Human tissue-based regenerative medicine corporations L&C BIO(290650)'s knee cartilage treatment MegaCarti showed that improvements in cartilage regeneration status and pain and knee function were maintained for up to four years after surgery.
The company plans to use this as a basis to proceed with the main assessment for new medical technology scheduled for the second half of this year and to expand clinical application.
L&C BIO said on the 12th that mid- to long-term four-year clinical results for MegaCarti were published online in the Nature portfolio international journal Scientific Reports.
MegaCarti is a cartilage-regeneration medical device made by decellularizing human-derived costal cartilage and processing it into particles.
The study was conducted on 40 patients who participated in a previous multicenter randomized controlled clinical trial by research teams from Yonsei University College of Medicine, Korea University College of Medicine, and National Health Insurance Service Ilsan Hospital. The researchers tracked patients who underwent MegaCarti combined with microfracture for up to four years after surgery using magnetic resonance imaging (MRI), and assessments of pain, knee function, and quality of life.
The total MOCART score, an MRI-based index for evaluating cartilage regeneration, was 56.4 at one year after surgery, 58.3 at two years, 55.2 at three years, and 54.2 at four years. After peaking at two years and then declining slightly, the score at four years was at a level similar to those at one and three years.
Clinician-reported improvement maintained through four years. According to the paper, all patient-reported outcome measures evaluating knee function and pain improved significantly compared with before surgery. In particular, the KOOS total score and the symptom and quality-of-life domains showed additional improvement from one to four years.
The paper concluded that microfracture using MegaCarti maintained the quality of regenerated cartilage tissue on MRI at a relatively similar level across one, three, and four years of follow-up, and that clinical improvements also persisted through four years.
Earlier in 2023, the researchers reported in a randomized controlled trial that the MegaCarti combination group showed superior quality of regenerated cartilage tissue on MRI at 48 weeks after surgery compared with the microfracture-only group.
This study is meaningful in that it secured mid- to long-term four-year follow-up data beyond MegaCarti's initial clinical effects. The company expected it would positively affect the new medical technology assessment. The company is facing the main assessment for new medical technology to be conducted in the second half of this year.
Commercialization is also underway. L&C BIO signed a domestic co-distribution and exclusive distribution agreement for major Asian countries with global medical device corporations CONMED. The company plans to ramp up domestic and overseas sales based on secured clinical evidence and expanded application of the new medical technology.
A L&C BIO official said, "Through this study, the clinical evidence for MegaCarti has expanded from initial effects to mid- to long-term sustainability over four years," and added, "We expect it will serve as evidence supporting the main assessment for new medical technology and the expansion of clinical application."
References
Scientific Reports (2026), DOI: https://doi.org/10.1038/s41598-026-63052-7