---
schema_version: "secwatch.filing_event.v1"
accession: "0001493152-24-021463"
form_type: "8-K"
ticker: "NSPR"
cik: "0001433607"
company_name: "InspireMD, Inc."
filed_at: "2024-05-28T23:59:59+00:00"
generated_at: "2026-06-01T07:57:09.455300+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

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

## Summary
- 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.

## SEC filing metadata
- accession: 0001493152-24-021463
- form_type: 8-K
- ticker: NSPR
- cik: 0001433607
- company_name: InspireMD, Inc.
- filed_at: 2024-05-28T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1433607/000149315224021463/0001493152-24-021463-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1433607/000149315224021463/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001493152-24-021463
- JSON: https://secwatch.observer/filing/0001493152-24-021463.json
- Plain text: https://secwatch.observer/filing/0001493152-24-021463.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.