Smith+Nephew (NYSE:SNN) reported that its CARTIHEAL AGILI-C implant demonstrated clinically superior outcomes for knee cartilage repair compared to the surgical standard of care after five years of follow-up in a multicenter, randomized controlled trial. The study, published in the American Journal of Sports Medicine, found higher overall Knee injury and Osteoarthritis Outcome Scores (KOOS) for the implant at all time points out to 60 months.
“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 an orthopedic surgeon at the Hospital for Special Surgery, who was involved in the trial. “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.”
The trial data showed that patients treated with the aragonite-based implant reported significantly better pain relief and quality of life improvements over the five-year period. They also experienced superior functional gains in activities related to daily living, sport, and recreation at the two, four, and five-year marks compared to patients who received either microfracture or debridement procedures.
The results, combined with a recently awarded Category I Current Procedural Terminology (CPT) code effective in 2027, position the FDA-approved implant to address a patient group that historically had limited effective options. The implant is designed for a broad range of chondral and osteochondral defects, filling a gap between early non-surgical interventions and full joint replacement.
Broader Market Access and Adoption
The new CPT code is expected to streamline the reimbursement process for the CARTIHEAL procedure, a critical step for wider adoption by physicians and hospitals in the United States. The implant’s efficacy in patients with mild to moderate osteoarthritis, a group often excluded from traditional cartilage repair, significantly expands its addressable market.
“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.”
The implant itself is a biphasic scaffold composed of aragonite, a naturally occurring calcium carbonate, which helps repair cartilage and restore the underlying subchondral bone.
This article is for informational purposes only and does not constitute investment advice.
