UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 (State or Other Jurisdiction of Incorporation) Delaware 001-42756 83-1081863 (Commission File Number) (IRS Employer Identification No.) 1800 Aston Ave, Suite 100 Carlsbad, California 92008 (Address of Principal Executive Offices) (Zip Code) Registrant's Telephone Number, Including Area Code: (760) 766-1923 Check the appropriate box below if th ...

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]

CARLSBAD, Calif., Jan. 06, 2026 (GLOBE NEWSWIRE) -- Carlsmed, Inc. (Nasdaq: CARL) (“Carlsmed” or the “Company”), today announced the publication of a new retrospective cohort study in Global Spine Journal demonstrating that 3D preoperative planning combined with patient-specific, anatomically designed interbody implants significantly reduces mechanical complication–related reoperations in complex adult spinal deformity (ASD) surgery. The study compared 2-year revision rates among ASD patients receiving Carl ...

CARLSBAD, Calif., Dec. 16, 2025 (GLOBE NEWSWIRE) -- Carlsmed, Inc. (Nasdaq: CARL) (“Carlsmed” or the “Company”), today announced that Mike Cordonnier, Chairman and CEO of Carlsmed will be presenting at the J.P. Morgan 2026 Healthcare conference on Wednesday, January 14th at 4:30-5:10 pm PT in San Francisco, CA. During the conference, Carlsmed Management will be hosting 1x1 investor meetings. About Carlsmed, Inc. Carlsmed is a medical technology company pioneering AI-enabled personalized spine surgery soluti ...

Key Takeaways CARL has begun U.S. commercialization of its aprevo cervical platform with more than 50 cases completed.CARL's AI-driven planning and 3D-printed implants showed improved alignment and workflow integration.NTAP reimbursement, FDA clearance and clinical milestones strengthened CARL's platform outlook.Carlsmed (CARL) recently announced the U.S. commercial launch of its aprevo Technology Platform for cervical fusion procedures at the Cervical Spine Research Society (CSRS) 53rd Annual Meeting in Wa ...

Carlsmed (NasdaqGS:CARL) FY Conference December 03, 2025 09:00 AM ET Company ParticipantsMike Cordonnier - CEOConference Call ParticipantsMatt O'Brien - AnalystMatt O'BrienGood morning, everybody. Thanks so much for joining us. My name is Matt O'Brien. I'm one of the med tech analysts here at Piper Sandler. Very excited to have Carlsmed here with us, you know, all the way across the country. Thanks for coming. From the company, we have Mike, who is the CEO. Leo, CFO, is back in the audience. Mike, thanks ag ...

First 50+ cervical cases completed; observations on initial clinical experience to be presented by early adopters at the Carlsmed CSRS Lunch WorkshopCARLSBAD, Calif., Dec. 03, 2025 (GLOBE NEWSWIRE) -- Carlsmed, Inc. (Nasdaq: CARL) (“Carlsmed” or the “Company”), today announced the U.S. commercial launch of its aprevo® Technology Platform for cervical fusion surgeries. Surgeons involved in the clinical evaluation will also present early clinical data at the Cervical Spine Research Society (CSRS) 53rd Annual ...

Core Viewpoint - Carlsmed, Inc. is set to present at the 37th Annual Piper Sandler Healthcare conference, highlighting its focus on AI-enabled personalized spine surgery solutions aimed at improving healthcare outcomes and reducing costs [1]. Company Overview - Carlsmed is a medical technology company specializing in AI-enabled personalized spine surgery solutions [3]. - The company's mission is to enhance outcomes and lower healthcare costs associated with spine surgery and related areas [3]. Event Details - Mike Cordonnier, Chairman and CEO of Carlsmed, will present at the conference on December 3rd from 9:00 to 9:25 am ET in New York, NY [1]. - The company will also host one-on-one investor meetings during the conference [1]. - A live webcast of the presentation will be available for registered participants, with a replay accessible afterward [2].

Carlsmed (NasdaqGS:CARL) Q3 2025 Earnings Call November 06, 2025 04:30 PM ET Speaker0Ladies and gentlemen, thank you for standing by, and welcome to the Carlsmed Third Quarter 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.Speaker2Thank you, operator. We ...

Revenue Growth - For the three months ended September 30, 2025, Carlsmed recognized revenue of $13.1 million, a 98.4% increase from $6.6 million in the same period of 2024[134]. - For the nine months ended September 30, 2025, revenue reached $35.3 million, up 99.1% from $17.8 million in the prior year[134]. - Revenue for the three months ended September 30, 2025, was $13.1 million, a 98.4% increase from $6.6 million in the same period of 2024, driven by increased volume of surgical procedures with the aprevo Technology Platform[163]. - Revenue for the nine months ended September 30, 2025, was $35.3 million, a 99.1% increase from $17.8 million in the same period of 2024, also driven by increased volume of surgical procedures with the aprevo Technology Platform[164]. Product Development and Innovation - The aprevo Technology Platform has been used to treat over 2,600 patients since its commercial launch in October 2021[140]. - The FDA granted Breakthrough Device Designation for the aprevo cervical spine fusion in September 2023, with commercialization expected by early 2026[138]. - The company launched a digital production system in November 2024, reducing delivery time for interbody implants to eight business days[135]. - The company plans to expand its commercial infrastructure and market access initiatives to grow the base of surgeons using the aprevo Technology Platform[141]. - Research and development expenses are expected to increase as Carlsmed accelerates product and software innovation[154]. Financial Performance - Cost of sales for the three months ended September 30, 2025, was $3.1 million, a 75.6% increase from $1.8 million in the same period of 2024, primarily due to increased sales of aprevo interbody implants[165]. - Gross margin improved to 75.9% for the three months ended September 30, 2025, compared to 72.8% in the same period of 2024, attributed to reduced production fees and decreased inventory reserve expenses[166]. - Total operating expenses for the three months ended September 30, 2025, were $19.0 million, a 50.8% increase from $12.6 million in the same period of 2024[169]. - Research and development expenses for the three months ended September 30, 2025, were $4.4 million, a 10.2% increase from $4.0 million in the same period of 2024, mainly due to higher personnel costs[169]. - Sales and marketing expenses for the three months ended September 30, 2025, were $9.6 million, a 45.1% increase from $6.6 million in the same period of 2024, driven by increased personnel-related costs and commissions[171]. - General and administrative expenses for the three months ended September 30, 2025, were $4.9 million, a 155.8% increase from $1.9 million in the same period of 2024, primarily due to increased professional service and legal fees[173]. - Interest income for the three months ended September 30, 2025, was $1.0 million, a 142.1% increase from $0.4 million in the same period of 2024, due to higher daily average cash balances from IPO proceeds[176]. - Net loss for the three months ended September 30, 2025, was $8.5 million, a 9.1% increase from $7.8 million in the same period of 2024[162]. - Adjusted EBITDA for the nine months ended September 30, 2025, was $(19.9) million, reflecting a 4.0% increase from $(19.2) million in 2024[182]. Cash Flow and Financing - Cash and cash equivalents as of September 30, 2025, totaled $115.4 million, with an accumulated deficit of $92.2 million[183]. - Net cash used in operating activities for the nine months ended September 30, 2025, was $23.7 million, compared to $21.3 million in 2024[192]. - Proceeds from the initial public offering (IPO) amounted to $93.5 million, net of underwriting discounts and commissions, contributing to net cash provided by financing activities of $100.2 million for the nine months ended September 30, 2025[197]. - The Customers Loan Agreement was amended to increase borrowing capacity, with a term loan of up to $50 million, contingent upon revenue milestones[186]. - The maturity date of the Term Loan was extended to October 15, 2030, with an interest-only period through October 15, 2027[187]. - Cash payments to vendors during the nine months ended September 30, 2025, totaled $34.4 million, while payroll-related cash payments were $19.8 million[193]. - The company expects existing cash and cash equivalents, along with anticipated sales from aprevo interbody implants, to fund operations for at least the next 12 months[188]. - Total principal amount outstanding under the Customers Loan Agreement as of September 30, 2025, was $15.6 million, maturing on October 31, 2029[199]. Company Classification - The company may take advantage of exemptions for up to five years as an emerging growth company, ceasing to be one when total annual gross revenues reach $1.235 billion or more[205]. - The company is classified as a "smaller reporting company" with a market value of shares held by non-affiliates less than $700 million and annual revenue below $100 million[206]. - The company can continue to rely on exemptions from certain disclosure requirements if it remains a smaller reporting company after ceasing to be an emerging growth company[206].