sorin group strategy in north america grand opening...

Eros RoncaiaVP / GM Mitroflow DivisionSorin Group Canada Inc.

Sorin Group strategy in North America

Grand opening of Mitroflowtissue valve new facility

Vancouver – May 21st 2004 3

AGENDA

9.15-9.45 Drago Cerchiari“The Sorin Group”

9.45-10.15 Rodger Stewart“Sorin North America activity”

10.15-10.30 Jeffrey S. Swanson, MD“Anatomy and diseases of heart valves”

10.30-10.45 Coffee break

10.45-11.15 Franco Vallana“Present and future in tissue valves”


AGENDA

11.15-11.45 Jim Trevor“The Cardiac Valves WW Market”

11.45-12.00 W. R. Eric Jamieson, MD“Mechanical vs tissue: a different clinical approach”

12.00-12.30 Q&A session

12:30-13.45 Business Lunch

13.45-14.15 Eros Roncaia“Mitroflow Operations”

14.15-15.45 Facility Tour

15.45 –16.00 Eros RoncaiaConclusions


Disclaimer

This presentation contains management preliminary estimates and forward-looking statements, including information related to Sorin projectedfinancial performance and the expected development of the med-techindustry, in particular in the cardiovascular and renal care segments.These statements are based on estimates and assumptions made by management of the company and are believed to be reasonable, as of this date, though by their nature future estimates are uncertain and difficult to predict. Actual results or experience could differ materially from the information contained herein.

This communication does not constitute an offer or solicitation forthe sale, purchase or acquisition of securities of any of the companies mentioned in any jurisdiction.

Sorin Group overview

Drago CerchiariCEO Sorin Group


Sorin: at the heart of medicaltechnologyThe Sorin Group is a leader in medical technologies to treat cardiovascular and renal diseases

Sorin operates in four segments of the medical technology market:

– Cardiac Surgery (CS)

– Vascular Therapy (VT)

– Cardiac Rhythm Management (CRM)

– Renal Care (RC)


Sorin is a global leading medicaldevices group

60%23%

3%

14%

Cardiac SurgeryCardiac RhythmManagement

Vascular Therapy

Renal Care

60%23%

9%

8%

EuropeNorth America

Japan

RoW

2003 Revenues (%) by Business Unit

2003 Revenues (%) by Geography


How we created the new Sorin Group

Jan 2004

Listing on Milan Stock ExchangeCompany Foundation Entering the Sorin Group

70’s 200240’s . . . 60’s 80’s 1992 1999 20032001


• € 715 million Net Revenues 2003, listed on the Milan Stock Exchange

• 4,800 employees, ∼ 30% in North America

• 500+ patents and 1,000+ trademarks

• 450+ R&D people across Europe and North America

• 30+ years of experience led to excellence in technology

• 5,000+ health care centers served

• Over 1 million cardiovascular devices and over 3.5 million dialyzers

sold per year

Key Facts

Every 30 seconds a patient depends on a Sorin therapy…


Sorin Group activities

Mitroflow


A full range player in a € 14 bncardiovascular market

Cardiac Surgery (CS)

Physician

Pathology -procedure

Market size2003 (€ bn)

CAGR 03-08

Marketshare (units)

Mainplayers

Vascular Therapy (VT)Cardiac Rhythm Management (CRM)

Cardiac surgeon and team

Interventionalcardiologist/radiologist

Cardiologist / electro-physiologist

Coronary diseases (by-pass), valve dysfunction

Coronary and vascular occlusions (Angioplasty)

Arrhythmia, Heart Failure

1.8 5.6 6.6

5% 11% 11%

Oxys: 38-40% wwMech.Valves: >50% EU

18-20% USTissue Valves: >20% EU

IDE in US

Coated (non DES): 6-7% EUDES: in clinical trials EU

Pacemakers: 12-13% EU~ 1% US

ICDs: 3-4% EU< 1% US

CRT-D: 1-2% EU

Medtronic, Edwards, Guidant, St. Jude, Terumo

J&J, Guidant, Boston Sc., Medtronic, Abbott, Terumo

Medtronic, Guidant, St. Jude, Biotronik


CARDIAC SURGERY STRATEGY: MAINTAIN AND GROW OUR LEADERSHIP

Strengthen leadership in Cardiopulmonary & Mechanical Heart Valves

• Innovative (new Mini by-pass system) & broader product range• Cobe/Carbomedics integration & account management focus

Fill market share gap between mechanical and tissue valves

• Percutaneous valve project via technology cross-fertilization

Expand geographically in underpenetrated markets

Expand into minimally invasive surgery

• Same customers• Superior clinical data and reliability in both valves segments

• Asia, Eastern Europe, RoW market shares growth


CRM STRATEGY: MARKETING FOCUS TO COMPLEMENT TECHNOLOGICAL EXCELLENCE

• Alto 2 ICD launched late 2003

• Alto 2 MSP CRT-D: launched April 2004

• New generation product range in 2005 (GXD II electronic platform)

EU: brady to drive growth of ICDs and CRT-D

US: increase market penetration

• Leverage existing CS infrastructure and customer relationships

• Develop a direct salesforce and other distribution channels in selected areas

• Accelerate CRT-D FDA approval

• Enhance positioning of ELA brand as the innovator in physiological pacing

ELA integration (Manufacturing, R&D, Sales & Marketing)

Sorin group account management organization to foster new customers acquisition


CUSTOMER-CENTRIC ORGANIZATION

SVP, BU Renal CareStefano Rimondi

President, BU CRMA. M. Ballester

President,BU Vascular Therapy

& New BusinessesGregory Cash

President, BU Cardiac SurgeryFranco Vallana

President,International

Eric Beard

President,North AmericaRodger Stewart

VP, Chief Internal AuditingAldo Lombardi

VP, Chief Financial OfficerAnton Failla

SVP, Corporate DevelopmentCarlo Vanoli

SVP, HR & OrganizationGiovanni Caruso

Chief Executive OfficerDrago Cerchiari

ChairmanUmberto Rosa

VP, Strategic Planningopen

Chief Scientific Officeropen


SORIN ROAD MAP FOR THE NEW SORIN

Year

Phase

CS

VT

CRM

Mainproductlaunches

2004 2005 2006 2007 2008

• Synergyminiby-pass

• Genius (2nd generationmini by-pass)

• Tissuevalve (US)

• Janus(EU)

• Symphony(pacemaker)

• Alto2 (ICD)

• CRT-D(EU)

• Newelectronicplatform

• Alto 2 in Japan

• CRT-D(US)

• Percutaneousvalve

2003

• Integration and cost reduction

• Launching new product ranges in EU

• Investing to prepare US expansion (distribution, clinical trials)

Growth and profitability driven by:• US expansion• Full benefits from integration• New and less invasive

technologies

• Janus(US)

• Angelplatelet gel

• Activat


REVENUES BY GEOGRAPHY: NORTH AMERICA HIGHER CONTRIBUTION

66%

77%

34%

23%

0

400

800

1200

2003 2008P

EU+Row North America

CAGR NA 20%

€ mn

Sorin Group in North America

Rodger StewartPresident North America Region


Sorin Group presence in NorthAmerica

Mitroflow

COBE Cardiovascular Inc., the leading supplier of perfusion and autotransfusion systemsManufactures oxygenators, custom perfusion sets, and autotransfusion equipment and disposables for surgery and distributes heart-lung machines. It is the owner of a broad portfolio of patents that helped it to achieve a leadership position in the United States. Headquarters and production facilities are in Denver, Colorado. Member of the Sorin Group since May 1999.

CarboMedics Inc., a leader in the development ofproducts for treatment of valvular heart diseaseManufacture mechanical heart valves and products to repair human heart valves. Headquarters and production facilities are in Austin, Texas. Member of the Sorin Group since January 2003.

Mitroflow, a top player in the tissue heart valves market headquartered in Vancouver, Canada.

Ela Medical Inc., the commercial branch for North America for cardiac rhythm management products, located in Minneapolis.


Sorin Group presence in NorthAmerica . . .

1,223 employees in NA28% of total Sorin Group

1,550 hospitals served in NA(5,000 centers worldwide)

EMPLOYEES

HOSPITALS SERVED


. . . a large and fast growing market

• Oxygenators 36-38%

• Heart-Lung Machines 40-45%

• Autotransfusion disposables > 40%

• Mechanical Heart Valves 18-20%

• Tissue Valves IDE

• Pacemakers ~ 1%

• ICDs (Implantable Cardioverter Defibrillators) < 1%

(2003 market share in units. Sorin estimates)

North America represents 70%+ of the global cardiovascularmarket and Sorin has strong market shares in Cardiac Surgeryand an entry position in high growth segments


Growth strategy in North America

From …

• A strong Cardiac Surgery player with excellent brand recognition

• A recognized player also in CRM and Vascular Therapy

• Different companies operating independently

• One Group working together under a strong Sorin brand

• “Product driven” • Customer focused through a service leadership position

• Account management customer-centric organization

• Customers unaware of our product and technology breadth

• Known as an innovative customer focused company with a breadth of solutions

To …


North America strategy by segment

CardiacSurgeryCardiacSurgery

Strengthen leadership position- New product pipeline- Synergies across companies- Prepare for tissue valve launch

VascularTherapyVascularTherapy

Explore distribution partnership after demonstration of clinical superiority

CRMCRMPenetrate pacemaker, ICD and CRT-Dmarkets leveraging our full product lineand strengthened organization


North America cs strategyWhat we have to do

• Improve our mechanical valve market share

• FDA approval of tissue valve and platelet gel

• Expand products range to complement our distribution channel and customer

• Establish Sorin brandrecognition consistent with our comprehensive product offerings

• Utilize account management to leverage strengths across BU

Our assets

• Strong market share position in CP & ATS

• Strong and comprehensive product line in CP, ATS, HLM, & valves

• Strong, tenured, experienced sales & distribution network

• Strong brand recognition with COBE and CarboMedics

• Solid NA infrastructure to support significant growth


What we have to do

• Well trained and certified sales network with the needed support infrastructure

• Complete the product range to meet NA demand

• Continuous and timely FDA approval of new products

• Obtain FDA certification for CRT-D

• Establish Ela brand recognition consistent with our technology and product offering

North America CRM penetration strategy

• Distinctive technology in SW and sensors

• New competitive platform released in 2004

• Small CRM sales/support infrastructure but strong CS platform

• Strong reputation in NA market in CS through COBE and CarboMedics

• Good IP portfolio but product range still incomplete to meet NA demand

Our assets


New sales and marketing approach

• Account management leveraging synergies across sales channels

New approach for North

America sales and marketing

• Sorin Group brand development

• Customer centric approach

• Increased clinical study investment

• Strong reputation to be leveraged across businesses

• Strong, focused tactical marketing supported by strategic marketing


2003-08 Revenues in NA to more than double

200

2003

426

CAGR20%

2008

US$ 195 mn *

US$ ~400 mn *

* Assuming US$/€ 1,2

Present and future in tissue valves

Franco VallanaPresident Cardiac Surgery BU Sorin Group


Heart valves


Leaflets

• 2 (bileaflet valve)• 1 (monodisc valve)• Always coated of PyC

Suitable for both AORTIC and MITRAL replacements

Mechanical valves: basic design feature

Housing

• Solid PyC (with stiffening rings)• Metal alloys with PyC film coating

(Carbofilm)

Sewing Ring

• PET, PTFE (polymeric fabrics)


Stented porcine

• Natural pig aortic valveStented pericardium

• Sheets of bovine pericardiumSewing ring

• Plastic frame (stent) or metallic frame, covered with PET fabric

Biological valves: basic design feature

Suitable for both AORTIC and MITRAL replacements


Fresh Tissue

Tissue Treated with Glutaraldehyde

Tissue fixation


Cross stitchesStress free opening

SORIN BIOMEDICA• Pericarbon More• Soprano

Sorin Group biological valves


MITROFLOW

Acetal homopolymer stentSilicone/tungsten sewingringPolyester knit stent coveringTissue mounted outside the stent



• Stentless porcine– Natural pig aortic valve– Covering of PET fabric

Suitable for AORTIC replacement only

Biological valves: basic design feature

• Stentless pericardium– Sheets of pericardium– No covering


SORIN BIOMEDICA - Stentless Models



Mechanical valves vs biological valves

No anticoagulationIdeal haemodynamics

Plus:

Limited Durability (7-15 years)Tissue mineralization (higher in youngpatients)

Limitation:

BIOLOGICAL VALVES

--

--

Life-lasting durabilityPlus:

Continuous anticoagulation intakePeriodical blood controlRisk of sudden dysfunction

Limitation:

MECHANICAL VALVES

-

---


Mechanical vs biological indications

Personal preference:Age:Clinical history:Life style:

PATIENT-WISE

----

Anticoagulation vs reoperationLife expectationContraindication to the anticoagulationProfession, hobbies

Pathology:Anatomy:Surgeon:Technique:

SURGEON-WISE

----

EndocarditisSmall annulus, mitral valveConfident handlingCalcified annulus


Mechanical vs biological indications

Women who foresee to have babiesPatients with contraindications to the anticoagulationPatient’s refusal to take anticoagulants

* Exceptions:

---

• Adults < 65 years old*: Mechanical valves

• Adults > 65 years old: Biological valves


• Increased mean age of the patients population• Rheumatic Disease decreasing in developed countries• Improvement in durability and new designs of the latest

generation of bioprostheses

The global market of bioprostheses is growing

Increased confidence of the surgeon in the products

Shift of the age of the target population

Increasing number of patients who choose biological valves


• The pericardium valve is TAILORED using carefully selected materials with high mechanical resistance

• Repeatable manufacturing standard qualities and performances

• Lower pressure gradients

ADVANTAGES

Pericardium vs porcine valves


Effective orifice area by prosthetic type

MECHANICALSTENTED

PERICARDIUMSTENTLESS

PERICARDIUMSTENTEDPORCINE


STENTED VALVES

Plus: Easy implantability

Limitation: Pressure gradients

Physiological Haemodynamics (close to

Zero Pressure Gradients)

Plus:

Biological valves: Stentless vs stented

Requires surgical skills and longer cross

clamp times

Limitation:

STENTLESS VALVES


Trends in heart valve market

1988

80%Mechanical

20%Biological

1998

70%

30%

2003

56%

44%

85%Porcine

15%Bovine

70%

30%

55%

45%

100%Stented

0%Stentless

89%

11%

80%

20%


Product-related

Patient-relatedSurgery-related

CALCIFICATION• Product implantation• Leaflet distortion

Factors involved in biological valves tissue calcification process

• Product design• GA per se (toxicity)• Cell debris (dead tissue)

• Age• Renal failure


Anticalcification treatments in biological valves

Glutaraldehyde

Glutaraldehyde with pre/post treatments

Detergents, ethanol (decellularization/lipids extraction)GA neutralizers (toxic aldehyde residues elimination)

--

Alternative cross-linking

Photo-sensitive dyeNo-ReactTM

--


Comparative studies between

Detoxified samples

Non-detoxified samples

•Unchanged Tissue stability

•Unchanged Mechanicalproperties

•Structural characteristicsare preserved

•Toxicity is eliminated

•Calcification is expected to be reduced

Sorin Group: Detoxification post-treatment with homocysteic acid


The DuraNol treatment makes use of a short and long chain alcohol combination, comprised of 5% 1,2-octanediol in an ethanolic buffered solution.

It is aimed at reducing phospholipid content and subsequently lowering the propensity of pericardial tissue to calcify in vivo.

Sorin Group: DuraNol treatment


Pericarbon More•Mitral•Aortic Mitroflow

•Aortic

Freedom Stentless•Aortic

Freedom Solo•Aortic

Soprano•Aortic


Heart Valve Market

Jim TrevorVP Global Strategic Marketing

Cardiac Surgery BU


Heart Valve Market in 2003

1.2+ million procedures in cardiac surgical operatingroom worldwide

292,000 heart valves implanted or repaired worldwide

$ 810 million (*) the value of the WW Valve and RepairMarket:• Mechanical Heart Valves: $ 360 M• Tissue Valves: $ 405 M• Repair Products: $ 45 M

(*) Sources: UBS Medical Supplies & Devices Report, Jan. 2004, Industry Sources and Sorin Group estimates


Strong increase in mitral valve repair rather than replacement

• Especially in the USA where approximately half of the mitral valvesurgeries in 2003 were repaired

• Continued strong surgeon training and interest

• Better for the patient, preservation of the native mitral valve

Worldwide mechanical valve implants are being impacted by an increase in both tissue valve replacement and mitral valverepair

Valve Market Trends (cont’d)


Unprecedented product reliability and broad product range

Sorin Group has over 800,000 mechanical valves implanted without any post-op structural failures

No other mechanical valve manufacturer in the world canmake that statement

Sorin Group has the broadest product offering in the world:• Delivered into 80+ countries• Two brands: Carbomedics and Sorin• Full line of mechanical bi-leaflet valves• Full line of stented and stentless tissue valves• Full line of annulolplasty rings (valve repair rings)


CarboMedics Mechanical Valves


Valve Market Trends

Worldwide trend towards implanting tissue valves

• Longer patient follow-up data available (+17 years of clinical data)

• Increased surgeon confidence in the product for younger patients

• No required anticoagulation therapy

• Increased mean age of cardiac patient population (baby boomersreaching 65 years of age)

• Strong direct-to-patient marketing programs focusing onanticoagulation concerns, patients requesting tissue valves

• Higher WW pricing for tissue valves


Mitroflow


WW Valve & Repair Trend

47%

48%

5%

50%

45%

5%

Mechanical Mechanical

Tissue Tissue

RepairRepair

• Total WW Market Size in 2003: $810M

• Market growth: 4.5%

• Continued premium pricing for tissue valves

Sources: UBS Medical Supplies & Devices Report, Jan. 2004, Industry Sources and Sorin Group estimates

2002 Revenue 2003 Revenue


Europe Valve & Repair Trend

43%

55%

2%

46%

52%

2%

Mechanical

Mechanical

Tissue

Tissue

Repair

Repair

• Total European Market Size: $177M

• Market growth: ~2%

• Flat or declining pricing in some key countries


2002 Revenue2003 Revenue


ROW Valve & Repair Trend

26%

73%

1%

25%

74%

1%

2002 Revenue

2003 Revenue

Mechanical

Mechanical

Tissue

TissueRepair

Repair

• Total ROW Market Size: $210M

• Strongest growth area for valve/repair market: > 10%

• Strong mechanical valve market, low pricing (except for Japan)



N. America Valve & Repair Trend

59%

33%

8%

62%

29%

9%

2002 Revenue

2003 RevenueMechanical

Mechanical

Tissue

Tissue

Repair

Repair

• Total North America Market Size: $422M

• Market Growth: ~3%

• Continued shift from mechanical to tissue valves and mitral repairSources: UBS Medical Supplies & Devices Report, Jan. 2004, Industry Sources and Sorin Group estimates


WW Tissue Valve Market

21%

66%

13%

2003 Revenue

N America

ROW Europe

• Total WW Tissue Market Value: $405M

• > 65% of the WW Tissue Valve Revenues is in N. America



Mitroflow aortic pericardial valve


Semi-stented valve

23mm Mitroflowversus

19mm Other Pericardial Valve

19mm 19mm 21mm 23mm

Other Pericardial Valve

MitroflowAortic Pericardial Heart Valve


Superior hemodynamics & durability

Haemodynamic Comparison Between6 and 18 months

Mean Transvalvular Gradient (mmHg)

25

20

15

10

5

0

11.659.7

14.5

7.2 7.6

11.9

21mm 23mm

Mitroflow1

Stentless Valve A2

Other Pericardial Valve (Model A)3

1. Garcia-Bengochea, J., et al., Clinical Results with the new Mitroflow Aortic Pericardial Bioprosthesis. Abstract; VIII International Symposium for Cardiac Bioprosthesis 2000.

2. Kwok, LY., et al. Aortic Valve Replacement with the Freestyle Stentless Bioprosthesis 5 year experience. Circulation 1999; 100[Suppl II]:II-17-II-23.

3. Lesbre, JP., et al. Evaluation des nouvelles bioprosthesis pericardiques par Doppler pulse et continu. Arch Mal Coeur 1986; 10:1439-1448


Mitroflow Aortic Pericardial Heart Valve

Heamodynamics = Superior performance

Durability = 17 years of reliability

Superior Design = Ease of implantation

Sizing = Choices for the smallest root or annulus

Eros RoncaiaVP / GM Mitroflow DivisionSorin Group Canada Inc.


Mitroflow – Company Profile

• Manufacturer of pericardial heart valve prostheses, the Mitroflow Pericardial Heart Valve

• Established in 1982

• Departments: Operations, Quality Assurance, R&D/Industrialization, Human Resources, Administration

• Field support (Sales & Marketing, Customer Service, Clinical Affairs, and Regulatory) provided by Sorin Group organization


Mitroflow – Company Facts

• To date, about 34,000 Mitroflow implanted

• 2003 generated revenues: € 7.2M (€ 6.2M in 2002, +16%)

• 2003 sales units: 4,460 (3,611 in 2002, +23.5 %)

• Q1 2004 sales units: +31.5% vs Q1 2003

• 2003 Western Europe tissue valves market share: 14%

• IDE Clinical Trial started in Nov-03. As of May 14th,105implants, 21 sites with products, 4 more waiting for Ethics Committee approval


Mitroflow – Company Facts

• Number of employees: 145

• Operations (Manufacturing, QC, PM, Logistics): 116

• R&D (R&D, Industrialization, QA, Microbiology): 19

• Administration (HR, Finance, IT): 10

• ISO 9001 certified since 1995

• CE Mark granted in 1997

• ISO 13485 (“Medical devices -- Quality management systems - Requirements for regulatory purposes”) certifiedsince 2003


Mitroflow 2003 units sold by area

GREECE0%

SWITZERLAND2%

FRANCE9%

BENELUX6%

SPAIN11%

EAST EUROPE0%

ITALY6% UK

18%

SCANDINAVIA9%

GERMANY & AUSTRIA24%

CANADA5%

USA0%

PORTUGAL3%

MIDDLE EAST5%

LATIN AMERICA2%

FAR EAST0%


Mitroflow 2004 E units sold by area

GREECE1%

SWITZERLAND2%

FRANCE10%

BENELUX6%

SPAIN10%

EAST EUROPE1%

ITALY6%

UK13%

SCANDINAVIA7%

GERMANY & AUSTRIA16%

CANADA5%

USA8%

PORTUGAL3%

MIDDLE EAST6%

LATIN AMERICA3%FAR EAST

3%


Mitroflow pericardium supply


Mitroflow – Product


Mitroflow – Process



Valve Visual Inspection

Covered StentSubassembly

Bare Stent Sewing Ring

TissueApplication

TissueFixation

ComponentBatching



Valve Holder

Valve Holder Attachment

Sterilization

PackagingInsert

Label Preparation, Final Packaging and Inspection

Distribution

FunctionTest

Finished Valve Visual Inspection


Mitroflow – Facility

• Overall extension: 5,000 m2

• Eight clean rooms for a total of 670 m2 (possible clean room expansion: 220 m2)

• Office space 1,000 m2, warehouse: 450 m2

• Expected capacity: 25,000 valves/year

• Investment: € 6M

• First department moved: Covered Stent on March 2nd 2004

• First valve sterilized: April 15th 2004


Mitroflow – Clean RoomsCovered Stent

TissueApplicationFunction

TestValveVisual

PossibleExpansionHolder

application

Solution Prep

Microbiological LabSterilization

APPENDIX


SORIN GROUP MISSION

Utilize Medical Technology(*)

to develop advanced and effective Therapies

to treat Cardiovascular/Haemodynamic

diseases

throughout the World

(*) Medical Technology is a convergence of many different disciplines: Mechanical, chemical andelectronic engineering; Materials science; Medical and biological science (haematology,physiology, hystology, etc.); and, more recently: Information technology; Nanotechnology;Drug delivery technology; Biological tissue engineering


History of the Sorin Group

1956Sorin S.p.A. (Società Ricerche e Impianti Nucleari) is established by Fiat and Montecatini.Its corporate purpose includes “studies and research on and construction and management of nuclear power plants.”

mid ’60sSorin begins to redirect its significant technical and scientific knowhow toward the biomedical field, focusing on pacemakers (the first model, Pulsicor, dates back to 1965), hemodialysis and radioisotopes. Subsequently, it launches research into the production of a pyrocarbon heart valve (the first valve is implanted in 1975).

1986The Sorin Group joined the Snia family of companies, growing through internal R&D andinternational acquisitions until it became a world-class industrial enterprise with apresence in all of the main segments of the cardiovascular and renal care markets.

1990Bellco, one of the leading European player in hemodialyses (founded in 1972), was taken over by Sorin.



1992Sorin Biomedica purchased Shiley, the Cardiovascular Devices Division of a groupheaded by Pfizer Inc.(USA), which included:- Dideco, the European leader in the market for extracorporeal blood circulation andautologous blood transfusion products- Stöckert, a leading world producer and distributor of heart-lung machines.

1999Cobe Cardiovascular (Denver, USA – incorporated in 1964) one of the leading player inCardiac Surgery, was acquired by the Sorin Group, thus becoming the worldwide leaderin cardiopulmonary systems.

2001

Ela Medical (Paris, F - founded in 1977) was acquired from Sanofi – Synthélabo. The acquisition strengthened the Group’s position in the cardiac rhythm management market (pacemakers and implantable defibrillators). Ela Medical’s assets included a vast portfolioof patents, a direct sales presence in the U.S. market and a line of FDA-approvedproducts, as well as a respectable share of the European market



2002Soludia, a French company specialized in the manufacture of dialysis solutions, wasacquired.

2003Carbomedics a U.S. producer of mechanical heart valves based in Austin, Texas (founded in 1969), was acquired from Centerpulse. This acquisition significantly strengthened the leadership position of the Sorin Group in heart valves and increased its penetration of the U.S. market.

January 5, 2004Following Snia’s partial proportional demerger, the Sorin Group, which is headed by theholding company Sorin S.p.A., has been listed independently on the Online Stock Market of Borsa Italiana.


1964 ELA’s first pacemaker

1964 First customized Heart-Lung Pack

1967 Sorin’s first Pacemaker

1973 First modular Heart-Lung Machine

1977 First implant of a Sorin’s cardiac valve

1977 First Dideco Oxygenator

1982 First European autotransfusion system

1989 First Dual Chamber Pacemaker

1995 First world-wide implant of a Dual Chamber ICD

1998 Sorin’s CARBOSTENT first Human Implant

1998 First Human Implant of a MSP pacemaker

2000 Heart failure: publication of the MUSTIC results

2001 First fully automatic autotransfusion system with blood quality monitoring

2003 First fully integrated oxygenation system

2003 First Human Implant of a Sorin drug eluting stent

(In light blue: first in the industry)

A 38 history of breakthroughs


Sorin Group products, companiesand brands

• Dialyzers• Haemodialyses equipment• Liquids, cartridges, concentrates

• Coronary stents (Carbon-coatedand drug-eluting*)

• Peripheral stents (Iliac, Renal,Infra-poplietal)

• Pacemakers• Implantable Cardioverter

Defibrillator (ICD)• Heart Failure treatment devices

(CRT-D, CRT-P)

• Cardiopulmonary systems:Oxygenators, Custom Packs

• Heart-Lung Equipment• Heart Valves (mechanical and

tissue) and annuloplasty rings

• Blood lines andaccessories• New Therapies*

• Balloon Catheters andangioplasty accessories• New Blood Derivatives Technology*

• Programmers• Leads• Holters• Electrophysiology

catheters

• Autotransfusion systems• Other products:

- monitors- blood derivatives

Mirandola (I)Tolouse (F)

BellcoLaboratoires Soludia

Saluggia (I)Sorin Biomedica Cardio

Paris (F)Saluggia (I)

Ela MedicalSorin Biomedica CRM

Austin (USA)Denver (USA) Mirandola (I)Vancouver (CA)Saluggia (I)Münich (D)

CarbomedicsCobe CVDidecoMitroflowSorin Biomedica Cardio Stöckert

CARDIACSURGERY

CARDIACRHYTHMMANAGEMENT

VASCULARTHERAPY & NEW BUSINESSES

RENAL CARE

Product Lines Companiesand Brands

Manufacturingsites

* Under clinical investigation


More than 1 millionprocedures/year in the world

CARDIAC SURGERY: € 1.8 BN MARKET, GROWING 5% PY

TREATED DISEASESCoronary artery occlusion; Heart Valve defects; Heart Failure – Heart transplant

DEVICESCardiopulmonary bypass system

(oxygenators, Heart-Lung Machines, auto-transfusion disposable and equipment)

Artificial mechanical and tissue heart valves, annuloplasty rings

SORIN’S MARKET POSITIONWorld leader in Cardiopulmonary Systems and Mechanical Heart Valves (~ 40% market share)A solid and growing presence in Tissue heart valve (> 20% in Europe, ongoing clinical trials in US)

SORIN’S COMPANIES/BRANDNAMESCobe CV (Denver, Usa), CarboMedics( Austin, Usa), Mitroflow (Vancouver, Canada), Dideco(Mirandola, Italy), Stöckert (Munich, Germany)


More than 10% of population above70 years of age suffering from

different heart arrhythmias

CARDIAC RHYTHM MANAGEMENT:€ 6.6 BN MARKET, GROWING 11% PY

TREATED DISEASESBradycardia (slow heart beat) Tachycardia (fast heart beat)Heart Failure

DEVICESPacemakersImplantable Cardioverter Defibrillators (ICD)Cardiac Re-synchronization devices (CRT-P and CRT-D)Holters, Electrophysiology catheters

SORIN’S MARKET POSITION>12% EU market share in pacemakers, 3-4% in EU in ICDsPenetrating the ICD market (EU and US) with new generation devicesStrong technology platform to become a winner in advanced CRM therapy (CRT, physiological pacing, other new clinical indications)

SORIN’S COMPANIES/BRANDNAMESElaMedical, Sorin Biomedica


About 2 million/year patients undergoing angioplasty and stenting

procedure in the world

VASCULAR THERAPY: € 5.6 BN MARKET, GROWING 11% PY

TREATED DISEASESCoronary artery occlusion Peripheral artery occlusion

DEVICESStents (coronary and peripheral) and CathetersAccessories (guiding wires and catheters, diagnostic catheters, others)

SORIN’S MARKET POSITION6-7% EU market share with CarboStent (a carbon-coated,non-thrombogenic stent with low restenosis occurrence)Janus, a new generation, revolutionary Drug Eluting Stentin European clinical trials

SORIN’S COMPANIES/BRANDNAMESSorin Biomedica Cardio


Dideco S.p.A. is a world leader in the design and production of oxygenators andextracorporeal blood circulation systems for open-heart surgery. The company also manufactures machinery and equipment for the therapeutical treatment of blood. This equipment is used for self-transfusion and apheresis applications. Headquarters and production facilities are in Mirandola (Modena). Member of the Sorin Group since 1992.

Cobe Cardiovascular Inc. manufactures oxygenators for surgery and distributes heart-lung machines. It is the owner of a broad portfolio of patents that helped it to achieve a leadership position in the United States. Headquarters and production facilities are in Denver, Colorado. Member of the Sorin Group since May 1999.

Stöckert Instrumente GmbH is the world’s leading producer of heart-lung machines used for extracorporeal circulation. It also manufactures tubes and aspirators. Headquarters and production facilities are in Munich, Germany. Member of the SorinGroup since 1992.

Business Profile – Main Companies


Ela Medical S.A., a manufacturer of pacemakers and defibrillators, is one of Europe'stop developers of leading-edge technologies for the control of cardiac rhythm. Headquarters and production facilities are in Paris. Member of the Sorin Group since April 2001.

Sorin Biomedica CRM S.r.l. has a leadership position in the high-tech biomedical market, offering a complete line of pacemakers, electrodes and programmers.Headquarters and production facilities are in Saluggia (Vercelli).

Sorin Biomedica Cardio S.p.A., a producer of cardiac valves and stents, combines outstanding design capabilities with proprietary technologies such as Carbofilm.Headquarters and production facilities are in Saluggia (Vercelli).

CarboMedics Inc. manufactures mechanical and tissue heart valves and products torepair human heart valves. Headquarters are in Austin, Texas, and production facilities are in Austin, Texas, and Vancouver, Canada. Member of the Sorin Group since January 2003.



Bellco S.p.A. is one of the top European manufacturers of hemodialysis products with a complete line of disposables and equipment for the tratment of chronic renal failure. Headquarters are in Mirandola (Modena) and production facilities are in Mirandola(Modena), Saluggia (Vercelli) and Villacidro (Cagliari). Member of the Sorin Group since 1990.

Soludia S.A. produces powdered and liquid solution concentrates and infusion solutionsfor dialysis. Headquarters and production facilities are in Toulouse, France. Member of the Sorin Group since April 2002.


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