The essential choice in cell processing

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Diana Skinner
8 years ago
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1 The essential choice in cell processing

2 Established in 1997 The Biosafe Group is an internationally active medical technology company with its roots in the Lake Geneva region of Switzerland. Since it was established in 1997, the company has grown to become the industry standard in cord blood banking and in the fast developing field of cellular therapy, serving its customers with innovative cell processing solutions. Biosafe SA is a US FDA-registered establishment as well as an ISO 9001:2008 and ISO 13485:2003/AC:2007 certified company, working under the European Medical Devices Directive 93/42/EEC annex II.3. The Sepax has been cleared by the FDA and was approved in China by the SFDA.

serving its customers with innovative cell processing solutions.

3 Industry standard in automated cell processing To date, over 1000 Sepax systems have been installed in stem cell laboratories and hospitals in more than 50 countries worldwide. For adult stem cell banking Sepax was the first automated cell processing technology to be specifically developed for use in cord blood banks. With its complete range of accessories it allows the safe and individual preparation of a child s stem cells for long-term storage. It is today the industry standard in public and private cord blood banks and is used by a majority of the world s leading public banks that form the NetCord organization. For regenerative medicine A safe and reliable system, Sepax has long found it s place in the transplantation of hematopoietic stem cells and point-of-care cell therapy indications. More recently, the development and manufacture of innovative cell-based and gene therapy products require cutting-edge technologies like Sepax. Sepax has been adopted in leading clinical studies and products in a multitude of emerging biological therapies.

With its complete range of accessories it allows the safe and individual preparation of a child s stem cells for long-term storage.

4 Our milestones 2014 Full Chinese product registration 2013 Opening of Latin America subsidiary 2013 Introduction of Smart-Max for automated cryopreservation & thawing 2013 One millionth separation chamber (single use kit) produced 2012 Chinese SFDA clearance for Sepax ,000 procedures, 800 Sepax devices in 50 countries 2011 Worldwide market launch of Sepax % growth per year and profitability 2008 Industry standard : every 3 minutes a cord processed by Sepax 2008/09 Opening of US and Asian subsidiary 2007 US FDA 510(k) + Japan MLHW 2005 Extension of developments to regenerative medicine 2000 Introduction of Sepax for cord blood processing

countries 2011 Worldwide market launch of Sepax 2 2008 70% growth per year and profitability 2008 Industry standard : every 3 minutes a cord processed by Sepax

5 Worldwide presence Our innovative product solutions are marketed worldwide through our direct sales force and a growing network of distribution partners. Biosafe products are used around the world in hundreds of cell processing procedures every day with a broad scope of use.

6 Sepax platform technology The development and manufacture of innovative cell-based and gene therapy products requires cutting-edge technologies, which meet experts needs. With a proven track record, the Sepax solution for automated cell processing meets these core requirements in addition to ensuring a pharmaceutical-grade cellular product. Sepax 2 fully automated and integrated system Automated & standardized solutions for cell processing Closed and mobile system with full traceability Highly efficient and consistent cell recoveries Single use kit closed sterile processing environement Custom-made applications and process control Protocol cell separation software

With a proven track record, the Sepax solution for automated cell processing meets these core requirements in addition to ensuring a pharmaceutical-grade cellular

7 Partnering with Biosafe means working with a team of experts with 17+ years experience in cell processing. Cell concentration, separation and washing Sepax 2 Cell based product Cell expansion Point-of-care Laboratory GMP Stem cells Cryo-preservation Injection into the patient

Cell concentration, separation and washing Sepax 2 Cell based

8 Swiss made quality & service We incorporate in-house : Research & development Production facilities Quality assurance to guarantee our clients the best quality & service FDA 510(k) cleared

10 Our mission Since the beginning of Biosafe s activities, every sample processed with our system is important to us as it represents a hope for life. It reflects our philosophy of respecting the unique, irreplaceable nature of each human being. Evidence of the outstanding capabilities of adult stem cells is increasing every day and we at Biosafe will always be looking for innovation in cell processing. Develop and implement enabling technologies to enhance cord blood banking and regenerative medicine

Evidence of the outstanding capabilities of adult stem cells is increasing every day and we at Biosafe will always be looking

11 Contact details Headquarters Biosafe SA Asia Office Biosafe Asia Pacific Ltd. America Office Biosafe America, Inc. Rte du Petit-Eysins Eysins Switzerland t f info@biosafe.ch Room 3012, 30/F Tower 1 The Gateway, 25 Canton Road Tsim Sha Tsui, Kowloon Hong Kong t f info@biosafeasiapacific.com 1225 North Loop West Suite 120, TX Houston USA t f info@biosafeamerica.com China Office Biosafe Medical Device International Trading (Shanghai) Co. Ltd. Rm 80, 38F, Park Place No Nanjing West Road Shangai China t f info@biosafeasiapacific.com 中国分公司唯安医疗设备贸易 ( 上海 ) 有限公司中国上海市静安区南京西路 1601 号越洋广场 38 楼 80 室上海 t f info@biosafeasiapacific.com Latin America Office Biosafe Latin America Chedid Jafet, 222 5th Floor Block D Vila Olímpia São Paulo Brazil t info@biosafelatinamerica.com

ch Room 3012, 30/F Tower 1 The Gateway, 25 Canton Road Tsim Sha Tsui, Kowloon Hong Kong t +852 2956 7500 f +852 2956 2110 info@biosafeasiapacific.

Sepax. your child s cord blood is in safe hands. World leader in adult stem cell processing

Sepax. your child s cord blood is in safe hands. World leader in adult stem cell processing Sepax your child s cord blood is in safe hands World leader in adult stem cell processing Biosafe Experience Credibility Innovation Dear Customer, Innovation in cell processing is our credo and this is