This document summarizes postmarketing studies comparing the Russian-made Calypso drug-eluting stent to analogous foreign stents. It describes two ongoing comparative registry studies - E-Calypso and Patriot - that are evaluating the safety and efficacy of the Calypso stent versus competitors like the Resolute Integrity and Xience Prime stents. The document outlines the study designs, endpoints, inclusion/exclusion criteria and administrative details of the comparative studies which are taking place in Russia through 2016. It also provides technical specifications and performance data indicating the Calypso stent is competitive with leading foreign stents while offering significant cost savings.

1. Comparative postmarketing
studies (Phase IV)
of Russian drug-eluting
Coronary Stent CALYPSO
versus analogues.
7 Nov 2015
Vietnam National Heart Association National Scientific Meeting in Ninh Bình city, Vietnam.

2. 2007
2009
15 types of products
for interventional cardiology
2012
ISO 9001:2008,
ISO 13485:2012
$ 5 mil.
35 k local stents implantations
are performed
60 clinics in 37 Russian regions
2400 implantations
98,7%
Occluder, cavafilter
Collaborative work of the company with
the scientific community
Russian developer and producer
of coronary stents
the foundation of the company in the Technopark of Novosibirsk Academgorodok. The company’s manufacturing
site has the same location.
Bare metal stents “Sinus” and balloon catheters “Colubris” were registered by the Federal Service on Surveillance
in Healthcare and Social Development of Russian Federation
are being manufactured since 2011
the beginning of the production of the sirolimus-eluting coronary stent “Calipso”
international certificates are received in 2013
annual insurance coverage
according to the data prior June 2015
use company’s medical products according to the data as of June 2015
have been included into the register maintained by independent experts of The Moscow Department of Health
N.V. Sklifosovsky Federal Research Institute of Emergency Medicine as a part of the study conducted in nine
Russian clinics (Moscow, Novosibirsk, Barnaul, Tomsk, Krasnoyarsk, Vladivostok and Yaroslavl).
of endovascular procedures included into the register were successful.
new developments at the stage of certification.
the foundation for the development of the innovative and affordable treatments

3. Calypso
next-generation coronary stents

4. Calypso
next-generation coronary stents

5. Technical specifications
Stent material
Stent coating material
Design
Foreshortening
Guiding catheter compatibilit
Nominal Pressure (NP)
Rated Burst Pressure (RBP)
Lesion Entry Profile
The material distal shaft
The material proximal shaft
Guide wire diameter
The period of sterility from
the date of manufacture
Catheter type
Cobalt Chromium L605
PGA-PLA
Matrix
0%
4Fr (1,32 мм)
9 атм
18 атм
0,0165’’ (0,419 мм)
Nylon with hydrophilic coating
Hypotube stainless steel with
PTFE coating
0,014’’
2 years
Rapid Exchange

6. Russian developer and producer
of coronary stents

7. Innovation platform CALIPSO
has the best Recoil rates

8. Innovation platform CALIPSO
is not inferior to the best foreign
counterparts in radial stiffness

9. Innovation platform CALIPSO
has the best bending stiffness rates

10. Innovation platform CALIPSO
provides optimal balance between radial
and bending stiffness rates.
Bending stiffness rate
Radialstiffnessat80%ofnominaldiameter

11. Innovation platform CALIPSO
has the same drug excretion profiles as
the best foreign counterparts

12. Innovation platform CALIPSO
has the same drug excretion profiles as
the best foreign counterparts

13. Innovation platform CALIPSO
has the drag from the same Limus -
group as the best foreign counterparts
Sirolimus Everolimus (Abbott) Zotarolimus (Medtronic)

14. Innovation platform CALIPSO
trial results
According to the trial results* the stent`s key
characteristics such as conduction, radial
stability, fatigue resistance and recoil are highly
competitive with the features of the best world
analogues. The stent has one of the best value
of the adaptiveness to vessels.
* trials were performed using the stand model. Parameters can be provided upon request.
Error estimate is 4%.

15. Register stent by Angioline
N = 2411
• in the hospitals in 7 regions and 9 clinics in Russia (2012-2013)
• 68% - acute coronary syndrome (ACS)
• Success rate 98.7%
Coordinating Chief Researcher Prof. Kokov L., Lopotovsky P. PhD, Porhomenko M.
N.V.Sklifosovsky Research Institute of Emergency Medicine
2380 (98,7%)
9 (0,37%)
12 (0,5%)
10 (0,41%)

16. E-CALIPSO POSTMARKETING COMPARATIVE REGISTRY STUDY OF THE FIRST RUSSIAN
BIORESORBABLE DRUG ELUTING CORONARY STENT “CALIPSO” (ANGIOLINE
INTERVENTIONAL DEVICE) VERSUS RESOLUTE INTEGRITY CORONARY STENT
(MEDTRONIC INC.)
Scientific coordinator Alexey Sozykin, MD, PhD
Start February 2015 Finish July 2016
Medical Centers 1. Moscow
2. Moscow
E-CALIPSO

17. Schematic diagram of study design
E-CALIPSO POSTMARKETING COMPARATIVE REGISTRY STUDY OF THE FIRST RUSSIAN BIORESORBABLE
DRUG ELUTING CORONARY STENT “CALIPSO” (ANGIOLINE INTERVENTIONAL DEVICE) VERSUS RESOLUTE
INTEGRITY CORONARY STENT (MEDTRONIC INC.)
RANDOMIZATION
1:1
Calipso group (CALIPSO stent)
Resolute Integrity group (Resolute Integrity stent)
Enrollment period Admission period
Т2 Т3
- Assessment of clinical and laboratory parameters
- stent implantation, assessment of clinical and laboratory parameters
Т0 Т4
6-9 months follow-up visit
PCI PROCEDURE
Т1
30 days follow-up visit

18. PATRIOT
A Single-blind, Prospective, rAndomized, MulTicenter Study evaluating Efficacy and
Safety of SirRolimus-DelIvering CALYPSO CorOnary StenT Versus Everolimus-
Delivering Xience Prime (Abbott Vascular) coronary stent
Start March 2015 Finish December 2016
Comparison of efficacy and safety of Calypso Angioline
stents versus Xience Prime Abbott Vascular stents
Objective of the study
1. Moscow
2. Moscow
3. Orenburg
4. Vladivostok
5. Krasnoyarsk
6. Kemerovo
Medical Centers
Study tasks To demonstrate non-inferiority of Calipso stents to Xience Prime in
terms of clinical efficacy

19. Administration of study
Coordinating
Chief Researcher
Monitoring data
Angiography laboratory
Ethical support
The independent clinical
events committee
Eugene Kretov
Ye. N. Meshalkin Novosibirsk
Research Institute of Circulation Pathology
Research organization
«AmeRuss Clinical Trials»
Vitaly Baystrukov
Ye. N. Meshalkin Novosibirsk
Research Institute of Circulation Pathology
Independent Interdisciplinary
Committee on Ethical Review
Moscow
Bagrat G. Alekyan
President of Russian Scientific Society
of Endovascular Therapies

20. Schematic diagram of study design
A Single-blind, Prospective, Randomized, Multicenter Study evaluating Efficacy and Safety of Sirolimus-
Delivering CALYPSO Coronary Stent Versus Everolimus-Delivering Xience Prime (Abbott Vascular) coronary
stent (PATRIOT)
Calipso
N=406
Xience
Prime
N=204

21. Efficacy endpoints
Primary endpoint (combined):
1. Complication related to target lesion within 1 year determined as cardiac death, target-artery-
related myocardial infarction, or clinically indicated revascularization of the target lesion.
Secondary endpoints:
1. Individual components of the primary endpoint: death due to any cause; Q-positive and Q-
negative myocardial infarction; clinically indicated target-vessel revascularization, any target-
vessel revascularization, any target-lesion revascularization, or stent thrombosis (determined,
possible, or probable).
2. Late luminal loss (in the stent) (follow-up:12 months)
3. Device implantation success, lesion treatment success, and procedure success.

22. Efficacy endpoints
1. Patient of < 18 and > 75 y.o.
2. Acute coronary syndrome with ST elevation
3. Patients not tolerating
anticoagulants/disaggregants
4. Severe valve pathology requiring an operation
within 1 year
5. Glomerular filtration rate<30 mL/min
6. Anemia <100 g/L
7. Thrombocytopenia
8. Oncology
9. Ongoing bleeding
10. Clinical signs and/or symptoms of NYHA class IV
heart failure at the time of selection or
enrollment.
11. Heart failure hospitalization as a main diagnosis in
the last 12 months.
12. Lesion of coronary arteries requiring coronary
artery bypass grafting
1. Patients of either sex 18-75 y.o. with stable
coronary heart disease or acute coronary
syndrome having indications to
revascularization by means of angioplasty with
stenting.
2. Patients with a target lesion localized in a
coronary artery with the reference diameter
from 2.5 to 4 mm and >50% stenosis.
3. Signed informed consent.
Inclusion criteria: Exclusion criteria:

23. Calypso meets the standards
and performance of the best
competitors made equipment in
its class at significant cost
savings.

24. Thank you
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