InspireMD's Q4 2024: Navigating Contradictions in CGuard Prime Approval, Market Focus, and Commercialization Strategies

These are the key contradictions discussed in InspireMD's latest 2024Q4 earnings call, specifically including: U.S. approval timing for CGuard Prime, focus on the U.S. and OUS markets, and expectations for U.S. commercialization:



Strong Financial Performance and Market Expansion:
- InspireMD reported CGuard revenue reaching a new quarterly high of $1.95 million in Q4 2024, reflecting a 10.6% year-over-year increase, with $7 million in revenue for the full year 2024.
- The growth was driven by increased unit sales of CGuard stents, with 3,512 sold in Q4 and 12,100 for the full year, contributing to over 60,000 implants sold to date.

Anticipated U.S. Approval and Market Opportunity:
- InspireMD anticipates U.S. approval and launch of CGuard Prime in the first half of 2025, which is expected to significantly expand U.S. market revenue potential.
- With U.S. TCAR procedures reaching over 7,000 in Q4, global unit sales were nearly half of the U.S.-only TCAR market, indicating a substantial opportunity upon U.S. market entry.

Investment in Clinical Pipeline and Regulatory Approval:
- InspireMD received an IDE approval for C-GUARDIANS II and III pivotal studies, aiming to expand its product offerings in the TCAR market.
- These studies are anticipated to accelerate regulatory approvals and commercialization efforts in the U.S. market, with enrollment progressing well and expected trial initiations in Q2 2025.