Biosafe's Sepax System Receives Chinese SFDA Approval
EYSINS, Switzerland, November 19, 2012 /PRNewswire/ --
Biosafe Group SA, announced today that it has obtained Chinese SFDA registration for its Sepax® device, completing its worldwide registration program. Sepax is now available for immediate sale in China through Biosafe's recently established local subsidiary in Shanghai and is the first fully-automated cell separation system approved for use in the Chinese stem cell processing market.
Olivier Waridel, Chief Executive Officer of Biosafe, said "This is a major milestone for the Biosafe Group and we are pleased to offer our industry-leading products throughout the People's Republic of China. We look forward to contributing to developping its rapidly expanding cord blood banking, by providing state-of-the-art technology and premium service".About the Biosafe Group Founded in 1997, Biosafe Group SA, the world-leader in cell processing for stem cell banking and regenerative medicine applications, is active in design, manufacture and marketing of automated cell processing systems. Headquarted in Switzerland and privately-owned, Biosafe operates through four regional subsidiaries ( Geneva, Houston, Hong-Kong and Shanghai) and is present in more than 45 countries, either directly or through distributors. Biosafe's flagship Sepax cell separation technology is a versatile platform dedicated to adult stem cell processing, adressing major medical markets such as cord blood banking, stem cell transplantation and regenerative medicine. The Sepax system is used by the majority of public and family cord blood banks in the world, with more than 800 devices installed. Besides cord blood banks, Sepax is used in numerous translational medicine and point of care applications. Key advantages of Sepax patented technology are full automation, easy handling, a closed capability system, fast processing, stable and repeatable performance. Sepax technology is complemented by a number of accessories ranging from automated cryoprotectant delivery systems (Coolmix®) to an extensive single use article portfolio.
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