SC Engineering "Cellontec 'RegenSeal' Obtains Market Approval in Malaysia"

Cellontech, a subsidiary of SCN Engineering, will actively pursue performance creation following its entry into overseas markets this year.

Regenerative medicine specialized bio company Cellontech announced on the 19th that it has obtained medical device marketing approval for ‘RegenSeal’ from the Medical Device Authority (MDA) under the Ministry of Health Malaysia.

RegenSeal is a collagen-based tissue supplement that implants bio-collagen to replenish soft tissues such as tendons and ligaments that are defective or damaged. Bio-collagen is a medical collagen independently developed by Cellontech and registered in the U.S. Food and Drug Administration (FDA) Drug Master File (DMF). It is a high value-added core raw material that promotes the regeneration of various damaged human tissues.

A Cellontech official said, “It is significant that we have succeeded in commercializing a liquid injectable form of bio-collagen raw material in the overseas soft tissue regenerative medicine market.” He added, “Among the major ASEAN (Association of Southeast Asian Nations) countries’ medical device markets, which rank third largest in the Asia-Pacific region after Japan and China, Malaysia is the second largest market after Thailand. We will make every effort to ensure that RegenSeal achieves rapid sales growth in overseas markets by cooperating with local medical device distributors.”

Cellontech is simultaneously promoting the entry of RegenSeal and Korea’s first collagen intra-articular injection ‘Katizol’ and cartilage reconstruction product ‘Katipil’ into the ASEAN market.

In particular, for Katizol, after signing an exclusive sales supply contract guaranteeing a minimum order quantity worth 9.5 billion KRW over five years with Khang Lam, a Vietnamese medical device distribution specialist, last year, it is currently in the process of obtaining local marketing approval based on large-scale domestic clinical data. Full-scale sales are expected to begin as early as the second half of this year.

A Cellontech official emphasized, “We will do our best to ensure that the overseas expansion achievements accumulated so far contribute to performance improvement this year,” and added, “We expect that the unique product competitiveness based on bio-collagen raw materials will play a key role in strengthening global market penetration, starting with the rapidly growing ASEAN market due to economic growth and aging.”