secwatch.observer — SEC 8-K summary
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Issuer:     InspireMD, Inc. (NSPR)
CIK:        0001433607
Form:       8-K
Filed at:   2023-08-31T23:59:59+00:00
Accession:  0001493152-23-030726
Event type: other_material
Sentiment:  positive
Materiality: 0.45
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

InspireMD: C-Guardians 30-day results abstract accepted for VIVA23 presentation
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- Abstract of 30-day results from C-Guardians IDE trial accepted as late-breaking presentation at VIVA23 (Oct 30-Nov 2, Las Vegas) on Nov 1, 2023, by Dr. Chris Metzger.
- Trial enrolled 316 patients across 25 U.S. and European sites; includes symptomatic and asymptomatic carotid artery stenosis patients.
- Primary endpoint: composite of death, all stroke, MI through 30 days and ipsilateral stroke 31-365 days; performance goal: upper bound 95% CI <11.6%.
- CEO expects one-year data in H2 2024; if positive, may support PMA and potential U.S. launch of CGuard Prime EPS in H1 2025.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1433607/000149315223030726/0001493152-23-030726-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1433607/000149315223030726/form8-k.htm
  HTML page:      https://secwatch.observer/filing/0001493152-23-030726

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