Smith+Nephew (LSE:SN, NYSE:SNN), the global medical technology company, today announces further compelling evidence from a multicenter, randomized controlled trial highlighting the clinical superiority of its CARTIHEAL AGILI-C Cartilage Repair Implant recently published in the American Journal of Sports Medicine (AJSM). The CARTIHEAL AGILI-C Cartilage Repair Implant resulted in higher overall Knee injury and Osteoarthritis Outcome Scores (KOOS) versus surgical standard of care* for all time points out to 60 months.1,2
- Superior pain relief: Patients treated with the CARTIHEAL AGILI-C Implant reported significantly better knee pain relief, and quality of life improvements over a 5-year period.1
- Superior functional gains: Patients treated with the CARTIHEAL Implant reported superior improvements in performing activities related to daily living, sport and recreation at 2, 4 and 5-years.1,2
- Patients with/without osteoarthritis (OA): Equal clinical outcomes were found in OA and non-OA patients receiving the CARTIHEAL Implant.1,2
“Having been involved with CARTIHEAL from the initial trial design, through patient enrollment, and now in daily clinical use, I’m thrilled by the 5-year outcomes. Notably, CARTIHEAL patients had twice the reduction in pain scores compared to standard care,” said Dr. Andreas Gomoll, Professor of Orthopedic Surgery at Weill-Cornell Medical School and Attending Orthopedic Surgeon at the Hospital for Special Surgery in New York. “What excites me even more is that these outcomes were comparable for both patients with and without osteoarthritis. This represents a vital new option for those in the osteoarthritis treatment gap where cartilage is too damaged for standard repair but not enough for joint replacement. Historically, these patients relied on non-surgical methods with mixed success. Now, we have a durable solution to restore function and quality of life.”
Smith+Nephew's FDA-approved CARTIHEAL Implant is revolutionizing the cartilage repair landscape with the implant’s broad indication allowing physicians to treat patients who previously may not have had access. The implant recently received a Category I Current Procedural Terminology (CPT) code for procedures that will go into effect on January 1, 2027.
“Patients need an off the shelf scaffold with strong clinical evidence—one that can effectively treat both chondral and osteochondral defects, even in those with mild to moderate osteoarthritis. These new 5-year results further validate the promise of the CARTIHEAL Implant,” said Professor Elizaveta Kon from Humanitas Research Hospital. “They show that we can finally offer a reliable, evidence backed solution to a large patient population that, in many cases, has had limited treatment options. Seeing such durable outcomes is truly exciting.”
About the CARTIHEAL AGILI-C Cartilage Repair Implant
The CARTIHEAL Implant is commercially available in the United States, including Puerto Rico. Composed of aragonite, a naturally occurring calcium carbonate acting as a biphasic scaffold – the implant is able to repair cartilage and restore subchondral bone.3-7 To learn more about Smith+Nephew’s CARTIHEAL AGILI-C Cartilage Repair Implant, please visit www.smith-nephew.com/cartiheal.
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* compared to debridement or microfracture
References
- Altschuler N ZK, Di Matteo B, et al. Five-Year Follow-up of a Multicenter Randomized Controlled Trial Comparing an Aragonite-Based Scaffold with Microfracture and Debridement for Chondral and Osteochondral Knee Lesions. Am J Sports Med 2026.
- 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 $6.2 billion in 2025. 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.
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