Carlsmed’s aprevo® Powers First Personalized Cervical Spine Surgery
Rhea-AI Summary
Carlsmed (Nasdaq: CARL) has achieved a significant milestone with the first successful aprevo® cervical spine procedure performed on July 14, 2025, at UC San Diego Health. The procedure was conducted by Dr. Joseph Osorio, Chief of Spine Surgery in the Department of Neurological Surgery.
The aprevo® platform utilizes AI-powered surgical planning and digital production to create personalized spine devices that match each patient's unique anatomy and alignment requirements. The technology, which received FDA Breakthrough Device designation for cervical applications, is expected to launch commercially in the US in 2026.
Positive
- None.
Negative
- Commercial launch not expected until 2026
- Limited clinical experience with cervical application to date
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CARLSBAD, Calif., July 28, 2025 (GLOBE NEWSWIRE) -- Carlsmed, Inc. (Nasdaq: CARL) (“Carlsmed”), a medical technology company pioneering AI-enabled personalized spine surgery solutions, today announced the successful completion of the first aprevo® cervical procedure on July 14, 2025 by Joseph Osorio, MD, PhD, Chief of Spine Surgery in the Department of Neurological Surgery at UC San Diego (UCSD) Health in San Diego, CA.
The aprevo® devices are designed to match the unique anatomical and alignment needs of each patient through Carlsmed’s proprietary AI-powered surgical planning platform and digital production system.
Dr. Osorio, who has extensive experience utilizing the aprevo® platform for lumbar spine fusion procedures, noted, “Leveraging the aprevo® system for cervical fusion surgery allows a level of alignment which I believe is not achievable with traditional implants. The ability to customize each device to the patient’s unique pathology and anatomy represents a meaningful advancement for my practice.”
“On the heels of our IPO, this first cervical procedure represents an exciting milestone as we expand our personalized surgical solutions to the cervical spine,” said Mike Cordonnier, Chairman and CEO of Carlsmed. “We are proud to partner with Dr. Osorio and UCSD Health to bring this breakthrough technology to patients. Our goal is to reduce the need for revision surgeries, improve outcomes, and enhance value across the healthcare system as we work toward establishing a new standard of care.”
Carlsmed was granted Breakthrough Device designation for aprevo® cervical by the FDA and expects a US commercial launch in 2026.
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 Company’s current expectation of launching aprevo® cervical in the United States in 2026 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 the 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
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