Welcome to our dedicated page for Inspiremd SEC filings (Ticker: NSPR), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
InspireMD filings document regulatory disclosures for a Nasdaq-listed medical device company focused on CGuard carotid stent systems and related neuro protection technology. Recent Form 8-K reports cover operating and financial results, Regulation FD materials, FDA IDE and product-recall disclosures, capital-raising arrangements under an at-the-market equity distribution agreement, and executive employment matters.
Proxy materials describe annual meeting voting items, board and compensation governance, and stockholder procedures. Registration-statement references and capital-structure disclosures identify common stock, shelf registration mechanics, offering terms, and Nasdaq Capital Market listing information.
InspireMD, Inc. director Ward Scott R. reported open-market purchases of company common stock. He bought 15,995 shares on May 6 and 73,255 shares on May 7 at a weighted average price of $1.15 per share, with individual trade prices ranging from $1.13 to $1.15. Following these transactions, he directly holds 237,096 shares of InspireMD common stock.
InspireMD, Inc. director Paul Stuka increased his stake through open-market purchases of Common Stock. On May 7, 2026, he bought 6,378 shares at $1.15 per share, and on May 6, 2026 he bought 1,517 shares at $1.12 per share. After these transactions, he directly holds 531,599 shares of InspireMD common stock. A footnote explains that the May 7 price reflects a weighted average for multiple trades executed between $1.14 and $1.15 per share.
InspireMD, Inc. director Gary S. Roubin made an open-market purchase of 90,000 shares of Common Stock. He bought the shares at a weighted average price of $1.18 per share, through multiple trades between $1.15 and $1.20. Following this transaction, he directly owns 834,478 shares, increasing his personal stake in the company.
InspireMD reported sharply higher Q1 2026 revenue but deeper losses and serious liquidity risk. Revenue rose to $3.4 million, up 122% from $1.5 million, driven mainly by the U.S. launch of CGuard Prime and growth in international sales.
Gross margin improved slightly to 20.2%, but operating expenses climbed to $14.7 million as the company expanded U.S. R&D and commercialization. Net loss widened to $13.7 million, and operating cash outflow reached $12.3 million. Cash and marketable securities totaled $41.6 million at quarter end.
The company disclosed a voluntary U.S. recall of its CGuard Prime 135 cm delivery system, with estimated reserves of about $700,000 for customer returns and $650,000 for inventory impairment and remediation. Management states there is substantial doubt about its ability to continue as a going concern without additional capital, and highlights ongoing geopolitical risks tied to its Israeli manufacturing base.
InspireMD reported strong growth for the first quarter of 2026, with revenue reaching $3.4 million, up 122% from $1.5 million a year earlier. U.S. revenue was $1.2 million, a 36% sequential increase, while international revenue rose 48% year over year to $2.2 million.
Despite this growth, the company recorded a net loss of $13.7 million, or $0.16 per share, as operating expenses climbed to $14.7 million to support U.S. commercialization. InspireMD booked an inventory impairment charge, but on an adjusted basis gross margin improved to 34.1% of revenue.
Operationally, the company received FDA IDE approval to initiate the CGUARDIANS III trial for its SwitchGuard neuro protection system in TCAR procedures and expects FDA decisions on its original CGuard delivery system in Q3 2026 and CGuard Prime 80 cm in H2 2026. Management also outlined expected reserves tied to the U.S. recall of CGuard Prime.
InspireMD filed an 8-K detailing a mix of product setback and regulatory progress. The company has initiated a voluntary U.S. recall of its CGuard Prime 135 cm carotid stent delivery system after controlled-launch experience showed technical success in procedures did not meet performance expectations. The CGuard stent implant itself is not included in the recall and continues in use.
Management highlighted strong demand, citing Q1 2026 global year-over-year unit sales growth of 53% and 34% quarter-over-quarter U.S. unit sales growth, but is withdrawing its prior full-year 2026 revenue guidance due to the temporary pause in U.S. commercialization while it awaits anticipated FDA approval of the original CGuard delivery system in the third quarter of 2026. InspireMD also expects FDA approval of the CGuard Prime 80 cm system for TCAR procedures in the second half of 2026 and is pursuing design improvements to the 135 cm system, with FDA approval anticipated in the first half of 2027.
Separately, the FDA has approved an Investigational Device Exemption for the CGUARDIANS III pivotal study of the SwitchGuard neuro protection system for use with the CGuard Prime 80 cm stent platform in TCAR procedures, supporting plans for a potential U.S. commercial launch of SwitchGuard in 2027 and expanding access to a TCAR market estimated at approximately 35,000 procedures annually in the United States.
InspireMD filed an 8-K detailing a mix of product setback and regulatory progress. The company has initiated a voluntary U.S. recall of its CGuard Prime 135 cm carotid stent delivery system after controlled-launch experience showed technical success in procedures did not meet performance expectations. The CGuard stent implant itself is not included in the recall and continues in use.
Management highlighted strong demand, citing Q1 2026 global year-over-year unit sales growth of 53% and 34% quarter-over-quarter U.S. unit sales growth, but is withdrawing its prior full-year 2026 revenue guidance due to the temporary pause in U.S. commercialization while it awaits anticipated FDA approval of the original CGuard delivery system in the third quarter of 2026. InspireMD also expects FDA approval of the CGuard Prime 80 cm system for TCAR procedures in the second half of 2026 and is pursuing design improvements to the 135 cm system, with FDA approval anticipated in the first half of 2027.
Separately, the FDA has approved an Investigational Device Exemption for the CGUARDIANS III pivotal study of the SwitchGuard neuro protection system for use with the CGuard Prime 80 cm stent platform in TCAR procedures, supporting plans for a potential U.S. commercial launch of SwitchGuard in 2027 and expanding access to a TCAR market estimated at approximately 35,000 procedures annually in the United States.
InspireMD, Inc. executive Marvin Slosman filed a Schedule 13D reporting beneficial ownership of 2,556,760 shares of InspireMD common stock, representing 5.18% of the outstanding shares. This stake reflects his role as Chief Executive Officer and director.
The holdings include 16,722 common shares, multiple tranches of restricted stock units that are currently exercisable or become exercisable within 60 days, and 696,005 shares issuable upon exercise of stock options that are currently exercisable or become exercisable within 60 days. Only 10,330 shares were purchased for cash in a July 2025 private placement for $24,998.60; the remainder were granted as equity compensation.
Based on company information, InspireMD had 46,838,962 shares outstanding as of the date referenced. Slosman states he has no present plans for corporate actions such as mergers or control changes, and he reports no transactions in InspireMD shares in the prior 60 days, while reserving the right to buy or sell securities in the future.
InspireMD, Inc. has called its 2026 Annual Meeting of Stockholders for June 3, 2026 at its Tel Aviv offices. Stockholders will vote on re-electing three Class 3 directors, including CEO Marvin Slosman, and on several key corporate matters.
The agenda includes amending the certificate of incorporation to increase authorized common shares from 150,000,000 to 250,000,000, ratifying Kesselman & Kesselman (PwC network) as independent auditor for 2026, and approving a potential adjournment to solicit additional proxies if needed. Holders of InspireMD common stock at the April 10, 2026 record date, when 46,892,979 shares were outstanding, are entitled to vote, either in person or by proxy, with detailed instructions provided for registered and street-name holders.
InspireMD, Inc. is soliciting stockholder votes at its annual meeting to be held June 3, 2026, to elect three Class 3 directors and to approve an amendment to increase authorized common stock from 150,000,000 shares to 250,000,000.
The board also asks ratification of Kesselman & Kesselman as auditor and approval of an adjournment proposal. The record date for voting was April 10, 2026, and shares outstanding were 46,892,979 as of April 10, 2026.