2
0.17 1.19 pre-clinical science 37.44 3.17 In-Vivo Vascular Response Study Renu Virmani, M.D., CV Pathology Institute, MD, U.S.A. Acute Swine Shunt Model Study Renu Virmani, M.D., CV Pathology Institute, MD, U.S.A. Objective and purpose: In-Vivo chronic evaluation of vascular response after stenting using Cobra PzF Coronary Stent System (CeloNova ® BioSciences, Inc.) in the Porcine Model (5, 28, and 90 day evaluation) Design: Pre-clinical Porcine Study (N=66) Endpoints: Histologic Inflammation Score, Morphologic Neointimal Area, Thrombus formation at 5 days, 28 days, and 90 days Objective and purpose: Evaluation of Cobra PzF Stents in an acute shunt model. Assess the thrombo- resistance of Cobra PzF compared to leading CoCr BMS Design: Acute Swine Shunt Model (N=12) Endpoints: Platelet coverage intensity and platelet positive area 40 30 20 10 0 4 3 2 1 0 4 3 2 1 0 4 3 2 1 0 Struts with Granulomas Neointimal Area (mm 2 ) Inflammation Score Neointimal Area (mm 2 ) 2.28 2.24 0.00 1.49 p=0.0467 p=0.0216 p=0.1290 p=0.0017 -100% -53% -93% -47% 28 DAYS 28 DAYS 28 DAYS 90 DAYS Neointimal Area (mm 2 ) Inflammation Cobra PzF demonstrates lower neointimal response at 28 and 90-days Cobra PzF demonstrates reduced platelet adhesion and thrombus formation COBRA PzF Leading CoCr BMS Z-stack image of the entire luminal surface in tile mode of CD61_CD42b platelet mark- ers labeled with an Alexa Fluor ® 488 dye [x5magnification, green channel] Z-stack image of the entire luminal surface in tile mode of CD61_CD42b platelet mark- ers labeled with an Alexa Fluor ® 488 dye [x5magnification, green channel] Scanning Electron Micrograph of stent struts x200 Scanning Electron Micrograph of stent struts x200 Euro PCR 2013 Highlights Cobra PzF Leading CoCr BMS LEGEND:

pre-clinical science · 2013. 7. 15. · 0.17 1.19 pre-clinical science 37.44 3.17 In-Vivo Vascular Response Study Renu Virmani, M.D., CV Pathology Institute, MD, U.S.A. Acute Swine

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Page 1: pre-clinical science · 2013. 7. 15. · 0.17 1.19 pre-clinical science 37.44 3.17 In-Vivo Vascular Response Study Renu Virmani, M.D., CV Pathology Institute, MD, U.S.A. Acute Swine

0.17

1.19

pre-clinical science

37.44

3.17

In-Vivo Vascular Response Study Renu Virmani, M.D., CV Pathology Institute, MD, U.S.A.

Acute Swine Shunt Model Study Renu Virmani, M.D., CV Pathology Institute, MD, U.S.A.

Objective and purpose: In-Vivo chronic evaluation of vascular response after stenting using Cobra PzFCoronary Stent System (CeloNova® BioSciences, Inc.) in the Porcine Model (5, 28, and 90 day evaluation)Design: Pre-clinical Porcine Study (N=66)Endpoints: Histologic Inflammation Score, Morphologic Neointimal Area, Thrombus formation at 5 days,28 days, and 90 days

Objective and purpose: Evaluation of Cobra PzF Stents in an acute shunt model. Assess the thrombo-resistance of Cobra PzF compared to leading CoCr BMS Design: Acute Swine Shunt Model (N=12) Endpoints: Platelet coverage intensity and platelet positive area

40

30

20

10

0

4

3

2

1

0

4

3

2

1

0

4

3

2

1

0

Struts with Granulomas

Neointimal Area (mm2)

Inflammation Score

Neointimal Area (mm2)

2.28

2.24

0.00

1.49

p=0.0467

p=0.0216

p=0.1290

p=0.0017

-100%

-53%

-93%

-47%

28 DAYS

28 DAYS 28 DAYS

90 DAYS

Neo

intim

al A

rea

(mm

2 )Inflammation

Cobra PzF™ demonstrates lower neointimal response at 28 and 90-days

Cobra PzF™ demonstrates reduced platelet adhesion and thrombus formation

COBRA PzF™ Leading CoCr BMS

Z-stack image of the entire luminal surface in tile mode of CD61_CD42b platelet mark-ers labeled with an Alexa Fluor® 488 dye [x5magnification, green channel]

Z-stack image of the entire luminal surface in tile mode of CD61_CD42b platelet mark-ers labeled with an Alexa Fluor® 488 dye [x5magnification, green channel]

Scanning Electron Micrograph of stent struts x200

Scanning Electron Micrograph of stent struts x200

Euro PCR2013 Highlights

Cobra PzF™Leading CoCr BMSLEGEND:

Page 2: pre-clinical science · 2013. 7. 15. · 0.17 1.19 pre-clinical science 37.44 3.17 In-Vivo Vascular Response Study Renu Virmani, M.D., CV Pathology Institute, MD, U.S.A. Acute Swine

clinical outcomes

CeloNova BioSciences, Inc.18615 Tuscany Stone, Ste 100San Antonio, TX 78258+1.210.497.6682celonova.com

CeloNova BioSciences Germany GmbHUlm, Germany

CeloNova®, COBRA PzF™, PzF™, CATANIA™, and Polyzene® are trademarks of CeloNova BioScience, Inc. Alexa Fluor® is a trademark of Molecular Probes, Inc. ©2013 CeloNova® BioSciences, Inc.

For more information about COBRA PzFor CeloNova® BioSciences, please emailus at [email protected].

ATLANTA-FME (France & Middle East)Interim Analysis of the French experience (n=379) 12-month follow-up• A retrospective, multicenter review of a prospective database with the CATANIA™ stent in France and the Middle East• Current interim analysis concentrated on French patients with completed 12-month follow-up• All patients underwent PCI with CATANIA stent• There was no exclusion criteria

8%

6%

4%

2%

0

12%

10%

8%

6%

4%

2%

0

MACE TLR MI Cardiac Death SAT Late ST

7.0%

3.9%

0.8%2.2%

0.26% 0.0%

n=3793.9% TLR; No (0) LST

12-month Clinical Outcomes Compared with Published Data

TLR3%

2%

1%

0

Late Stent Thrombosis

PzF ModifiedStent

LeadingCoCr BMS

DESDESLeadingCoCr BMS

PzF ModifiedStent

APM0084 Rev A