[E-Daily Reporter SONG YOUNG-DOO ] NIBEC CO., LTD.(138610)announced on the 9th that its bone graft-collagen composite material, “OCS-B Collagen,” has received marketing authorization from Brazil’s National Health Surveillance Agency (ANVISA). As a result, the company can now sell OCS-B Collagen in Brazil in addition to its existing OCS-B product, thereby expanding its local product portfolio.
Brazil is considered one of the world’s largest dental implant markets, second only to the United States. The market for dental regenerative materials is also growing steadily due to an aging population and increasing demand for aesthetic treatments. The company expects that this approval will not only expand its product lineup but also enable substantial revenue growth, as it has established a system that allows for immediate sales upon approval.
NIBEC CO., LTD.’s dental regenerative materials are supplied to countries around the world through the global distribution networks of leading dental companies Straumann and Nobel Biocare. The company plans to further expand its supply to the Latin American market, building on this expansion of product approval in Brazil.
This approval is significant not only because it expands the number of countries where the products are sold but also because it enhances the stability of the medical device business. Based on the cash flow generated by its medical device business, NIBEC CO., LTD. is concurrently conducting research and development on its new drug pipeline, including NP-201, a treatment for idiopathic pulmonary fibrosis (IPF). This structure allows the medical device business to serve as a stable cash cow, thereby increasing the company’s capacity to invest in new drug development.
Following the acquisition of certification under the European Medical Device Regulation (MDR) earlier this year, the company has secured product approval in Brazil, thereby expanding its global regulatory approvals. Currently, the company is also in the process of obtaining product approval to enter the Japanese market, with a strategy to strengthen the global competitiveness of its medical device business based on approvals in key countries.
NIBEC CO., LTD. official stated, “By securing Brazilian marketing authorization for OCS-B Collagen, following OCS-B, we have expanded the range of products available for supply in the local market,” adding, “We plan to continue the stable growth of our medical device business in Brazil and other Latin American markets while, based on this foundation, continuing to invest in the development of our new drug pipeline.”