Proven superiority of the BioMatrix FlexTM stent in STEMI patients at 2 years2

Proven safety and efficacy of the BioMatrix FlexTM stent confirmed out to 2 years in an “All-Comers” population2

Statistically significant reductionof MACE inSTEMI patients

LEADERS “All-Comers” RCT Design

(PI: S. Windecker, Co-PI: P. Serruys)

Limus Eluted from A Durable versusERodable Stent Coating

Randomized (1:1),Single-Blind, Multi-Center Study

9 mo

10 Sites in Europe

“Real World”: SVG, De Novoor Restenotic Coronary Artery Lesions,Chronic Stable Angina, Silent Ischemia,

Acute Coronary Syndromes

98.8%

1 yr 97.6%

2 yr 97.0%

Clinical Follow-Up

BioMatrix FlexTM

n= 857Cypher® SelectTM

n= 850

Primary Endpoint:Non-inferiority for cardiac death, MI, or

clinically indicated TVR at 9 months

LEADERSmet its primary endpoint

1

Relative reduction of MACE of 12%

BioMatrix FlexTM

proves low Late Loss

1

In-Stent Late Loss at 9 months0.13 mm BioMatrix FlexTM

vs. 0.19 mm Cypher® SelectTM

The cumulative incidence of MACE continues to diverge over time in favor of the BioMatrix Flex™ stent compared to the Cypher® Select™ stent.

-16%-12%

20

15

10

5

00 3 6 9 12 15 18 21 24

Months

MAC

E %

1 yearHR 0.88 [0.66 to 1.17]

p = 0.37*

MAC

E %

8.1%

19.3%

MACE= Cardiac Death, MI, or clinically indicated TVR *p value for superiority

-57.8%

BioMatrix FlexTM

Cypher® SelectTM

p <0.01*

n = 135 n = 140

2 yearsHR 0.84 [0.65 to 1.08]

p = 0.18*

MACE = Cardiac Death, MI, or clinically indicated TVR *p values for superiority

15.4%

12.1%

10.7% 13.0%

BioMatrix Flex, Biolimus A9 and BA9 are trademarks or registered trademarks of Biosensors International Group, Ltd. in the United States and other countries.

All cited trademarks are the propertyof their respective owners.

Not available for sale in the United Statesand certain other countries.

© 2010 Biosensors International Group, Ltd.All rights reserved.

BioMatrix FlexTM

Cypher® SelectTM

BIOSENSORS EUROPE SARue de Lausanne 291110 Morges - SwitzerlandTel. +41 (0)21 804 80 00Fax: +41 (0)21 804 80 01

BIOSENSORS INTERVENTIONAL TECHNOLOGIES PTE LTDBlk 10 Kaki Bukit Avenue 1#06-01/04 - Kampong Ubi Industrial Estate Singapore 417942Tel. +65 6213 5725 – Fax: +65 6213 5737

Post-hoc Analysis

BIOMATRIX FLEX - LEADERS LEAFLET = VERSO207x297 (to be slided inside the BioMatrix Flex Brochure)

No VLST after dual anti-platelet therapydiscontinuation with the BioMatrix FlexTM stent2

Signs of safety benefits for theBioMatrix FlexTM stent beyond 1 year2

Definite Stent Thrombosis - Very Late Stent Thombosis (VLST) per ARC definition

Superior strut coverage with theBioMatrix FlexTM stent compared

to the Cypher® SelectTM stent

LEADERS OCT Sub Studyat 9 months3

Lesions with at least 5%uncovered struts4

Cypher® SelectTM

n=26(n strut=6476)

39.4

BioMatrix FlexTM

n=20(n strut=4592)

3.6

%

0

10

20

30

40

p=0.005

10x

Superior stent apposition with theBioMatrix FlexTM stent compared

to the Cypher® SelectTM stent

Lesions with at least5% malapposed struts4

Cypher® SelectTM

n=26(n strut=6476)

6.7

BioMatrix FlexTM

n=20(n strut=4592)

0.3

%

0

2

4

6

8

p=0.04

20x

Lower rate of very late stent thrombosis with the BioMatrix FlexTM stent compared to the Cypher® SelectTM stent in an “All-Comers” population

3.0

2.5

2.0

1.5

1.0

0.5

0.0

2.22.5

1.2

0 0N=0/154 N=2/165 N=0/484 N=3/479

0.6

p = 0.73*

Patient who discontinued DAPTOverall Population

2 Y ST in LEADERS ST after DAPT ST after DAPT d/c < 12 M d/c > 12 M

Effect of DAPT Discontinuation

No VLST after DAPTdiscontinuationwas observed in the BioMatrix FlexTM group.Between 12 and 24 months, nearly 500 "All-Comers" patients were off DAPT.

REFERENCES

1. Windecker, S. et al., Biolimus-eluting stent with biodegradable polymer versus Sirolimus-eluting stent with durable polymer for coronary revascularization (LEADERS): a randomised non inferiority trial; The Lancet 2008; 372 No. 9644: 1163-1173

2. Klauss, V., LEADERS, 2-year Clinical Follow-Up, oral presentation, TCT 2009

3. Barlis, P. et al., An optical coherence tomography study of a biodegradable vs. durable polymer-coated limus-eluting stent: a LEADERS trial sub-study; European Heart Journal (2010) 31, 165-176

4. Di Mario, C., OCT: Differences between biodegradable and durable polymers - Insights from the LEADERS trial, oral presentation, TCT 2008

5. “All-Comers” trials

• LEADERS: Klauss, V., LEADERS, 2-Year Clinical Follow-Up, oral presentation, TCT 2009

• SIRTAX: Billinger, M. et al., Two-year clinical outcome after implantation of sirolimus-eluting and paclitaxel-eluting stents in diabetic patients; European Heart Journal (2008) 29, 718-725

• Bern/Rotterdam: Wenaweser, P. et al., Incidence and correlates of drug-eluting stent thrombosis in routine clinical practice: 4-year results from a large 2-institutional cohort study; J Am Coll Cardiol 2008;52:1154-1140

6. ”On-label” trials

• STEALTH I: Grube, E., Safety and Performance Evaluation of Biosensors Biolimus A9TM Eluting Stent (BioMatrixTM) STEALTH I: a 3-year safety follow-up, e-poster, TCT 2007

• Nobori I: Chevalier, B. et al., Nobori I Long term results: 2 years phase 1&2 and 3 years phase 1, EuroIntervention

• Endeavor IV: Leon, M.B., Zotarolimus-eluting Stent update, ACCi2 2009; The DES Summit, March 27-30, 2009; Orlando, FL

• SPIRIT III: Stone, G.W. et al, Randomized Comparison of Everolimus-Eluting and Paclitaxel-Eluting Stents, Circulation 2009;119:680-686

7. Based on currently available published data of randomized clinical trials in “All-Comers” population

*p value for superiority

0.2

0.50.6

0.5

0.1

0.8 0.8

1.0

0.3

BES

0

Very Late Stent Thrombosis in perspective

BES PES

NO

BO

RI

I

SES/PESSES/PES

BE

RN

RO

TT

ER

DA

M

NO

BO

RI

I

ST

EA

LTH

I

SES

LEA

DE

RS

SIR

TAX

BES

LEA

DE

RS

EN

DE

AVO

R I

V

EN

DE

AVO

R I

V

SP

IRIT

III

SP

IRIT

III

ZES PES EES PES

0

“All-Comers” Trials5

Definite (ARC)

For descriptive purposes only - RCTs with different protocols should not be compared

“On-Label” Trials6

Definite/Probable (ARC)

The VLST rate of the BioMatrix

FlexTM stent is the lowest as reported in the “All-Comers”multicenter RCTs7.

Biodegradable Polymer Durable Polymer

In the BioMatrix FlexTM group, VLST were limited to SVGs, which are excluded from the “On-Label” trials reported for the 1st generation of DES using durable polymers.

3.0

2.5

2.0

1.5

1.0

0.5

0.00 3 6 9 12 15 18 21 24

Ste

nt

Thro

mbos

is (

%)

Ste

nt

Thro

mbos

is (

%)

Months

Zoom at 1% scale p = ns

+0.2%

2.5%

2.0%2.2%

2.0%

+0.5%

BioMatrix FlexTM

Cypher® SelectTM

BioMatrix FlexTM

Cypher® SelectTM

10

81

8-0

00

-EN

- R

ev.0

1

www.biosensors.com

BIOMATRIX FLEX - LEADERS LEAFLET = VERSO207x297 (to be slided inside the BioMatrix Flex Brochure)