secwatch.observer — SEC 8-K summary
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Issuer:     InspireMD, Inc. (NSPR)
CIK:        0001433607
Form:       8-K
Filed at:   2024-10-07T23:59:59+00:00
Accession:  0001493152-24-039640
Event type: regulatory
Sentiment:  positive
Materiality: 0.70
Item codes: 7.01, 8.01
LLM model:  deepseek-v4-flash:cloud@v2

FDA approves IDE for InspireMD's CGUARDIANS II pivotal study of CGuard Prime 80cm stent system
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- FDA approved IDE application for CGUARDIANS II pivotal study of CGuard Prime 80cm Carotid Stent System during TCAR procedures.
- Study intended to facilitate approval of CGuard Prime for TCAR indication; U.S. commercial sales after approval.
- Co-principal investigators: Patrick Geraghty, M.D. (Washington Univ.) and Patrick Muck, M.D. (Good Samaritan Hospital).
- Company also advancing development of next-generation TCAR neuroprotection system, SwitchGuard NPS.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1433607/000149315224039640/0001493152-24-039640-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1433607/000149315224039640/form8-k.htm
  HTML page:      https://secwatch.observer/filing/0001493152-24-039640

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