Fourth quarter revenue of $15.2 million; 61% growth YoY Full year revenue of $50.5 million; 86% growth YoY CARLSBAD, Calif., Feb. 25, 2026 (GLOBE NEWSWIRE) -- Carlsmed, Inc. (Nasdaq: CARL) (“Carlsmed” or the “Company”), a medical technology company pioneering AI-enabled personalized spine surgery solutions, today reported financial results for the fourth quarter and full year ended December 31, 2025. "We delivered another very strong quarter with 61% revenue growth year-over-year, gross margin expansion ...

Core Insights - Carlsmed, Inc. reported preliminary revenue of approximately $15.2 million for Q4 2025, reflecting a growth of about 61% compared to Q4 2024 [1][5] - For the full year 2025, the company achieved revenue of approximately $50.5 million, marking an increase of around 86% over 2024 [1][5] Company Performance - The fourth quarter performance highlights a transformational year for Carlsmed, driven by the aprevo® platform technology, which enhances procedural predictability and aims to improve clinical outcomes in spine fusion [2] - In 2025, Carlsmed added 101 new surgeon users, resulting in a 61% increase in the total surgeon user base compared to the previous year [2] - The company anticipates continued growth and recognition of the aprevo® technology in 2026, particularly following the launch of aprevo® cervical, which has received positive early feedback from surgeons [2] Company Overview - Carlsmed is focused on pioneering AI-enabled personalized spine surgery solutions, with a mission to enhance outcomes and reduce healthcare costs associated with spine surgery [3]

Core Insights - Carlsmed, Inc. announced a new study showing that 3D preoperative planning combined with patient-specific interbody implants significantly reduces reoperations due to mechanical complications in complex adult spinal deformity surgery [1][2]. Study Findings - The study compared 2-year revision rates between patients receiving Carlsmed's aprevo personalized interbody implants and those receiving conventional stock implants, revealing a revision rate of 4.3% (n=115) for aprevo compared to 16.6% (n=997) for stock devices, indicating a 74% relative reduction in revisions [2]. - The average 2-year revision rate due to mechanical complications across four published studies is 24.9%, making the improvement with aprevo particularly significant [3]. Clinical Implications - The combination of 3D preoperative planning and patient-specific implants aids in achieving precise alignment and reduces the risk of proximal junctional kyphosis, a serious complication in ASD surgery [3]. - The findings validate the clinical value of personalized approaches in spine surgery, enhancing patient outcomes and reducing the economic burden associated with revision procedures [3]. Technology Overview - Carlsmed's aprevo Technology Platform integrates AI-enabled preoperative planning with customized interbody implants, addressing alignment challenges and limitations of traditional stock implants [4]. Company Background - Carlsmed is a medical technology company focused on pioneering AI-enabled personalized spine surgery solutions aimed at improving healthcare outcomes and reducing costs in spine surgery [5].

Core Insights - Carlsmed, Inc. has received NTAP reimbursement approval from CMS for its aprevo personalized interbody implants used in cervical fusion procedures, effective October 1, 2025, which will provide up to an additional $21,125 in reimbursement for qualifying inpatient procedures [1][2][3] Company Overview - Carlsmed is a medical technology company focused on AI-enabled personalized spine surgery solutions, aiming to improve patient outcomes and reduce healthcare costs [4] Technology and Innovation - The aprevo devices are designed to cater to the unique anatomical and alignment needs of each patient through an AI-powered surgical planning platform and digital production system [3] - Carlsmed has received Breakthrough Device designation from the FDA for cervical use and plans to launch the aprevo cervical device commercially in the U.S. in 2026 [3]