secwatch.observer — SEC 8-K summary
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Issuer:     InspireMD, Inc. (NSPR)
CIK:        0001433607
Form:       8-K
Filed at:   2023-11-01T23:59:59+00:00
Accession:  0001493152-23-038979
Event type: other_material
Sentiment:  positive
Materiality: 0.80
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

InspireMD reports positive 30-day C-GUARDIANS trial results: 0.95% DSMI rate in 316 patients
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- DSMI (death, stroke, MI) rate of 0.95% through 30 days post-procedure in 316 high-risk carotid artery stenosis patients.
- Trial enrolled from July 2021 to June 2023 across 24 US and EU sites; single-arm, prospective IDE study.
- Primary endpoint composite includes 30-day DSMI plus ipsilateral stroke from day 31 to 365; success if upper 95% CI < 11.6%.
- Primary endpoint results expected H2 2024; potential FDA premarket approval application targeted for H1 2025.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1433607/000149315223038979/0001493152-23-038979-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1433607/000149315223038979/form8-k.htm
  HTML page:      https://secwatch.observer/filing/0001493152-23-038979

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