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Carlsmed's aprevo® Personalized Interbody Implants Receive CMS New Technology Add-On Payment (NTAP) for Cervical Fusion Procedures

1. CMS grants NTAP for Carlsmed's aprevo® cervical fusion devices. 2. NTAP provides up to $21,125 in additional reimbursement for qualifying procedures. 3. This funding aims to improve patient outcomes and lower healthcare costs. 4. Commercial launch of aprevo® expected in 2026, following FDA breakthrough designation. 5. The decision reflects CMS's support for innovative medical technologies.

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Why Bullish?

The NTAP reimbursement can significantly enhance revenue prospects for Carlsmed, similar to how other companies benefited from CMS approvals in the past, potentially boosting stock price in the short-term.

How important is it?

The NTAP decision directly benefits Carlsmed's growth strategy, indicating strong market interest and potential future earnings, which is crucial for investor sentiment.

Why Short Term?

The immediate availability of NTAP reimbursement starting October 2025 could lead to increased hospital adoption rates, enhancing sales and affecting stock price in the coming months.

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AMGNABMDISRG
August 01, 2025 09:05 ET  | Source: Carlsmed 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 $21,125 in reimbursement on top of the Medicare Severity-Diagnosis Related Groups (MS-DRGs) for qualifying inpatient procedures. “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 

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