Articles from Carlsmed

Carlsmed, Inc. (“Carlsmed”), a commercial-stage medical technology company pioneering AI-enabled personalized spine surgery solutions, today announced that it has publicly filed a registration statement on Form S-1 with the U.S. Securities and Exchange Commission (the “SEC”) relating to a proposed initial public offering of shares of its common stock. The number of shares to be offered and the price range for the proposed offering have not yet been determined. Carlsmed has applied to list its common stock on the Nasdaq Global Select Market under the ticker symbol “CARL.” The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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. This innovative technology will enable the company to deliver its aprevo® personalized spinal fusion implants to hospitals in less than ten days.

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.

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.

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.

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. The study measured the difference in pelvic incidence (PI) and lumbar lordosis (LL), referred to as PI-LL mismatch, comparing personalized spine surgery and traditional spine surgery. Prior studies have shown that achieving optimal alignment during spine fusion surgery is highly correlated with reduced complications.

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.

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.

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.

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.

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.