Carlsmed, Inc. Releases New Study Results Showcasing the Efficacy of aprevo® Technology

CARLSBAD, Calif., January 6, 2026 – Carlsmed, Inc. (Nasdaq: CARL) has announced significant findings from a retrospective cohort study published in the Global Spine Journal. The study highlights how the integration of 3D preoperative planning with patient-specific interbody implants substantially reduces the risk of mechanical complications in complex adult spinal deformity (ASD) surgery.

Key Findings from the Study

The research compared the two-year revision rates of patients who received Carlsmed’s aprevo® personalized interbody implants against a cohort that used conventional stock implants. Notable results include:

• Patients using aprevo® had a revision rate of 4.3% (n=115).
• Patients utilizing conventional stock devices showed a revision rate of 16.6% (n=997).
• This represents a 74% relative reduction in revision rates (p<0.001).

Expert Insights on the Study

Justin Smith, MD, PhD of the University of Virginia and the study’s lead author, emphasized that achieving postoperative alignment remains a challenge in complex deformity cases. He noted, “When paired with 3D preoperative planning, patient-specific interbody implants can facilitate a more harmonious and precise restoration of distal lumbar lordosis, which has been shown to decrease the risk of developing proximal junctional kyphosis, a significant and potentially devastating mechanical complication in ASD surgery.”

Mike Cordonnier, CEO of Carlsmed, remarked, “Previously published data has demonstrated that 3D surgical planning combined with patient-specific interbody implants assist surgeons in achieving personalized alignment goals tailored to each patient. These findings further validate the clinical value of personalization in spine surgery, leading to better outcomes, enhanced quality of life, reduced reoperations, and lowering the economic burden associated with revision surgeries.”

Comparative Context of Revision Rates

Sigurd Berven, MD from the University of California San Francisco, another author of the study, pointed out that the revision rates in the comparator cohort were already relatively low, given the expertise of the surgeons involved. He noted, “Across four studies referenced in the paper, the average two-year revision rate due to mechanical complications is 24.9%, highlighting the significant improvement achieved with aprevo®.”

Access to the Full Study

The peer-reviewed article titled “Personalized Spine Surgery in Adult Deformity: Reoperation Rates and Mechanical Complications Following Customized Planning and Interbody Implant Use” is accessible online at the Global Spine Journal.

About Carlsmed

Carlsmed is a pioneering medical technology company that specializes in AI-enabled personalized spine surgery solutions. The company's mission focuses on improving patient outcomes and reducing healthcare costs associated with spine surgeries. By employing the aprevo® technology platform, Carlsmed aims to enhance surgical alignment tailored to individual patient anatomy and pathology while addressing challenges that traditional stock implants present.

Forward-Looking Statements

Any statements regarding future expectations or plans from Carlsmed regarding the potential of its products and their impact on patient outcomes are considered forward-looking. Actual results may vary significantly due to numerous factors, as outlined in the “Risk Factors” section of Carlsmed’s Registration Statement. The company may update these statements based on subsequent developments but has no obligation to do so.

Contact Information

For investor relations inquiries, please contact Caroline Corner, PhD at IR@Carlsmed.com. For media inquiries, reach LeAnn Burton, Senior Director of Brand Marketing at LBurton@Carlsmed.com.