Transcend Medical "What's Next" Presentation from OIS@ASCRS 2015

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Sean Ianchulev, MD MPH
Chief Medical Officer, Transcend Medical
Clinical Associate Professor, UC San Francisco
What next?

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Concept Feasibility Development Validation
2005 20158+ generations

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Concept Feasibility Development Validation
2005 2015
1000+ Cases
Pilot COMBO and
POAG
Complete
100
COMPASS
US-IDE RCT
Combined
Ongoing
505
CYCLE
EU Post-Market
Combined &
POAG
Ongoing
509
DUETTE
EU Post-Market
POAG
65
Ongoing

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Concept Feasibility Development Validation
2005 2015
People

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Concept Feasibility Development Validation
2005 2015
$89M

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The Potential of Micro-Invasive Glaucoma Surgery
MIGS is designed to bridge the gap between medications
and conventional glaucoma surgery.
Chronic med use CyPass Micro-Stent

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The Potential of Micro-Invasive Glaucoma Surgery
MIGS is designed to bridge the gap between medications
and conventional glaucoma surgery.
Trabeculectomy CyPass Micro-Stent

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CyPass Micro-Stent: The Next-Generation of MIGS
Caution: Investigational device. Limited by Federal (US) law to investigational use only.

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Why the Suprachoroidal space?
Large continuous space > Large Absorptive Capacity > Pressure Gradient

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CyPass Clinical Outcomes: EU studies
25.5
16.9 16.6 15.8
0.0
5.0
10.0
15.0
20.0
25.0
30.0
35.0
Baseline M6 M12 M24
MeanIOP(mmHg)
-29% -27%% reduction -35%
With Phaco
CyCle Study
CyPass Only
DUETTE Study
24.5
17.7
16.8
0.0
5.0
10.0
15.0
20.0
25.0
30.0
BL (n=65) M6 (n=52) M12 (n=48)
MeanIOP(mmHg)

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CyPass Clinical Outcomes: Safety
Am J Ophthalmol. 2015 Mar 3

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COMPASS trial: landmark study for glaucoma device
• Terminal wash out at 12 and 24 months
• Strict criteria for re-introduction of meds
• Rigorous analysis of endothelial cell density
• Strong primary endpoint outcome: 2-year diurnal un-medicated IOP change
N = 240
COMPASS trialN = 505
iStent trial
N = 276 ABC trial
N = 212 TVT trial
N = 255 EMGT trial

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What is the Future of MIGS?
CyPass Vx Infusion System

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What is the Future of MIGS?

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Preliminary Analysis of ViscoPass 1-YR Results
-7.0
± 4.2
-8.7
± 7.8
-9.9
± 5.8
-12.0
-10.0
-8.0
-6.0
-4.0
-2.0
0.0
CyPass only
(n=21)
CyPass + 30 uL
(n=21)
CyPass + 60 uL
(n=21)
IntraocularPressureDifference,mmHg
Paired Mean ± SD Change in IOP, by group, Baseline to 12M timepoint

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Stent Technology in Ophthalmology
The Next Frontier
Neurovascular
Cadiovascular
Pulmonary
Gastrointestinal
Urological/
Gyncological
Peripheral
Ophthalmology
MIGS