Mgen Solution Advances Preclinical Trials for 25 Trillion Won Xenogeneic Meniscus Implant... Clinical Trials Set for Next Year

On August 27, Mgen Solution announced that it has begun preclinical research for the development of a xenogeneic meniscus implant. The company plans to complete animal testing (preclinical studies) by July next year and apply for clinical trials with the Ministry of Food and Drug Safety in the second half of the year.

The xenogeneic implant being developed by Mgen Solution is a decellularized meniscus implant that utilizes xenogeneic tissues, such as those from cows and pigs, with cells removed to enhance human compatibility. Unlike conventional allografts, which face supply limitations due to a shortage of donors, xenogeneic implants can be supplied stably. As a result, there are high expectations for increased demand and market growth potential. The company currently holds a patent for its decellularization technology.

Currently, Mgen Solution is undergoing evaluation procedures through external specialized institutions as part of its preclinical process, and is preparing to enter clinical trials based on these results.

Osteoarthritis is a representative chronic degenerative disease, with the number of patients continuously increasing due to an aging population. According to the industry, osteoarthritis accounts for 11% of the global disease burden, affecting approximately 600 million patients worldwide. In particular, the number of osteoarthritis patients is known to be about 32 times higher than that of rheumatoid arthritis patients. According to market research firm Precedence Research, the global osteoarthritis therapeutics market is expected to grow to 18.4 billion dollars (approximately 25.6 trillion won) by 2032.

In Korea, more than 80,000 meniscus-related surgeries are performed annually, with a significant portion involving partial meniscectomy. The company explained, "There has been a consistent need for implants that can preserve or replace cartilage, as the risk of developing degenerative arthritis increases after meniscectomy."

Mgen Solution aims to commercialize its product by 2027 and plans to enter clinical trials as quickly as possible. A company representative emphasized, "Through our previously patented composite decellularization technology, we have secured a shorter process time and superior tissue compatibility compared to existing methods."

He stated, "Xenogeneic implants have significant potential to overcome the limitations of allografts," and added, "Depending on the clinical results, we will pursue not only domestic approval but also overseas approvals such as CE (Europe) and FDA (U.S. Food and Drug Administration)." He further mentioned, "We are also considering product lines utilizing xenogeneic tissues for ligaments, skin, and other applications based on our decellularization technology."

This content was produced with the assistance of AI translation services.