CordStem BAG FOR CRYOPRESERVATION OF STEM CELLS AND MECHANICALLY DIGESTED LIPOASPIRATE (LML) Intelligent labelling Complete traceability Satellite aliquots are univocally identified by a lot number, printed also on the bag, to ensure the correct identification and complete traceability throughout the entire Device’s Shelf Life. All CordStem variants are DMSO resistant - components have been tested to resist contact with 10% DMSO solution. Safety matters: the right steps for cryopreservation The CordStem bag - in all the available variants - is a biocompatible, resistant, flexible and transparent Medical Device intended for cryopreservation of stem cells and Mechanically Digested Lipoaspirate (LML). Devices have been tested to resist cryopreservation in liquid nitrogen up to temperature equal to -196°C. The dedicated EVA over wrap bag provided in conjunction with is adhesion-proof and very easy to fill. Bag and over wrap bag sizes compatible with most common storage containers dimensions. Complete traceability The satellite vials for aliquotation are univocally identified and heat sealed to the bag, allowing for storage and preservation of the collected sample. This feature reduces risks of loss of traceability or error during manipulation. The bag is also identified with a bar code readibly with the standard electronic pens able to direct the information to the internal mangement system. The label does not come into direct contact with the bag. DMSO resistant CordStem is equipped with three satellite aliquots with a maximum volume equal to 1,5 mL each, allowing collections of samples for biological testing without opening the circuit or thawing the entire bag. Aliquots are directly connected to the bag; connections are ensured over all the thawing cycle. The infeed/outfeed terminals are made of EVA. All tubes are designed with lenght, diameter and materials compatible with the most common welding system available. CordStem is equipped with 3 satellite aliquots allowing collection of three samples for biological testing. CordStem is available also in a customized variant (CS 50 G) with no aliquots. CordStem is the result of Biomed Device’s experience and long-term research: each technical detail has been designed and developed to offer a complete and safe device, fulfilling every user needs. CordStem complies with the current Guidelines applicable concerning treatment and manipulation of stem cells and lipoaspirated biological material, obtained form autologous adipose tissue, Mechanically Digested Lipoaspirate (LML) and satisfies the requirements of health care practitioners. High Quality materials certified for cryopreservation ensure the long - term freezing of CordStem. Three available testing opportunities CordStem has been designed to offer the highest quality standards and is easy to use. CordStem is equipped with a pocket suitably dimensioned for label application in order to avoid any direct contact with bag’s surface or contamination of the biological materials preserved. Resistance and versatility CordStem has been designed to offer the highest quality standards and is easy to use. CordStem bag and the dedicated over wrap bag are provided sterile, realized with biocompatible materials able to keep unchanged the original properties of resistance, flexibility and transparency; essential to read clearly and rapidly labelled information. All welds are single tested against crash test requirements and compliant with the thawing cycle according to applicable guide lines. All CordStem variants are DMSO resistant - components have been tested to resist contact with 10% DMSO solution up to 120 minutes. 4 Resistance, flexibility and transparency over time All welds are single tested against crash test requirements and compliant with the thawing cycle according to applicable guide lines. Intelligent labelling Certified quality CordStem is a Class IIa Medical Device marked according to current European Legislation. CordStem is manufactured in compliance with provisions of UNI EN ISO 13485, Current Edition. Biomed Device has implemented and maintains a Quality Management System certified according to UNI EN ISO 9001 and UNI EN ISO 13

LONG-TERM EXPERIENCES IN CRYOPRESERVATION OF MOBILIZED PERIPHERAL BLOOD STEM CELLSUSING A CLOSED-BAG SYSTEM: A TECHNOLOGY WITH POTENTIAL FOR BROADER APPLICATION. 11112 1 1 Silvia Spoerl, Robert Peter , Dagmar Wascher , Mareike Verbeek , Helge Menzel, Christian Peschel and Angela M. Krackhardt , Medizinische Klinik III, Klinikum rechts der Isar, Technische Universitat Munchen, Technische Universitat Munchen, Munchen, Germany Department of Hematology and Oncology, St Franziskus-Hospital, Malteser Norddeutschland, Flensburg, Germany. TRANSFUSION Volume 55, November 2015 A NEW FREEZING AND STORAGE...