secwatch.observer — SEC 8-K summary
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Issuer:     InspireMD, Inc. (NSPR)
CIK:        0001433607
Form:       8-K
Filed at:   2024-03-26T23:59:59+00:00
Accession:  0001493152-24-011233
Event type: other_material
Sentiment:  neutral
Materiality: 0.50
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

InspireMD's C-GUARDIANS 12-month abstract accepted for LINC 2024; prior 30-day DSMI 0.95%
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- Abstract of 12-month outcomes from C-GUARDIANS trial (316 patients, 24 sites) accepted for LINC 2024 (May 28-31, Leipzig).
- Previously reported 30-day DSMI rate of 0.95% (ITT) and 0.63% (per-protocol).
- Positive 12-month data could support PMA submission later in 2024 and potential U.S. launch of CGuard Prime in H1 2025.
- Trial evaluates CGuard Carotid Stent System for carotid artery stenosis; primary endpoint includes death, stroke, MI through 365 days.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1433607/000149315224011233/0001493152-24-011233-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1433607/000149315224011233/from8-k.htm
  HTML page:      https://secwatch.observer/filing/0001493152-24-011233

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