Carlsmed Secures $52.5M Series C Funding to Advance AI-Powered Personalized Spine Surgery Platform Ahead of IPO

Apr 03, 2024 09:03 CST Updated 09:03

Carlsmed

Developer of Adult Spinal Deformity Treatment Systems

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On March 18, Carlsmed, a developer of spinal deformity treatment systems, raised $52.5 million in Series C funding, led jointly by B Capital and U.S. Venture Partners. The funds will be used to accelerate the commercialization of the Aprevo® personalized spinal surgery platform for lumbar fusion procedures and the development of Aprevo® for cervical fusion procedures, which is set to launch in 2025.

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Carlsmed, Inc. was founded in 2018 and is headquartered in California, USA. It is a developer of spinal deformity treatment devices, engaged in the research, development, production, and sales of the Aprevo 3D medical printing device. Utilizing AI and biotechnology, the company analyzes and predicts treatment data for patients with spinal deformities, aiming to provide high-end medical solutions for patients.

Currently, Carlsmed has completed $95 million in financing:

01 Treatment Needs for Adult Spinal Deformities

Adult Spinal Deformity (ASD) affects 2~25% of American adults and 68% of the elderly, with at least 1.6 million American adults seeking treatment annually. Compared to arthritis, chronic lung disease, diabetes, and congestive heart failure, ASD has a greater impact on health-related quality of life. A time-series analysis study indicates that by 2030 and 2040, the hospitalization rate for spinal deformities will increase by approximately 75% and 122%, respectively, compared to the crude hospitalization rate baseline in 2014. During the same period, surgical correction rates for deformities will surpass conservative techniques, potentially increasing by 87.9% by 2030 and by 143% over the 2014 rate by 2040.

Although surgical treatment has been proven to be superior to conservative treatment, the incidence of adverse events and long-term complications from surgery is extremely high.

Up to 75% of patients still have radiographic malalignment after surgery.
More than 40% of patients have experienced significant adverse events related to surgery or implants (the average cost of one significant adverse event exceeds $100,000 and requires more than 50 days of hospitalization).
More than 20% of patients require revision surgery.

02 Aprevo for Cervical Fusion Surgery

To help surgeons determine surgical correction plans and reduce complications, Carlsmed provides surgeons with a comprehensive digital solution.UsePatient ChengLike and digital technology,In order to inform, engage, and empower patients during the preoperative decision-making process.

Through proprietary algorithms, Carlsmed combines predictive analytics and prior outcome data. Aprevo develops personalized surgical plans and implants for each patient. The implants, made of titanium alloy, are inserted through open incision or minimally invasive methods to fill bone graft cavities. They can be manufactured in varying heights, widths, and lengths, with options to incorporate lordosis and/or coronal angles. Additionally, patient outcome data is fed back into the surgical planning loop to enable continuous learning and create a closed-loop system for product iteration and optimization.

Unlike the mass production of traditional general implants, Aprevo designs personalized implants based on the patient’s anatomy, ensuring they match the shape and contour of the patient's vertebrae. In addition to achieving targeted alignment, the anatomical interface between the device and the vertebral endplates can improve the environment for vertebral fusion by increasing contact area, reducing high stress concentration points, improving load distribution of bone grafts, decreasing stress increases on adjacent discs and facets, and minimizing stress on posterior rods.

Comparison of Carlsmed Personalized Solutions with Traditional Implants

In addition, Aprevo implants and related instruments are sterile and can be packaged in a simple box, whereas traditional implant systems often require one or more instrument and implant trays that need sterilization. By comparison, Aprevo can minimize the risk of infection and revision costs while simplifying the surgical process and reducing operation time. The clinical procedure for using Carlsmed products is as follows:

Patient Imaging Scan: The patient's CT and X-ray imaging are crucial data for creating personalized surgical plans and devices, which are digitally sent to Carlsmed.
DesignCarlsmed uses patient imaging, physician preferences, and digital technology to generate personalized surgical plans and implant designs.
Doctor Review：The surgeon will review and finalize the detailed surgical plan and implant design to ensure the best fit for the patient's clinical needs.
Implant Manufacturing and Transportation: Once the plan is approved, the implant will be 3D printed, sterilized, packaged, and promptly delivered to the hospital for surgery.

In 2024, new clinical data on Aprevo technology was published in the *Global Spine Journal*, showing that the use of Aprevo personalized interbody devices significantly improved patient deformities. Carlsmed has received FDA Breakthrough Device Designation, with its implantable devices and software platform approved for use in lumbar patients via anterior, lateral, and transforaminal approaches. Additionally, the U.S. has introduced Aprevo® spine technology and New Technology Add-On Payment (NTAP) reimbursement for patients, while the Centers for Medicare & Medicaid Services (CMS) has granted Aprevo® Transitional Pass-Through (TPT) payments, further enhancing the adoption of the company’s technology within the healthcare system.

Author: Zhang Qiankun

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