secwatch.observer — SEC 8-K summary
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Issuer:     InspireMD, Inc. (NSPR)
CIK:        0001433607
Form:       8-K
Filed at:   2024-11-12T23:59:59+00:00
Accession:  0001493152-24-044599
Event type: earnings
Sentiment:  neutral
Materiality: 0.75
Item codes: 7.01
LLM model:  deepseek-v4-flash:cloud@v2

InspireMD Q3 revenue record $1.81M (+16.3% YoY); net loss $7.89M; submits PMA to FDA for CGuard Prime
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- Revenue record $1.81M, up 16.3% YoY; gross margin 22.9% down from 28.1% due to higher costs.
- Net loss $7.89M ($0.16/share) vs $5.18M ($0.15/share) in Q3 2023; operating expenses rose 46% to $8.88M.
- Submitted PMA to FDA for CGuard Prime carotid stent; targets U.S. approval in H1 2025.
- IDE approved for CGUARDIANS II pivotal study of CGuard Prime for TCAR procedures.
- Cash and marketable securities $40.4M at Sept 30, 2024; new Miami HQ to support U.S. launch.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1433607/000149315224044599/0001493152-24-044599-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1433607/000149315224044599/form8-k.htm
  HTML page:      https://secwatch.observer/filing/0001493152-24-044599

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