Carlsmed (CARL) investor relations material

Business overview and technology platform

• Founded in 2018 to address complex spine deformity surgery with a next-generation med tech platform.

• Platform uses patient imaging and surgeon data to create digital surgical plans and 3D print custom devices.

• Launched lumbar platform in 2021, receiving breakthrough technology status and enhanced Medicare reimbursement.

• Two-year outcome data shows a 74% reduction in reoperation rates compared to standard care.

• Medicare issued new DRG codes for custom, anatomically designed fusion devices in October last year.

Cervical platform launch and market opportunity

• Recently expanded platform to cervical spine fusion, with early clinical evaluations at over a dozen sites.

• Accelerated cervical launch due to strong surgeon feedback and upcoming research presentations.

• Cervical devices address high incidence of osteoporotic bone, offering large surface area coverage for better outcomes.

• Cervical and lumbar procedures each represent approximately 400,000 annual addressable cases in the U.S.

• Early clinical evaluation involved more than a dozen surgeons, with plans to train the next generation.

Financials, reimbursement, and adoption

• Enhanced reimbursement of up to $21,250 per inpatient procedure via New Technology Add-on Payment.

• 98% year-on-year top-line growth in Q3, with a 70% increase in surgeon user base.

• Shift from complex deformity to simpler degenerative cases, now 70% of procedures.

• Turnaround time for custom implants reduced from 56 days to 8 days over five years, with 5X production capacity increase.

• Gross margin grew to 76% in Q3, with 2024 revenue guidance of $49–$50 million.