Carlsmed


Carlsmed is a pioneering MedTech company specializing in AI-enabled personalized spine surgery solutions. Their mission is to improve patient outcomes and reduce healthcare costs through innovative, personalized surgical platforms and devices. They focus on advancing spine surgery with a comprehensive, integrated platform that supports pre-operative planning, intra-operative visualization, and post-operative analysis, all tailored to individual patient anatomy. The company is committed to transforming spine surgery with a patient-obsessed culture, guided by core values of doing what is right, achieving together, and prioritizing patient needs.

Industries

health-care
manufacturing
medical-device

Nr. of Employees

small (1-50)

Carlsmed

1800 Aston Ave., Suite 100, Carlsbad, CA 92008


Patents

Systems and methods for physician designed surgical procedures

US-12274509-B2

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Systems and methods for assisting and augmenting surgical procedures

US-12274506-B2

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Systems and methods for orthopedic implants

US-12274622-B2

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Patient-specific implant design and manufacturing system with a surgical implant positioning manager

US-12274510-B2

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Systems and methods for orthopedic implant fixation

US-12251320-B2

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Systems and methods for orthopedic implants

US-12251313-B2

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Products

Patient-specific interbody fusion implants (lumbar and cervical)

Implants designed from individual patient CT data to match vertebral endplate anatomy and planned alignment, manufactured via 3D printing and supplied sterile for spinal fusion procedures.

AI-enabled surgical planning and 3D visualization software

Clinical software that segments CT data, generates alignment targets, produces patient-specific device designs, and provides interactive 3D visualization for pre-op planning and intra-op reference.


Services

Production service that transforms surgeon-approved patient-specific implant designs into 3D-printed, sterile implants delivered to the operating room.

Provision of AI-enabled 3D planning workflows and visualization tools for creation, review and approval of patient-specific surgical plans.

Design and maintenance of a multi-center prospective registry to collect alignment, complications, revision and PROMs data for devices and procedures.

Provision of coding cards, payer resources and a coding hotline to assist providers in submitting appropriate billing for procedures using patient-specific devices.

Expertise Areas

  • Personalized implant design
  • AI-driven surgical planning
  • Additive manufacturing for medical implants
  • Clinical registry and real-world evidence generation
  • Show More (4)

Key Technologies

  • AI-enabled medical image segmentation
  • CT-based 3D patient modeling
  • Patient-specific implant CAD
  • Additive manufacturing (3D printing) for implants
  • Show More (4)

News & Updates

On December 4, 2024, Carlsmed announced FDA 510(k) clearance for the aprevo® Cervical ACDF Interbody System, marking a significant milestone in their personalized spine surgery technology.

On November 6, 2024, Carlsmed announced the successful launch of its state-of-the-art digital production line, enhancing the manufacturing and customization of spine devices.

On October 8, 2024, Kevin O’Boyle joined Carlsmed’s Board of Directors and will serve as Chair of the Audit Committee, bringing extensive industry experience.

On August 5, 2024, CMS assigned high reimbursement levels for spinal fusion cases using aprevo® devices, supporting broader adoption.

On March 18, 2024, Carlsmed announced a $52.5 million Series C funding round to accelerate commercialization and develop new applications for aprevo® technology.

New clinical data published in the Global Spine Journal demonstrates that aprevo® devices significantly improve surgical alignment outcomes.

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