Carlsmed’s aprevo® Personalized Interbody Implants Receive CMS New Technology Add-On Payment (NTAP) for Cervical Fusion Procedures
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.
Carlsmed (NYSE:CARL) ha ottenuto l'approvazione dal CMS per il New Technology Add-On Payment (NTAP) relativo alle procedure di fusione cervicale utilizzando i suoi impianti intersomatici personalizzati aprevo®. A partire dal 1° ottobre 2025, gli ospedali che eseguiranno procedure inpatient idonee con dispositivi aprevo® potranno beneficiare di un rimborso aggiuntivo fino a 21.125 dollari oltre ai pagamenti standard Medicare.
La designazione NTAP riconosce i significativi miglioramenti clinici di aprevo® rispetto alle alternative esistenti. La piattaforma abilitata dall'intelligenza artificiale crea impianti personalizzati che si adattano all'anatomia unica di ogni paziente, con l'obiettivo di ridurre gli interventi di revisione. Questa approvazione segue il rimborso CMS dell'anno precedente per i dispositivi di fusione lombare di Carlsmed. L'azienda prevede il lancio commerciale negli Stati Uniti nel 2026, supportato dalla designazione FDA Breakthrough Device per l'uso cervicale.
Carlsmed (NYSE:CARL) ha obtenido la aprobación del CMS para el New Technology Add-On Payment (NTAP) para procedimientos de fusión cervical utilizando sus implantes intersomáticos personalizados aprevo®. A partir del 1 de octubre de 2025, los hospitales que realicen procedimientos hospitalarios calificados con dispositivos aprevo® serán elegibles para un reembolso adicional de hasta 21,125 dólares además de los pagos estándar de Medicare.
La designación NTAP reconoce las mejoras clínicas significativas de aprevo® sobre las alternativas existentes. La plataforma habilitada con inteligencia artificial crea implantes personalizados que se ajustan a la anatomía única de cada paciente, con el objetivo de reducir cirugías de revisión. Esta aprobación sigue al reembolso del CMS del año anterior para los dispositivos de fusión lumbar de Carlsmed. La empresa espera lanzar comercialmente en EE. UU. en 2026, respaldada por la designación FDA Breakthrough Device para uso cervical.
Carlsmed (NYSE:CARL)은 CMS 신기술 추가 지불제도(NTAP) 승인을 받아 aprevo® 맞춤형 경추 간격 임플란트를 사용한 경추 융합 수술에 적용됩니다. 2025년 10월 1일부터 aprevo® 장치를 사용한 적격 입원 환자 수술을 수행하는 병원은 표준 메디케어 지급액 외에 최대 21,125달러의 추가 환급을 받을 수 있습니다.
NTAP 지정은 aprevo®가 기존 대안에 비해 임상적으로 큰 개선을 이뤘음을 인정한 것입니다. AI 기반 플랫폼은 각 환자의 고유한 해부학적 구조에 맞춘 맞춤형 임플란트를 제작하여 재수술을 줄이는 것을 목표로 합니다. 이번 승인은 전년도 Carlsmed의 요추 융합 장치에 대한 CMS 환급 승인에 이은 것입니다. 회사는 FDA 경추용 혁신 의료기기 지정 지원 아래 2026년 미국 내 상업적 출시를 기대하고 있습니다.
Carlsmed (NYSE:CARL) a obtenu l'approbation du CMS pour le New Technology Add-On Payment (NTAP) concernant les procédures de fusion cervicale utilisant ses implants intersomatiques personnalisés aprevo®. À partir du 1er octobre 2025, les hôpitaux réalisant des interventions hospitalières éligibles avec les dispositifs aprevo® pourront bénéficier d'un remboursement supplémentaire allant jusqu'à 21 125 dollars en plus des paiements standards de Medicare.
La désignation NTAP reconnaît les améliorations cliniques significatives d'aprevo® par rapport aux alternatives existantes. La plateforme assistée par intelligence artificielle crée des implants personnalisés adaptés à l'anatomie unique de chaque patient, visant à réduire les chirurgies de révision. Cette approbation fait suite au remboursement CMS de l'année précédente pour les dispositifs de fusion lombaire de Carlsmed. L'entreprise prévoit un lancement commercial aux États-Unis en 2026, soutenu par la désignation FDA Breakthrough Device pour l'usage cervical.
Carlsmed (NYSE:CARL) hat die Genehmigung des CMS für die New Technology Add-On Payment (NTAP) für zervikale Fusionsverfahren unter Verwendung seiner aprevo® personalisierten Interbody-Implantate erhalten. Ab dem 1. Oktober 2025 sind Krankenhäuser, die qualifizierte stationäre Eingriffe mit aprevo®-Geräten durchführen, berechtigt, eine zusätzliche Vergütung von bis zu 21.125 US-Dollar neben den regulären Medicare-Zahlungen zu erhalten.
Die NTAP-Zulassung erkennt die signifikanten klinischen Verbesserungen von aprevo® gegenüber bestehenden Alternativen an. Die KI-gestützte Plattform erstellt personalisierte Implantate, die der einzigartigen Anatomie jedes Patienten entsprechen, mit dem Ziel, Nachoperationen zu reduzieren. Diese Genehmigung folgt auf die CMS-Erstattung im Vorjahr für Carlsmeds Lendenwirbelfusionsgeräte. Das Unternehmen plant die kommerzielle Markteinführung in den USA im Jahr 2026, unterstützt durch die FDA Breakthrough Device-Auszeichnung für die zervikale Anwendung.
- 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
- Commercial launch not expected until 2026
- Revenue impact dependent on hospital adoption and procedure volumes
Insights
Carlsmed secured significant Medicare reimbursement for its personalized cervical implants, boosting hospital adoption and revenue potential.
This CMS New Technology Add-on Payment (NTAP) approval represents a major milestone for Carlsmed's cervical spine fusion technology. The NTAP designation provides hospitals with up to
The NTAP designation is particularly significant because CMS only awards it to technologies demonstrating substantial clinical improvement over existing alternatives. This regulatory recognition validates Carlsmed's AI-driven approach to personalized spine implants and should accelerate market penetration in the Medicare population—a key demographic for spine procedures.
With commercial launch planned for 2026 and FDA Breakthrough Device designation already secured, Carlsmed has positioned aprevo® with both regulatory and reimbursement advantages. The timing of the NTAP approval (effective October 1, 2025) aligns perfectly with their launch timeline, eliminating the typical reimbursement lag that often slows adoption of new medical technologies.
The unique ICD-10-PCS procedure codes granted with this approval will streamline billing processes and provide tracking mechanisms for utilization. From a market perspective, this approval positions Carlsmed competitively against larger spine companies by removing a significant barrier to hospital adoption—the financial disincentive to use innovative but more expensive technologies.
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
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LeAnn Burton
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FAQ
What is the maximum NTAP reimbursement amount for Carlsmed's aprevo® cervical fusion procedures?
When will Carlsmed's aprevo® cervical fusion implants be available commercially?
When does the NTAP reimbursement for Carlsmed's aprevo® cervical fusion procedures begin?
What makes Carlsmed's aprevo® implants different from traditional cervical fusion devices?
What regulatory designations has Carlsmed's aprevo® received for cervical use?
