INSPIREMD INC · Data as of 2026-09-08
2026
We continue to engage in a productive dialogue with FDA regarding our pending regulatory submissions for our CGuard Prime 80 cm implant for TCAR procedures, as well as our original CGuard platform for traditional carotid stenting procedures.Source filing
Q3 2026
InspireMD anticipates FDA approval for its original CGuard stent delivery system for CAS procedures in the U.S. in the third quarter of 2026.Source filing
Q3 2026
- FDA approval of the original CGuard delivery system anticipated in Q3 2026 -Source filing
H2 2026
In the first quarter of 2026, we submitted a premarket approval for the CGuard EPS with a view to potential FDA approval in the second half of 2026.Source filing
Late 2026
At the same time, the design improvements that we are making to the CGuard Prime 135 cm delivery system, which we voluntarily recalled last quarter, are progressing as planned, with an FDA submission anticipated before year-endSource filing
Q4 2026
We are currently performing verification and validation testing of these modifications in support of a PMA supplement to the FDA which we expect to submit in the fourth quarter of 2026.Source filing
H1 2027
The Company is also implementing design improvements to the CGuard Prime stent delivery system and anticipates FDA approval in the first half of 2027.Source filing
H2 2027
Additionally, the Company anticipates potential FDA clearance of its SwitchGuard neuroprotection system for TCAR procedures in the second half of 2027.Source filing