Cellumed's 'Partial Meniscus Replacement for Knee' Clinical Trials Progressing Smoothly at 3 Major Hospitals

[Asia Economy Reporter Hyunseok Yoo] Cellumed announced on the 23rd that clinical trials for the knee meniscus partial substitute `BMG (Bio Meniscus Graft)`, which is the first in Korea to receive manufacturing product approval from the Ministry of Food and Drug Safety, are progressing smoothly.

BMG is the first knee meniscus partial substitute developed by Cellumed in Korea. The clinical trials are being conducted with the support of the Pan-Government Project Group to apply for new medical technology evaluation.

Cellumed's BMG already obtained product approval from the Ministry of Food and Drug Safety in 2018, and additional clinical trials are underway based on the Ministry of Health and Welfare's judgment that it is a subject for new medical technology evaluation. Cellumed is continuously discussing clinical trials with leading domestic medical institutions for rapid commercialization.

Recently, it was selected as a national project to strengthen the government's medical device commercialization capabilities. Currently, clinical trials are being conducted through three major hospitals: Kyung Hee Medical Center, Myongji Hospital in collaboration with Hanyang University, and Samsung Seoul Hospital, which has passed the Institutional Review Board.

In this clinical trial, the safety and efficacy of partial meniscus transplantation using BMG and partial meniscectomy will be primarily evaluated in patients with damage to the medial or lateral meniscus.

A Cellumed official stated, “Since the clinical trial was selected as a national project, the future schedule will proceed without delay under the systematic management of well-known domestic clinical trial institutions,” adding, “Once the clinical trial is completed, the new medical technology evaluation process will begin immediately.”

He continued, “When full-scale sales begin, it can significantly delay the timing of artificial knee joint replacement for patients with poor joint conditions by replacing ineffective meniscus injury healing methods,” and added, “Currently, we are seeking sales channels mainly in regions with lower regulatory barriers such as South America and Southeast Asia, and we expect good results soon.”