Smith+Nephew announces new category I CPT® code for its CARTIHEAL™ AGILI-C™ Cartilage Repair Implant
Smith+Nephew (LSE:SN, NYSE:SNN), the global medical technology company, today announces that the American Medical Association (AMA) CPT Editorial Panel has established a Category I Current Procedural Terminology (CPT) code for procedures involving its CARTIHEAL AGILI-C Cartilage Repair Implant, effective January 1, 2027.
The new CPT code recognizes the clinical significance and growing adoption of the CARTIHEAL Implant, a single-stage, off-the-shelf solution for treating cartilage and osteochondral defects in the knee, including in patients with mild to moderate osteoarthritis (OA). The implant received Breakthrough Device Designation from the U.S. Food and Drug Administration and is the only FDA-approved device for this indication.
Clinical Impact
The CARTIHEAL Implant demonstrated an 87% reduction in the relative risk of total knee arthroplasty or osteotomy at 4 years compared to microfracture or debridement, according to data published from a multicenter randomized controlled trial.1 This positive data and broad knee indication, including OA, provides an additional treatment option for this patient population earlier in their treatment journey.
“This new CPT code is a major milestone for physicians and patients alike,” said Dr. Ken Zaslav of Northwell Health. “It validates the clinical value of the CARTIHEAL Implant and facilitates broader access to a technology that fills a true unmet need in the world of cartilage repair.”
Reimbursement and Access
The Category I CPT code will streamline reimbursement processes for providers and payers, supporting the integration of the CARTIHEAL Implant into standard clinical practice. It also reflects the AMA’s recognition of the procedure’s clinical efficacy, safety, and widespread physician adoption.
“This code represents a critical milestone on our journey to enable access to patients that can benefit from the CARTIHEAL Implant,” said Christie Van Geffen, SVP Global Sports Medicine Marketing for Smith+Nephew.
About the CARTIHEAL AGILI-C Cartilage Repair Implant
The CARTIHEAL Implant is commercially available in the United States, including Puerto Rico. The implant is composed of aragonite, a naturally occurring calcium carbonate, and acts as a biphasic scaffold that allows it to repair cartilage and restore subchondral bone.2-6 To learn more about Smith+Nephew’s CARTIHEAL AGILI-C Cartilage Repair Implant, please visit our booth at ICRS 2025 in Boston, MA October 11-13, or visit www.smith-nephew.com/cartiheal.
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Media Enquiries
Dave Snyder +1 (978) 749-1440
Smith+Nephew david.snyder@smith-nephew.com
CPT is a registered trademark of the American Medical Association (AMA). All rights reserved.
References
- Conte P, Anzillotti G, Crawford DC, et al. Differential analysis of the impact of lesions' location on clinical and radiological outcomes after the implantation of a novel aragonite-based scaffold to treat knee cartilage defects. Int Orthop. 2024;48(12):3117-3126
- Altschuler N, Zaslav KR, Di Matteo B, et al. Aragonite-Based Scaffold Versus Microfracture and Debridement for the Treatment of Knee Chondral and Osteochondral Lesions: Results of a Multicenter Randomized Controlled Trial. Am J Sports Med. 2023;51(4):957-967. doi:10.1177/03635465231151252
- Kon E, Di Matteo B, Verdonk P, et al. Aragonite-Based Scaffold for the Treatment of Joint Surface Lesions in Mild to Moderate Osteoarthritic Knees: Results of a 2-Year Multicenter Prospective Study. Am J Sports Med. 2021;49(3):588-598. doi:10.1177/0363546520981750
- Kon E, Filardo G, Shani J, et al. Osteochondral regeneration with a novel aragonite-hyaluronate biphasic scaffold: up to 12-month follow-up study in a goat model. J Orthop Surg Res. 2015;10:81. Published 2015 May 28. doi:10.1186/s13018-015-0211-y
- Matta C, et al. Differentiation.2019;107:24-34.
- Chubinskaya S, et al. Knee Surg Sports Traumatol Arthrosc. 2019;27(6):1953-1964.
About Smith+Nephew
Smith+Nephew is a portfolio medical technology business focused on the repair, regeneration and replacement of soft and hard tissue. We exist to restore people’s bodies and their self-belief by using technology to take the limits off living. We call this purpose ‘Life Unlimited’. Our 17,000 employees deliver this mission every day, making a difference to patients’ lives through the excellence of our product portfolio, and the invention and application of new technologies across our three global business units of Orthopaedics, Sports Medicine & ENT and Advanced Wound Management.
Founded in Hull, UK, in 1856, we now operate in around 100 countries, and generated annual sales of $5.8 billion in 2024. Smith+Nephew is a constituent of the FTSE100 (LSE:SN, NYSE:SNN). The terms ‘Group’ and ‘Smith+Nephew’ are used to refer to Smith & Nephew plc and its consolidated subsidiaries, unless the context requires otherwise.
For more information about Smith+Nephew, please visit www.smith-nephew.com and follow us on X, LinkedIn, Instagram or Facebook.
Forward-looking Statements
This document may contain forward-looking statements that may or may not prove accurate. For example, statements regarding expected revenue growth and trading profit margins, market trends and our product pipeline are forward-looking statements. Phrases such as "aim", "plan", "intend", "anticipate", "well-placed", "believe", "estimate", "expect", "target", "consider" and similar expressions are generally intended to identify forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other important factors that could cause actual results to differ materially from what is expressed or implied by the statements. For Smith+Nephew, these factors include: conflicts in Europe and the Middle East, economic and financial conditions in the markets we serve, especially those affecting healthcare providers, payers and customers; price levels for established and innovative medical devices; developments in medical technology; regulatory approvals, reimbursement decisions or other government actions; product defects or recalls or other problems with quality management systems or failure to comply with related regulations; litigation relating to patent or other claims; legal and financial compliance risks and related investigative, remedial or enforcement actions; disruption to our supply chain or operations or those of our suppliers; competition for qualified personnel; strategic actions, including acquisitions and disposals, our success in performing due diligence, valuing and integrating acquired businesses; disruption that may result from transactions or other changes we make in our business plans or organisation to adapt to market developments; relationships with healthcare professionals; reliance on information technology and cybersecurity; disruptions due to natural disasters, weather and climate change related events; changes in customer and other stakeholder sustainability expectations; changes in taxation regulations; effects of foreign exchange volatility; and numerous other matters that affect us or our markets, including those of a political, economic, business, competitive or reputational nature. Please refer to the documents that Smith+Nephew has filed with the U.S. Securities and Exchange Commission under the U.S. Securities Exchange Act of 1934, as amended, including Smith+Nephew's most recent annual report on Form 20-F, which is available on the SEC’s website at www. sec.gov, for a discussion of certain of these factors. Any forward-looking statement is based on information available to Smith+Nephew as of the date of the statement. All written or oral forward-looking statements attributable to Smith+Nephew are qualified by this caution. Smith+Nephew does not undertake any obligation to update or revise any forward-looking statement to reflect any change in circumstances or in Smith+Nephew's expectations.
◊ Trademark of Smith+Nephew. Certain marks registered in US Patent and Trademark Office.
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