Regenerative medicine specialized bio company Cellontech announced on the 21st that it has obtained medical device marketing approval for ‘CartiFill’ from the Medical Device Authority (MDA) under the Ministry of Health Malaysia.
CartiFill is the first domestic gel-type joint cartilage regeneration treatment medical device developed using Cellontech’s proprietary bio-collagen as the raw material. It is a tissue repair biomaterial that helps cartilage cells and bone marrow cells to locate during microfracture surgery. It received product approval from the Ministry of Food and Drug Safety in 2013. It was also recognized as a treatment material corresponding to the new medical technology announced by the Korea Health Industry Development Institute under the Ministry of Health and Welfare in 2013.
CartiFill proactively responded to local demand by obtaining a Special Access permit last year, allowing its use only in specific hospitals upon strong requests from Malaysian specialists. With the recent marketing approval from the local health authorities, the demand for CartiFill is expected to expand further.
Currently, Cellontech’s main products are expanding throughout ASEAN (Association of Southeast Asian Nations). Including CartiFill, the country’s first collagen intra-articular injection ‘Cartizol’ and tendon/ligament reconstruction material ‘Regenseal’ have either obtained or are pursuing marketing approvals in major ASEAN countries such as Malaysia, Thailand, Singapore, and Vietnam.
A Cellontech official stated, “The ASEAN market is experiencing increased demand for high-quality medical devices due to economic growth, population increase, and aging. We will actively cooperate with local specialized medical device distribution companies to ensure that products successfully commercialized locally establish themselves in the market and generate simultaneous overseas sales.”
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