ADVANCED TECHNOLOGY IN BLOOD SEPARATION Lmb Technologie GmbH ADVANCED TECHNOLOGY IN BLOOD SEPARATION

ErySep ! Unique and New Blood Separation Technology Blood Separation without mechanical devices Without Centrifuge Without Separation Press Without Power Supply Blood Separation by gravity force ErySep separates whole blood into two components ( RED CELL and PLASMA ) by itself without any other instruments Separated Blood Components in perfect quality Cells Free PLASMA Leukocyte Free RED CELL Concentrated RED CELL ( 55%-60% HTC )

ErySep ! Unique and New Blood Separation Technology Approved Clinical Results Studying on different parameters such as; pH, LDH, K, P, NH3, Osmolality, 2,3-DPG, Total protein, Hemoglobin in TU (g/unit), Loss of Hb, Haemolysis, Leucocytes, F VIII activity, Platelets, the results have been published in international scientific magazines. Validation in different Country Blood Banks German Blood Banks Indonesia Blood Banks UK Blood Banks Malaysia Blood Banks Spain Blood Banks Myanmar Blood Banks Bulgaria Blood Banks Taiwan Blood Banks Greece Blood Banks Philippines Blood Banks Chech Blood Banks Egypt Blood Banks Slovakia Blood Banks Yemen Blood Banks Belgium Blood Banks Jordan Blood Banks Turkish Blood Banks Saudi Blood Banks Russia Blood Banks All results meets with European Blood Components Standard Guide to the preparation, use and quality assurance of blood components - 15th Edition (2009)

ErySep ! Unique and New Blood Separation Technology WHY ERYSEP? ErySep is user friendly No necessary special education Work in all kind of environment (outdoor/indoor) It is activated in 5 minute, and no need extra efforts Staff can do their other daily work ErySep complete process by itself within 75 minutes. ErySep is a Closed Sterile System It can not effect outside conditions Cost Reduction No centrifuge & extractor investment No maintainance cost in routine usage No power supply Easy Handling 24 month shelflife in room condition Easy Product exchange & replacement Portable & ready work wherever needed Ready to use any time for any amount Expert can obtain specific demanded quantity ErySep can answer night time demand

ErySep ! Unique and New Blood Separation Technology ErySep® is a disposable system has standard triple blood bag whole blood bag red cell bag plasma bag with an integrated air drainage bag has standard leukocyte filter has test bag with vacu-container port has membrane filter embedded into separation chamber unit 5 4 1 2 3 1 6 2 4 5 6 3

ErySep ! Unique and New Blood Separation Technology HOW ErySep® WORKS? Donor Blood is taken into Mother bag by using an integrated needle on the system. ErySep works by gravity force, does not need any other instruments or power supply. System can activate just by breaking internal plastic valves, after hanging to a infusion stand. Tubular membrane with a diameter of <1 mm and hollows (pores) 0,2 µm make physical separation; Red Cells are pushed into Red Cell Bag, Plasma are pushed into Plasma Bag through the membrane filter.

ErySep ! Unique and New Blood Separation Technology Medical ADVANTAGES of ErySep® ErySep supplies Leuko-depleted Red Cell & Plasma Erysep supplies high HTC level into the Packed Red Cell Bag. ErySep supplies plasma, which is ready for FFP ErySep supplies Packed Red Cell Bag, which can be store 42 days. Leuko-depleted components are precious for Oncology and Hematology Patients Make available the fresh components at hospital for surgical operation purposes. Make available the fresh components for the patients need routine transfusion at hinterland.

Datas from Hospital Prag Dr. Bohaniek Time Day 0 Day 42 pH Average value 7.234857 6.893286 LDH (µkat/l) Average value 0.959286 4.957857 K (mmol/l) Average value 1.254286 39.25071 P (mmol/l) Average value 0.969286 3.660714 NH3 (µmol/l) Average value 10.20771 153.6929 Osmolality (mOsm/l) Average value 333.4286 352.8571 ATP (µmol/g Hb) Average value 2.621429 0.718571 DPG (µmol/g Hb) Average value 12.16543 0.363643 Hemolysis Average value 0.140714 0.7205

Dr. med.Dr.rer.nat Kurt Mannemann-Pohl Rating and Validation of ErySepe..aıood donation and Blood separation device Dr. med.Dr.rer.nat Kurt Mannemann-Pohl Germany – Hamburg - Pohl Fachaat fOr Laboratoriumsmedizin Facharzt fOr Transfusionsmedizin DipL. Chem. BACKGROUND: ErySep Blood Donation and Blood separation device has been validated in Hamburg at Marien Krankenhaus Blood bank. Whole results have been reported as clinical study. STUDY DESIGN AND METHODS: The used analysis methods performed in the laboratory of the Marienkrankenhaus Hamburg and are listed below. All analysers and reagents were CE certified. All analysis methods were under permanent supervision of our quality control system with permant internal and four external controls per year.

RBC Results German Studies ( n=15 ) Value Avarage volume unit 346 ml Hb 17,4 g/dl Haematocrit 54% Leucocytes in unit on day 1 0,03x10 6 Protein / unit 3,3 g/unit K+ in RBC on day 1 0,28mmol/l Free Hb on day 1 all<0,03 g/l Free Hb on day 42 1,5 g/l Units were sterile as tested with BacT/Alert Culture System of BioMerieux Plasma Results German Studies ( n=15 ) Plasma volume 232 ml Protein concentration 53,5 g/l Leukocytes per unit 0,02 WBC/unit Fibrinogen 191 mg/dl ATIII 82% of normal vWF-antigen F VIII Units were sterile as tested with BacT/Alert Culture System of BioMerieux

CONCLUSION: Easy to perform blood separation without the need for centrifuge, separator or even electricity; For donor and patient the procedure do not change; Plasma has a very good quality and is better than the standard blood bank quality; RBC’s are better compared to standard blood bank quality. Remarkable is the very low WBC contect of far less than 1 WBC/µl ( effect of the hollow fibres ); Variation of measured parameters were all within the accepted limits for blood bank routine. The ErySep-Device is a ready to use blood donation and separation system. It is allowing, to produce leukocyte depleted erythrocyte concentrate and a cell free plasma with an elegant and save procedure with less equipment and limited manpower. In one of the last validations of ErySep (09.01.2009). we can say, that the results of the related labor tests are identical with the standards of the European Guidelines. The ErySep is separating the donor blood only by earth gravitation, without electricity or using of centrifuges etc.

Spain / Cord Blood Bank. Banc de Sang i Teixits. Barcelona Cord Blood separation for obtaining fetal erithrocytes.Preliminar results. / December 2009. Marta Torrabadella Spain / Cord Blood Bank. Banc de Sang i Teixits. Barcelona BACKGROUND: Cord blood separation with membrane filter technology is totally new and available in 2009 commercially. The first clinical study made by Dr Brune in Germany. This is 2nd study, which was perfomed in December 2009. STUDY DESIGN AND METHODS: The aim of the study is to show characterization of cord blood components after separation with ErySep system. ErySep system offers the possibility of blood separation of plasma and erythrocyte concentrate by gravity

RBC concentration Value Range Mean fetal Hb 67,8% 76- 58,6 Median Hb obtained in RBC concentrate 5,5 1,8-10,6 Percentage hemolysis 0,26% 0,13 – 0,48 LDH (U/L) : Basal (n= 3 ) 143 114 - 186 K+ (mmol/l) : Basal (n= 3) 1,63 1,54 - 1,76 Plasma Value Range Plasma Volume (ml) (n= 11) 31.36 5 - 85 Platelet concentration (CellDyn) in Plasma (n= 13) 77.30 0 - 490 Protein (g/L) in Plasma (n= 12) 2,45 2- 3,3 K+ mmol/l in Plasma (n= 7) 4,38 3,13- 5,96 LDH (UI) in Plasma (n= 7) 370,85 206- 612 Free Hb (n= 12) 0.022 0,00- 0,06 WBC/µL (n= 13) 0.076 0- 1