Carlsmed Announces U.S. Launch of its aprevo® Technology Platform for Cervical Fusion Surgeries at the Cervical Spine Research Society (CSRS) 53rd Annual Meeting

Rhea-AI Summary

Carlsmed (Nasdaq: CARL) announced the U.S. commercial launch of its aprevo® Technology Platform for cervical fusion on December 3, 2025, and will present early clinical experience at the Cervical Spine Research Society (CSRS) 53rd Annual Meeting, December 3–6, 2025.

The aprevo® Cervical Interbody System pairs AI-driven preoperative planning with 3D-printed, patient-specific implants. Carlsmed reported its first 50+ cervical cases, noting efficient workflow integration, precise implant fit with maximized endplate coverage, and an ability to achieve planned sagittal and coronal alignment versus stock implants.

Carlsmed referenced prior aprevo® lumbar results showing lower complication rates and fewer revision surgeries, cited 370,000 U.S. cervical fusions performed this year as market context, and will hold a CSRS lunch workshop on Dec 4, 2025 at 12:30 PM EST.

Positive

• U.S. commercial launch of aprevo cervical platform on Dec 3, 2025
• Completed 50+ initial cervical cases in clinical evaluation
• CSRS presentation of early clinical observations Dec 3–6, 2025; workshop Dec 4

Negative

• None.

First 50+ cervical cases completed; observations on initial clinical experience to be presented by early adopters at the Carlsmed CSRS Lunch Workshop

CARLSBAD, 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 Meeting in Washington, D.C., December 3-6, 2025.

The aprevo^® Cervical Interbody System expands Carlsmed’s personalized spine platform, which combines AI-driven preoperative planning with 3D-printed, patient-specific implants tailored to each patient’s anatomy and pathology. The cervical system builds upon the success of the aprevo^® lumbar platform, which to date has demonstrated lower complication rates and fewer revision surgeries compared to standard stock implants.

With over 370,000 cervical fusion surgeries performed in the U.S. this year, the need for technologies that support improved alignment and anatomical fit in patients with poor bone quality continues to grow. Early clinical experience shows efficient workflow integration, precise implant fit with maximized endplate coverage, and, when compared with stock implants, an ability to achieve planned sagittal and coronal alignment goals.

“We are excited to bring the aprevo^® platform to cervical fusion procedures, representing an important milestone in our mission to transform spine surgery,” said Mike Cordonnier, Chairman and CEO of Carlsmed. “With positive clinical feedback from our first 50+ cases, strong reimbursement support and accelerating demand, we believe our cervical system has the potential to redefine the standard of care in cervical spine surgery.”

“Personalization represents the next frontier in cervical spine surgery,” said Dr. Andrew Chan, MD, at Columbia University / New York-Presbyterian Och Spine Hospital. “With aprevo^® Cervical we’re able to preoperatively plan in three dimensions and deliver a device that’s matched to each patient’s unique anatomy. That level of precision enhances how we correct alignment while helping broaden access to anterior cervical procedures for more complex patients.”

CSRS Lunch Workshop Details

Date: Thursday, December 4, 2025
Time: 12:30-1:30 pm EST
Room: Meeting Room 8 - Meeting Level
Panel Presenters: Andrew Chan, MD, Columbia University / New York-Presbyterian Och Spine Hospital, Deb Bhowmick, MD, Duke University, Department of Neurosurgery, and Venu Nemani, MD, PhD, Virginia Mason Medical Center

About Carlsmed

Carlsmed is a medical technology company pioneering AI-enabled personalized spine surgery solutions with a mission to improve outcomes and decrease the cost of healthcare for spine surgery and beyond.

Forward-Looking Statements

Any statements in this press release about future expectations, plans and prospects, including statements about the potential of, and demand for, the Company’s products, the Company’s expectations concerning the potential market size for its technology platform, and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “likely,” “will,” “would,” “could,” “should,” “continue,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including such important factors as are set forth under the caption “Risk Factors” in Carlsmed’s Registration Statement on Form S-1 on file with the U.S. Securities and Exchange Commission. The forward-looking statements included in this press release represent Carlsmed’s views as of the date of this press release. Carlsmed anticipates that subsequent events and developments will cause its views to change. However, while Carlsmed may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Carlsmed’s views as of any date subsequent to the date of this press release.

Investor Relations
Caroline Corner, PhD
IR@Carlsmed.com

Media
LeAnn Burton
Senior Director Brand Marketing
LBurton@Carlsmed.com

FAQ

What did Carlsmed (CARL) announce on December 3, 2025 about cervical fusion?

Carlsmed announced the U.S. commercial launch of the aprevo® cervical technology platform for cervical fusion on December 3, 2025.

How many initial cervical cases has Carlsmed completed with aprevo®?

Carlsmed reported completing its first 50+ cervical cases during the clinical evaluation.

When and where will Carlsmed present early aprevo® cervical data (CARL)?

Early clinical observations will be presented at CSRS Dec 3–6, 2025, including a lunch workshop on Dec 4, 2025 at 12:30 PM EST.

What features does the aprevo® Cervical Interbody System offer for surgeons?

The system combines AI-driven 3D preoperative planning with 3D-printed patient-specific implants tailored to each patient’s anatomy and pathology.

Does Carlsmed claim clinical advantages for aprevo® cervical versus stock implants?

Early experience cited precise implant fit, maximized endplate coverage, and the ability to hit planned sagittal and coronal alignment goals versus stock implants.

What market context did Carlsmed (CARL) cite for cervical fusion demand?

Carlsmed noted about 370,000 cervical fusion surgeries performed in the U.S. this year as context for demand.