FDA Premarket Approval for CGuard Prime
InspireMD received FDA premarket approval for CGuard Prime Carotid Stent System, marking a significant milestone and starting the U.S. commercial launch.
Successful Financing and Strong Cash Position
InspireMD raised $40.1 million through a private placement and $17.9 million from warrant exercises, strengthening the cash position by over $58 million.
Strong Early U.S. Market Reception
Following FDA approval, InspireMD completed procedures with double-digit U.S. physicians and secured stocking orders, indicating strong early market interest.
Progress in Clinical Pipeline
Enrollment continues for pivotal studies C-GUARDIANS II and III, and the tandem lesion study is halfway complete, indicating progress in expanding the use of CGuard Prime.