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 Reports Second Quarter 2024 Financial Results and Provides Business Update
– Announced positive outcomes from the C-GUARDIANS IDE clinical trial of the CGuard™ Prime carotid stent system demonstrating a one-year primary endpoint event rate of 1.95%, the lowest for any carotid stent or embolic protection device pivotal trial – – On track to submit a Premarket Approval (PMA) application to the FDA this quarter –… 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 to Report Second Quarter 2024 Financial Results and Provide Corporate Business Update on Tuesday, August 6th
InspireMD to Report Second Quarter 2024 Financial Results and Provide Corporate Business Update on Tuesday, August 6th -Conference call and webcast to be held at 8:30 a.m. EDT- Tel Aviv, Israel, and Miami, FL — July 30, 2024 – InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) device for the… 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
InspireMD Reports First Quarter 2024 Financial Results and Provides Business Update
– Generated first quarter 2024 CGuard EPS revenue of $1.51 million, an increase of 22.0% over the first quarter of 2023 – – Announced that an abstract detailing one-year outcomes from the C-GUARDIANS IDE clinical trial of CGuard™ Prime has been accepted for presentation at LINC 2024, to be held May 28-31 – – Named… Read More