InspireMD C-GUARDIANS trial shows 1.95% primary endpoint event rate; PMA filing planned H2 2024

InspireMD, Inc.

Primary endpoint event rate of 1.95% through 12 months post-procedure, lowest reported for any carotid stent pivotal trial.
316 patients enrolled at 24 US/EU sites from July 2021 to June 2023; high-risk carotid endarterectomy patients.
Data to support PMA application to FDA in H2 2024; US launch of CGuard Prime anticipated H1 2025 if approved.
Results presented at LINC 2024 on May 28; investigator confirmed neuroprotective potential of MicroNet technology.

This headline and bullets were generated automatically by deepseek-v4-flash:cloud@v2 from the public filing. Read the source on SEC.gov before relying on any specific claim. Not investment advice. See methodology for how this pipeline works.