CARLSBAD, Calif., Feb. 23, 2026 (GLOBE NEWSWIRE) -- Carlsmed, Inc. (Nasdaq: CARL) (“Carlsmed” or the “Company”), today announced that Mike Cordonnier, CEO and Chairman, will be presenting at the 2026 Canaccord Genuity Musculoskeletal Conference on March 2, 2026 at 11:30 AM CST in New Orleans, LA.   A live webcast will be available to registered participants. Following the presentation, the webcast replay will be available at https://event.summitcast.com/view/d69xRqMspwymhwGUDdQoes/JC9qqvWhWggYawxGnDNtmz Abo ...

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 ...

CARLSBAD, Calif., Feb. 10, 2026 (GLOBE NEWSWIRE) -- Carlsmed, Inc. (Nasdaq: CARL) (“Carlsmed” or the “Company”), today announced the successful completion of the first posterior lumbar spine surgery using the Company’s aprevo® Lumbar Bi-lateral Posterior System. The procedure was performed by Orthopedic Spine Surgeon CJ Kleck, M.D. at the University of Colorado Hospital in Denver, Colorado. “This clinical milestone strengthens our position as a leader in personalized, data-driven spine solutions designed to ...

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]

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. will be presenting at the J.P. Morgan 2026 Healthcare conference on January 14th, 2026, from 4:30-5:10 pm PT in San Francisco, CA [1] - The company will also host one-on-one investor meetings during the conference [1] Company Overview - Carlsmed is a medical technology company focused on AI-enabled personalized spine surgery solutions [2] - The company's mission is to improve healthcare outcomes and reduce costs associated with spine surgery and related procedures [2]

Core Insights - Carlsmed (CARL) has launched its aprevo Technology Platform for cervical fusion procedures, marking a significant expansion in its patient-specific surgical ecosystem following the success of its lumbar fusion platform [1][4] - The cervical system utilizes AI-driven surgical planning and 3D-printed implants tailored to individual patient anatomy, enhancing surgical precision and workflow integration [2][7] - The company has experienced a decline in stock value, with shares dropping 27.5% following the announcement, and a 15.1% decrease since its IPO compared to the industry’s 10.5% decline [3] Product Launch and Technology - The aprevo platform has completed over 50 cervical cases, with early clinical findings being shared at the Cervical Spine Research Society (CSRS) meeting [1][7] - The technology aims to improve alignment and coverage in cervical fusion surgeries, which are performed approximately 370,000 times annually in the U.S. [2][4] - Surgeons have reported improved precision and the ability to treat complex cases more effectively with the new platform [2] Market Position and Financial Outlook - Carlsmed's cervical platform is positioned as a leader in personalized spine surgery, supported by clinical validation, FDA clearance, and a growing number of surgeon adopters [4][9] - The company has a market capitalization of $352.6 million, indicating its current market presence [4] - The Centers for Medicare & Medicaid Services has granted New Technology Add-On Payment (NTAP) status for the cervical fusion procedures using aprevo implants, allowing hospitals to receive up to $21,125 in additional reimbursement per qualifying procedure starting October 2025 [9][10] Regulatory and Clinical Milestones - The FDA granted 510(k) clearance for the aprevo Cervical ACDF Interbody System in late 2024, recognized as a Breakthrough Technology for its potential to address unmet needs in cervical fusion [10] - The launch aligns with the company’s timeline and follows significant clinical partnerships and milestones, enhancing its commercial outlook [8][10]

Summary of Carlsmed Conference Call Company Overview - Carlsmed was founded in 2018, focusing on complex spine deformity surgery with a breakthrough technology platform that integrates patient imaging and surgeon data to create digital surgical plans and 3D printed devices for surgeries [4][5] Key Points Technology and Innovation - The technology has demonstrated a **74% reduction in reoperation rates** at the two-year mark compared to standard care [5] - The platform allows for precise alignment in spinal surgeries, addressing the challenges of traditional interbody fusion devices that often lead to biomechanical failures [6][7] - Carlsmed has expanded its technology to include **cervical spine fusion**, with early clinical evaluations showing promising results [9][12] Market Opportunity - The addressable market includes **over 400,000 annual lumbar spine fusion procedures** and a similar number for cervical procedures, indicating a substantial growth opportunity [8][15] - The company anticipates that cervical procedures will also become the standard of care, similar to lumbar procedures [15][16] Financial Aspects - The average selling price (ASP) for cervical procedures is expected to be slightly lower than lumbar, with enhanced reimbursement from Medicare of up to **$21,250** for hospitals [18][19] - Carlsmed reported a **98% year-on-year growth** in Q3, driven by both existing and new surgeons adopting the technology [23] Operational Efficiency - The turnaround time for producing surgical implants has improved from **10 days to 8 days**, significantly enhancing operational efficiency and surgeon satisfaction [26][30] - The company has achieved a **76% gross margin** in Q3, reflecting improved cost management and production efficiency [31] Sales and Marketing Strategy - Carlsmed employs a hybrid sales force model, combining dedicated accounts teams with contracted representatives to maximize market coverage [32][33] - The company is focused on expanding its medical education programs to train the next generation of surgeons, which is expected to drive adoption of its technology [25] Competitive Advantage - Carlsmed possesses a strong intellectual property portfolio, which serves as a barrier to entry for competitors [35] - The company’s capital-light model allows for quicker scalability and a different financial profile compared to traditional orthopedic companies [38][40] Additional Insights - The company is currently 100% hospital-based, with plans to adapt as procedures potentially move from inpatient to outpatient settings [19][21] - Approximately **10% of ACDF procedures** in the Medicare population are performed on an outpatient basis, indicating a significant market still available for Carlsmed [21] This summary encapsulates the key insights from the conference call, highlighting Carlsmed's innovative technology, market potential, financial performance, operational efficiencies, and competitive advantages in the med tech industry.