---
schema_version: "secwatch.filing_event.v1"
accession: "0001493152-24-036293"
form_type: "8-K"
ticker: "NSPR"
cik: "0001433607"
company_name: "InspireMD, Inc."
filed_at: "2024-09-16T23:59:59+00:00"
generated_at: "2026-05-31T04:33:34.483744+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# InspireMD submits PMA to FDA for CGuard Prime carotid stent; U.S. launch targeted H1 2025

## Summary
- PMA submission on Sept 16, 2024, seeks FDA marketing approval for CGuard Prime carotid stent system.
- Application based on C-GUARDIANS pivotal trial showing 1.95% primary endpoint major adverse event rate through 12 months.
- Trial enrolled 316 patients across 24 U.S. and European sites; lowest event rate reported for any carotid stent pivotal trial.
- U.S. commercial launch anticipated in first half of 2025, subject to FDA approval.
- CEO Marvin Slosman cites best-in-class clinical outcomes and building U.S. commercial infrastructure.

## SEC filing metadata
- accession: 0001493152-24-036293
- form_type: 8-K
- ticker: NSPR
- cik: 0001433607
- company_name: InspireMD, Inc.
- filed_at: 2024-09-16T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1433607/000149315224036293/0001493152-24-036293-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1433607/000149315224036293/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001493152-24-036293
- JSON: https://secwatch.observer/filing/0001493152-24-036293.json
- Plain text: https://secwatch.observer/filing/0001493152-24-036293.txt

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