun. 30, 2026
Organization, Consolidation and Presentation of Financial Statements [Abstract]  
DESCRIPTION OF BUSINESS

NOTE 1 - DESCRIPTION OF BUSINESS

 

  a. General
     
   

InspireMD, Inc., a Delaware corporation (the “Company”), together with its subsidiaries in Israel and Germany, is a medical device company specializing in the development and commercialization of products for the treatment of carotid artery disease and other vascular conditions. The Company’s portfolio includes two commercial products based on its proprietary CGuard™ carotid stent technology, designed to provide market-leading embolic protection during and after stenting procedures. A stent is an expandable scaffold-like metallic device placed in an artery to widen the lumen and restore blood flow.

     
    The Company’s first product, the CGuard™ Carotid Embolic Prevention System (“CGuard EPS”), integrates a self-expanding nitinol stent with a MicroNet™ mesh sleeve as a single device for carotid artery revascularization. The Company has received CE Mark recertification for CGuard EPS under the EU Medical Device Regulation (“MDR”). The Company’s CGuard EPS previously held CE Mark approval under the former Medical Device Directive (“MDD”). CGuard EPS is marketed in over 30 countries outside the United States, mainly in Europe, through a network of distributors. In the first quarter of 2026, the Company submitted a premarket approval (“PMA”) to the U.S. Food and Drug Administration (“FDA”) for the CGuard EPS.
     
   

The Company’s second product, the CGuard™ Prime Carotid Stent System (“CGuard Prime”), uses the same stent and MicroNet mesh with a differentiated deployment mechanism. CGuard Prime received PMA by the FDA on June 23, 2025. CGuard Prime also received MDR CE Mark approval on June 12, 2025. 

     
    In May 2026, the Company announced a voluntary recall in the U.S. of CGuard Prime, initiated in consultation with the FDA after the Company determined during a controlled launch that the technical success rate of its delivery system during CAS procedures did not meet performance expectations. The voluntary action was limited to the CGuard Prime delivery system and did not involve the CGuard stent implant. The Company’s assessment did not identify new safety concerns for patients who had previously received a CGuard implant.
     
   

As of June 30, 2026, substantially all affected products were returned and credits were issued to customers. The Company recorded approximately $734,000 as a reduction of revenue related to these returns. In addition, the Company recorded approximately $612,000 of inventory impairment associated with the recall.

 

 

  b.

Liquidity

     
    The Company has an accumulated deficit as of June 30, 2026, as well as a history of net losses and negative operating cash flows. The Company expects to continue incurring losses and negative cash flows from operations until the Company expands its commercial revenue to a scale that funds its commercial resources, development activities and support functions. As a result of these expected losses and negative cash flows from operations, along with the Company’s current cash position, the Company does not have sufficient resources to fund operations for at least the next 12 months. Therefore, there is substantial doubt about the Company’s ability to continue as a going concern. These financial statements have been prepared assuming that the Company will continue as a going concern and do not include any adjustments that might result from the outcome of this uncertainty.
     
    On July 17, 2026, the Company received a notification letter from the Nasdaq Listing Qualifications notifying the Company that it is not in compliance with the minimum bid price requirements set forth in Nasdaq Listing Rule 5550(a)(2) for continued listing on The Nasdaq Capital Market.
     
    Management’s plans include the continued commercialization of the Company’s products and raising capital through the sale of additional equity securities, debt or capital inflows from potential strategic partnerships and exercises of warrants. There are no assurances, however, that the Company will be successful in obtaining the level of financing needed for its operations. If the Company is unsuccessful in commercializing its products and raising capital, it may need to reduce activities, curtail or cease operations.
     
  c.

Risks Related to the Company’s Operations in Israel 

     
   

On October 7, 2023, Hamas launched a series of attacks on civilian and military targets in Southern Israel and Central Israel, to which the Israel Defense Forces responded. In addition, Iran, Hezbollah and the Houthi movement attacked military and civilian targets in Israel, to which Israel responded, including through increased air and/or ground operations in Lebanon, Syria, Yemen and Iran. Following years of conflict in the region, on October 9, 2025, Israel, Hamas, the United States and other countries in the region agreed to a framework for a ceasefire in Gaza between Israel and Hamas. On February 28, 2026, the United States and Israel launched joint combat operations in Iran to which Iran and Hezbollah responded with ballistic missile and drone attacks on Israel as well as other countries and U.S. military bases in the 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. How long and how severe the current conflicts in Gaza, Northern Israel, Lebanon, Iran or the broader region last and become is unknown at this time and any 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. The intensity and duration of the security situation in Israel have been difficult to predict, as are the economic implications on our business and operations and on Israel’s economy in general. As of the date of these condensed consolidated financial statements, conflict continues in parts of the region. The Company’s current manufacturing facility, certain of its key personnel and one of its offices are located in Israel. At this time, these activities remain largely unaffected.

     
   

During the three and six months ended June 30, 2026 and 2025, the impact of this war on the Company’s results of operations and financial condition was immaterial, but such impact may increase, which could be material, as a result of the continuation, escalation or expansion of such war.