EdwardsCardio Surgery and Interventional

Cardiology

MARKET RESEARCHjanuary2008

The potential market in Romania

According to the official site www.drg.ro, in 2006 there were 169.828 cases of pacients with cardiac insuficiency.

23% of this number had suffered surgical procedures that required implants of at least one tipe of cardiac prosthesis or other tipe of product used in cardiac surgery or interventional cardiology, that means a total of 40.000 pacients.

Only half of them benefit from financial help through the national health program for preventing and controling of the cardiovascular deaseses.

The potential market in Romania

This tipe of products are financed by the National Unique Fund of Health Insurance through subprograms with curativ.

Therefore, in 2004, through The Subprogram for Prevention and control of cardiovascular deseases were treated 3165:

- 1.685 with cardiovascular surgery procedures- 1.480 with interventional cardiology and electrophisiology

proceduresOn the page below we have the funds allocated in 2004 for the health

subprograms:

Program/subprogram Medication and medical orderly materials- RON

Medication and medical orderly materials- EUR

Weight in total funds

Total707,000,000 € 198,595,506

1. Social Health programs106,000,000 € 29,775,281 15%

1.2 Supervision and control of HIV/SIDA infections94,000,000 € 26,404,494 13%

1.3 Supervision and control of tuberculosis12,000,000 € 3,370,787 2%

2. Programs for preventions and control of intransmissible deseases 601,000,000 € 168,820,225 85%

2.1 Prevention and control of cardiovascular deseases 22,250,000 € 6,250,000 4%

2.2 Prevention si control in oncologic pathology190,000,000 € 53,370,787 32%

2.3 Prevention and precocious diagnosis in other neurological deseases 37,000,000 € 10,393,258 6%

2.4 Prevention si control in diabetes and other nutrition deseases 150,000,000 € 42,134,831 25%

2.5 Profylaxis in psychiatrical and psyhosocial pathology 10,000,000 € 2,808,989 2%

2.6 Prevention in nephrological and dyalisis pathology165,000,000 € 46,348,315 27%

2.7 Prevention si control in hemophilia 5,000,000 € 1,404,494 1%

2.8 Prevention in endocrine pathology4,800,000 € 1,348,315 1%

2.9 Prevention in orthopedics and traumathology16,500,000 € 4,634,831 3%

2.12 Organs and tissue transplants450,000 € 126,404 0%

The Subprogram for Prevention and Control of Cardiovascular Deseases in 2004

Economic indexes of the subprogram:- Average Cost /year/pacient treated with cardiovascular

surgery procedures – aprox. 2150EUR- Average Cost /year/pacient treates with interventional

cardiology and electrphisiology procedures – aprox.1800EUR

This amounts represent the outgoes for the medical orderly materials required for the treatment through speciffic procedures.

The Program for Prevention and Control of Cardiovascular Deseases in 2006

In 2006, 19.127 pacients benefit from this program:- 7087 with cardiovascular surgery procedures- 10.520 with interventional cardiology and electrophisiology

procedures Economic indexes in 2006:- Average Cost /year/pacient treated with cardiovascular

surgery procedures – aprox 1000EUR- Average Cost /year/pacient treates with interventional

cardiology and electrphisiology procedures – aprox. 580EUR

The allocated funds for this program grows in value with 132% comparing with 2004!

Program/subprogram in 2006 Medication and medical orderly materials- RON

Medication and medical orderly materials- EUR

Weight in total funds

Total general1,441,831,000 € 405,008,708

1 Supervision and control of HIV/SIDA infections150,000,000 € 42,134,831 10%

2 Supervision and control of tuberculosis13,785,000 € 3,872,191 1%

3 Prevention and control of cardiovascular deseases51,513,000 € 14,469,944 4%

4 Prevention si control in oncologic pathology323,242,000 € 90,798,315 22%

5 Prevention and precocious diagnosis in other neurological deseases 65,000,000 € 18,258,427 5%6 Prevention si control in diabetes and other nutrition deseases 267,625,000 € 75,175,562 19%7 Prevention si control in hemophilia

20,000,000 € 5,617,978 1%8 Treatment of osteoporosis pacients and pacients with goiter due to iodine deficiency and malignant proliferation 5,200,000 € 1,460,674 0%9 Treatment through endoprothesis of pacients with articulation affection pre-existent or obtained and through segmentary implant for pacients with spinal column deformities. 30,000,000 € 8,426,966 2%10 Post-transplant status treatement in ambulatory for pacients with transplants 50,000,000 € 14,044,944 3%11 Alternate treatment of renal function for pacients with chronyc renal insuficiency 456,466,000 € 128,220,787 32%

12 Treatment of cystic fibrosis adult pacients 9,000,000 2,528,090 1%

Coronary deseases mentioned in The Program for Prevention and Control of Cardiovascular

Deseases

1. For cardiovascular surgery:

- Adult pacients with acquired cardiac affections (ischaemic heart desese –IHD -, cardiac tumours, cardiac valvuloplasty, pathogy of abdominal aorte);

- Congenital heart cardiopathy;

- Arterial, venuos and limphatic pathology;

- Lung and chest pathology;

- Cardiac pacients with affection of other organs.

Coronary deseases mentioned in The Program for Prevention and Control of

Cardiovascular Deseases

2. For interventional cardiology and electrophisiology:

- Pacients with at least one arterial stenosis (coronarian, carotidian,renal, peripheral arteries);

- Pacients with acute coronary syndrome (unstable pectoral angina or myocardium infarct);

- Pacients with degenerated/stenosys venous grafons, - Pacients with arrhythmias resiliant to conventional treatment, that

benefits from electrophisiological therapy.

Medical orderly materials for cardiac surgery approved by Ord. 1025/402 from 22 aug 2006

Oxygenators for adults and kids Sets of cardioplegie Mechanical heart velves Biological hert valves Rings for valvulaplasty Vascular and cardiac prosthesis Suture materials, hemostasys materials de hemostaza, fibrin bio-glue, fire

pentru osteosinteze sternale, clipuri metalice de titan, electrozi epicardici temporari

Baloon for aortic counter-throb (contrapulsatie aortica) set for cell-saver set of hemofilter for adults and kids Pressure doms Aortic cannula

Medical orderly materials for cardiac surgery approved by Ord. 1025/402 from 22 aug 2006

Venous cannula and other kind of cannulas (aortic vent, left ventricular vent, set perfuzie multipla, canule administrare cardioplegie etc.)

conducte valvulate Cardioplegie (?) solutions Chest vacuums Sounds for vascular flow measurments Cells for monitoring Hct, Hb si SvO2 continuous during extracorporeal

circulation Centrifugal pumps heads for adults and kids Cells for monitoring the sangvin flow for the centrifugal pump Oxigenatoare(?) ECMO and afferent cannular Sets for ventricular assitance Cartridges for ACT monitoring

Medical orderly materials for cardiac surgery approved by Ord. 1025/402 from 22 aug 2006

Temperature sensors for oxigenatoare and cardioplegie sets Height sensors for oxigenatoare Incision fields infiltrated with iodine and neimpregnate Surgery fileds campuri chirurgicale (one use) Surgery overall(gown) Stabilizing systems for tissue in vederea revascularizarii pe cord batand

tip Octopus, Starfish intracoronarian shunt Aortic pounches Electric pencil lancet Disposables for surgery ablation in cardiac arrhythmia

Medical orderly materials for Intensive Care Unit approved by Ord. 1025/402 from 22 aug 2006

Central venous catheters catetere for adults and kids Arterial catheters for adults and kids Swan-Ganz catheter Catheters for PICO cardiac flow device incalzitor pacient compatibil cu aparatura din dotare butelii de oxid nitric Nitrate oxide cylinder senzori de saturatie de oxigen si PO2 Invasive pressure cells

Medical orderly materials for interventional cardiology approved by Ord. 1025/402 from 22 aug

2006 Diagnosis catheters Diagnosis guides set for arterial and venous puncture (needles, sheaths (teci), introductors, guides) Auxiliary materials for catheterism (syrngies, needles, conector tubes, pressure

doms, perssure cuff, manifolduri (?), perfusion tube) Catheters guide for percutaneous interventions (coronary, carotidic, renal

arteries, peripheral veins) Guides for percutaneous interventions Baloons for percutaneous dilatations Coronary stants Auxiliary materials for percutaneous procedures (manometer syringies, Y

connectors, vents, introductors, torquer) Peripherial dilatation baloons

Medical Units involved in The Program for Prevention and Control of Cardiovascular Deseases

1. Cardiovascular Surgery:

- "Prof. dr. C.C. Iliescu“ Institute of Cardiovascular Deseases Bucharest;

- "Prof. dr. Niculae Stancioiu“ Heart Institute Cluj-Napoca;

- Institute of Cardiovascular Deseases Timişoara;

- Institute of Cardiovascular Deseases and Transplant Targu Mures;

- Prof. Dr. George I. M. Georgescu" Institute Cardiovascular Deseases "- Iaşi;

- Emergency Clinic Hospital Bucharest;

- Army Clinic Emergency Center for cardiovascular deseases- Bucurest.

Medical Units involved in The Program for Prevention and Control of Cardiovascular Deseases

2. Interventional cardiology and electrophysiology

- "Prof. dr. C.C. Iliescu“ Institute of Cardiovascular Deseases Bucharest;

- "Prof. dr. Niculae Stancioiu“ Heart Institute Cluj-Napoca;

- Institute of Cardiovascular Deseases Timişoara;

- Institute of Cardiovascular Deseases and Transplant Targu Mures;

- Emergency District Hospital Targu Mures;

- Prof. Dr. George I. M. Georgescu" Institute Cardiovascular Deseases "- Iaşi;

- Cardiology Center Craiova;

- Emergency Clinic Hospital Bucharest;

- Spitalul Universitar de Urgenta Bucureşti;

- “Sf. Ioan” Clinic Hospital Bucharest;

- Clinic Hospital Colentina - Bucharest;

- Emergency District Hospital Cluj-Napoca;

- Army Clinic Emergency Center for cardiovascular deseases- Bucharest.

COMPETITION

1.MEDTRONIC SUA – exclusiv distributor Silva Trading (no 1 on the romanian market)

1. BIOTRONIK GERMANIA – exclusiv distributor Eximrom Biocard SRL

REPLANT MEDICAL LTD

Competition– MEDTRONIC SUAMEDTRONIC –exclusiv distributor Silva Trading

Informations about the producer: - american established in 1949 in Minneapolis, SUA,

investing almost 10% of turnover in research and development in medical sector.

- With net sales of 10 million USD till the end of 2005, with 67% in SUA si 33% in Europa, Africa, Asia, 33000 employees worldwide, with branches in over 120 countries

REPLANT MEDICAL LTD

COMPETITIONMEDTRONIC – distribuitor exclusiv Silva Trading

Informations about DISTRIBUTOR: - Established in 1992 as a private partnership in

various products import- Starting with 1997 it became an importer and

distributor of products for interventional cardiology- Starting with 2005 Silva Trading offers it’s clients

finance possibility (credits between 100-12.000EUR)

- Silva Trading has ISO 9001 certificate of quality management

REPLANT MEDICAL LTD

Silva Trading– financial informations RON

REPLANT MEDICAL LTD

Nr. Crt. Indicator 2006

(RON) 2005

(RON) 2003

(RON)

Sales growth

2006/2005

Sales growth

2005/2003

1Annual turover 12,409,456 9,050,662 6,104,173 37% 48%

2Total revenues 13,414,562 9,537,437 6,315,651 41% 51%

3Total expenditures

11,457,173 7,680,783 5,609,201 49% 37%

4Net profit 1,634,896 1,556,421 529,301 5% 194%

5No. of Employees

13

13 9

Silva Trading– financial informations EUR

REPLANT MEDICAL LTD

Nr. Crt. Indicator 2006(EUR)

2005(EUR)

2003(EUR)

Sales growth

2006/2005

Sales growth

2005/2003

1Annual turover 3,476,038 2,535,199 1,709,852 37% 48%

2Total revenues 3,757,580 2,671,551 1,769,090 41% 51%

3Total expenditures

3,209,292 2,151,480 1,571,205 49% 37%

4Net profit 457,954 435,972 148,264 5% 194%

5No. of Employees

13 13 9

MEDTRONIC –products portfolio

1. Products for cardiovascular deseases2. Neurological products3. Spinal products4. Surgery “navigation” technique

Products for cardiovascular deseases :- Interventional surgery- Cardiac surgery- Cardiac incitation (stimulare)- Electriphysiology- Monitoring external intervention in cardiac

emergencyREPLANT MEDICAL LTD

MEDTRONIC – products portfolio in cardiac surgery

REPLANT MEDICAL LTD

Produs Explicatie

Mechanical heart valves with oscillatory disc and bidisc

Proteze cardiace pentru pozitie mitrala sau aortica, de diferite dimensiuni, cu un disc oscilant (model MedHall Easy Fit) sau cu doua discuri (model Advantage), cu proprietati hemodinamice deosebite si cu peste 25 de ani de utilizare cu rezultate excelente.

Biological heart valves with/without stent

Proteze cardiace porcine cu stent (model Hancock II, Mosaic) cu peste 20 de ani de performante clinice foarte bune si durabilitate dovedite. Proteze cardiace biologice fara stent (model Freestyle), valve de generatia a III-a, o alternativa chirurgicala optima ce ofera multiple optiuni de implant.

Valvulary conduct with biological heart valve and apical connector for left ventricle

Conduct recomandat pentru reconstructia malformatiilor/patologiilor cardiace si ale vaselor mari, congenitale sau dobandite, obtinut prin suturarea unei valve biologice cu stent la mijlocul unui tub din netesut, prezervat in glutaraldehida. Conectorul apical pentru ventricolul stang (curbat la 900 pentru a facilita anastomoza la aorta descendenta) se foloseste impreuna cu conductul cu valva biologica furnizand o metoda alternativa pentru eliberarea tractului ventricular stang obstructionat.

Valvulary conduct for right ventricular tract

Conduct utilizat in reconstructia tractului ventricular drept, in cazul unor malformatii congenitale ale acestuia, inlocuirii valvei pulmonare in timpul procedurii Ross sau inlocuirea unei homogrefe nefunctionale implantata anterior (model Contegra)

Ring for mitral or trycuspid reconstruction, semirigid or flexible

Sisteme de anuloplastie, inel incomplet sau banda continua, flexibil -pentru valva mitrala sau tricuspida - model Duran An Core sau semirigid -pentru valva mitrala-model Colvin Galloway, cu flexibilitate graduala a partii posterioare si cu forma anatomica a valvei normale.

MEDTRONIC – products portfolio in cardiac surgery

REPLANT MEDICAL LTD

Produs Explicatie

Aortic perforator

Dispozitiv specific pentru perforarea tesutului aortic utilizat in timpul procedurilor de bypass coronar, pentru a crea o deschidere potrivita in peretele vasului.

Oxigenator and set extracorporeal circulation for adults and kids, standard or heparinat

Oxigenator pentru adulti (model Affinity NT)sipentru copii intre 8-20 kg ( model Minimax Plus), in variante standard sau tratate cu heparina siseturi de circulatie extracorporeala realizate in conformitate cu cerintele spitalului.

Sistem de livrare cardioplegie si seturi de cardioplegie

Sistem complex de furnizare cardioplegie (model CSS), cu o gama larga de parametrii ce pot fi variati in functie de protocolul dorit si seturi de cardioplegie realizate dupa solicitarile spitalului

Extracorporeal circulatin cannulas

Gama completa, de peste 550 modele de canule pentru circulatia extracorporeala si alte accesorii necesare perfuziei in chirurgia cordului.

anastomosis devices

Constituit din nitinol (model U-Clip) (un aliaj "cu memorie") sistemul este menit sa asigure a anastomoza reproductibila, sigura si care elimina inconvenientele suturii. Sistemul EnClose II, un dispozitiv pentru anastomoza proximala este proiectat pentru a preintampina necesitatea clamparii partiale a aortei si a crea un campfara sange.

ACT determination device

Echipament modern destinat chirurgiei cardiace (determinarea ACT la pacientii carora li se administreaza doze mari de heparina - HRACT si identificarea prezentei heparinei in diferite situatii clinice - HTC) sau laboratoarelor de cateterism sau in terapie intensiva (determinarea ACT in doze mici - LRACT)

Heparine monitoring system

Masurarea timpului de coagulare nu este intotdeauna o indicatie adecvata a heparinizarii, fiind un test global, care este influentat de multe variabile,motiv pentru care sistemul HMS Plus vine in intampinarea necesitatilor din blocul operator de masurare a heparinei intr-un anumit moment sau de determinare a necesarului individual de heparina al pacientului.

REPLANT MEDICAL LTD

Produs Explicatie

 Autotransfusion system (cell-saver)

Un echipament complet automat(model Autolog) conceput sa furnizeze un concentrat de calitate de elemente figurate, in conditiile unei hemolize minime si a unei indepartari maxime a componentelor nedorite

Sistem autolog de separare trombocite

Un echipament performant, complet automat, usor de utilizat (model Magellan), destinat obtinerii unui concentrat plachetar, a plasmei sarace in trombocite sau aunui gel bogat in trombocite, folosit ca agent hemostatic intr-o gama larga de aplicatii chirurgicale (chirurgia cardiaca si toracica,plastica,orala si maxilo-faciala, ortopedica si spinala, neurochirurgie, ORL si alte diferite leziuni ale tesuturilor moi sau oaselor)

Ablation Surgical System

Generator de ablatie cu radiofrecventa (model Cardioblate)pentru tratarea intraoperatorie a fibrtilatiei atriale, cu folosirea unor dispozitive cu irigare pentru a facilita crearea unor leziuni eficiente.

Cardiopulmonar by-pass system with centrifugal pump

Sistemul mobil Bio-Medicus PBS poate fi utilizat atat sala de operatie, cat si in reanimare, laborator de cateterism sau transport de urgenta. In asistarea mecanica de scurta durata, pompa centrifugala este considerata mai putin destructiva pentru elementele sanguine in comparatie cu pompa cu role.

Devices for Cardiac Sugery on beating cord

Gama completa de produse necesare procedurilor de by-pass coronarian pe cord batand (Off-pump), care include: departator de stern special conceput pentru acest tip de chirurgie (model Octobase), stabilizator de tesuturi(model Octopus), sistem de pozitionare a cordului (modele Starfish sau Urchin), sunturi intracoronare, sistem de curatire a campului chirurgical (model Blower Mister)

Oxigenator pentru ECMO

Oxigenatoarele cu membrana siliconica (singura care imita procesul de transfer gazos din plamanul uman), alaturi de celelalte componente necesare procedurilorECMO (rezervor, schimbator de caldura, tubulatura specifica) sunt destinate circulatieie extracorporeale de lunga durata.

Sistem de monitorizare a saturatiei in oxigen si hematocritului

Sistem folosit "in-line" in operatiile de chirurgie cardiaca pentru monitorizarea saturatieiin oxigen (venoase si arteriale)si hematocritului

MEDTRONIC – products portfolio in interventional cardiology

REPLANT MEDICAL LTD

Angioplasty (catheter with baloon)Coronary stentCoronary stents with antistenosis substance

Competition– BIOTRONIK GERMANIABIOTRONIK –exclusiv distribuitor Eximrom Biocard

Informations about the producer: - One of the best european producer of products for

cardiac surgery and interventional cardiology, based in 1963

Informations about distributor(EXIMROM BIOCARD): - Based in 1998- It is the second exclusiv distributor for Biotronik (after

Electra Trading wich was the exclusive distributor for Biotronik till 2002)

- Unfortunately it doesn’s have a web pageREPLANT MEDICAL LTD

Eximrom Biocard– financial informations RON

REPLANT MEDICAL LTD

No. Index 2006

(RON) 2005

(RON) Sales growth 2006/2005

1Annual turover 373,509 376,558 -1%

2Total revenues 377,106 381,415 -1%

3Total expenditures

352,107 336,318 5%

4Net profit 20,969 38,543 -46%

5No. of Employees

3 3