Carlsmed, Inc.
Carlsmed, Inc. (CARL)
Overview
Carlsmed, Inc. is a commercial-stage medical technology company that develops AI-enabled, personalized spine fusion surgery solutions, headquartered in Carlsbad, California. The company went public on Nasdaq in July 2025, raising roughly $100 million. For fiscal year 2025, Carlsmed reported revenue of $50.5 million, up 85.9% from $27.2 million in 2024, with gross margin of 75.3%; the company remains unprofitable, posting a net loss of $29.6 million in 2025 against an accumulated deficit of $100.8 million. Carlsmed's platform, branded aprevo, has been used in roughly 3,200 patients since its commercial launch in October 2021, and 253 surgeons used the platform as of year-end 2025, up from 152 a year earlier.
What They Do & How They Make Money
Carlsmed sells a combined software-and-implant solution for lumbar and cervical spine fusion surgery. Using a patient's CT imaging, the aprevo Technology Platform builds a 3D anatomical model and AI-assisted surgical plan, which the surgeon reviews and approves; Carlsmed then manufactures a patient-specific, 3D-printed titanium interbody implant matched to that plan and delivers it (along with single-use surgical instruments) to the hospital or surgical center within about six business days via an asset-light, made-to-order production model using contract manufacturers. Revenue comes from selling these personalized implant-and-instrument kits per surgery, with additional value delivered through the MyAprevo visualization app and post-operative "aprevo intelligence" outcome reports. The company's addressable market is large: it estimates roughly 445,200 U.S. lumbar fusion procedures and 372,600 cervical fusion procedures annually, representing a combined total addressable market of about $19.4 billion, against an estimated pool of roughly 4,000 U.S. spine surgeons Carlsmed could ultimately reach.
Competitors
Carlsmed's 10-K frames its competitive position primarily against traditional, non-personalized spine fusion using off-the-shelf ("stock") implants — the standard of care from large orthopedic device makers such as Medtronic, Stryker, Zimmer Biomet, and Globus Medical, all of which offer generic interbody cage lines. Additional competitive pressure could come from other emerging patient-specific or AI-driven surgical planning companies entering the spine space, as well as hospital systems and surgeons who prefer established stock-implant workflows for cost or familiarity reasons.
Competitive Position
Carlsmed's core differentiator is clinical evidence: its COMPASS Registry, a 338-patient prospective study, found a 4.3% two-year revision rate for aprevo patients versus 16.6% for stock implants — a 74% relative reduction that gives surgeons a data-backed reason to switch from commodity implants. The company has also built real intellectual property depth (48 issued patents and roughly 120 pending applications covering its implants, manufacturing process, and AI algorithms) plus a growing proprietary dataset (about 4 million de-identified radiographic images and over 40,000 patient-specific anatomical models) that should get harder to replicate as it compounds. Because each implant is custom-manufactured per patient, Carlsmed also earns better unit economics (75.3% gross margin) than a typical device distributor. The risks are that the company is small and still deeply unprofitable, competing against orthopedic giants with vastly greater sales-force scale, hospital relationships, and financial resources, and adoption depends on convincing conservative surgeons and hospital purchasing committees to move away from established stock-implant products. Carlsmed's trajectory will depend on continuing to convert surgeons at its current pace, scaling its production system without eroding margins, and building enough of a data/outcomes moat to fend off both incumbents and future patient-specific entrants.