ADVANCED TECHNOLOGY IN BLOOD SEPARATION

Lmb Technologie GmbH

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 BanksUK Blood Banks Malaysia Blood BanksSpain Blood Banks Myanmar Blood BanksBulgaria Blood Banks Taiwan Blood BanksGreece Blood Banks Philippines Blood BanksChech Blood Banks Egypt Blood BanksSlovakia Blood Banks Yemen Blood BanksBelgium Blood Banks Jordan Blood BanksTurkish Blood Banks Saudi Blood BanksRussia Blood Banks

• All results meets with European Blood Components Standard• Guide to the preparation, use and quality assurance of blood components - 15th Editio

n (2009)

ErySep ! Unique and New Blood Separation TechnologyWHY 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

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 TechnologyMedical 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.

Time Day 0 Day 42

pH Average value7.2348

576.89328

6

LDH (µkat/l) Average value0.9592

864.95785

7

K (mmol/l) Average value1.2542

8639.2507

1

P (mmol/l) Average value0.9692

863.66071

4

NH3 (µmol/l) Average value10.207

71153.692

9

Osmolality (mOsm/l) Average value333.42

86352.857

1

ATP (µmol/g Hb) Average value2.6214

290.71857

1

DPG (µmol/g Hb) Average value12.165

430.36364

3

Hemolysis Average value0.1407

14 0.7205

Datas from Hospital Prag Dr. Bohaniek

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/lUnits were sterile as tested with BacT/Alert Culture System of BioMerieuxPlasma 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 82% of normal

F VIII 82% of normal

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.

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) 1,631,54 -

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