1. The Endospan Solution for AAA
Jacob Cynamon, MD Department of Radiology Montefiore Medical Center/ AECOM
CRT 2012

2. The Problem
EVAR and TEVAR in patients with small, tortuous iliac arteries
Simple design and deployment devices are not available
No Truly Percutaneous Solution

3. The Solution Trivascular- Ovation Device CE mark
U.S. Humanitarian Device Exemption Approval
14 Fr OD Delivery for small tortuous iliac arteries

4. The Solution
Endospan- Horizon

5. Horizon – AAA Stent Graft
True 14 Fr. OD hydrophilic coated delivery system
One-sided percutaneous
Proximal and distal anatomical fixation
No cannulation of the contralateral limb needed
Simple and intuitive sequential implantation steps

6. Endospan Founded in ’09 Venture backed, based in Israel.
Simpler, more Intuitive solutions for treating Aneurysms
Three Endograft Programs - Clinical Phase During 2012

7. Active Endograft Programs
AAA - Horizon™
J/PRAA - Honest™
Arch TAA - Nexus™

8. “Out of the Box” Design = Low Crossing Profile
Innovative serial component design leads to dramatic reduction in crossing profile

9. Horizon – Video

10. Deployment in a bovine aorta
Horizon – In-Vivo
Deployment in a bovine aorta

11. R&D Process: From Concept to Patient
Numerical model building
Fluid dynamics testing
Fatigue/durability simulator designed and built
400,000,000 cycles durability test performed

12. Elaborate Testing Methodology
Testing under axial and radial loading conditions
Full 400 M cycles completed in 6wks
Real-life pulsatile regimen
Worst-case hypertensive scenarios
Proprietary methodology & testers (patent pending)

13. Horizon™ – Clinical Plans
Human studies to commence Q2 ’12
Main European study sites – Dusseldorf , Zurich and Modena (Prof.’s Kolvenbach, Lachat, Coppi)
20 patient feasibility study
Subsequently commencing EU registration study for CE Mark

14. Honest™ – Hostile Neck Stent Graft
What are the goals?
A real “off-the-shelf” product
Quick turnaround diagnosis - treatment
Low crossing profile
Easy branch cannulation
Reasonable pricing

15. Honest™ – J/PRAA Stent Graft

16. Horizon™ & Honest™ Timelines
Horizon - EU
Q1’ Q2’ Q1‘ Q2-Q4’ Q1’ Q4’13
Regulatory Strategy Prepared
Binding Approval by Notified Body
IRB Submission to IRB (& MoHs)
FIM Study
CE Registration Study
CE Mark Granted
Honest - EU
Q4’ Q1,Q2’12 Jun.‘ Q3,Q4’ Q1’ Q3’13
Design Input; Reg. Strategy Prepared
R&D->V&V; Approval of Reg. Strategy.
IRB Submission to IRB (& MoHs)
FIM Study
CE Registration Study
CE Mark Granted
Honest - US
Q3’ Q1’ Q4’14
Pre IDE Meeting
IDE Pivotal Study
PMA Submission

17. Deployment in a silicone phantom
Nexus
Deployment in a silicone phantom

18. Nexus™ Timelines EU US Q1’12 Mid.’12 Q3,Q4‘12 Q1’13 Q2’13
Reg. Strategy approved by Notified Body
IRB Submission to IRB (& MoHs)
FIM/Registration Study
CE Mark Application
CE Mark Granted US
Q1’ Mid.’ Q3,Q4‘ Q1’ Q2’13
HUD Designation Filed; Approved
Pre IDE Meeting
Setting-Up IDE Sites
HDE Submission
HDE Approved; Market Launch

19. Conclusions
Solutions for low profile EVAR and TEVAR are in the Pipeline
14 Fr fully percutaneous devices will be available (I predict)
Endospan’s novel approach to AAA and TAA repair needs safety and efficacy validation
The future is bright