Tag: InspireMD

InspireMD Supports CMS’ Final National Coverage Determination (NCD) Expanding Coverage of Carotid Stenting (CAS) to Include Both Asymptomatic and Standard Risk Patients

TEL AVIV, Israel and MIAMI, Oct. 12, 2023 (GLOBE NEWSWIRE) — InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke, today announced its support for the Centers for Medicare and Medicaid Services (CMS) final National Coverage Determination (NCD) which expands coverage […]

InspireMD Announces Senior Leadership Changes to Support Commercial Growth Initiatives

TEL AVIV, Israel and MIAMI, Oct. 03, 2023 (GLOBE NEWSWIRE) — InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke, today announced senior leadership additions and changes intended to support the company’s commercial growth initiatives, including potential approval of the CGuard Prime […]

InspireMD Announces Completion of Enrollment in C-Guardians U.S. Investigational Device Exemption (IDE) Clinical Trial

Trial designed to support potential U.S. marketing approval of the CGuard™ Prime EPS stent system Study also included first-in-human cases treated with CGuard Prime CAS stent delivery platform Company anticipates study results and Premarket Approval (PMA) submission in H2 2024, potential U.S. approval in H1 2025 TEL AVIV, Israel, June […]

InspireMD Announces Private Placement of Up to $113.6 Million

Led by Marshall Wace with participation from OrbiMed, Rosalind, Nantahala, Soleus, Velan and certain InspireMD Board members $42.2 million financing upfront with up to an additional $71.4 million tied to exercise of milestone-driven warrants TEL AVIV, Israel and MIAMI, May 15, 2023 (GLOBE NEWSWIRE) — InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention […]

InspireMD Announces Successful First-in-Human Procedure Utilizing CGuard Prime, its Next Generation Carotid Artery Stent (CAS) Platform

Procedure performed as part of the company’s ongoing CGuardians U.S. Investigational Device Exemption (IDE) trial designed to support potential U.S. marketing approval of the CGuard stent system CGuardians enrollment on track to be completed by the end of Q2 2023 TEL AVIV, Israel, May 01, 2023 (GLOBE NEWSWIRE) — InspireMD, […]

InspireMD Reports Fourth Quarter and Year-End 2022 Financial Results and Provides Business Update

– 2022 CGuard EPS revenue of $5.1 million increased 18.9% over 2021 –            – Resumed shipments of CGuard EPS to CE Mark territories under the pre-existing Medical Device Directive (MDD) regulatory framework; Company anticipates re-certification under new Medical Device Regulation (MRD) framework in coming weeks –            – Continued enrollment in the C-Guardian […]

InspireMD Announces Promotion of Andrea Tommasoli to Chief Operating Officer

Mr. Tommasoli formerly served as the Company’s Senior Vice President of Global Sales & Marketing since 2020 and has significant prior commercial leadership experience at Integra LifeSciences and St. Jude Medical TEL AVIV, Israel, March 20, 2023 (GLOBE NEWSWIRE) — InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention […]

InspireMD Announces Hiring of Medical Device Commercial Veteran Shane Gleason as General Manager of North America and VP of Global Marketing

Seasoned veteran in vascular space adds significant expertise in U.S. commercial market readiness and global strategic marketing TEL AVIV, Israel, Feb. 14, 2023 (GLOBE NEWSWIRE) — InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke, today announced that it has hired […]