Press Releases

InspireMD Announces Establishment of Global Headquarters in Miami, Florida to Support Anticipated U.S. Launch and Commercialization of the CGuard Prime Carotid Stent System

Miami, Florida — October 15, 2024 – InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke, today announced the establishment of its global headquarters in Miami, Florida. The new facility will ideally position the Company to support the anticipated U.S. launch and commercialization of the CGuard… Read More

InspireMD Announces Approval of Investigational Device Exemption (IDE) Application for CGUARDIANS II Pivotal Study of the CGuard Prime 80cm Carotid Stent System

Miami, Florida — October 7, 2024 – InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke, today announced that the U.S. Food and Drug Administration (FDA) has approved the company’s Investigational Device Exemption (IDE) Application to initiate the CGUARDIANS II pivotal study of its CGuard Prime… Read More

InspireMD Announces Submission of Premarket Approval Application to FDA Seeking U.S. Regulatory Approval of the CGuard™ Prime Carotid Stent System

InspireMD Announces Submission of Premarket Approval Application to FDA Seeking U.S. Regulatory Approval of the CGuard™ Prime Carotid Stent System PMA based on overwhelmingly positive results from the pivotal C-GUARDIANS clinical study that were first presented at LINC 2024 in May U.S. commercial launch anticipated in H1 2025, if approved Tel Aviv, Israel, and Miami,… Read More

New! Mullings Group Interview with InspireMD Leadership

Dear Investors, We are pleased to share with you an exciting development that highlights our continued success and promising future. Recently, Joe Mullings, Chairman & CEO of the Mullings Group and a med tech consultant, expert and recruiter, conducted an insightful interview with our CEO, Marvin Slosman, Chief Commercial Officer, Shane Gleason, and Executive VP… Read More

InspireMD Congratulates CREST-2 Investigators on Completion of Trial Enrollment

CGuard was the only investigational carotid stent approved by FDA for inclusion in the trials CREST-2 included 23 cases implanted with CGuard Tel Aviv, Israel, and Miami, Florida — Augst 5, 2024 – InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke, today congratulated the lead… Read More

InspireMD Announces Full Exercise of Series H Warrant Tranche for Gross Proceeds of $17.9 Million

Series H warrants exercisable following release of positive outcomes results related to one-year follow-up from the Company’s C-GUARDIANS pivotal trial.     Participating warrant holders include Marshall Wace, OrbiMed, Rosalind,              Nantahala, Soleus, Velan, and certain InspireMD Board members.      Represents first of four milestone-driven warrant tranches pursuant to… Read More

InspireMD Announces Presentation of Positive One-Year Follow-Up Results from the C-GUARDIANS U.S. Investigational Device Exemption (IDE) Clinical Trial of CGuard at LINC 2024

Data demonstrate lowest reported primary endpoint event rate of 1.95% through twelve months post-procedure for any carotid stent or embolic protection device pivotal trial Study results to support a Premarket Approval (PMA) application to FDA in H2 2024 U.S. commercial launch of the CGuard™ Prime Carotid Stent System anticipated in H1 2025, if approved  Tel… Read More