L&C Bio MegaCarti knee cartilage benefits hold for 4 years

[이데일리 김진수 기자] L&C Bio said Aug. 12 that it has secured four-year durability data for MegaCarti, its knee cartilage regeneration device, building on the early efficacy demonstrated in an earlier randomized controlled trial.

The findings were published online in Scientific Reports, an SCIE-indexed journal in the Nature portfolio with an impact factor of 4.9. With four-year follow-up data now added to the short-term comparative trial, the company said it expects a favorable effect on the full new health technology assessment scheduled for the second half of this year and on broader clinical adoption.

The paper, “Midterm clinical and radiological outcomes of augmented microfracture using acellular particulated costal allocartilage for knee cartilage defects,” was written by researchers including Kim Sung-hwan, Jung Min and Chung Kwang-ho of Yonsei University College of Medicine, Jang Ki-mo of Korea University College of Medicine and Park Sang-hoon of National Health Insurance Service Ilsan Hospital.

The team prospectively followed 40 patients from a previous multicenter randomized controlled trial who received MegaCarti together with microfracture surgery, tracking MRI-based cartilage regeneration, pain, knee function and quality of life over four years.

Total scores on the MOCART scale, an MRI-based measure of cartilage repair tissue, were 56.4 at one year after surgery, 58.3 at two years, 55.2 at three years and 54.2 at four years. Scores peaked at the two-year mark, and the overall condition of the repair tissue observed at one year was maintained through four years. The proportion of patients showing homogeneous repair tissue rose to 71.3% at four years from 41.3% at one year.

Clinical improvement reported by patients also held through the four-year mark. IKDC scores climbed to 72.4 from 43.4 before surgery, and total KOOS scores rose to 80.7 from 54.1, while pain on a visual analog scale fell to 12.6 from 49.0. All patient-reported outcome measures improved significantly from presurgical levels, and no reoperations, joint replacements or additional cartilage procedures related to the treated lesions occurred during the four-year follow-up.

MegaCarti is a cartilage regeneration medical device made from human costal cartilage that is decellularized and processed into particles. In the earlier multicenter randomized controlled trial, it produced significantly higher-quality cartilage repair tissue on MRI at 48 weeks after surgery than microfracture alone. That study was published in the Orthopaedic Journal of Sports Medicine in 2023.

The significance of the latest study lies in adding four-year durability to the early comparative efficacy established by the earlier trial. The condition of the repair tissue on MRI was broadly maintained through four years, and patients‘ clinical gains in pain and knee function remained significantly better than before surgery.

The results could work in MegaCarti’s favor in the full new health technology assessment and in any subsequent expansion of its use, according to the company, because the data strengthen the clinical evidence available for the assessment by documenting not only early regeneration but also durability over four years. If the scope of approved use widens, L&C Bio said, that would also support greater clinical uptake and patient access.

Commercialization is moving ahead as well. L&C Bio has signed an agreement with Conmed, a global medical device company, covering co-marketing in South Korea and exclusive distribution in major Asian markets. With the post-signing preparation period now behind it, the company said full-scale sales are expected to follow. L&C Bio said the combination of four-year clinical evidence and expanded new health technology approval should give momentum to its push into domestic and overseas markets.

“Following the earlier randomized controlled trial, this study extends MegaCarti‘s clinical evidence from early efficacy to four-year durability,” an L&C Bio official said. “We expect this data to serve as important support for the full new health technology assessment and for broader clinical application going forward.”