[Edaily Reporter Kim Hyung-il ] L&C Bio ( L&C BIO(290650)), a human tissue-based regenerative medicine company, announced on the 12th that it has secured four-year mid-to-long-term clinical follow-up data for its knee cartilage treatment, “MegaCarti.”

MegaCarti is a medical device for cartilage regeneration made by decellularizing human costal cartilage and processing it into a particulate form. In a previously conducted multicenter, randomized controlled clinical trial, the quality of regenerated cartilage tissue was found to be significantly higher on MRI scans taken 48 weeks post-surgery compared to treatment with microfracture alone; the results of this study were published in 2023 in the international journal *The Orthopaedic Journal of Sports Medicine*.

The results of this study were published in *Scientific Reports*, an international journal in the *Nature* family. Following the initial efficacy confirmed in the previous randomized controlled clinical trial, L&C BIO conducted a four-year follow-up to verify whether the improvements in cartilage regeneration, pain relief, and knee function were sustained over the long term.

The research team conducted a four-year follow-up on 40 patients who had participated in the previous multicenter randomized controlled clinical trial and who had undergone a combination of Megacarti and microdrilling. They evaluated cartilage regeneration, pain, knee function, and quality of life using magnetic resonance imaging (MRI).

The total score on the Modified Observation Score for Cartilage Regeneration (MOCART)—an MRI-based indicator of cartilage regeneration—was 56.4 points one year post-surgery, 58.3 points at two years, 55.2 points at three years, and 54.2 points at four years. After peaking at the two-year mark, the overall condition of the regenerated tissue remained stable through the four-year follow-up. The proportion of cases showing homogeneous regenerated tissue increased from 41.3% at 1 year to 71.3% at 4 years.

Clinical improvement as perceived by the patients also persisted through the 4-year mark. The International Knee Documentation Committee (IKDC) score increased from 43.4 preoperatively to 72.4 at the 4-year mark, and the total Knee Injury and Osteoarthritis Outcome Score (KOOS) also rose from 54.1 to 80.7. The Visual Analog Scale (VAS) for pain decreased from 49.0 to 12.6.

Among the patients followed for four years, there were no cases of reoperation, total knee arthroplasty, or additional cartilage surgery related to the treated cartilage lesions. This study is significant in that it adds four years of follow-up results to the initial efficacy confirmed in previous clinical trials. Based on these data, L&C BIO plans to utilize them for the full evaluation of new medical technologies scheduled for the second half of this year and for the future expansion of clinical applications.

Commercialization is also underway. L&C BIO previously signed an agreement with global medical device company CONMED for co-marketing in South Korea and exclusive sales rights in major Asian countries. The company plans to begin full-scale sales following a preparatory period.

An L&C BIO official stated, “Following the existing randomized controlled clinical trials, this study has expanded the clinical evidence for Megacarti from initial efficacy to mid- to long-term sustainability over four years,” adding, “We expect this evidence to support the full evaluation of new medical technologies and the future expansion of clinical applications.”