1. DESolve® SERIES OF CLINICAL STUDIES
Stefan Verheye, MD, PhD ZNA Middelheim
Antwerp, Belgium
On behalf of the EXCELLA investigators
DESolve is CE Mark approved; Not available for sale in the U.S.
PMN 420-A Rev A

2. Disclosure Statement of Financial Interest
Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below.
Affiliation/Financial Relationship
Company
Grant/Research Support
Consulting Fees/Honoraria
Major Stock Shareholder/Equity
Royalty Income
Ownership/Founder
Intellectual Property Rights
Other Financial Benefit
Company Names
Elixir

3. DESolve Key Features
Degrades within 6 months and fully resorbs within 2 years allowing early vascular restoration
70% mass loss (resorption) within 1 year
Overexpansion capability for optimal deployment
Unique self correction designed to reduce malapposition and prevent chronic recoil
Early lumen and scaffold enlargement at 6 months
Sustained safety and efficacy out to 4 years
Post- Procedure
6-Month Follow-up
36-Month Follow-up
DESolve is CE Mark approved; Not available for sale in the U.S.

4. DESolve Nx Clinical Study
Single Arm Registry
126 patients
13 sites
Europe, Brazil, New Zealand
Coordinating Investigators:
A. Abizaid, Sao Paulo, Brazil; S. Verheye, Antwerpen, Belgium
Inclusion Criteria
Treatment of a single de novo coronary artery lesion
Reference vessel diameter: mm
Lesion length: <12mm, DAPT 12 months
MACE
30d
6mo
1yr
18m
2yr
3yr
4yr
5yr
Imaging QCA, IVUS, OCT, MSCT (subset)
STUDY PURPOSE:
To assess performance of DESolve Scaffold System through clinical and imaging endpoints
PRIMARY IMAGING ENDPOINT: 6-month in-scaffold late lumen loss
PRIMARY CLINICAL ENDPOINT: Major Adverse Cardiac Events (MACE), a composite of Cardiac Death, Target Vessel MI and Clinically Indicated TLR at 6 months
SECONDARY ENDPOINTS:
MACE: At 30 days, 1, 2, 3, 4 and 5 years; scaffold thrombosis
QCA: In-segment late lumen loss, binary restenosis, and percent diameter stenosis
IVUS: In-scaffold percent volume obstruction, malapposition
OCT: In-scaffold percent obstruction, strut coverage
MSCT: Percent diameter stenosis, lumen area
DESolve is CE Mark approved; Not available for sale in the U.S.

5. DESolve Nx Clinical Trial
6 to 48 Month Clinical Outcomes
Hierarchical Events
0 to 1440 days, n (%) 6M
(N=122)*
12M
(N=122)
24M
36M
48M
Major Adverse Cardiac Events
3.3%
5.7%
7.4%
8.2%
9.0%
Cardiac Death**
1 (0.8%)
2 (1.6%)
3 (2.5%)
4 (3.3%)
Target Vessel MI***
Q-wave MI
Non-Q- wave MI
Clinically Indicated-TLR
5 (4.1%)
Definite Scaffold Thrombosis
*Modified Intent to Treat = those patients in which a scaffold was implanted in target lesion.
**One death with probable ST based on ARC, scaffold undersized as assessed by IVUS; one death with suspected pulmonary embolus with right heart failure, non-scaffold related; one death due to non-target vessel occlusion and PCI, non-scaffold related; one death due to sudden death at home.
***MI during follow up attributed to multi modality imaging procedure ; MI due to proximal segment stenosis
+ ARC-defined
DESolve is CE Mark approved; Not available for sale in the U.S.

6. DESolve Nx Clinical Trial
Primary Imaging Endpoint QCA Results
Paired Analysis
Dante
ZNA
In-Scaffold Analysis
Post Procedure
NL= 122*
6 Months
NL= 113
18 Months
N = 19
36 Months
RVD (mm)
3.05 ± 0.25
2.96 ± 0.28
3.01 ± 0.29
2.95 ± 0.33
MLD (mm)
2.64 ± 0.28
2.44 ± 0.43
2.39 ± 0.43
2.45 ± 0.45
LLL (mm) -
0.20 ± 0.32
0.29 ± 0.34
0.22 ± 0.33
Median Late Loss (mm)
0.11
[0.03 , 0.19]
0.20
[0.09, 0.36]
0.16
[0.04, 0.31]
Diameter Stenosis (%)
13.2 ± 7.5
17.8 ± 13.2
20.8 ± 11.1
16.4 ± 13.5
Paired LLL at 6 and 18m, p=ns; LLL at 6 and 36m, p=ns.
Slide combines all QCA time points
DESolve is CE Mark approved; Not available for sale in the U.S.

7. DESolve Nx Clinical Trial
IVUS Results
In-Scaffold Analysis
Baseline
N = 40
6 months
Dante
18 months
N = 18
ZNA
36 months
N = 15
Mean Lumen Area (mm2)
5.93 ± 1.17
6.51 ± 1.43
6.60 ± 1.54
6.68 ± 1.82
Min Lumen Area (mm2)
4.84 ± 1.09
4.77 ± 1.11
4.44 ± 1.23
4.47 ± 1.27
Mean Vessel Area (mm2)
12.96 ± 3.48
13.74 ± 3.37
15.28 ± 3.95
15.04 ± 4.70
Mean Scaffold Area (mm2)
5.94 ± 1.18
6.87 ± 1.55 NA
Values are mean ± SD
Dante Pazzanese, Sao Paulo, Brazil – single center follow-up 18m ZNA Antwerpen, Belgium – single center follow-up 36m
NA = No visible struts for analysis at 18m and 36m time points
DESolve is CE Mark approved; Not available for sale in the U.S.

8. DESolve Nx Clinical Trial
OCT Results
In-Scaffold Analysis
Baseline
N = 38
6 months
Dante
18 months
N = 20
ZNA
36 months
N = 19
Mean NIH Obstruction (%)
N/A
11.21 ± 4.19
22.05 ± 5.94 NA
Covered struts per
patient (%)
98.79 ± 1.69
99.98 ± 0.11
NIH thickness- covered struts (µm)
0.1 ± 0.03
0.2 ± 0.05
Values are mean ± SD
Dante Pazzanese, Sao Paulo, Brazil – single center follow-up 18m ZNA Antwerpen, Belgium – single center follow-up 36m
NA = No visible struts for analysis
PMN 395 Rev A
DESolve is CE Mark approved; Not available for sale in the U.S.

9. DESolve Nx Case Study: 28-07
PRE
POST
6m FU
LLL: 0.01 mm
36m FU
LLL: mm
Courtesy of S. Verheye, ZNA Middelheim, Belgium
PMN 332 Rev A
DESolve is CE Mark approved; Not available for sale in the U.S.

10. DESolve Nx Case Study: 28-07
Post-Procedure
6-Month FU
36-Month FU
0.4 mm
4.8 mm
7.9 mm
10.2 mm
12.1 mm
LA: 7.04 mm2
SA: 7.08 mm2
LA: 7.99 mm2
SA: 7.99 mm2
LA: 6.85 mm2
SA: 6.76 mm2
LA: 6.66 mm2
SA: 6.60 mm2
LA: 8.05 mm2
SA: 8.11 mm2
LA: 6.61 mm2
SA: 7.87 mm2
LA: mm2
SA: mm2
LA: 7.87 mm2
SA: 9.99 mm2
LA: 6.70 mm2
SA: 8.82 mm2
LA: 6.53 mm2
SA: 8.97 mm2
LA: 9.68 mm2
LA: mm2
LA: 9.81 mm2
LA: 7.70 mm2
LA: mm2
OCT serial evaluation show lumen growth overtime with no visible struts at 36months
Courtesy of S. Verheye, ZNA Middelheim, Belgium
Lumen gain overtime – no scaffold at 36m
DESolve is CE Mark approved; Not available for sale in the U.S.

11. DESolve Nx Clinical Trial: Conclusions
4-year data demonstrates sustained safety and
efficacy, well beyond full resorption of the scaffold
Safety
Low 48-month overall MACE (9.0%)
No late or very late scaffold thrombosis (definite or probable)
Efficacy
Low late lumen loss at 6m maintained through 18 and 36m
Sustained neointimal suppression at 18 and 36m
(IVUS and OCT)
Early lumen gain at 6m sustained through 36m (IVUS)
DESolve is CE Mark approved; Not available for sale in the U.S.

12. DESolve Cx Clinical Study
Single Arm Registry
~15 to 20 sites
Europe and Brazil
50-pt imaging study
100-pt post market study
Coordinating Investigators:
A. Abizaid, Sao Paulo, Brazil; S. Verheye, Antwerpen, Belgium
Inclusion Criteria
Treatment of a single de novo coronary artery lesion
Reference vessel diameter: mm
Lesion length: <12mm, DAPT 12 months
Clinical: MACE
30d
6mo
1yr
2yr
Imaging: QCA, IVUS, OCT
STUDY PURPOSE:
To assess performance of DESolve CX Scaffold System through clinical and imaging endpoints
PRIMARY IMAGING ENDPOINT: 6-month in-scaffold late lumen loss
PRIMARY CLINICAL ENDPOINT: Major Adverse Cardiac Events (MACE), a composite of Cardiac Death, Target Vessel MI and Clinically Indicated TLR at 6 months
SECONDARY ENDPOINTS:
MACE: At 30 days, 1 and 2 years; scaffold thrombosis
QCA: In-segment late lumen loss, binary restenosis, and percent diameter stenosis
IVUS: In-scaffold percent volume obstruction, malapposition
OCT: In-scaffold percent obstruction, strut coverage
DESolve CX is not available for sale.

13. DESolve Cx Clinical Trial
Baseline Patient Demographics
Patient Characteristics
DESolve Cx
(N = 50)
Age, years (± SD)
60.0±10.3
Male
68.0%
Diabetes mellitus
20.0%
Current Smoker
26.0%
Hypercholesterolemia
84.0%
Hypertension
70.0%
Previous myocardial infarction
40.0%
Previous CABG
0.0%
Previous PCI
Unstable angina
6.0%
DESolve CX is not available for sale.

14. DESolve Cx Clinical Trial Lesion Characteristics
Baseline Characteristics
Lesion Characteristics
DESolve Cx
(N = 25)
DESolve Nx
(N = 126)
Target Vessel % (LAD/LCX/RCA)
36/32/32
38/31/31
Lesion Length, mm (± SD)
17.74 ± 7.59
11.2 ± 3.8
Reference Vessel, mm (± SD)
3.05 ± 0.39
3.00 ± 0.30
AHA/ACC Lesion class C
43.5%
2.9%
Ostial Lesion 4%
3.2%
Moderate to Heavy Calcification
28%
18.3%
Moderate to Severe Tortuosity 0%
1.6%
Pre-dilatation
96%
100%
Post dilatation
84%
57.9%
DESolve CX is not available for sale.

15. DESolve Cx Clinical Trial
6 Month Clinical Outcomes
Hierarchical Events
0 to 180 days
30 days
(N=50)
6 months
(N=25)
Major Adverse Cardiac Events
Cardiac Death
Target Vessel MI
Q-wave MI
Non-Q- wave MI
Clinically Indicated-TLR
Definite/probable Scaffold Thrombosis
1 patient with non-ischemic driven TLR
DESolve CX is not available for sale.

16. DESolev Cx Clinical Trial
Preliminary Imaging Endpoint QCA Results
In-Scaffold Analysis
DESolve Cx
Post
N = 25
DESolve Nx Post
N = 126
6 months
DESolve Nx
N = 113
RVD (mm)
3.08 ± 0.43
3.05 ± 0.25
3.03 ± 0.42
2.96 ± 0.28
MLD (mm)
2.76 ± 0.36
2.64 ± 0.28
2.58 ± 0.45
2.44 ± 0.43
Mean Late Loss (mm) -
0.18 ± 0.29
0.20 ± 0.32
Median Late Loss (mm)
0.09 [0.02,0.26]
0.11 [0.03,0.19]
Diameter Stenosis (%)
10.1 ± 6.7
13.2 ± 7.5
14.7 ± 11.0
17.8 ± 3.2
Values are mean ± SD; % (n), or Median (interquartile range 25%, 75%).
MLD – Minimum luminal diameter; LLL – late lumen loss.
*Modified Intent to Treat = those patients in which a scaffold was implanted in target lesion.
DESolve CX is not available for sale.

17. DESolve Cx Case Example – Matched OCT Cross-Sections
Post-Procedure – Mean scaffold area: 7.76 mm2; MSA: 6.17 mm2
6 Months – Mean scaffold area: 8.13 mm2; MSA: 6.87 mm2; 98.93% strut coverage; mean NIH thickness: 50 μm
0.9 mm
6.7 mm
11.4 mm
16.8 mm
17.5 mm
DESolve CX is not available for sale.

18. DESolve Cx: Vasomotion at 6m follow up
Pre-Nitrate
Preliminary evaluation of vasomotion in scaffold pre and post nitroglycerin infusion of DESolve Cx during the 6m angiographic follow-up
Increase in scaffold vessel max diameter from 3.19mm to 3.56 mm observed for an max increase of 0.37 mm and mean increase of 0.16 mm
Post-Nitrate
Courtesy of S. Verheye, ZNA Middelheim, Belgium
(non-core lab, off-line QCA analysis)
DESolve CX is not available for sale.

19. DESolve Cx Clinical Trial
Conclusions
Interim analysis (25 pts) shows promising results
Safety
No major adverse cardiac events reported to date
No stent thrombosis
Efficacy
Late lumen loss of 0.18mm is similar to the DESolve Nx trial results of 0.20mm
6-month follow-ups complete in Q1 2017
DESolve CX is not available for sale.

20. DESolve Post-Market Clinical Follow-up (PMCF)
Study purpose
A post-market observational study to evaluate long-term safety and performance of the CE Mark approved DESolve Scaffold
N = 102
Key Inclusion:
Up to 2 de novo native coronary artery lesions
Reference vessel diameters of mm
Lesion length ≤ 24 mm
Vessel or lesion characteristics:
Major artery or branch
Stenosis ≥ 50% and < 100 %
Excludes excessive tortuosity, angulation, and moderate or heavy calcification
DAPT recommended for 12 months
Key Endpoints:
Clinically-indicated major adverse cardiac events (cardiac death, target vessel MI, and clinically indicated TLR) 1, 6 months and 1, 2, 3, 4, 5 years
Acute success
Stent Thrombosis
H. Nef PhD, MD “DESolve platform(s) real world experience”, TCT 2016
DESolve is CE Mark approved; Not available for sale in the U.S.

21. DESolve PMCF Clinical Results
Hierarchical Events
0 to 180 days, n (%)
30 D
N=100
6 M
12 M
MACE
1 (1.0%)
2 (2.0%)
4 (4.0%)
Cardiac Death
0 (0.0%)
TV-MI*
CI-TLR
3 (3.0%)
Definite/Probable ST*
TV-MI – target vessel myocardial infarction
CI-TLR – clinically-indicated target lesion revascularization
*Incomplete coverage of a proximal lesion resulting in acute closure, MI and TLR
DESolve is CE Mark approved; Not available for sale in the U.S.

22. DESolve PMCF Trial Conclusions
Results from the DESolve PMCF demonstrate the continued safety and performance of the DESolve Novolimus Eluting Bioresorbable Coronary Scaffold System through 6 months
Patient demographics and lesion/vessel distribution was similar to the DESolve Nx pivotal trial
Low composite endpoint of cardiac death, TV-MI and CI-TLR at 12 months (4.0%)
Clinical results are in-line with the DESolve Nx pivotal study and similar to DES platforms
DESolve is CE Mark approved; Not available for sale in the U.S.

23. DESappear SFA Study (Akesys PRAVA)
Prospective, Single-Arm Safety and Performance Study
~60 patients
~12 International Sites
Europe & New Zealand
Coordinating Investigators: Dr. Marc Bosiers, Belgium; Prof. Dierk Scheinert, Germany
Key Inclusion Criteria:
Symptomatic claudication (Rutherford 2-4)
Vessel diam ≥ 5.0 mm to ≤ 6.0mm, lesion ≤ 53 mm in length
Target lesion is ≥ 50% DS
Clinical and DUS follow-up 3d 6m
1yr
2yr
3yr
Imaging QCA, OCT
PRIMARY SAFETY ENDPOINT:
Composite of freedom from perioperative death through 30-day & freedom from major adverse limb events defined as the occurrence of major amputation, thrombectomy or thrombolysis, or major open surgical revascularization through 6 month follow up
PRIMARY EFFECTIVENESS ENDPOINT:
Primary patency defined as freedom from restenosis (>50% diameter reduction defined by Duplex Ultrasound) or clinically driven target lesion revascularization through 6 months
PRAVA is not available for sale and developed by Akesys Medical

24. AKESYS PRAVA DEVICE DESCRIPTION
PLLA-based polymer scaffold
Elution rate: approximately 30% of the drug is eluted over 4 weeks and 90% at 6 months
Degrades within 6 months and fully resorbs within 2 years allowing early vascular restoration
PRAVA is not available for sale and developed by Akesys Medical

25. First PRAVA Implant 67 yr old male Rutherford 4 - severe claudication
CAD, Type 2 diabetes, hypertension, hyperlipidemia, former smoker, chronic kidney disease
Pre-dilatation 6.0x40 at 6 atm with <20% residual stenosis
6.0x57mm Prava Scaffold- inflated to 13 atm
6.0x40mm post-dilatation at 14 atm and final 7% DS
Pre-procedure
Final
Courtesy of Dr. Holden, Auckland City Hospital, NZ
PRAVA is not available for sale and developed by Akesys Medical

26. Akesys Prava Summary
Elixir is expanding BRS technology into clinical indications with significant unmet clinical needs
First implant of PRAVA (SFA) performed on 11 October 2016
Below-The-Knee Clinical study enrollment to begin H2 2017
PRAVA is not available for sale and developed by Akesys Medical

27. Summary Elixir has the broadest portfolio of bioresorbable scaffolds
DESolve
Sustained safety and efficacy out to 4 years
Degrades within 6 months and fully resorbs within 2 years allowing early vascular restoration
70% mass loss (resorption) within 1 year
US and Japan randomized trials to follow
DESolve Cx
Interim angiographic data with the 120µm scaffold looks very promising
6-month follow-up completed in Q1 2017
Commercial launch Q1 2017
DESolve NXT Plus
Clinical study enrollment to begin Q2 2017
Elixir is expanding BRS technology into clinical indications with significant unmet clinical needs
DESappear SFA study is ongoing
DESolve is CE Mark approved; Not available for sale in the U.S.
DESolve Cx and DESolve NXT are not available for sale.
PRAVA is not available for sale and developed by Akesys Medical