‘The Korean renegerative biopharmaceutical firm CGBIO has received accreditation from the American Association of Tissue Banks (AATB) for human tissue processing quality control (QC) system’, said CGBIO officials on March 4, 2021.
The AATB is the premier standard setting body promoting the safety and use of donated human tissue around the world. It publishes standards, accredits tissue banks, and certifies personnel. It is the only national tissue banking organization in the United States. Many tissue banks worldwide including Korea have attempted to gain AATB accreditation but without success because AATB standards are very strict and scrupulous.
This accreditation certified the overall operation of CGBIO’s human tissue processing QC system. As a result, AATB accreditation requirements were fully met in all test items. In particular, the sophisticated facility and equipment of both Seongnam Tissue Bank and Hyangnam Tissue Bank were highly appraised in terms of operation and stable QC system, according to CGBIO officials.
CGBIO is operating the largest tissue bank in Korea. This AATB accreditation positions CGBIO as a supplier to provide better quality of human tissue implants to patients suffering from various disasters, accidents, and disability. With this accreditation, CGBIO will set its foot-prints in the global export market through human tissue business for doctors in Latin America and Asia as well as the United States.
CGBIO plans to aggressively target markets for breast reconstruction and bone implant through its human tissue products such as a hydrated acellular dermal matrix (ADM) CGDerm One Step, a bone implant DBM Allomix Fiber, and a freeze-dried allogenic bone Allo Bone.
The Transparency Market Research forecasts that, with the drastic increase in the incidence of breast cancer, the global breast reconstruction market is expected to reach $1.9 billion in scale by 2026, up from $1.4 billion in 2019, at a CAGR of 5%. With the rising number of breast reconstruction procedures after mastectomy, ADM products account for more than 20% of the breast reconstruction market. Based on the easy-to-use convenience and better stability profile of CGDerrm One Step, CGBIO expects that this product could generate KRW 30 billion in the U.S. ADM market in 2021.
“The market size for human tissue implants is anticipated to grow at a sustained pace in the years to come as life science sector continues to evolve,” said CGBIO CEO Hyun Seung Yu. “CGBIO aims to be a global market leader in regenerative medicine. With this AATB accreditation, we will soon set our foot-prints in human tissue and medical device markets in the U.S., Latin America, and Asia Pacific.”
CGBIO is a total healthcare provider with a goal to enhance the quality of life by offering a wide range of interventional medical devices necessary for remodeling of musculoskeletal and connective tissue damage associated with diseases. Recently, CGBIO has expanded its business to the field of aesthetics and face-lifting and provided essential and convenient products for use in hospitals through its excellent biomaterial-based technology and a variety of collaborations with clinical experts.
