Press Releases

CARLSBAD, Calif.–(BUSINESS WIRE)–Carlsmed, Inc. (“Carlsmed” or the “Company”) a MedTech company pioneering AI-enabled personalized spine surgery, today announced FDA 510(k) clearance for the aprevo® Cervical ACDF Interbody System.

CARLSBAD, Calif.–(BUSINESS WIRE)–Carlsmed, a commercial-stage medical technology company and pioneer of the personalized spine surgery market, today announced the successful launch of its state-of-the-art digital production line.

CARLSBAD, Calif.–(BUSINESS WIRE)–Carlsmed, the leader in personalized spine surgery, announced that Kevin O’Boyle has joined its Board of Directors and will serve as the Chair of the Audit Committee.

CARLSBAD, Calif.–(BUSINESS WIRE)--Carlsmed, the leader in personalized spine surgery, announced today that in the Hospital Inpatient Prospective Payment System Final Rule for fiscal year 2025, the Centers for Medicare & Medicaid Services (CMS) assigned spinal fusion cases with aprevo^® custom-made anatomically designed interbody fusion devices to the highest level of the new spinal fusion Medicare Severity-Diagnosis Related Groups (MS-DRGs) it created. The new assignments and payment rates are favorable and will go into effect on October 1, 2024.

CARLSBAD, Calif.–(BUSINESS WIRE)– Carlsmed, an AI-enabled personalized surgery Medtech company, announced today a $52.5M Series C funding round co-led by B Capital and U.S. Venture Partners. These proceeds will be used to accelerate the commercialization of the aprevo^® personalized spine surgery platform for lumbar fusion procedures and the development of aprevo^® for cervical fusions, which will launch in 2025.

CARLSBAD, Calif.–(BUSINESS WIRE)– Carlsmed announced today that new clinical data on its aprevo^® technology has been published in the Global Spine Journal. This landmark study of a patient-matched cohort concluded that the use of aprevo^® personalized interbody devices enables a significant improvement in achieving alignment.

CARLSBAD, Calif.–(BUSINESS WIRE)– Carlsmed announced today that the FDA granted Breakthrough Device designation for its aprevo® technology for treatment of patients with cervical spine disease. This is Carlsmed’s second Breakthrough Device designation, complementing the company’s family of lumbar patient-specific interbody fusion devices for anterior, lateral, and transforaminal approaches.

CARLSBAD, Calif.–(BUSINESS WIRE)–Carlsmed^® announced today that the first patients have been enrolled in the COMPaSS™ study. COMPaSS, Clinical Outcome Measures in Personalized aprevo^® Spine Surgery, is a multi-center post market prospective observational registry. The study will collect data on patients with degenerative spinal conditions and are treated surgically with Carlsmed^® aprevo^® devices and will track outcomes for a period of two years.

CARLSBAD, Calif.–(BUSINESS WIRE)–Carlsmed^® announced today that it closed an oversubscribed $30M Series B funding round, led by B Capital Group, a global, multi-stage investment firm. Existing investors, U.S. Venture Partners, The Vertical Group, Cove Fund and Wavemaker Three-Sixty Health, also participated in the round. The company plans to use the Series B funds to ramp commercialization of aprevo®, Carlsmed’s FDA cleared personalized surgical devices.

CARLSBAD, Calif.–(BUSINESS WIRE)–Carlsmed^® announced today that the Center for Medicare & Medicaid Services (CMS) has granted aprevo^® a Transitional Pass-Through (TPT) payment as part of the quarterly update of the 2021 Medicare Hospital Outpatient Prospective Payment System. The aprevo^® Personalized Interbody Devices were the only devices to receive TPT status in this update. The pass-through payment provides outpatient facilities with an incremental Medicare payment for procedures in which aprevo^® is used.

CARLSBAD, Calif.–(BUSINESS WIRE)–Carlsmed^® , Inc., announced today the U.S. launch of the aprevo^® patient-specific spine technology and the New Technology Add-On Payment (NTAP) reimbursement.

CARLSBAD, Calif.–(BUSINESS WIRE)–Carlsmed^® announced today that aprevo^® has been recognized by Orthopedics This Week with the prestigious Spine Technology Award. This award was presented at a ceremony today at the North American Spine Society (NASS) meeting in Boston. The award is given annually to exemplary and innovative spine surgery products that improve spine care, as judged by a panel that includes leading spine surgeons. Early clinical data supporting aprevo^® is being presented at NASS during the Innovative Technologies Session.

CARLSBAD, Calif.–(BUSINESS WIRE)–Carlsmed^® , Inc., a commercial stage medical device technology company, is announcing today that it has partnered with the International Spine Study Group Foundation (ISSGF), the premier study group on adult spinal deformity, to collect data on surgical treatment with personalized interbody devices. Long term outcomes data will be collected to assess the role of aprevo^® devices in improving patient outcomes and reducing postoperative complications.

SAN DIEGO–(BUSINESS WIRE)–Carlsmed^® , Inc. is announcing today that the first aprevo patient specific spinal surgery has been successfully performed. Christopher Ames, M.D., director of spinal tumor and spinal deformity surgery at UC San Francisco Medical Center, assisted by Patrick Maloney, M.D., performed this landmark surgical procedure.

SAN DIEGO–(BUSINESS WIRE)–Carlsmed^® , Inc., today announced it has been granted 510(k) clearance and Breakthrough Device Designation by the FDA for its aprevo patient specific interbody devices for the correction of adult spinal deformity. The Carlsmed^® aprevo^® device is the first implant ever to receive both Breakthrough Device Designation and 510(k) market clearance from the FDA.