‘Recombinant human bone morphogenetic protein-2 (rhBMP-2) NOVOSIS of the Korean regenerative biopharmaceutical firm CGBIO has obtained approval for application in orthopedics and dentistry by the Federal Commission for the Protection against Sanitary Risk (COFEPRIS) in Mexico as a medical device’, said CGBIO officials.
NOVOSIS is a composite bone graft material consisting of 100% hydroxyapatite ceramic with rhBMP-2. In a damaged bone, sustained release of rhBMP-2 from NOVOSIS can effectively contribute to the differentiation of stem cells into osteogenic cells.
In particular, CGBIO’s bioactive ceramic supporter is a platform technology in which rhBMP-2 is loaded more effectively than general supporters. It is slowly released, with an integrated bioreaction and less side effects. CGBIO has filed a patent cooperation treaty (PCT) application for rhBMP-2 formulation technology. NOVOSIS developed by CGBIO received a World Class Product of Korea in 2017 and won Jang Young Sil Award in 2019.
To date, some local companies have launched bone grafts with rhBMP-2. Their indication is limited to dentistry. Now that local clinical trials for NOVOSIS were successfully completed in patients undergoing spinal fusion, NOVOSIS was approved for orthopedics for the first time in Korea in 2017. In 2020, the Ministry of Health and Welfare announced that ‘NOVOSIS is a novel medical technology whose safety and efficacy has been fully established’.
The Mexican device market size is valued at around $5.7 billion in 2018 according to Mexico’s CANIFARMA. Mexico’s medical device market will grow up to CAGR of 7.0% each year of a five-year period (2019-2024), thus reaching $8.1 billion in 2024. In particular, imports make up more than 82.3% of medical devices sold in Mexico. Thus, its market has a big growth potential.
CGBIO expects that the approval of NOVOSIS in Mexico will provide a significant opportunity for the rapid growth of CGBIO. NOVOSIS will be distributed in Mexico through a local orthopedic device distributor Imbiomex from October 2021.
“We will work together well with the local partner in Mexican medical device market having a lucrative potential, paving the way to export NOVOSIS as an essential material in bone fusion,” said CGBIO CEO Hyun Seung Yu. “We will also try to gain NOVOSIS approval from Australia, China, Japan, and U.S. as scheduled to launch this product around the world.”
