secwatch.observer — SEC 8-K summary
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Issuer:     InspireMD, Inc. (NSPR)
CIK:        0001433607
Form:       8-K
Filed at:   2026-06-11T12:05:40+00:00
Accession:  0001493152-26-028221
Event type: other_material
Sentiment:  positive
Materiality: 0.75
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1433607/000149315226028221/0001493152-26-028221-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1433607/000149315226028221/form8-k.htm
  HTML page:      https://secwatch.observer/filing/0001493152-26-028221

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer