Carlsmed’s aprevo® Personalized Interbody Implants Receive CMS New Technology Add-On Payment (NTAP) for Cervical Fusion Procedures
Rhea-AI Summary
Carlsmed (NYSE:CARL) has secured CMS New Technology Add-On Payment (NTAP) approval for cervical fusion procedures using its aprevo® personalized interbody implants. Starting October 1, 2025, hospitals performing qualifying inpatient procedures with aprevo® devices will be eligible for up to $21,125 in additional reimbursement on top of standard Medicare payments.
The NTAP designation recognizes aprevo®'s significant clinical improvements over existing alternatives. The AI-enabled platform creates personalized implants matching each patient's unique anatomy, aiming to reduce revision surgeries. This approval follows the previous year's CMS reimbursement for Carlsmed's lumbar fusion devices. The company expects U.S. commercial launch in 2026, supported by FDA Breakthrough Device designation for cervical use.
Positive
- Additional reimbursement of up to $21,125 per procedure through NTAP program
- FDA Breakthrough Device designation received for cervical use
- Expansion of CMS coverage following previous lumbar fusion devices approval
- AI-powered technology designed to reduce revision surgeries
Negative
- Commercial launch not expected until 2026
- Revenue impact dependent on hospital adoption and procedure volumes
News Market Reaction – CARL
On the day this news was published, CARL declined 3.27%, reflecting a moderate negative market reaction.
Data tracked by StockTitan Argus on the day of publication.
CARLSBAD, Calif., Aug. 01, 2025 (GLOBE NEWSWIRE) -- Carlsmed, Inc. (“Carlsmed”), a medical technology company pioneering AI-enabled personalized spine surgery solutions, today announced that in the Hospital Inpatient Prospective Payment Systems Final Rule (IPPS) for fiscal year (FY) 2026, the Centers for Medicare & Medicaid Services (CMS) granted New Technology Add-On Payment (NTAP) reimbursement to cervical fusion procedures using the company’s aprevo® personalized interbody implants.
The NTAP program is designed to provide additional reimbursement to hospitals that use designated new medical technologies in the first few years of market introduction. These new technologies demonstrate significant clinical improvement in diagnosis or treatment for Medicare beneficiaries compared to existing alternatives. Starting October 1, 2025, through the NTAP program, cervical fusion procedures utilizing Carlsmed’s aprevo® devices are eligible for additional payment from CMS and private payors. The NTAP will use unique ICD-10-PCS procedure codes and provide up to an additional
“We appreciate CMS’s support in making innovative medical technologies more accessible to Medicare beneficiaries by mitigating some of the financial burden on hospitals,” said Mike Cordonnier, Chairman and CEO of Carlsmed. “Our aprevo® personalized surgery platform is designed to reduce the need for revision surgeries and empower surgeons to achieve optimal alignment for each patient. Building upon the CMS reimbursement granted to our lumbar fusion devices last year, we are pleased that this decision enables us to continue our mission to improve outcomes and decrease the cost of healthcare for spine surgery patients.”
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. Carlsmed received Breakthrough Device designation for cervical use by the FDA and anticipates a U.S. 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
IR@Carlsmed.com
Media
LeAnn Burton
Senior Director Brand Marketing
LBurton@Carlsmed.com
