SHANGHAI, China and PALO ALTO, Calif., July 27, 2015 (GLOBE NEWSWIRE) -- Cellular Biomedicine Group Inc. (NASDAQ:CBMG) ("CBMG" or the "Company"), a biomedicine firm engaged in the development of effective treatments for degenerative and cancerous diseases, today announced that it has received two new certifications from the China Food and Drug Administration (the "CFDA") for its proprietary cell and tissue preservation media kits respectively, in accordance with the CFDA's new regulations announced on June 1, 2015.
Dr. William (Wei) Cao, Chief Executive Officer of CBMG, commented: "We are pleased to receive the certificates, which further validate the quality of our medical device inventions, which are crucial to the safety and efficacy of our clinical trials of cell and tissue based therapies, including ReJoinTM Human Adipose Mesenchymal Progenitor Cell (haMPC) treatment for Knee Osteoarthritis (KOA). These certified kits enable long-term preservation and long distance shipment of cells and tissue, without freezing them down, from and to the point of care for ready applications by physicians. The latest certifications further strengthen our Vertically Integrated Cell Manufacturing System (VICMS) to centralize the processing and supplying of autologous cell therapies, and reinforce our potential to be a world-class biotechnology company, serving large unmet medical needs."
Cell Preservation Media Kit
CBMG's cell preservation media kit (CPMK) is a Class I Medical Device consisting of a proprietary media used to preserve the viability and vitality of both mesenchymal stem cells (MSC) and immune cells for longer than conventional solutions. When CBMG benchmarked its proprietary CPMK against other commercially available solutions, it was found that the cells in CPMK maintained their viability and vitality to a higher degree and for a longer duration than in other products. The kit is manufactured in CBMG's certified cGMP manufacturing facilities and several China patents have been filed.
Tissue Preservation Media Kit
CBMG's tissue preservation media kit (TPMK) is a Class I Medical Device used to maintain viable tissues for the extraction of MSCs. This proprietary invention of CBMG, for which a China patent and an international Patent Cooperation Treaty (PCT) patent have been filed, is manufactured in CBMG's certified cGMP manufacturing facilities.
About Cellular Biomedicine Group
Cellular Biomedicine Group, Inc. develops proprietary cell therapies for the treatment of certain degenerative diseases and cancers. Our developmental stem cell, progenitor cell, and immune cell projects are the result of research and development by scientists and doctors from China and the United States. Our flagship GMP facility in China, consisting of six independent cell production lines, is designed, certified and managed according to U.S. standards. To learn more about CBMG, please visit: www.cellbiomedgroup.com
Forward-Looking Statements
Statements in this press release relating to plans, strategies, trends, specific activities or investments, and other statements that are not descriptions of historical facts may be forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking information is inherently subject to risks and uncertainties, and actual results could differ materially from those currently anticipated due to a number of factors, which include, but are not limited to, risk factors inherent in doing business. Forward-looking statements may be identified by terms such as "may," "will," "expects," "plans," "intends," "estimates," "potential," or "continue," or similar terms or the negative of these terms. Although CBMG believes the expectations reflected in the forward-looking statements are reasonable, they cannot guarantee that future results, levels of activity, performance or achievements will be obtained. CBMG does not have any obligation to update these forward-looking statements other than as required by law.