EYSINS, Switzerland – Biosafe, an automated cell processing systems company, said it has received the official registration from the China Food and Drug Administration (CFDA) of its single use disposable kits.
Following earlier approval by the CFDA of the company's Sepax cell processing machine, Biosafe is now primed to launch sales of its products in China.
"We are the only company in our field which has received CFDA approval for both its equipment and kits. We are now eager to offer our industry-leading products throughout the People's Republic of China, having set up a Shanghai-based subsidiary in 2012 already,” said Olivier Waridel, CEO of the Biosafe Group.
The Sepax device, used in conjunction with its proprietary single use disposable kits, offers a wide range of applications in cord blood banking and in the rapidly developing regenerative medicine area. It is used in a point of care environment such as cardiovascular and orthopedic, while in biotechnology and pharmaceutical processes it provides a versatile cell processing platform.
“We have been in contact with a number of major Chinese companies and institutions, which will now be able to access our state of the art technology. We see tremendous potential both in the cord blood banking and regenerative medicine markets,” he said.
Biosafe also offers a range of complementary products, such as the recently launched Smart-Max, for the preparation of cellular products. The group operates through regional subsidiaries in Geneva, Houston, Hong-Kong, Shanghai and Sao Paulo, and is present in more than 50 countries, either directly or through distributors.
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