1. EXCELLA BD Randomized Trial 12-month Results
Ricardo Costa, MD
On behalf of the EXCELLA BD Investigators
•••••••• Elixir Medical Confidential 1

2. Elixir Medical DESyne BDTM Novolimus Eluting Coronary Stent System
Platform features
Cobalt chromium alloy stent
81 µm thickness
Thin polymer matrix
No primer coating
< 3µm coating thickness
Novolimus drug dose of 5 mcg per mm stent length
Active metabolite of Sirolimus
DESyne BDTM
Biodegradable polymer degrades in 6-9 months, drug release over 4 weeks
Workhorse DES that leaves behind bare metal surface

3. EXCELLA BD Randomized Clinical Trial
RANDOMIZED (3:1), SINGLE BLIND, MULTI-CENTER CLINICAL TRIAL
Co-Principal Investigators:
A. Abizaid and S.Verheye
Angiographic Core Lab: CRC
IVUS Core Lab: Stanford University
CEC/DSMB: CRC
Data Management: CRC
Single/Multiple De Novo Native Coronary Artery Lesions (A-B2)
Vessel Diameters: mm
Stent Diameters: mm
Lesion Length: ≤24 mm
Stent Lengths: mm
Pre-Dilatation required/ Post-Dilatation at physicians discretion
Cobalt Alloy Stent + Bioabsorbable Polymer + 5µg per mm Stent Length
ENDEAVOR DES Control
n= 31
Geography: Belgium, Germany and Brazil
DESyne BD DES
n= 115
Clinical Follow-up
Angiographic/IVUS (Subset) Follow-up
30d mo mo mo yrs
Primary Endpoint: In-Stent Late Lumen Loss at 6 months (QCA)
Device and Procedure (Clinical) Success
Device-oriented composite endpoint (Death, MI, or TLR)
Key Secondary Endpoints: at 1, 6, 9, 12mo and 2-5 yrs
Clinically driven TLR, TVR and TVF at 1, 6, 9, 12mo and 2-5 yrs
Stent thrombosis rates at 1, 6, 9, 12mo and 2-5yrs
ABR, LLL and % volume obstruction at 6 months
Anti-Platelet Therapy for 12 months
Clinical Follow-up
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4. EXCELLA BD Study Organization
Principal Investigators
Alexandre Abizaid
Stefan Verheye
Steering Committee:
Peter Fitzgerald
DSMB
Otavio Berwanger
Adriana Moreira
Ricardo Pavenello
Clinical Event Committee
Aurea Chaves
Dimytri Siqueira
Sergio Braga
Angiographic Core Lab
Cardiovascular Research Center, Sao Paulo, Brazil
IVUS Core Lab
Stanford University – Peter Fitzgerald
Date Coordination Center

5. EXCELLA BD Investigators
J. SCHOFER
HAMBURG - GERMANY 42
ABIZAID
SAO PAULO, BRAZIL 28
R. BOTELHO
UBERLANDIA, BRAZIL 24
S. VERHEYE
ANTWERPEN - BELGIUM 23
K.E. HAUPTMANN
TRIER - GERMANY 13
M. PERIN 6
H. CASTELLO
M. WIEMER
BAD OEYNHAUSEN - GERMANY 5
C. DUBOIS
LEUVEN - BELGIUM 3
M. WAINSTEIN
PORTO ALEGRE, BRAZIL 1

6. Patient Flow and Follow-up
151 patients (NL=168)
enrolled and randomized
1 Deregistered
3 Withdrew consent
3 no study stent
1 Deregistered
Novolimus-eluting stent
N=115 pts (NL=127)
Zotarolimus-eluting stent
N=31 pts (NL=38)
6-day clinical FUP
N=115 pts
9-month clinical FUP
N=31 pts
Clinical FUP 100%
6-month clinical FUP
N=113 pts
6-month clinical FUP
N=31 pts
Clinical FUP 98.6%
6-month angio FUP
N=107 pts
(NL= 119) (NIVUS = 35)
6-month angio FUP
N=31 pts
(NL= 38) (NIVUS = 16)
Angio FUP 94.5%
Intention to treat analysis
Pts, patients; NL number of lesions; NIVUS number of IVUS

7. Baseline Patient Characteristics
DESyne BD
(N=115 patients)
ZES
(N=31 patients)
Age, years (± SD)
65.0±9.3
60.4±10*
Male
63.5%
77.4%
Diabetes mellitus
28.7%
25.8%
Current Smoker
18.3%
29.0%
Hypercholesterolemia
72.2%
80.7%
Hypertension
80.9%
Previous myocardial infarction
25.2%
32.3%
Previous CABG
5.2%
0.0%
Previous PCI
20.0%
Unstable angina
10.4%
9.7%
*p=0.028; all others p=ns

8. Baseline Lesion Characteristics
DESyne BD
(N=127 lesions)
ZES
(N=38 lesions)
Target Vessel
Left anterior descending
43.3%
39.5%
Left Circumflex
27.6%
21.1%
Right coronary artery
29.1%
AHA/ACC Lesion class C
16.5%
Lesion Length, mm (± SD)
14.59±5.53
15.30±5.29
Reference Vessel, mm (± SD)
2.94±0.38
3.01±0.46
Ostial Lesion
3.1%
2.6%
Moderate to Heavy Calcification
34.6%
36.8%
Thrombus
0.8% 0%
Bifurcation
7.9%
5.5%
p=ns for all characteristics

9. Angiographic Results 6 months
In-Stent Analysis
Novolimus
Zotarolimus
P value
RVD. mm
N(L)=119
N(L)= 38
Post-procedure
3.00±0.37
3.08±0.35
0.31
At 6-months
2.95±0.37
2.99±0.38
0.67
MLD / Late Lumen loss (LLL), (mm)
Acute gain
1.87±0.42
2.01±0.43
0.09
MLD post-procedure
2.76±0.37
2.90±0.34
0.04
MLD at 6-months
2.64±0.39
2.22±0.53
<0.001
LLL at 6-months (in-stent)
0.12±0.15
0.67±0.47
< 0.001
Diameter Stenosis (%)
8.5±44
6.2±4.5
0.002
11.0±6.6
25.6±15.1
Binary Restenosis (%) (in-stent)
0.0%
7.9%
0.003

10. Zone of non-inferiority Pre-specified margin=0.20mm
Primary Endpoint Analysis: 6-month In-Stent Late Lumen Loss
Novolimus
0.12
Zotarolimus
0.67
DELTA*
(Upper 1-sided 95% CI)
-0.55 (-0.44)
Non-inferiority
P value
<0.001
Superiority
*Least square means
Zone of non-inferiority
Pre-specified margin=0.20mm
Zone of Superiority
Zone of non-inferiority
Zone of inferiority
Superior
-0.60
-0.50
-0.40
-0.30
-0.20
-0.10
0.00
0.10
0.20
0.30
0.40
Upper one-sided 95% CI
Met Primary Non-Inferiority Endpoint and Superiority Endpoint

11. Clinical Results –12 months
0 to 360 days, % (n)
DESyne (N=112)
Endeavor
(N= 31)
P-Value
HIERARCHICAL EVENTS
DEVICE ORIENTATED COMPOSITE
2.7%
3.2%
1.00
CARDIAC DEATH
0.0% --
TARGET VESSEL MI
0.9%
CLINICALLY-INDICATED TLR
1.8%
0.52
Definite/Probable Stent Thrombosis
Modified Intention to Treat (patients who received a study stent)

12. Cardiac Events at 12 months
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13. Conclusions
The EXCELLA BD trial demonstrated both non-inferiority and superiority of the Elixir DESynetm BD Novolimus eluting stent compared to control for the primary endpoint of in-stent late lumen loss at 6 months
Angiographic binary restenosis for the DESyne BD stent was significantly less compared to control (0.0% vs. 7.9%, p=0.003)
The composite endpoint of cardiac death, TV-MI and CI-TLR remains low and unchanged from 6 months for both groups demonstrating clinical safety of the Elixir DESyne BD stent
There was no reported stent thrombosis through 12 months