other material
confidence high
sentiment neutral
materiality 0.60
InspireMD enrolls first patient in CGUARDIANS II pivotal TCAR study for CGuard Prime
InspireMD, Inc.
- First patient enrolled by Dr. Patrick Muck at Good Samaritan Hospital (TriHealth, Cincinnati).
- Prospective, single-arm study: 50+ evaluable patients; acute device/technical success endpoints.
- CEO targets FDA approval for CGuard Prime CAS indication in H1 2025; TCAR market ~30,000 procedures/year.
- Over 60,000 CGuard devices sold globally; MicroNet mesh cited for protective outcomes.