InspireMD, Inc. Q1 FY2025 earnings call

• CGuard revenue grew 1.2% year-over-year to $1.53 million with 2,611 units sold, showcasing global commercial presence.
• Optimistic for CGuard Prime FDA approval in Q3 2025, actively addressing feedback and preparing for commercial launch.
• C-GUARDIANS II pivotal study enrollment is strong and on track for first half 2026 approval.
• Successfully enrolled the first four patients in the Tandem Lesion Early Feasibility Study.
• Onboarded and trained roughly 20 high-powered sales and marketing professionals, preparing for U.S. launch of CGuard Prime.

CGuard revenue reached $1.53 million, reflecting a 1.2% growth year-over-year. This revenue translates to unit sales of 2,611 CGuard stent sold, contributing to a global commercial foundation with roughly 64,000 implants sold to date.

• Optimistic for CGuard Prime FDA approval in Q3 2025.
• C-GUARDIANS II study is on track for first half 2026 approval.
• Anticipate C-GUARDIANS III IDE submission in Q3 with possible FDA clearance in late 2026.
• TCAR represents a significant growing opportunity with over 30,000 procedures annually in the U.S.

• Delays in FDA approval due to agency resource constraints and statutory review timelines.
• Uncertainties related to regulatory feedback and response times impacting approval timelines.

Q: Adam Maeder asked about the timing change for CGuard Prime FDA approval, inquiring about the primary reason for the slight push to Q3 2025 and the latest dialogue with FDA.

A: Marvin Slosman explained the delay was due to a late facility site audit completed in February 2025 affecting the statutory review window, but remained confident in approval with ongoing interactive engagement with FDA.

Q: Frank Takkinen inquired about team changes and hiring cadence post-FDA commentary.

A: Marvin Slosman stated the team remains intact, confident in submission track, and hiring cadence is architected around approval timeline, with Shane Gleason adding the plan is to build foundation then scale post-approval.

Q: Frank Takkinen followed up on CREST-2 trial readout.

A: Shane Gleason explained CREST-2 results depend on enrolled patient subsets, with likely no major practice change as less severe patients are typical in practice.