Carlsmed (CARL) Corporate presentation summary

Business and market

• Integrated AI-enabled platform spans pre-op planning, personalized intra-op devices and post-op analytics, aiming to reduce spine-surgery reoperations and healthcare costs.

• U.S. market includes ~800,000 annual spine fusion procedures; estimated addressable markets are ~$13B for lumbar and ~$6B for cervical products.

Clinical evidence and reimbursement

• Peer-reviewed adult spinal deformity data showed 2-year revision rates of 4.3% with aprevo versus 16.6% with stock devices, a 74% reduction; aprevo cohort included 115 patients.

• All aprevo lumbar procedures have incremental hospital reimbursement versus stock procedures; projected average incremental reimbursement is ~$30K per procedure.

• Qualifying inpatient aprevo cervical procedures may receive up to $21,125 in incremental CMS reimbursement; procedures are covered by Medicare, Medicare Advantage and commercial payors.

Products and expansion

• aprevo lumbar and cervical portfolios offer patient-specific interbody devices; design features include porous titanium surface lattice and endplate-matched geometry.

• corra cervical plating offers personalized plate sizing, planned screw-hole positions and trajectories, and 2-, 3- or 4-hole configurations.

• aprevo bi-lateral posterior extends personalized 3D planning to a U.S. segment of ~30,000 annual procedures, or 7.0% of total TLIF volume.

• 2026 milestones include first in-person aprevo cervical and bi-lateral posterior procedures, plus FDA 510(k) clearances for aprevo cervical and corra cervical plating.