MGEN Solution Confirms Safety and Efficacy of Bio-Derived Meniscal Implant in Preclinical Trials

MGEN Solution (032790) is accelerating its preparations for entering clinical trials, having confirmed the safety and tissue compatibility of its bio-derived meniscal implant 'XMI-HD' in preclinical studies.

On August 11, MGEN Solution announced that it had implanted XMI-HD into the meniscal region of pig models, which have similar body weight and joint size to humans. The graft remained stable throughout the study period. Histological assessments also revealed no abnormal findings such as excessive inflammatory responses or tissue necrosis.

In particular, microscopic observations using H&E (Hematoxylin & Eosin) staining showed that in the area where XMI-HD was implanted, the graft maintained the structure of the damaged region and formed connections with the surrounding native meniscal tissue. Infiltration and distribution of surrounding tissue cells within the graft were also observed.

The difference became even clearer when compared to the defect group without the implant. The defect group showed only limited tissue continuity in the damaged area. MGEN Solution explained that these results suggest XMI-HD can adapt to the surrounding tissue in the damaged meniscal region and may provide an environment conducive to tissue remodeling.

The meniscus is a key structure in the knee joint, absorbing external shocks and distributing loads created by body weight. Damage to or significant removal of this region can result in reduced knee function and, over the long term, a higher likelihood of developing degenerative joint changes.

XMI-HD is being developed to replace both the structure and function of such damaged menisci. If commercialized, the product could provide a new treatment option for patients with meniscal injuries and is expected by the company to expand the market for therapies that preserve knee function.

Market growth prospects are also attracting attention. According to industry reports, the global degenerative arthritis treatment market is projected to grow from about USD 5.5 billion (KRW 7.6 trillion) in 2025 to about USD 10.9 billion (KRW 15 trillion) by 2033. As of 2025, knee osteoarthritis accounted for 59.5% of the total degenerative arthritis treatment market. The domestic degenerative arthritis market is also expected to more than double between 2025 and 2033.

MGEN Solution is also progressing with follow-up steps for the commercialization of XMI-HD. The company is currently conducting biological safety tests, while also establishing GMP manufacturing facilities and preparing for mass production.

After completing the preclinical studies and setting up the manufacturing facilities, the company aims to enter clinical trials and begin pilot production in 2027. Since XMI-HD is a medical device, it will undergo clinical and regulatory processes specific to medical devices, which differ from the traditional Phase 1, 2, and 3 drug development process.

The company plans to collect about one year of clinical and follow-up data after conducting clinical trials and will then proceed with product licensing procedures.

A company representative said, "Through this evaluation, we have secured foundational data necessary for future clinical studies, including not only safety but also tissue compatibility at the implantation site and cell infiltration." The spokesperson added, "We will expedite the remaining biological safety tests and the establishment of GMP manufacturing facilities to proceed as planned with clinical entry and pilot production."

In summary, MGEN Solution has confirmed the safety and tissue compatibility of XMI-HD in preclinical pig studies and plans to proceed with biological safety assessments and GMP facility construction, targeting clinical trials and pilot production in 2027.

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