InspireMD (NSPR) 25th Annual Needham Virtual Healthcare Conference summary

Innovation and Technology Overview

• Introduced a self-expanding carotid stent with MicroNet mesh and SmartFit technology, designed to prevent plaque prolapse and embolization, improving stroke prevention outcomes.

• CGuard stent demonstrated less than 1% complication rate at 30 days in the C-GUARDIANS FDA trial, with consistent results across global studies and lowest 30-day and 1-year death/stroke/MI rates among FDA approval trials.

• Meta-analysis of 68,000 patients and ten clinical trials with over 2,000 patients show CGuard’s MicroNet technology delivers superior event and restenosis reduction compared to other stents.

• The CREST-2 study and CMS coverage expansion in October 2023 have catalyzed a stent-first approach in the market.

• The company is developing a SwitchGuard neuroprotection device, targeting approval in the second half of 2027.

Market Trends, Opportunity, and Commercial Strategy

• Carotid intervention market is underpenetrated, with only 10-15% of diagnosed patients treated annually and procedures projected to rise from 160,000 in 2025 to 200,000 in 2030.

• CMS coverage expansion in October 2023 made stenting reimbursable for standard risk, accelerating the shift from surgery to stenting and broadening eligibility.

• U.S. market potential for carotid stenting is estimated at nearly $1B, with a 12% CAGR for stent procedures expected to rise to 13% post-2025.

• U.S. market approval in July 2025 and a growing commercial team are driving adoption, with over 70,000 devices sold globally and an average 25% market share outside the U.S.

• The market is expected to shift from 20% stenting/80% surgery to 70-80% stenting over the next several years.

Financial Position and Operational Outlook

• Raised $113 million in May 2023 via PIPE, with milestone-based financing totaling up to $153.7 million and additional funding in July 2025, providing runway into Q2 2027.

• Ended last year with $54 million in cash; expects to need an additional $35-40 million as commercialization progresses.

• U.S. gross margins are above 70%, expected to improve further with scale and new product introductions.

• Manufacturing is expanding from Israel to a partner facility in North Carolina, with U.S. production expected by end of 2026.

• Revenue growth is accelerating, with 2026 guidance at $13–$15 million, reflecting a 56% increase over 2025.