CARLSMED, INC.

Carlsmed, Inc. (NASDAQ: CRMD) is a commercial-stage medical technology company pioneering artificial intelligence-enabled personalized spine surgery solutions. The company's website is www.carlsmed.com.

Carlsmed develops and commercializes the aprevo Technology Platform, an integrated digital technology solution designed to improve outcomes and reduce costs in spine fusion surgery. The platform combines AI-enabled software that generates personalized surgical plans with custom-designed interbody implants tailored to each patient's unique spinal anatomy and pathology, along with single-use surgical instruments. The aprevo platform addresses limitations of traditional spine fusion surgery, which relies on stock implants of fixed sizes and shapes that often fail to match individual patient anatomy, resulting in malalignment and high revision surgery rates.

The company's primary focus is on lumbar and cervical spine fusion procedures. The FDA cleared aprevo lumbar interbody implants in December 2020 for adult spinal deformity and in August 2022 for degenerative disc disease. Commercial launch for lumbar procedures began in October 2021. In November 2024, the FDA cleared aprevo cervical interbody implants, with the first in-human cervical procedure completed in July 2025 and commercial launch commencing in December 2025. The company also received FDA clearance for its cervical plating system in December 2025.

Carlsmed operates a scalable, inventory-light business model leveraging contract manufacturing organizations for on-demand production of patient-specific implants. The company markets its technology through a combination of direct sales teams and independent sales agents. As of December 31, 2025, 253 surgeon users had completed one or more aprevo procedures, with the company estimating approximately 4,000 potential spine surgeons in the United States addressable market.

The company has established a significant competitive moat through its intellectual property portfolio of 48 issued patents and approximately 120 pending applications, along with proprietary data assets including approximately four million de-identified radiographic images used to train AI models and over 40,000 three-dimensional patient-specific anatomical models. For the year ended December 31, 2025, Carlsmed recognized revenue of $50.5 million with a gross margin of 75.3%.