secwatch.observer — SEC 8-K summary
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Issuer:     InspireMD, Inc. (NSPR)
CIK:        0001433607
Form:       8-K
Filed at:   2026-05-04T23:59:59+00:00
Accession:  0001493152-26-021105
Event type: earnings
Sentiment:  negative
Materiality: 0.75
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

InspireMD Q1 revenue $3.4M (+122% YoY); voluntary recall of CGuard Prime 135 cm
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- Net loss $13.7M ($0.16/share) vs $11.2M loss a year ago; operating expenses rose to $14.7M.
- GAAP gross profit $0.7M (20.2% margin); adjusted gross profit $1.2M (34.1%) excluding $0.5M impairment charge.
- Voluntary recall of CGuard Prime 135 cm; expected costs $700K returns + $650K inventory/remediation.
- FDA approved IDE for CGUARDIANS III trial of SwitchGuard NPS; CGuard Prime 80 cm TCAR approval expected H2 2026.
- Original CGuard FDA approval anticipated Q3 2026; over 625 cumulative procedures with CGuard Prime since launch.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1433607/000149315226021105/0001493152-26-021105-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1433607/000149315226021105/form8-k.htm
  HTML page:      https://secwatch.observer/filing/0001493152-26-021105

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