---
schema_version: "secwatch.filing_event.v1"
accession: "0001641172-25-016293"
form_type: "8-K"
ticker: "NSPR"
cik: "0001433607"
company_name: "InspireMD, Inc."
filed_at: "2025-06-24T23:59:59+00:00"
generated_at: "2026-05-18T22:14:47.004624+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.9
calibrated_materiality_score: 0.9
confidence: "high"
source: SEC EDGAR
---

# InspireMD receives FDA PMA approval for CGuard Prime carotid stent system; triggers $17.9M warrant tranche

## Summary
- FDA approved CGuard Prime carotid stent system on June 23, 2025 for stroke prevention in carotid artery stenosis.
- Pivotal C-GUARDIANS trial (316 patients) showed lowest 30-day (0.95%) and 1-year (1.93%) major adverse event rates.
- FDA approval triggers second warrant tranche; gross proceeds expected $17.9M if exercised in full.
- Proceeds to fund U.S. commercial launch, new regulatory pathways, and product development.
- Over 65,000 CGuard Prime implants to date; investors include Marshall Wace, OrbiMed, etc.

## SEC filing metadata
- accession: 0001641172-25-016293
- form_type: 8-K
- ticker: NSPR
- cik: 0001433607
- company_name: InspireMD, Inc.
- filed_at: 2025-06-24T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.9
- calibrated_materiality_score: 0.9
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1433607/000164117225016293/0001641172-25-016293-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1433607/000164117225016293/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001641172-25-016293
- JSON: https://secwatch.observer/filing/0001641172-25-016293.json
- Plain text: https://secwatch.observer/filing/0001641172-25-016293.txt

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