Carlsmed's aprevo® implants receive CMS reimbursement for cervical fusion procedures, enhancing access for Medicare patients starting October 2025.
Quiver AI Summary
Carlsmed, Inc., a medical technology company focused on AI-enabled personalized spine surgery, announced that the Centers for Medicare & Medicaid Services (CMS) will provide New Technology Add-On Payment (NTAP) reimbursement for cervical fusion procedures using its aprevo® personalized interbody implants starting October 1, 2025. The NTAP program aims to support hospitals adopting new medical technologies that show significant improvements in treatment, allowing for up to an additional $21,125 in reimbursement for qualifying procedures. Carlsmed’s CEO, Mike Cordonnier, expressed gratitude for CMS's efforts to enhance access to innovative technologies for Medicare beneficiaries and highlighted the company’s commitment to improving surgical outcomes and reducing healthcare costs. The aprevo® platform, which addresses patients' unique anatomical needs through a specialized AI-powered surgical planning system, is expected to launch commercially in 2026 following its FDA Breakthrough Device designation.
Potential Positives
- The Centers for Medicare & Medicaid Services (CMS) has granted New Technology Add-On Payment (NTAP) reimbursement for Carlsmed's aprevo® personalized interbody implants, enhancing potential revenue for the company.
- The NTAP program is expected to provide up to an additional $21,125 in reimbursement for qualifying inpatient procedures, which could incentivize hospitals to adopt Carlsmed's technology.
- This decision builds on previous reimbursement granted for lumbar fusion devices, indicating a positive trend in CMS support for Carlsmed's innovations.
- The company received Breakthrough Device designation from the FDA for its cervical use, which may facilitate a smoother path for market entry and commercial launch anticipated in 2026.
Potential Negatives
- The company is reliant on the new NTAP reimbursement program, which may create vulnerability if future reimbursement policies change or if the effectiveness of the aprevo® devices does not meet expectations.
- The anticipated U.S. commercial launch of the aprevo® cervical device in 2026 suggests a delay in bringing their product to market, potentially missing out on early adoption opportunities and revenue generation.
- The press release includes forward-looking statements that carry inherent risks, indicating that actual outcomes may significantly differ from the company’s expectations, which could impact investor confidence.
FAQ
What is Carlsmed's aprevo® device?
Carlsmed's aprevo® device is a personalized interbody implant designed for cervical fusion procedures using AI-powered surgical planning.
What reimbursement was granted by CMS for aprevo®?
CMS granted a New Technology Add-On Payment, providing up to $21,125 in additional reimbursement for qualifying cervical fusion procedures.
When will the aprevo® devices be commercially launched?
Carlsmed anticipates the U.S. commercial launch of aprevo® cervical devices in 2026.
How does NTAP benefit hospitals using aprevo®?
The NTAP program mitigates financial burdens on hospitals, allowing for additional reimbursements when using innovative technologies like aprevo®.
What is Carlsmed's mission?
Carlsmed aims to improve outcomes and decrease the cost of healthcare for spine surgery through personalized, AI-enabled solutions.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
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Full Release
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.
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