Carlsmed's Innovative Implants Gain NTAP Approval for Cervical Use
Carlsmed’s Latest Advancement in Spine Surgery Technology
Carlsmed, Inc., a progressive medical technology company, is making waves in the field of personalized spine surgery with their AI-powered solutions. Recently, the Centers for Medicare & Medicaid Services (CMS) has granted New Technology Add-On Payment (NTAP) reimbursement for Carlsmed’s groundbreaking aprevo® personalized interbody implants. This significant announcement, made in the context of the Hospital Inpatient Prospective Payment Systems Final Rule (IPPS) for the upcoming fiscal year, marks an important milestone for the company.
NTAP Program and Its Impact on Hospitals
The NTAP program serves as a vital financial incentive for hospitals implementing new medical technologies that show considerable clinical improvements over standard practices. This program aims to alleviate some of the monetary pressures faced by healthcare facilities while introducing these innovative technologies. As of October 1, 2025, hospitals utilizing the aprevo® devices in cervical fusion surgeries will see enhanced payment opportunities through CMS, which could translate to as much as an additional $21,125 per procedure for qualifying inpatient cases.
Testimony from Carlsmed’s Leadership
Mike Cordonnier, Carlsmed's Chairman and CEO, expressed gratitude for CMS's efforts to make innovative technologies accessible to more patients. He emphasized the importance of reducing revision surgeries and achieving optimal patient alignment with the aprevo® personalized surgery platform. This recent reimbursement decision builds upon the prior approval received for lumbar fusion devices, reinforcing Carlsmed’s commitment to improving surgical outcomes while reducing overall healthcare costs.
Personalized Solutions with AI Technology
The aprevo® devices stand out because they are uniquely tailored to fit each patient’s anatomical needs. Carlsmed’s proprietary AI-driven surgical planning platform facilitates a precise matching of the implants to individual patients, further honing the surgical process. With a Breakthrough Device designation granted by the FDA for cervical usage, Carlsmed is poised for a commercial launch in the U.S. by 2026.
About Carlsmed
Founded with a vision to redefine spine surgery, Carlsmed is committed to leveraging cutting-edge technology to enhance patient outcomes while managing costs. Their innovations reflect a dedication to continuous improvement and patient-centered care in the medical landscape.
Frequently Asked Questions
What is the aprevo® implant?
The aprevo® implant is a personalized interbody implant developed by Carlsmed, designed using AI to meet the specific anatomical needs of patients undergoing spine surgery.
What does NTAP stand for?
NTAP stands for New Technology Add-On Payment, a CMS program that provides additional reimbursement to hospitals for using specified new medical technologies.
When will the NTAP program take effect?
The NTAP program for Carlsmed's aprevo® implants will begin on October 1, 2025.
How does this approval benefit hospitals?
This approval enables hospitals to receive additional compensation for cervical fusion procedures using aprevo® implants, alleviating some financial burden during the adoption of new technologies.
What is Carlsmed’s mission?
Carlsmed's mission is to pioneer AI-enabled personalized spine surgery solutions that improve outcomes and lower healthcare costs for patients.
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