Naibec Secures Approval for Key Bio Material from US FDA and 31 Countries... "Expanding Global Market"

Naibec announced on the 9th that it has obtained product approvals in 31 countries worldwide, including Europe and the U.S. Food and Drug Administration (FDA), for its core bio-material products such as ‘OCS-B’, ‘OCS-B Collagen’, and ‘Regenomer’. Naibec is expanding its global presence not only in key markets including Europe, the U.S., and China but also in South America, ASEAN, Japan, and Russia.

This year, Naibec expects sales growth after obtaining the European Union (EU) Medical Device Regulation (MDR) certification for its major products. It has already passed the ‘ISO13485 (Medical Device Quality Management System)’ based on MDR standards. The company has successfully completed the ‘Post-Market Clinical Follow-up (PMCF)’. Currently, only the technical document review remains, and certification is expected within this year.

In the U.S., Naibec has received FDA approval for major products including ‘OCS-B’, ‘OCS-H’, ‘OCS-B Collagen’, ‘Regenomer’, and ‘CleanPlant’, and is currently undergoing product approval procedures for ‘Xenoguide’. ‘Ossgen-X15’ and the new product ‘Pepticol EasyGraft’ are planned to apply for new product approvals this year.

In the Chinese market, Naibec obtained product approval for its flagship product OCS-B from the National Medical Products Administration (NMPA) in 2020. OCS-B demonstrated efficacy and safety in a large-scale clinical trial involving 280 patients at five major local hospitals. The company is currently awaiting product approval for OCS-B Collagen.

Naibec has also received product approvals for its major bio-material products in Australia, Canada, Colombia, Mexico, Thailand, Malaysia, and Singapore. The company plans to continuously expand its overseas export countries, including Japan, Brazil, and Russia.

A Naibec representative stated, “With the increase in the elderly population, global demand for implants is expected to rise significantly. Especially in developed countries, as awareness of oral health and aesthetics increases, there is a strong tendency to prefer implants, so the market for essential bone regeneration bio-materials is expected to grow steadily.”

He added, “Since Naibec’s bio-material products have already been verified for efficacy, safety, and quality through large-scale clinical trials in Europe and China, the expansion of the global market will accelerate.”