Carlsmed Pioneers AI-Enabled Personalized Spine Surgery Solutions

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Carlsmed is a commercial-stage medical technology company that is pioneering AI-enabled personalized spine surgery solutions with its aprevo Technology Platform. The platform consists of AI-enabled software solutions, custom-designed interbody implants, and single-use surgical instruments to address the limitations of traditional spine fusion surgery and improve patient outcomes. Carlsmed's solutions are focused on providing personalized surgical plans and implants to achieve proper spinal alignment for patients with degenerative disc disease and adult spinal deformity.

Why it matters

Traditional spine fusion surgery often lacks robust pre-operative planning and uses stock implants that fail to match each patient's unique anatomy, leading to poor alignment, post-operative complications, and increased likelihood of revision surgery. Carlsmed's aprevo Technology Platform aims to address these limitations and improve long-term outcomes, reducing the significant economic burden of revision surgeries on the healthcare system.

The details

The aprevo Technology Platform utilizes AI-enabled algorithms and 3D modeling to develop personalized digital surgical plans and custom-designed interbody implants for each patient. This aims to achieve proper spinal alignment and reduce the need for revision surgery. Carlsmed's solutions are 510(k) cleared by the FDA for lumbar interbody fusion and are in development for cervical fusion procedures.

• In November 2024, Carlsmed received FDA 510(k) clearance for its aprevo interbody implants for cervical interbody fusion surgeries.
• In 2025, Carlsmed plans to continue building its aprevo Technology Platform for cervical fusion procedures by 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, pending necessary additional clearances.

What’s next

Assuming Carlsmed gets the necessary additional clearances, the company expects to commercialize the aprevo Technology Platform for cervical fusion surgery in 2026.