Edwards

Cardio Surgery and Interventional

Cardiology

MARKET RESEARCH
january2008
 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
procedures
On the page below we have the funds allocated in 2004 for the health
subprograms:
 Program/subprogram Medication and Medication and
medical orderly medical orderly Weight in total
materials- RON materials- EUR funds
Total
707,000,000 € 198,595,506  
1. Social Health programs
106,000,000 € 29,775,281 15%
1.2 Supervision and control of HIV/SIDA infections
94,000,000 € 26,404,494 13%
1.3 Supervision and control of tuberculosis
12,000,000 € 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 pathology
190,000,000 € 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 pathology
165,000,000 € 46,348,315 27%
2.7 Prevention si control in hemophilia
5,000,000 € 1,404,494 1%
2.8 Prevention in endocrine pathology
4,800,000 € 1,348,315 1%
2.9 Prevention in orthopedics and traumathology
16,500,000 € 4,634,831 3%
2.12 Organs and tissue transplants
450,000 € 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 Medication and
orderly materials- RON medical orderly Weight in
materials- EUR total funds
Total general
1,441,831,000 € 405,008,708  
1 Supervision and control of HIV/SIDA infections
150,000,000 € 42,134,831 10%
2 Supervision and control of tuberculosis
13,785,000 € 3,872,191 1%
3 Prevention and control of cardiovascular deseases
51,513,000 € 14,469,944 4%
4 Prevention si control in oncologic pathology
323,242,000 € 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

3. 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

 MEDTRONIC SUA – exclusiv distributor Silva

Trading (no 1 on the romanian market)

4. BIOTRONIK GERMANIA – exclusiv distributor Eximrom

Biocard SRL

REPLANT MEDICAL LTD

 Competition– MEDTRONIC SUA
MEDTRONIC –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

 COMPETITION
MEDTRONIC – 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
Sales Sales
growth growth
Nr. 2006 2005 2003 2006/20 2005/20
Crt. Indicator (RON) (RON) (RON) 05 03
Annual 12,409,4 9,050,66 6,104,17
1 turover 56 2 3 37% 48%
Total 13,414,5 9,537,43 6,315,65
revenues
2 Total 62 7 1 41% 51%
expenditure 11,457,1 7,680,78 5,609,20
3s 73 3 1 49% 37%
1,634,89 1,556,42
4Net profit 6 1 529,301 5% 194%
No. of
5 Employees 13 13 9    

REPLANT MEDICAL LTD

Silva Trading– financial informations
EUR
Sales Sales
growth growth
Nr. 2006 2005 2003 2006/20 2005/20
Crt. Indicator (EUR) (EUR) (EUR) 05 03
Annual
1 turover 3,476,038 2,535,199 1,709,852 37% 48%
Total
2 revenues
Total 3,757,580 2,671,551 1,769,090 41% 51%
expenditure
3s 3,209,292 2,151,480 1,571,205 49% 37%

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

No. of
5 Employees 13 13 9    

REPLANT MEDICAL LTD

 MEDTRONIC –products portfolio

1. Products for cardiovascular deseases

2. Neurological products
3. Spinal products
4. Surgery “navigation” technique

Products for cardiovascular deseases :

- Interventional surgery
- Cardiac surgery
- Cardiac incitation (stimulare)
- Electriphysiology
- Monitoring external intervention in cardiac
emergency
REPLANT MEDICAL LTD
MEDTRONIC – products portfolio in cardiac
surgery
Produs
Mechanical heart valves with oscillatory disc and
bidisc
Biological heart valves with/without stent
Valvulary conduct with biological heart valve and
apical connector for left ventricle
Valvulary conduct for right ventricular tract
Ring for mitral or trycuspid reconstruction,
semirigid or flexible
REPLANT MEDICAL LTD
Explicatie
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.
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.
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.
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)
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
Produs
Aortic perforator
Oxigenator and set extracorporeal circulation for adults
and kids, standard or heparinat
Sistem de livrare cardioplegie si seturi de cardioplegie
Extracorporeal circulatin cannulas
Explicatie
Dispozitiv specific pentru perforarea tesutului aortic utilizat in timpul
procedurilor de bypass coronar, pentru a crea o deschidere
potrivita in peretele vasului.
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 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
Gama completa, de peste 550 modele de canule pentru circulatia
extracorporeala si alte accesorii necesare perfuziei in chirurgia
cordului.

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
anastomosis devices necesitatea clamparii partiale a aortei si a crea un campfara sange.
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
ACT determination device (determinarea ACT in doze mici - LRACT)
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
Heparine monitoring system individual de heparina al pacientului.
REPLANT MEDICAL LTD
Produs
 Autotransfusion system (cell-saver)
Sistem autolog de separare trombocite
Ablation Surgical System
Cardiopulmonar by-pass system with
centrifugal pump
Devices for Cardiac Sugery on beating cord
Oxigenator pentru ECMO
Sistem de monitorizare a saturatiei in oxigen si
hematocritului
Explicatie
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
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)
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.
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.
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)
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 folosit "in-line" in operatiile de chirurgie cardiaca pentru monitorizarea
saturatieiin oxigen (venoase si arteriale)si hematocritului
REPLANT MEDICAL LTD
MEDTRONIC – products portfolio in interventional
cardiology

Angioplasty (catheter with baloon)

Coronary stent
Coronary stents with antistenosis
substance

REPLANT MEDICAL LTD

Competition– BIOTRONIK GERMANIA
BIOTRONIK –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 page
REPLANT MEDICAL LTD
Eximrom Biocard– financial informations RON

Sales
growth
2006 2005 2006/200
No. Index (RON) (RON) 5
Annual
1 turover 373,509 376,558 -1%
Total
2 revenues 377,106 381,415 -1%
Total
3 expenditures 352,107 336,318 5%

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

No. of
5 Employees 3 3  

REPLANT MEDICAL LTD