InspireMD, Inc.

InspireMD announced the resignation of Raymond W. Cohen from its Board of Directors, effective July 1, 2026. Mr. Cohen, a Class III director and member of both the Audit and Compensation Committees, cited personal considerations for his departure. The company stated that his resignation was not due to any disagreement with InspireMD, its Board, or management. The Nominating and Corporate Governance Committee plans to identify suitable candidates to fill the vacant position.

InspireMD, Inc. announced that its Compensation Committee approved inducement grants of 91,161 restricted shares to six new non-executive employees. These grants, made under the 2024 Inducement Plan, are intended to incentivize the new hires in accordance with Nasdaq Listing Rule 5635(c)(4). The restricted stock vests over a three-year period, with one-third vesting on the first anniversary and the remainder in two equal installments on the second and third anniversaries, subject to continued employment.

InspireMD announced positive 30-day outcomes from its CGUARDIANS II clinical trial for the CGuard Prime 80 cm implant, intended for transcarotid artery revascularization (TCAR) procedures. The trial demonstrated 100% acute device success with no deaths, strokes, myocardial infarctions, or stent thrombosis reported within 30 days. A Premarket Approval (PMA) supplement is currently under FDA review, with potential approval in the second half of 2026, which could significantly expand the company's addressable market to include TCAR procedures.

InspireMD announced the enrollment of the first patient in its CGUARDIANS III pivotal study for the SwitchGuard neuro protection system (NPS). This study evaluates the safety and efficacy of SwitchGuard NPS, used with the CGuard Prime 80 cm stent platform, in transcarotid artery revascularization (TCAR) procedures. The company aims to capture a share of the estimated 70,000 TCAR procedures expected annually in the U.S. by 2030, with the SwitchGuard NPS potentially setting a new standard of care.

InspireMD, Inc. held its 2026 annual meeting of stockholders, where an amendment to the Company's Amended and Restated Certificate of Incorporation was approved. This amendment increases the authorized number of common stock shares from 150,000,000 to 250,000,000. Additionally, stockholders re-elected Marvin Slosman, Raymond Cohen, and Dan Dearen to the board of directors and ratified Kesselman & Kesselman as the independent registered public accounting firm for the 2026 fiscal year.

InspireMD, Inc. announced that Mr. Paul Stuka will not seek re-election as a Class I director and plans to retire from the Board of Directors at the Company's 2027 Annual Meeting of Stockholders. Mr. Stuka currently serves as the Chair of the Board and the Compensation Committee, and is a member of the Audit and Nominating and Corporate Governance Committees. His decision was not due to any disagreement with the company, and he is expected to continue serving until his term expires. The Nominating and Corporate Governance Committee will identify suitable candidates for the Board as part of succession planning.

InspireMD reported a significant 122% increase in Q1 2026 revenue to $3.398 million, but its net loss widened to $13.689 million. The company disclosed substantial doubt about its ability to continue as a going concern due to a history of losses and negative operating cash flows. Additionally, subsequent to the quarter, InspireMD announced a voluntary recall of its CGuard Prime 135 cm carotid stent delivery system in the U.S., estimating $1.35 million in related reserves for customer returns and inventory impairment.

InspireMD reported Q1 2026 revenue of $3.4 million, a 122% year-over-year increase, driven by strong demand for CGuard Prime in the U.S. and original CGuard internationally. The company received FDA IDE approval for the CGUARDIANS III clinical trial of its SwitchGuard neuro protection system and anticipates FDA approval for the original CGuard delivery system in Q3 2026. However, InspireMD initiated a voluntary recall of its CGuard Prime 135 cm carotid stent delivery system to implement technical enhancements, expecting a financial impact of $700,000 for customer returns and $650,000 for inventory impairment and remediation costs.

InspireMD, Inc. reported Q1 2026 total revenue of $3.4 million, marking a 122% year-over-year increase, driven by strong demand for CGuard Prime in the U.S. and original CGuard internationally. The company received FDA IDE approval to initiate the CGUARDIANS III clinical trial for its SwitchGuard neuro protection system and anticipates FDA approval for the original CGuard delivery system in Q3 2026 and CGuard Prime 80 cm in H2 2026. However, InspireMD also initiated a voluntary recall of its CGuard Prime 135 cm delivery system for technical enhancements, which is expected to impact short-term availability and incur approximately $1.35 million in related costs. The net loss for Q1 2026 was $13.7 million.

InspireMD announced that the U.S. FDA has approved its Investigational Device Exemption (IDE) Application for the CGUARDIANS III pivotal study. This study will evaluate the company's SwitchGuard neuro protection system (NPS), including next-generation enhancements, for use with its CGuard Prime 80 cm stent platform in transcarotid artery revascularization (TCAR) procedures. The company aims for a U.S. commercial launch of the SwitchGuard NPS in 2027, if approved.