Core Insights - Carlsmed has launched its aprevo Technology Platform for cervical fusion surgeries in the U.S., with early clinical data to be presented at the CSRS Annual Meeting [1][2] Company Overview - Carlsmed is a medical technology company focused on AI-enabled personalized spine surgery solutions, aiming to improve outcomes and reduce healthcare costs [5] Product Details - The aprevo Cervical Interbody System enhances Carlsmed's personalized spine platform, utilizing AI-driven preoperative planning and 3D-printed, patient-specific implants [2] - The cervical system builds on the success of the aprevo lumbar platform, which has shown lower complication rates and fewer revision surgeries compared to standard stock implants [2] Market Context - Over 370,000 cervical fusion surgeries were performed in the U.S. this year, indicating a growing need for technologies that improve alignment and anatomical fit, especially for patients with poor bone quality [3] - Early clinical experience indicates efficient workflow integration and precise implant fit, achieving planned sagittal and coronal alignment goals [3] Clinical Feedback - Positive clinical feedback has been received from the first 50+ cases, with strong reimbursement support and increasing demand for the cervical system [4] - Experts highlight the importance of personalization in cervical spine surgery, noting that the aprevo Cervical system allows for three-dimensional preoperative planning tailored to each patient's anatomy [4]

Core Insights - Carlsmed, Inc. reported a third quarter revenue of $13.1 million, reflecting a 98% year-over-year growth [1][6] - The company raised its full year 2025 revenue guidance to a range of $49 million to $50 million, indicating an expected growth of 80% to 84% over 2024 [5][6] Financial Performance - Revenue for Q3 2025 was $13.1 million, up from $6.6 million in Q3 2024, marking a 98% increase [6][17] - Gross profit for Q3 2025 was $9.9 million, compared to $4.8 million in Q3 2024, with a gross margin of 75.9% [6][17] - Operating expenses for Q3 2025 totaled $19.0 million, an increase from $12.6 million in Q3 2024, with specific expenses as follows: - Research and development: $4.4 million [6][17] - Sales and marketing: $9.6 million [6][17] - General and administrative: $4.9 million [6][17] - The net loss for Q3 2025 was ($8.5) million, compared to a net loss of ($7.8) million in Q3 2024 [6][17] - Adjusted EBITDA loss for Q3 2025 was ($8.2) million, compared to ($7.7) million in Q3 2024 [6][17] Business Highlights - The company expanded gross margins to 76% and increased surgeon users by over 70% year-over-year [2] - Lead times for surgical plan approval were reduced to within 8 business days, down from 10 business days in Q2 2025 [6] - The CMS New Technology Add-On Payment (NTAP) for cervical procedures became effective on October 1, 2025, with a commercial launch expected in early 2026 [6] - Over 50 cervical aprevo procedures have been successfully completed as part of the clinical evaluation program [6] - Data presented at the Scoliosis Research Society Annual Meeting indicated a 75% reduction in revision surgery at a two-year time point for aprevo compared to a matched cohort [6] Leadership Changes - Jennifer Kamocsay was appointed as Chief Legal Officer and Secretary, bringing over a decade of corporate legal experience [6]

Core Insights - Carlsmed, Inc. has been added to the Russell 2000 Index, effective after market close on September 22, 2025, marking a significant milestone following its IPO in July 2025 [1][2] - The inclusion in the Russell 2000 Index is seen as validation of Carlsmed's differentiated business model and growth potential, enhancing its visibility among investors [2] Company Overview - Carlsmed is a medical technology company focused on AI-enabled personalized spine surgery solutions, aiming to improve healthcare outcomes and reduce costs associated with spine surgery [3] Industry Context - The Russell 2000 Index represents approximately 10 percent of the total market capitalization of the broader Russell 3000 Index, which is widely utilized by investment managers and institutional investors for benchmarking [2] - Approximately $9 trillion in assets are benchmarked against Russell's U.S. indexes, indicating the significance of the Russell 2000 Index in the investment landscape [2]

Group 1 - Carlsmed, Inc. is set to report its second quarter 2025 financial results on August 28, 2025, after market close [1] - A conference call and webcast will be held on the same day at 1:30 PM Pacific Time to discuss the financial results [2] - Carlsmed specializes in AI-enabled personalized spine surgery solutions, aiming to improve healthcare outcomes and reduce costs [3]

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] - The company has received Breakthrough Device designation from the FDA for cervical use and plans to launch the product commercially in the U.S. in 2026 [3]

Core Insights - Carlsmed, Inc. has successfully completed its first cervical procedure using the aprevo system, marking a significant milestone in personalized spine surgery solutions [1][3] - The aprevo devices utilize an AI-powered surgical planning platform to customize surgical solutions based on individual patient anatomy and alignment needs [2][3] - The company aims to reduce revision surgeries and improve healthcare outcomes, with plans for a US commercial launch of the aprevo cervical device in 2026 after receiving FDA Breakthrough Device designation [3][4] Company Overview - Carlsmed is a medical technology company focused on AI-enabled personalized spine surgery solutions, with a mission to enhance surgical outcomes and reduce healthcare costs [4]

Core Viewpoint - Carlsmed, Inc. has successfully completed its first cervical procedure using the aprevo® system, marking a significant milestone in the expansion of its AI-enabled personalized spine surgery solutions [1][3]. Company Overview - Carlsmed is a medical technology company focused on pioneering AI-enabled personalized spine surgery solutions, aiming to improve healthcare outcomes and reduce costs associated with spine surgery [4]. Product Details - The aprevo® devices are designed to cater to the unique anatomical and alignment needs of each patient through a proprietary AI-powered surgical planning platform and digital production system [2]. - The system allows for a level of alignment in cervical fusion surgery that is believed to be unattainable with traditional implants, representing a meaningful advancement in surgical practices [3]. Strategic Goals - The company aims to reduce the need for revision surgeries, improve patient outcomes, and enhance overall value within the healthcare system, working towards establishing a new standard of care [3]. - Carlsmed has received Breakthrough Device designation for the aprevo® cervical from the FDA and anticipates a commercial launch in the United States in 2026 [3].