Core Insights - Carlsmed has demonstrated strong early customer traction, expanding its user base by nearly 70% last year, ending with 253 trained surgeon users [1] - The company aims to improve outcomes and reduce costs in spine surgery through a personalized, data-driven technology platform [3] Financial Performance - Carlsmed generated $50.5 million in revenue in its first year as a public company, representing an 86% year-on-year growth [2][5] - The company projects revenue between $70 million and $75.5 million for the current year, indicating a 44% growth at the midpoint [2][5] - In Q4, Carlsmed reported revenue of "north of $15 million" with a gross margin of 76.5% [2][5] Technology and Innovation - The aprevo Technology Platform enables patient-specific 3D surgical planning, on-demand 3D-printed implants, and sterile single-use instruments across the surgical workflow [6][16] - The platform has reduced order-to-delivery times from about eight weeks to six days, enhancing operational efficiency [13] Clinical and Reimbursement Advantages - Two-year data published in the Global Spine Journal showed a 74% reduction in revision rates for patients treated with Carlsmed's personalized approach compared to traditional methods [4][9] - Carlsmed has received FDA Breakthrough Device Designation and secured New Technology Add-on Payment (NTAP) for its lumbar offering, providing significant incremental hospital payments [10][12] Market Focus and Expansion - Carlsmed is focused on the U.S. spine market, serving both lumbar and cervical segments, with an estimated annual addressable procedure volume of over 800,000 [7] - The company has recently expanded into cervical spine procedures, targeting specific patient populations with tailored implants [11][12] Operational Improvements - The company has implemented a "zero inventory" model for hospitals, allowing for on-demand delivery of sterile-packed instruments and implants [14] - Carlsmed has completed its first posterior minimally invasive bilateral approach using the aprevo platform, showcasing its commitment to innovation [14]

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]

Financial Data and Key Metrics Changes - In 2025, the company reported revenue of $50.5 million, representing an 86% year-over-year growth from $27.2 million in 2024 [20] - Gross margins improved to 75.3% in 2025 from 73.8% in 2024, with fourth quarter gross margins at 76.5%, up from 74.7% in Q4 2024 [17][20] - The company recorded a GAAP net loss of $29.6 million for 2025, compared to a net loss of $24.3 million in 2024 [20] Business Line Data and Key Metrics Changes - The fourth quarter of 2025 saw revenue of $15.2 million, a 61% increase year-over-year, driven by the expansion of surgeon users and utilization rates [17] - The average revenue per procedure remained consistent year-over-year, indicating stable pricing despite growth in volume [17] Market Data and Key Metrics Changes - The company successfully added 101 new surgeon users in 2025, showcasing rapid clinical adoption in a market eager for innovation [9] - The launch of the aprevo cervical spine fusion technology in December 2025 is expected to enhance market penetration, particularly in a segment historically characterized by high variability in outcomes [9][10] Company Strategy and Development Direction - The company focuses on patient-centric innovation, with recent advancements including the bilateral posterior aprevo procedure and the Cora personalized fixation portfolio [11][12] - The strategic emphasis on surgeon education is evident, with expanded medical education efforts to support the adoption of the aprevo platform [14] - Commercial execution remains a priority, with plans to double sales regions in the U.S. and enhance service levels through partnerships with contracted sales agents [15] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future, anticipating continued revenue growth and improved adjusted EBITDA driven by operational efficiencies and market expansion [20] - The company aims for 2026 revenue in the range of $70 million to $75 million, representing a 44% growth at the midpoint compared to 2025 [20] Other Important Information - The company achieved a reduction in production lead times to 6 business days, down from 8 days in Q4 2024, which is expected to enhance surgeon adoption and operational efficiency [18][10] - Cash and investments totaled $109.9 million as of December 31, 2025, providing a solid financial foundation for future growth [21] Q&A Session Summary Question: Can you discuss the new indications or platforms announced in the quarter? - Management highlighted the bilateral aprevo lumbar procedure as a means to accelerate adoption in the posterior surgery market, while the Cora plates represent a significant step in personalizing cervical procedures [24][25] Question: What was the contribution of the cervical launch in the quarter? - The cervical portfolio has seen positive responses since its launch, with expectations for continued ramp-up in 2026 [28][29] Question: Can you provide insights on existing lumbar users and cervical adoption? - Approximately 10% of total users have been trained on cervical procedures, indicating strong initial adoption and confidence in future growth [30] Question: What are the expectations for 2026 guidance? - The guidance reflects a cautious approach, with expectations for continued surgeon training and adoption across both lumbar and cervical platforms [32][33] Question: How is the reduced lead time impacting the business? - The reduction in lead time is expected to facilitate new surgeon adoption and improve reorder rates, enhancing overall business performance [34][35] Question: What are the expectations for average selling prices (ASPs) moving into 2026? - ASPs are expected to remain stable for lumbar procedures, while cervical procedures may introduce some downward pressure on overall ASPs due to different reimbursement profiles [39] Question: How will G&A expenses trend in 2026? - G&A expenses are anticipated to decline as a percentage of revenue, allowing for continued investment in R&D and sales and marketing [40][41]

Carlsmed (NasdaqGS:CARL) Q4 2025 Earnings call February 25, 2026 04:30 PM ET Company ParticipantsCaroline Corner - Investor RelationsFelipe Lamar - Senior Equity Research AssociateLeo Greenstein - CFOMichael Cordonnier - CEO and ChairmanTravis Steed - Managing Director in Equity ResearchConference Call ParticipantsJenny Rabinowitz - Global Investment Research AnalystRyan Zimmerman - Managing Director and Senior Equity Research AnalystNone - AnalystOperatorLadies and gentlemen, thank you for standing by, and ...

Carlsmed (NasdaqGS:CARL) Q4 2025 Earnings call February 25, 2026 04:30 PM ET Speaker5Ladies and gentlemen, thank you for standing by, and welcome to the Carlsmed fourth quarter and full year 2025 earnings conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. I would now like to turn the conference over to your first speaker today, Caroline Corner, Investor Relations. Please go ahead, Caroline.Speaker1Thank yo ...

For the fiscal year ended December 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Washington, D.C. 20549 l FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Commission File Number 001-42756 CARLSMED, INC. (Exact name of Registrant as specified in its Charter) Delaware 83-1081863 (State or other jurisdiction of inc ...

Core Insights - Carlsmed, Inc. reported a fourth quarter revenue of $15.2 million, reflecting a 61% year-over-year growth, and a full year revenue of $50.5 million, representing an 86% increase year-over-year [1][6][13] - The company achieved a gross margin of 76.5% in Q4 2025, up from 74.7% in Q4 2024, indicating improved profitability [2][6] - Carlsmed's operating expenses for Q4 2025 were $20.9 million, significantly higher than $11.7 million in Q4 2024, driven by increased research and development, sales and marketing, and general administrative costs [6][13] Financial Performance - Fourth quarter revenue was $15.2 million, a 61.2% increase from $9.4 million in Q4 2024 [6] - Full year revenue reached $50.5 million, an 86% increase compared to $27.2 million in 2024 [6] - Gross profit for Q4 2025 was $11.6 million, compared to $7.0 million in Q4 2024, with a gross margin of 76.5% [6] - Operating expenses for Q4 2025 totaled $20.9 million, up from $11.7 million in Q4 2024, with R&D expenses at $5.3 million, sales and marketing at $10.8 million, and general and administrative at $4.9 million [6][13] - The net loss for Q4 2025 was ($8.6) million, compared to a net loss of ($4.7) million in Q4 2024 [6][13] - Adjusted EBITDA for Q4 2025 was ($8.4) million, compared to ($4.6) million in Q4 2024 [6][13] Business Highlights - The company launched the aprevo cervical system and the myaprevo ecosystem for browser and mobile integration [6] - Carlsmed performed its first in-human aprevo bi-lateral posterior fusion procedure and personalized corra™ cervical plating procedure in February 2026 [6] - Recent data published in the Global Spine Journal indicated a 74% reduction in revision rates at two years for aprevo lumbar patients compared to non-aprevo patients [2][6] 2026 Financial Outlook - Revenue for 2026 is projected to be between $70 million and $75 million, indicating a growth of approximately 44% at the midpoint compared to 2025 [7]

Core Viewpoint - Carlsmed, Inc. is set to present at the 2026 Canaccord Genuity Musculoskeletal Conference, highlighting its focus on AI-enabled personalized spine surgery solutions aimed at improving healthcare outcomes and reducing costs [1][2]. Group 1: Company Overview - Carlsmed, Inc. is a medical technology company specializing in AI-enabled personalized spine surgery solutions [2]. - The company's mission is to enhance outcomes and lower healthcare costs associated with spine surgery and related areas [2]. Group 2: Event Details - Mike Cordonnier, CEO and Chairman of Carlsmed, will present at the conference on March 2, 2026, at 11:30 AM CST in New Orleans, LA [1]. - A live webcast of the presentation will be available for registered participants, with a replay accessible afterward [1].

The corra™ Cervical Plating System marks the debut of Carlsmed's patient-specific fixation portfolioCARLSBAD, Calif., Feb. 18, 2026 (GLOBE NEWSWIRE) -- Carlsmed, Inc. (Nasdaq: CARL) (“Carlsmed” or the “Company”), today announced the first personalized cervical plating procedure using the corra™ Cervical Plating System, the latest addition to its portfolio of personalized spine surgery solutions. The procedure, which was performed by Dr. Aaron Clark at the University of California San Francisco (UCSF), repre ...

CARLSBAD, Calif., Feb. 11, 2026 (GLOBE NEWSWIRE) -- Carlsmed, Inc. (Nasdaq: CARL), a medical technology company pioneering AI-enabled personalized spine surgery solutions, today announced it will report its fourth quarter and full year 2025 financial results after market close on Wednesday, February 25, 2026. Management will also host a conference call and concurrent webcast starting at 1:30 PM Pacific Time. Conference Call Information To participate in this event, dial in approximately 5 to 10 minutes befo ...