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

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

2 Biosafe Experience Credibility Innovation

3 Dear Customer, Innovation in cell processing is our credo and this is apparent in all Biosafe s daily activities. Over the years, Biosafe has steadily established its leadership by providing state of the art technology that greatly contributes to the efficiency and reliability of adult stem cell processing. Indeed, we were the first to introduce automated cord blood separation with our Sepax system back in Today, the vast majority of allogeneic and autologous cord blood banks trust our technology throughout the world. We are also at the leading edge in developments in the Regenerative Medicine area with our enabling technology. Every sample processed by our system is important to us. Every sample represents a hope for life and we accept no compromises. This is why our technology cares for each sample, allowing optimized performance and results. It also reflects our philosophy of respecting the unique, irreplaceable nature of each human being. These are the values that we share at Biosafe and we strive to incorporate them daily in our products and services, so as to offer you the best individualized solution to meet your expectations. We thank you for trusting our products. Yours truly, Claude FELL President and Founder 3

4 Cord blood stem cells, your child s long-term insurance The umbilical cord blood of your baby is a natural and easily accessible resource of highly vital stem cells. Collection and storage of these stem cells may provide the key to a number of therapies for your child in the future. To date, more than 70 different diseases have been treated with cord blood transplants, a number constantly increasing with scientific and medical progress. Stem cell isolation is a crucial step in cord blood banking Once your child s umbilical cord blood has been collected after birth, it is sent to the bank s processing center for stem cell isolation. This very crucial isolation procedure enables the removal of other blood components as well as concentration of the stem cells prior to preparation for cryogenic storage. collection of a baby s umbilical cord blood collection 4

5 Sepax processes each child s cord blood separately, one unique sample at a time safe and automated adult stem cell isolation isolation stem cell safeguarding Sepax in cord blood banking safeguarding preservation of stem cells for the future preservation 5

6 Automated stem cell processing means quality processing Automated technology is now widely accepted as an essential part of ensuring the quality of this isolation step that has a direct impact on the number of cells that are recovered from the initial cord blood unit. Sepax provides processing in a closed environment, ensuring safety and sterility. Your baby s cord blood is uniquely special During the procedure, no other external centrifuge or operator intervention is required. These key advantages explain why the majority of the world s leading cord blood banks have chosen the Sepax system after evaluating alternative technologies. Because we understand the unique qualities of your baby s stem cells, Sepax processes every cord blood unit individually, respecting its biologic specificity and unique cell characteristics. In fact, Sepax is the only cord blood processing technology that isolates the stem cells one cord blood unit at a time, ensuring full traceability and eliminating the risk of accidental mix-up with other cord blood units. 6

7 The world s leading cord blood banks put their trust in Sepax fully automated system unique every child s cord blood processed individually quality safety closed system US FDA clearance, CE mark, Japan MHLW approval regulatory accreditations innovation patented technology Sepax, the reference in cord blood processing For a large majority of the world s public and private cord blood banks, the Sepax system is the first choice when it comes to processing cord blood. An active participant in its fields of interest, Biosafe is a proud Official NetCord Collaborator, a foundation that groups leading public cord blood banks worldwide. Their combined current inventory of nearly 200,000 cord blood units is recognised as the largest source of high-quality cord blood units for transplantation. By choosing to store your child s cord blood in a bank using Sepax, you can rest assured that the recovery of stem cells will be optimized. 7

8 Every 3 minutes a cord blood sample is processed by Sepax somewhere in the world Leading the way in regenerative medicine The Sepax system is a versatile cell separation platform extending beyond cord blood banking the technology has been adopted in leading clinical research studies in the field of regenerative medicine, processing both cord blood and other stem cell rich cellular products such as bone marrow or peripheral blood. adult stem cell banking bone marrow - > - > umbilical cord blood - > - > peripheral blood - > - > Sepax technology: cell processing volume reduction density gradient separation cell washing regenerative medicine 8

9 Your benefits at a glance Biosafe representatives Biosafe Scientific Inc. Sepax is installed in over 40 countries Biosafe SA headoffice Credibility Sepax was the first fully automated stem cell processing device available for cord blood processing and the first to be cleared by the US FDA and is today the industry standard with more references in scientific publications than any other automated technology. Sepax is used in the most stringent regulatory environments world-wide and complies with the highest industry quality standards, such as FACT and AABB. Experience In the last 10 years Sepax technology has processed stem cells from more than 350,000 newborns. With Sepax systems installed in over 40 countries, a large majority of the world s leading public and private banks put their trust in Sepax technology. Most transplantation outcome record Public cord blood banks have supplied over 11,000 cord blood units for transplantation to date and their technology selection criteria are based solely on quality and performance Sepax has been chosen by over 70% of the Netcord organization that groups the leading public cord blood banks around the world. 9

10 Scientific publications Cord Blood Banking Anderson Cancer Center, Houston, USA / Sepulveda C.A, McMannis J.D. et al. / Evaluation of an Automated Ficoll Procedure to Enrich for Mononuclear Cells for Use in Clinical Trials; American Society of Hematology ASH Atlanta 2007 Institute for Transplantation Diagnostics and Cell Therapeutics Heinrich-Heine-University Düsseldorf, Germany / Körschgen L., Kögler G. et al / Volume reduction of cord blood units (CB) using an automated system and comparison of clinical outcome data using unseparated and volume-reduced CB units the Düsseldorf experience; European Group for Blood and Marrow Transplantation EMBT Lyon 2007 London Cord Blood Bank, National Blood Service, Middlesex, United Kingdom / Armitage S. / Cord Blood Processing: Volume Reduction / Cell Preservation Technology Volume 4, Number 1, 2006 Besançon Cord Blood Bank, Besançon, France / Lapierre V., Maddens S. et al. / Cord blood volume reduction using an automated system (Sepax) versus a semi-automated system (Optipress II) versus a manual method (Hydroxyethyl Starch Sedimentation) for routine cord blood banking: a comparative stud; International Society for Cellular Therapy ISCT Berlin 2006 Anderson Cancer Center, Houston, USA / Karandish S. et al. / Routine Automated Processing of Cord Blood Units Using the Sepax Cells Processing System American Society of Hematology ASH Orlando 2006 National blood transfusion center of Mexico, Mexico / Calderon E. et al. / Thirty month experience at the Mexican national cord blood bank: new hope for many children. International Society for Cellular Therapy ISCT Berlin 2006 Barcelona Cord Blood Bank, Hospital Duran I Reynals, Barcelona, Spain / L. Rodriguez, S. Querol et al. / Washing of cord blood grafts after thawing: high cell recovery using an automated and closed system / VOX Sanguinis (2004) 87, UZ Gasthuisberg, Leuven, Belgium / K- Theunissen et al. / Highly Efficient and reproducible cord blood banking using the Biosafe Sepax and Coolmix Devices International Society for Cellular Therapy ISCT Dublin 2004 Barcelona cord blood bank / S. Querol et al. / An automated and closed procedure for cord blood processing, freezing and thawing: the Barcelona cord blood bank experience / Bone Marrow Transplantation, volume 33 supplement 1,

11 About Biosafe Biosafe was founded in 1997 in the Lake Geneva region of Switzerland and has grown to become a leader in the field of cell processing for cell therapy and regenerative medicine applications. The company maintains a close relationship with customers and the scientific community and has established a reputation for innovative product development supported by a solid scientific base. The Sepax patented cell separation technology incorporates the Swiss values of quality and precision. Sepax is a registered trademark of Biosafe SA. Biosafe is a US FDA registered establishment, Japan MHLW (Ministry of Health and Labor Welfare) approved as well as an ISO 9001:2000 and ISO 13485:2003 certified company working under the European Medical Devices Directive 93/42/EEC annex II.3.

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