secwatch.observer — SEC 8-K summary
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Issuer:     InspireMD, Inc. (NSPR)
CIK:        0001433607
Form:       8-K
Filed at:   2026-11-12T21:45:54+00:00
Accession:  0001493152-26-051453
Event type: regulatory
Sentiment:  positive
Materiality: 0.80
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4.1-flash:cloud@v2

InspireMD wins FDA approval for CGuard Prime TCAR stent, doubling US addressable market
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- FDA approved the PMA supplement for the CGuard Prime TransCarotid Stent System (80 cm delivery) for TCAR procedures used with an embolic protection system specified in labeling.
- Approval adds access to more than 35,000 annual US TCAR procedures, doubling CGuard Prime's TAM; TCAR plus CAS total ~75,000 US carotid stenting procedures yearly per company estimates.
- CGUARDIANS II pivotal trial: 50 patients across 11 US sites; 100% acute device success with zero death, stroke, MI or stent thrombosis at 30 days.
- Commercial entry can proceed independently of the investigational SwitchGuard NPS, which is still enrolling in the CGUARDIANS III pivotal trial.
- CEO Marvin Slosman called it a 'strong near-term growth driver' and said InspireMD is the first company with both CAS and TCAR delivery options.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1433607/000149315226051453/0001493152-26-051453-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1433607/000149315226051453/form8-k.htm
  HTML page:      https://secwatch.observer/filing/0001493152-26-051453

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