---
schema_version: "secwatch.filing_event.v1"
accession: "0001493152-26-028221"
form_type: "8-K"
ticker: "NSPR"
cik: "0001433607"
company_name: "InspireMD, Inc."
filed_at: "2026-06-11T12:05:40+00:00"
generated_at: "2026-06-11T12:10:18.034883+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# InspireMD reports 100% acute device success, zero adverse events in CGUARDIANS II TCAR trial

## Summary
- Acute device success 100% (50/50 patients); no deaths, strokes, or MI at 30 days.
- No stent thrombosis observed; complete stent patency in evaluable subjects.
- PMA supplement under FDA review; potential approval H2 2026 for TCAR use.
- CEO cites line-of-sight to full TCAR toolkit, addressing >35,000 annual US procedures.

## SEC filing metadata
- accession: 0001493152-26-028221
- form_type: 8-K
- ticker: NSPR
- cik: 0001433607
- company_name: InspireMD, Inc.
- filed_at: 2026-06-11T12:05:40+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1433607/000149315226028221/0001493152-26-028221-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1433607/000149315226028221/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001493152-26-028221
- JSON: https://secwatch.observer/filing/0001493152-26-028221.json
- Plain text: https://secwatch.observer/filing/0001493152-26-028221.txt

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