Carlsmed (CARL) 25th Annual Needham Virtual Healthcare Conference summary

Business overview and technology platform

• Focuses on improving outcomes and reducing costs in spine surgery through a patient-specific digital surgery platform, Aprevo, for lumbar and cervical spine fusion.

• Utilizes AI-driven digital planning, virtual modeling, and 3D printing to create custom devices for each patient, enabling just-in-time delivery and post-op data collection.

• Achieved FDA Breakthrough Device designation for lumbar technology and expanded to cervical applications, addressing a combined $16 billion market in the U.S.

• Exited last year with $50.5 million in revenue, over 75% gross margins, and a strong cash position after going public.

Clinical outcomes and reimbursement

• Two-year data published in Global Spine Journal showed a 74% reduction in reoperations for Aprevo lumbar technology compared to stock devices.

• CMS issued new DRGs and a New Technology Add-on Payment, providing elevated reimbursement for both lumbar and cervical procedures, incentivizing hospital adoption.

• Technology targets high-risk populations, such as cervical fusion patients with poor bone quality, reducing revision rates.

• Early clinical data shows nearly 80% of personalized Aprevo levels achieve targeted sagittal alignment within three degrees.

Commercial expansion and market adoption

• Added over 100 new surgeon users last year, with a significant Q4 spike driven by commercial and education team expansion.

• Currently covers all U.S. regions through a hybrid sales model of direct territories and over 100 independent agents.

• Professional education and medical events, such as ISASS, have generated strong interest and conversion among surgeons.

• Revenue guidance for 2024 is $70–$75 million, targeting 44% year-on-year growth.