InspireMD receives FDA PMA approval for CGuard Prime carotid stent system; triggers $17.9M warrant tranche

InspireMD, Inc.

FDA approved CGuard Prime carotid stent system on June 23, 2025 for stroke prevention in carotid artery stenosis.
Pivotal C-GUARDIANS trial (316 patients) showed lowest 30-day (0.95%) and 1-year (1.93%) major adverse event rates.
FDA approval triggers second warrant tranche; gross proceeds expected $17.9M if exercised in full.
Proceeds to fund U.S. commercial launch, new regulatory pathways, and product development.
Over 65,000 CGuard Prime implants to date; investors include Marshall Wace, OrbiMed, etc.

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