secwatch.observer — SEC 8-K summary
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Issuer:     InspireMD, Inc. (NSPR)
CIK:        0001433607
Form:       8-K
Filed at:   2024-12-09T23:59:59+00:00
Accession:  0001493152-24-049199
Event type: other_material
Sentiment:  neutral
Materiality: 0.60
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

InspireMD enrolls first patient in CGUARDIANS II pivotal TCAR study for CGuard Prime
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- First patient enrolled by Dr. Patrick Muck at Good Samaritan Hospital (TriHealth, Cincinnati).
- Prospective, single-arm study: 50+ evaluable patients; acute device/technical success endpoints.
- CEO targets FDA approval for CGuard Prime CAS indication in H1 2025; TCAR market ~30,000 procedures/year.
- Over 60,000 CGuard devices sold globally; MicroNet mesh cited for protective outcomes.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1433607/000149315224049199/0001493152-24-049199-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1433607/000149315224049199/form8-k.htm
  HTML page:      https://secwatch.observer/filing/0001493152-24-049199

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