a.

General

InspireMD, Inc., a Delaware corporation (the “Company”), together with its subsidiaries, including InspireMD Ltd., an Israeli corporation, and InspireMD GmbH, a German corporation, is a medical device company focusing on the development and commercialization of products for the treatment of carotid artery disease and other vascular disease, including the Company’s proprietary CGuard™ stent platform. A stent is an expandable scaffold-like device, usually constructed of a metallic material, that is inserted into the lumen of an artery to create patency and improved blood flow. A sleeve of MicroNet™ mesh is attached over a stent to provide embolic protection both during and after stenting procedures.

The Company’s carotid product (CGuard™ EPS) combines MicroNet and a self-expandable nitinol stent in a single device to treat carotid artery disease.

The Company markets its products through distributors in international markets, mainly in Europe, and is seeking FDA approval for its CGuard Prime carotid stent system to enter the U.S. market.

b.

Liquidity

The Company has an accumulated deficit as of December 31, 2024, 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 its product, CGuard™ EPS, reaches commercial profitability. 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 consolidated 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.

Management’s plans include the continued commercialization of the Company’s product and raising capital through the sale of additional equity securities, debt or capital inflows from 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

In October 2023, Israel was attacked by a terrorist organization and entered a state of war on several fronts. As of the date of these consolidated financial statements, sustained conflict in the region is ongoing and Israel has entered into certain ceasefires, the results of which are uncertain. The Company operations, including its production facility, are located in Israel. Currently, such activities in Israel remain largely unaffected.

During the years ended December 31, 2024 and 2023, 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.

d.

Risks Related to the Geopolitical and Military Tensions Between Russia and Ukraine in Europe

The Company derived approximately 14.5% and 13.5% in the years ended December 31, 2024 and 2023, respectively, of total sales in Russia and Belarus. The escalation of geopolitical instability in Russia and Ukraine as well as currency fluctuations in the Russian Ruble could negatively impact the Company’s operations, sales, and future growth prospects in that region.