Carlsmed Leads Surgical Instruments Industry with Personalized Spine Solutions

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Carlsmed (NASDAQ:CARL) is a commercial-stage medical technology company pioneering AI-enabled personalized spine surgery solutions. The company's aprevo Technology Platform, which includes custom-designed interbody implants and surgical instruments, is designed to address the limitations of traditional spine fusion surgery and improve clinical outcomes. Carlsmed is currently focused on the lumbar spine fusion market and is developing the platform for cervical spine fusion as well.

Why it matters

Carlsmed's approach aims to improve upon traditional spine fusion surgery, which often lacks robust pre-operative planning and relies on one-size-fits-all implants that fail to match each patient's unique anatomy. This can lead to poor alignment and increased risk of revision surgery, imposing significant health and economic burdens. Carlsmed's personalized solutions seek to optimize surgical results and reduce the need for costly revision procedures.

The details

The aprevo Technology Platform utilizes AI-enabled algorithms to develop personalized digital surgical plans and custom-designed interbody implants for each patient. This aims to achieve proper spinal alignment and improve clinical outcomes. The platform is FDA-cleared for lumbar spine fusion and Carlsmed expects to commercialize it for cervical fusion in 2026. Carlsmed markets the aprevo Technology Platform through a direct sales team and independent agents, and has demonstrated favorable clinical results in studies.

• Carlsmed received FDA 510(k) clearance for its aprevo interbody implants for cervical interbody fusion surgeries in November 2024 after previously receiving FDA Breakthrough Device Designation.
• Carlsmed plans to continue building its aprevo Technology Platform for cervical fusion procedures in 2025, including pursuing additional clearances for advancements to its cervical software platform and personalized plating solutions.
• Carlsmed expects to commercialize the aprevo Technology Platform for cervical fusion surgery in 2026.

What’s next

In April 2025, the Centers for Medicare and Medicaid Services (CMS) announced proposed ICD-10-PCS ('X-codes') for the use of custom-made anatomically designed fusion devices for cervical spine fusion surgeries. If approved in the CMS Final Rule, these X-codes will identify claims that are eligible for hospitals to receive NTAP of up to $21,125 per cervical spine fusion procedure using Carlsmed's aprevo Technology Platform.