L&C Bio Confirms Clinical Significance of Knee Cartilage Treatment Medical Device 'MegaCati'

Decellularization of Human-Derived Cartilage...World's First Human Tissue-Based
Multicenter Clinical Trial Confirms Regenerative Effects

[Asia Economy Reporter Lee Gwan-joo] Regenerative medicine research and development company L&C Bio announced on the 19th that ‘MegaCarti,’ the world’s first human tissue-based medical device for treating knee joint cartilage damage, has confirmed statistically significant cartilage regeneration effects and safety through clinical trials.

MegaCarti, developed by L&C Bio, is the world’s first human tissue-based medical device for treating knee joint cartilage damage, using decellularized human-derived cartilage called hyaline cartilage for transplantation. By directly injecting the decellularized hyaline cartilage into the damaged area, it immediately supplements the knee joint cartilage after the procedure, providing rapid pain relief and restoring the damaged cartilage through the self-integration of the injected cartilage.

L&C Bio conducted a clinical trial with a total of 90 patients classified as ICRS grade 3 to 4 (international standard criteria for cartilage defect severity), corresponding to severe degenerative arthritis. The patients were randomly assigned one-to-one to a test group treated with MegaCarti and a control group treated only with microfracture surgery.

After 48 weeks of cartilage regeneration evaluation, the test group treated with MegaCarti showed statistically significant regenerative effects compared to the control group. The MOCART (Magnetic Resonance Observation of Cartilage Repair Tissue) scores were 55.97±10.46 for the test group and 42.95±17.39 for the control group, meeting the primary endpoint. Additionally, through further X-ray imaging assessing the degree of knee cartilage defect using the K-L grade (Kellgren-Lawrence grade), the test group showed statistically significant improvement at 48 weeks post-procedure compared to the control group.

This clinical trial was conducted at four domestic hospitals?Shinchon Severance Hospital, Gangnam Severance Hospital, Korea University Anam Hospital, and National Health Insurance Service Ilsan Hospital?after receiving clinical trial approval from the Ministry of Food and Drug Safety in December 2019. No serious adverse effects were observed in terms of safety.

Based on the results of this clinical trial, L&C Bio plans to apply for medical device product approval (NDA) from the Ministry of Food and Drug Safety and accelerate its entry into global markets, including China. Lee Hwan-cheol, CEO of L&C Bio, stated, “Since the excellent cartilage regeneration effect was confirmed with a single MegaCarti procedure, we will launch it as soon as possible to provide patients with a new treatment option that offers actual cartilage regeneration effects at a reasonable cost compared to existing procedures.” He added, “We will also expedite preparations for entry into global markets such as China and the United States.”