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BIOSENSORS-CLINICAL UPDATE “LEADERS AND BEYOND”. John E Shulze, CTO BIOSENSORS INTERNATIONAL GROUP Jan 29, 2010. MY CONFLICTS OF INTEREST ARE: EMPLOYEE AND SHAREHOLDER OF BIOSENSORS INTERNATIONAL. Biosensors Research:.

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slide1

BIOSENSORS-CLINICAL UPDATE“LEADERS AND BEYOND”

John E Shulze, CTO

BIOSENSORS INTERNATIONAL GROUP

Jan 29, 2010

slide2

MY CONFLICTS

OF INTEREST ARE:

EMPLOYEE AND SHAREHOLDER OF BIOSENSORS INTERNATIONAL

biosensors research
Biosensors Research:
  • There is an unmet market need for DES that have a high effectiveness for suppression on NH combined with a low incidence of late stent thrombosis upon cessation of antiplatelet therapies.
  • Development of Acute & SubAcute Thrombosis in stents is multifactorial and we should expect that higher risk patients/procedures will result in more early thrombosis and perhaps greater needs for antiplatelet therapy.
  • However, Rapid healing, leading to complete endotheliazation and return of normal endothelial function inside the stent we believe to be the most important factors in reducing risk of VLST and maybe LST.
  • Both PLA biodegradable coating technology and “polymer free” coating technologies developed by Biosensors are intended to provide faster healing of the stent, 6-9 months in the case of BioMatrix and similar to a bare stent in the case of the Biofreedom Stent.
slide4

BioMatrix™

The abluminalbiodegradablepolymer DES

PLA biodegradation and BA9™ elution

Abluminal biodegradable coating absorbed after 6-9 months*

* Data on file - molecular weight<10kDa

slide5

Stent

Biodegradable Polymer and Primer Coating

BioMatrix

BioMatrix Flex

BioMatrix II

FUTURE 1 and 2 STEALTH FIM BEACON Registry

STEALTH PK

LEADERS

Stent

Stent

Primer: Parylene

Primer: Parylene

No Primer

Matrix: Polylactic Acid

Matrix: Polylactic Acid

Matrix: Polylactic Acid

Source: S. Windecker, PCR 2008

trial design
Trial Design

Stable and ACS Patients Undergoing PCI

Assessor-blind

1:1 Randomisation

N=1700 Patients

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 month)

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

primary endpoint cardiac death mi and tvr @ 9 months 2
Primary EndpointCardiac Death, MI and TVR @ 9 Months2

15

Pnon-inferiority = 0.003

SES 10.5%

-12%

10

Cumulative Incidence (%)

MACE %

BES 9.2%

5

0

0

1

2

3

4

5

6

7

8

9

Months of Follow-up

BES reached its primary endpoint

2Windecker S. et al., The Lancet 2008; 372 No. 9644: 1163-1173

slide9
MACE

2-year HR

0.84 [0.65 to 1.08]

P = 0.18*

15.4%

Δ 2.4%

13.0%

1-year HR

0.88 [0.66 to 1.17]

P = 0.37*

20

BES

SES

15

12.1%

Δ 1.4%

%

10

10.7%

5

0

0

3

6

9

12

15

18

21

24

Months

MACE = Cardiac Death, MI, or Clinically-Indicated TVR

* P values for superiority

cardiac death or mi
Cardiac Death or MI

1-year HR

1.01 [0.70 to 1.45]

P = 0.95*

2-year HR

0.92 [0.66 to 1.27]

P = 0.59*

10

9.1%

BES

Δ0.8%

SES

8

8.3%

6.9%

Δ0%

6.9%

6

%

4

2

0

0

3

6

9

12

15

18

21

24

Months

*P values for superiority

superior strut coverage and stent apposition 3
Superior Strut Coverage and Stent Apposition3

Lesions with at least 5% uncovered struts

Lesions with at least 5% malapposed struts

p = 0.005

p = 0.04

20 x

10 x

%

%

N strut = 4592

N strut = 6476

N strut = 4592

N strut = 6476

BES with an abluminal biodegradable polymer achieved a 10 x better strut coverage and a 20 x better stent apposition vs. SES with a symmetric durable polymer at 9 months

3Di Mario C., TCT 2008

definite st through 2 years
Definite ST through 2 years

3.0

2.5

2.0

1.5

1.0

0.5

0.0

0

3

6

9

12

15

18

21

24

Zoom at 1% scale

2.5%

+0.5%

BES

SES

2.2%

2.0%

+0.2%

%

2.0%

complex patients stemi 1 2 m onth mace
Complex Patients – STEMI12 Month MACE

p=0.02

p=0.07

-57%

-77%

p= 0.22

p=0.04

MACE

%

Superior clinical outcomes for the BES vs. SES up to 12 months

Buszman, P., PCR 2009

biosensors product pipeline
BIOSENSORS PRODUCT PIPELINE

BioFreedom: complete elimination of polymer,

Use of Surface texturing, yields more rapid drug

clearance to enhance healing:

  • Changes to stent platform,

stent delivery catheter, coating methods, and connector design,

for the Biomatrix Flex design…..

BioMatrix

BioMatrix Flex

  • Enhance flexibility
  • Increase stent retention
4 month late lumen loss
4 Month Late Lumen Loss

P< 0.0001

P= 0.002

P= 0.09

Late Loss mm (median)

In-segment

P = 0.09

P = 0.77

P = 0.71

P = 0.32

P = 0.35

P = 0.89

P = 0.99

P = 0.19

P = 0.37

conclusions
Conclusions
  • The biodegradable PLA polymer with complete release of drug and polymer within 6-9 months differentiates the Biolimus eluting stents from other DES with limus drugs eluted from durable polymers
  • The abluminal surface coating manufacturing technology reduces the polymer exposure compared with symmetric coatings
conclusions1
Conclusions
  • The clinical trial program demonstrates that Biolimus A9 released from a biodegradable PLA coating is a safe antiproliferative combination for use in DES. The clinical studies in both simple and complex lesions have consistently achieved or exceeded clinical endpoints compared to BMS and other approved DES with:

-low MACE at various clinical endpoints up to and including 4 years

-low %DS & late loss

-no very late Thrombosis

  • Clinical Trial data is currently available in the Biolimus program in over 4000 patients , and during 2010, additional >5000 patients (e-BioMatrix).
  • Ongoing and planned clinical trials in an additional >5000 patients will evaluate the durability of the BioMatrix results in large populations and in a wide range of more complex patients and lesion subsets incl AMI.
slide20

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Tel. (41) 0 21 804 80 00 – Fax (41) 0 21 804 80 01

customer@biosensors.com