NSPR biotech catalysts & pipeline

INSPIREMD INC · Data as of 2026-10-25

Upcoming catalysts

CGuard Carotid Stent System — Regulatory decision

2026

"These amendments align a meaningful portion of our outstanding warrants with a significant near-term regulatory milestone with important commercial implications: the anticipated FDA approval of CGuard Prime 80 cm for TCAR expected later this year," said Marvin Slosman, Chief Executive Officer of InspireMD.

Source filing

CGuard Carotid Stent System — Regulatory decision

Q4 2026

Amendments align trigger event of existing warrants with anticipated FDA approval of CGuard Prime 80 cm, which the Company continues to anticipate in Q4 2026 -

Source filing

CGuard Carotid Stent System — NDA/BLA submission

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

CGuard Carotid Stent System — PDUFA

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

SwitchGuard neuroprotection system — Regulatory decision

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

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