Inspiremd, INC 8-K filings

InspireMD, Inc. announced the elimination of its Chief Commercial Officer position, with Shane Gleason's last day of employment set for July 31, 2026.

InspireMD received a Nasdaq delisting warning due to failing to meet the minimum bid price requirement, with 180 days to regain compliance.

InspireMD, Inc. announced the resignation of board member Raymond W. Cohen, effective July 1, 2026, due to personal considerations.

InspireMD reports 100% acute device success and no major adverse events in its CGUARDIANS II clinical trial for the CGuard Prime 80 cm implant in TCAR procedures, awaiting FDA review.

InspireMD's 2026 annual meeting saw stockholders approve a significant increase in authorized common stock, alongside director re-elections and auditor ratification.

InspireMD announced that Board Chair Paul Stuka will not seek reelection at the 2027 Annual Meeting, initiating a formal succession planning process.

InspireMD announced a 122% year-over-year revenue increase for Q1 2026 to $3.4 million, alongside FDA IDE approval for a new clinical trial, but also initiated a voluntary recall of its CGuard Prime 135 cm system.

InspireMD has initiated a voluntary recall of its CGuard Prime 135 cm delivery system due to performance issues while simultaneously receiving FDA approval for its SwitchGuard IDE study.

InspireMD, Inc. has entered into a new Equity Distribution Agreement with BTIG, LLC, allowing for the potential sale of up to $75 million in common stock, while simultaneously terminating a previous agreement with Piper Sandler & Co.

InspireMD, Inc. announced robust fourth-quarter and full-year 2025 financial results, driven by CGuard Prime's U.S. launch and international demand, alongside strategic advancements in TCAR procedures.

InspireMD, Inc. announced the dismissal of Chief Operating Officer Andrea Tommasoli, effective April 1, 2026, with a six-month notice period.

InspireMD announces the resignation of director Kathryn Arnold, effective December 31, 2025, with specific compensatory arrangements approved by the Compensation Committee.

InspireMD announced a 39% revenue increase to $2.5 million in Q3 2025, driven by the successful U.S. commercial launch of its CGuard Prime carotid stent system.

InspireMD, Inc. announced the appointment of seasoned medical device executive Dan Dearen to its Board of Directors, replacing Thomas J. Kester.

InspireMD, Inc. announced the appointment of director Raymond W. Cohen to its Audit and Compensation Committees.

InspireMD, Inc. announced its second quarter 2025 financial results, reporting increased net losses despite achieving key regulatory approvals and commencing the U.S. commercial launch of its CGuard Prime carotid stent system.

InspireMD announced a combined $58 million in gross proceeds from a private placement and warrant exercise, alongside the appointment of seasoned medical technology executive Raymond W. Cohen to its Board of Directors, bolstering its financial position for the U.S. launch of its FDA-approved CGuard Prime carotid stent system.

InspireMD, Inc. announced the official U.S. commercial launch of its CGuard Prime carotid stent system for stroke prevention, following its premarket application approval from the U.S. Food and Drug Administration.

InspireMD, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted premarket approval (PMA) for its CGuard Prime Carotid Stent System, a significant milestone for stroke prevention.

InspireMD, Inc. announced it has received CE Mark approval under the European Medical Device Regulation (MDR) for its CGuard Prime Embolic Prevention System (EPS), clearing the path for commercial launch in CE marked markets and advancing its stroke prevention technology.

InspireMD, Inc. announced the appointment of Michael Lawless as its new Chief Financial Officer, effective by June 30, 2025, succeeding Craig Shore, to lead the company's financial strategy during its upcoming U.S. launch of CGuard Prime.

InspireMD, Inc. announced the successful re-election of Michael Berman and Scott R. Ward to its Board of Directors and the ratification of Kesselman & Kesselman as its independent registered public accounting firm for the 2025 fiscal year at its annual meeting.

InspireMD announced a marginal revenue increase but a significant rise in net loss for Q1 2025, while expressing optimism for FDA approval of its CGuard Prime system in Q3 2025.

InspireMD reports increased revenue for Q4 and full year 2024, driven by growth in new and existing markets, while awaiting potential FDA approval for its CGuard Prime carotid stent system.

InspireMD's Chief Financial Officer, Craig Shore, has announced his retirement, effective upon the appointment of his successor, with a transition period planned for 2025.

InspireMD has announced the enrollment of the first patient in its CGUARDIANS II clinical trial, evaluating the CGuard Prime Carotid Stent System for Transcarotid Artery Revascularization (TCAR) procedures.

InspireMD has appointed Scott R. Ward, a seasoned medical technology executive, to its Board of Directors, effective November 25, 2024.

InspireMD reported record quarterly revenue and unit sales, submitted a Premarket Approval application to the FDA for its CGuard Prime stent, and established a new headquarters in Miami.

InspireMD, Inc. has established its global headquarters in Miami, Florida, to support the anticipated U.S. launch and commercialization of its CGuard Prime carotid stent system.

InspireMD has received FDA approval for its Investigational Device Exemption (IDE) application to begin the CGUARDIANS II pivotal study of its CGuard Prime 80cm Carotid Stent System.