secwatch.observer — SEC 8-K summary
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Issuer:     InspireMD, Inc. (NSPR)
CIK:        0001433607
Form:       8-K
Filed at:   2024-05-28T23:59:59+00:00
Accession:  0001493152-24-021463
Event type: other_material
Sentiment:  positive
Materiality: 0.70
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

InspireMD C-GUARDIANS trial shows 1.95% primary endpoint event rate; PMA filing planned H2 2024
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- Primary endpoint event rate of 1.95% through 12 months post-procedure, lowest reported for any carotid stent pivotal trial.
- 316 patients enrolled at 24 US/EU sites from July 2021 to June 2023; high-risk carotid endarterectomy patients.
- Data to support PMA application to FDA in H2 2024; US launch of CGuard Prime anticipated H1 2025 if approved.
- Results presented at LINC 2024 on May 28; investigator confirmed neuroprotective potential of MicroNet technology.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1433607/000149315224021463/0001493152-24-021463-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1433607/000149315224021463/form8-k.htm
  HTML page:      https://secwatch.observer/filing/0001493152-24-021463

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