secwatch.observer — SEC 8-K summary
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Issuer:     InspireMD, Inc. (NSPR)
CIK:        0001433607
Form:       8-K
Filed at:   2024-09-16T23:59:59+00:00
Accession:  0001493152-24-036293
Event type: regulatory
Sentiment:  positive
Materiality: 0.85
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

InspireMD submits PMA to FDA for CGuard Prime carotid stent; U.S. launch targeted H1 2025
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- PMA submission on Sept 16, 2024, seeks FDA marketing approval for CGuard Prime carotid stent system.
- Application based on C-GUARDIANS pivotal trial showing 1.95% primary endpoint major adverse event rate through 12 months.
- Trial enrolled 316 patients across 24 U.S. and European sites; lowest event rate reported for any carotid stent pivotal trial.
- U.S. commercial launch anticipated in first half of 2025, subject to FDA approval.
- CEO Marvin Slosman cites best-in-class clinical outcomes and building U.S. commercial infrastructure.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1433607/000149315224036293/0001493152-24-036293-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1433607/000149315224036293/form8-k.htm
  HTML page:      https://secwatch.observer/filing/0001493152-24-036293

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