Summary of Carlsmed Conference Call Company Overview - **Company**: Carlsmed - **Industry**: Medical Device, specifically focused on spine surgery - **Founded**: 2018 - **Public Company Status**: Recently went public Core Business and Technology - Carlsmed aims to improve healthcare outcomes and reduce costs in spine surgery by minimizing patient reoperations through a comprehensive technology platform that spans preoperative, intraoperative, and postoperative phases [2][3] - The company has developed the **aprevo® Technology Platform**, which allows for virtual modeling of patient pathology and creation of personalized surgical plans and devices [6][10] Financial Performance - **Q4 Revenue**: Over $15 million with a gross margin of 76.5%, representing a year-on-year growth of 61% [3] - **Full Year Revenue**: $50.5 million in the first year as a public company, an 86% year-on-year growth [3] - **2023 Revenue Guidance**: Projected revenue between $70 million and $75.5 million, indicating a growth of 44% at the midpoint [4] Market Opportunity - The U.S. spine surgery market includes approximately 445,000 lumbar procedures and 373,000 cervical procedures annually, totaling over 800,000 addressable procedures [5][6] - Carlsmed has seen a nearly 70% increase in its user base, ending the year with 253 trained surgeon users [4] Clinical Validation and Outcomes - Clinical data published in the Global Spine Journal indicates a 74% reduction in revision rates at the two-year mark for patients undergoing the aprevo personalized surgery compared to traditional methods [7] - The company has received Breakthrough Device Designation from the FDA, which facilitates better reimbursement options for its technologies [13][18] Reimbursement and Adoption - Carlsmed has secured a New Technology Add-on Payment from Medicare, providing over $21,000 in incremental reimbursement for hospitals adopting its cervical technology [18] - The company emphasizes the importance of payer support for technology adoption, which can lead to improved patient outcomes and reduced costs [11][14] Product Innovations - The company has expanded its platform to include cervical surgery, addressing specific challenges such as subsidence in patients with osteoporosis [15][18] - Recent innovations include a personalized cervical plating platform and a bilateral approach for minimally invasive procedures, enhancing the surgical experience and outcomes [20][21] Future Outlook - Carlsmed is focused on expanding its technology within the spine market before considering applications in other medical segments [28] - The company aims to continue its rapid growth trajectory and enhance the adoption of its personalized surgery approach [22] Additional Insights - The company utilizes a hybrid commercial model, leveraging both sales agents and direct teams for customer acquisition and support [4] - The technology allows for a zero-inventory business model, simplifying logistics for hospitals [21] - Carlsmed is aware of ongoing clinical studies involving wearable technology for post-operative recovery, although it is not directly integrating such technology at this time [22]

As filed with the Securities and Exchange Commission on July 15, 2025. UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 1 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Carlsmed, Inc. (Exact name of registrant as specified in its charter) Delaware (State or other jurisdiction of incorporation or organization) 3841 (Primary Standard Industrial Classification Code Number) 83-1081863 (I.R.S. Employer Identification No.) Carlsmed, Inc. 1800 Aston Ave, Su ...

As filed with the Securities and Exchange Commission on June 26, 2025. Registration No. 333– UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Carlsmed, Inc. (Exact name of registrant as specified in its charter) 3841 83-1081863 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification No.) Carlsmed, Inc. 1800 Aston Ave, Suite 100 Carlsbad, California 92008 (760) 766-1923 (Address, including ...