InspireMD (NSPR) 24th Annual Needham Virtual Healthcare Conference summary

Market opportunity and industry trends

• Carotid intervention market is shifting from open surgery to stenting, driven by expanded CMS reimbursement in October 2023, enabling a stent-first approach for all risk categories.

• U.S. market potential is estimated at $900 million to $1 billion, with 155,000 annual interventions; global opportunity is even larger.

• Stenting is becoming the predominant procedure, mirroring trends in other vascular interventions as reimbursement and technology improve.

• The market is multidisciplinary, involving neurosurgeons, interventional cardiologists, and vascular surgeons, all showing enthusiasm for new stent technologies.

• The company has sold over 60,000 stents globally and built a pipeline including TCAR and CAS access technologies.

Technology and clinical evidence

• The MicroNet mesh technology, a 20-micron PET layer, is designed to prevent plaque prolapse and post-procedural embolic events, aiming to improve clinical outcomes.

• Clinical trials and real-world data show consistently low event rates, with pivotal trial results under 1% for 30-day death, stroke, and MI, outperforming competitors.

• Meta-analysis of 68,000+ patients confirms second-generation stents, especially CGuard, have superior short- and long-term outcomes compared to first-generation devices.

• Five-year data demonstrates durability and consistency, supporting the go-to-market strategy and physician confidence.

• The CGuardians study and other published data reinforce the safety and efficacy of the stent in both controlled and real-world settings.

Regulatory and commercialization roadmap

• FDA approval for the transfemoral stent system is expected in the first half of 2024, with TCAR-indicated stent approval targeted for mid-2026 and full TCAR system launch by late 2026 or early 2027.

• The company is enrolling patients in the CGuardians 2 trial for the TCAR system, aiming for a first-half 2026 approval, and pursuing 510(k) clearance for the SwitchGuard neuroprotection system.

• Commercial expansion is focused on the U.S., leveraging granular claims data to target high-volume centers and recruit experienced sales professionals.

• The go-to-market strategy is deliberate, combining scientific rigor with targeted sales efforts, and leveraging established OUS market presence.

• The company plans to offer both stent and neuroprotection systems for TCAR, increasing revenue opportunities compared to CAS, where only the stent is sold.