1. John E Shulze, CTO Biosensors International Inc
Drug Application in
Stent Technology:
How to Diversify?
John E Shulze, CTO
Biosensors International Inc 1

2. My Conflicts of interest are:
Chief Technology Officer
and a shareholder of
Biosensors International Inc.1
(1Biosensors’ development pipeline products to be discussed
in this Presentation)

3. BIOLIMUS A9™ DRUG
RAPAMYCIN DERIVATIVE
Developed specifically for stent application by Biosensors
Potent immunosuppressive and anti-inflammatory properties
LIPOPHILICITY COMPARISON
Highest lipophilic and hydrophobic properties of commercially available limus drugs
Mainly localized effects, minimal drug release into bloodstream

4. ABLUMINAL BIODEGRADABLE COATING
The Abluminal Biodegradable Polymer DES
ABLUMINAL BIODEGRADABLE COATING
Early BMS-like endothelial coverage1
More targeted tissue release
Less systemic exposure
BIOLIMUS A9™ DRUG
Biosensors’ proprietary rapamycin derivative
Highest lypophilicity of the common limus drugs1
BIODEGRADABLE PLA
Simultaneous PLA biodegradation and BA9™ elution
No PLA /BA9™ coating on the stent after 6 to 9months2
EN – Rev.01
1 Data on file at Biosensors Intl
2 In vivo testing in porcine model demonstrates abluminal coating is absorbed after 6 to 9 months - Data on file at Biosensors Intl

5. Trial Design (LEADERS)
Stable and ACS Patients Undergoing PCI
Assessor-blind
1:1 Randomisation
N=1700
Patients
3-year follow-up
(N=1,621; 95.0%)
BES
BioMatrix Flex N=850
SES
Cypher Select N=850
1:3 Randomisation
Clinical F/U
N=640
Angio F/U
N=210
Clinical F/U
N=640
Angio F/U
N=210
1o endpoint: CV death, MI, clinically-indicated TVR (9 months)
2o endpoints: Death, CV death, MI, TLR, TVR
Stent thrombosis according to ARC Angiographic study: In-stent % diameter stenosis
Late loss, binary restenosis
DAPT recommended for 12 month

6. Primary Endpoint MACE (Cardiac Death, MI and TVR) @ 9 Months15
pnon-inferiority = 0.003
Cypher® Select™ 10.5% 10
MACE %
BioMatrix Flex™ 9.2% 5 1 2 3 4 5 6 7 8 9
Months of Follow-up
BioMatrix Flex™ reached its primary endpoint
Windecker S. et al., The Lancet 2008; 372 No. 9644:

7. MACE
3-year HR
0.82 [0.65 to 1.03]
P = 0.09*
1-year HR
0.88 [0.66 to 1.17]
P = 0.37*
13.0%
15.4%
2-year HR
0.84 [0.65 to 1.08]
P = 0.18*
BES 20
19.0%
SES 15
15.7%
12.1% % 10
10.7% 5 6 12 18 24 30 36
Number at risk
BES
857
851
761
743
729
712
668
SES
850
846
749
732
713
686
639
Months
*P values for superiority
MACE = Cardiac Death, MI, or Clinically-Indicated TVR
Serruys, P. W., oral presentation ,TCT 2010

8. Definite ST through 3 years
BES
2.0%
1-year HR
0.99 [0.51 to 1.94]
P = 0.98*
2.2%
2.5%
2-year HR
0.90 [0.48 to 1.67
P = 0.73*
3-year HR
0.78 [0.43 to 1.43]
P = 0.43*
4.0
SES
1.0
2.0
3.0
2.9%
Δ 0.7% %
Δ 0.3%
2.2%
Δ 0.0% 6 12 18 24 30 36
Months
Number at risk
BES
857
846
808
797
787
774
732
SES
850
841
801
792
779
758
715
*P values for superiority
Serruys P.W., oral presentation, TCT 2010
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9. PROVISIONAL STENTING USE

10. Micro-CT Biomatrix results
MV STENTING
AFTER KISSING

11. MACE in Complex Patients%
Months
8.4%
19.7%
15.9%
6.8% 5 10 15 20 6 12 18 24 36 30
10.0%
21.3%
3-year HR
0.43 [0.23 to 0.84]
P = 0.01* 25
STEMI
15.3%
21.8%
18.6%
12.7%
17.0%
23.8%
0.69 [0.46 to 1.04]
P = 0.08*
High Syntax Score (>16)
BES
SES
Bifurcations %
15.6%
18.9%
16.4%
12.9% 5 10 15 20 6 12 18 24 36 30
18.5%
23.3%
3-year HR
0.79 [0.53 to 1.16]
P = 0.22* 25
16.0%
24.1%
0.65 [0.41 to 1.03]
P = 0.06*
15.0%
23.5%
17.1%
13.0%
Multi-vessel
*P values for superiority
Windecker, S., oral presentation ,TCT 2010

12. Grube E., oral presentation, TCT 2010
BioFreedom™
Selectively micro-structured surface holds drug in abluminal surface structures
Hypothesis: Polymer-free drug release via porous-eluting stents may reduce late events caused by polymer stent coatings.
Potential advantage
Avoid long term late adverse effects that might be attributable to the polymer
Improved surface integrity since there is no polymer to be sheared or peeled away from the stent struts
Possible shorter need of dual antiplatelet therapy
Proprietary Highly Lipophilic Limus drug
Grube E., oral presentation, TCT 2010

13. BioFreedom FIM Design BioFreedom FIM 4 Month Angio FU
182 patients
First Cohort
Second Cohort
12 Month Clinical FU 99%
4 Month Angio FU
75 patients
12 Month Angio FU
107 patients
BioFreedom
standard dose
(BFD SD)
N=25
low dose
(BFD LD)
N=26
TAXUS® Liberté ®
N=24
Angio FU 92%
BioFreedom
standard dose
(BFD SD)
N=35
low dose
(BFD LD)
N=36
TAXUS® Liberté ®
Angio FU 92%
Enrollment Period
Sept – Jan 2009
Enrollment Period
Jan 2009 – Jun 2009

14. 12 Month Angiographic FU In-Stent Late Lumen Loss: 2nd Cohort
Primary Endpoint
Non – inferiority
P values
P = 0.001
P = 0.21
(mm)
N = 31
N = 35
N = 31
Grube E., oral presentation, TCT 2010
All values are presented as median [IQR]

15. 12 Month MACE All Patients (1st + 2nd Cohorts)
BFD SD
N = 60
BFD LD
N = 62
Taxus
MACE*
(All Death, MI, Emergent Bypass or TLR)
3 (6.1%)
7 (11.6%)
3 (5.5%)
All Death
1 (1.8%)
0 (0.0%) MI
1 (1.6%)
Q Wave MI
Non-Q Wave MI
1 (1.6%)**
Emergent Bypass
TLR
6 (10.0%)
No ST event out to 12 months: ARC defined Definite, Probable or Possible!
*Time to first event
**In-hospital MI
All p values are non significant.
Tests were performed for BFD SD vs. Taxus and BFD LD vs. Taxus.

16. The AXXESS stent The AXXESS stent is a dedicated bifurcation stent
Nitinol self explandable stent
Using PLA/BA9™ abluminal coating technology
4 references: 3.0 and 3.5 mm in diameter; 11 and 14 mm in lengths
2 models: bifurcation and LM (difference in sizes of the conical shape)
The AXXESS stent is associated to a clinical program
AXXESS Plus and DIVERGE for de novo bifurcation
AXXENT for LM lesion
THE AXXESS stent received CE mark in August 2010
Indication: bifurcation
AXXESS

17. Restenosis in DIVERGE
Any in-Bifurcation restenosis:
6.4% (9/140 at 9 months)
Lowest restenosis rates ever reported in a bifurcation study of any kind
Parent Vessel RS
3 pts
Side Branch RS
4pts
2 pts
Both

18. What is next?

19. Sparrow™ Microstent: designed for small vessels
The smallest profile drug-eluting stent system in the world
60% smaller than the nearest available coronary stent system.
limus drug with a biodegradable polymer matrix
Self-expanding ultra-thin Nitinol stent
0.014-inch guidewire delivery system
unique “stent-on-the-wire” construction
BMS System CE Marking 3/2010
Non-Sterile,
reusable, hand-held
Power Supply
Sterile,
Disposable
Adapter
Delivery
System
Stent
Lead Connection/
Wire Extension
TCT 2010

20. CARE II DESIGN Primary Endpoint: In Stent Late lumen loss @ 8 mo
2 Arm Sub-Set
1:1 randomization
Sparrow DES: Sparrow BM
4 Centers
CARE II RCT
4:4:3 (80:80:60)
Total N=220 + roll in
3 Arm Sub-Set
1:1:1 randomization
Sparrow DES: Sparrow BM:
Micro-Driver/Driver BM
14 Centers
IVUS sub-study (n = 7 centers)
Sparrow - BM
(N=60)
Micro-Driver/
Driver
Sparrow – DES
(~6ug/mm Sirolimus)
Sparrow - BM
(N=20)
Sparrow – DES
(~6 ug/mm Sirolimus)
Primary Endpoint:
In Stent Late lumen 8 mo
Sparrow DES= 80
Sparrow BM = 80
Micro-Driver/Driver = 60 20 20

21. CARE II 8 month QCA Binary Restenosis (in Lesion)
SES Sparrow Stent demonstrated superior
in-stent LLL -
CARE II Primary Endpoint met
(%)
P=0.0012 %
CMI-SES
CMI-BMS
Driver
Mean (mm)
0.29±0.45
0.86±0.54
0.94±0.39
Range (mm) p
0.0001
< n 30 31 25
P=.00006
6.7
45.2 44
CMI-SES
(n=30)
CMI-BMS
(n=31)
Driver
(n=25)
Abiziaid A.C. et al., TCT 2010

22. *BA9 application under development
Take-home message
BA9 shows sustained Safety and Efficacy – Independent from stent platform or method of drug delivery!
BioMatrixTM
BioMatrixTM Flex
BioFreedomTM
AXXESSTM Plus
Sparrow-DES
Nobori
(Terumo)
Custom NXTM (XTENT)
Stainless Steel
Balloonexpandable
Abluminal biodegradable polymer
Polymer Free
Nitinol
Self-expandable
Designed for Bifurcations
Sirolimus*/PLA
Designed for small vessels SS
BA9/PLA
Cobalt-Chrome
*BA9 application under development

23. BioMatrix Flex™ Drug Eluting Coronary Stent System is CE approved
Not available for sale in the United States and certain other countries
of Biosensors International group, Ltd. in the United States and other countries
BioMatrix Flex, Biolimus A9 and BA9 are trademarks or registered trademarks
All cited trademarks are the property of their respective owners
© 2011 Biosensors International Group, Ltd. All rights reserved