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Sean Ianchulev, MD MPHChief 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 20151000+ Cases

Pilot COMBO and POAG

Complete

100

COMPASSUS-IDE RCTCombined

Ongoing

505

CYCLEEU Post-MarketCombined & POAG

Ongoing

509

DUETTEEU Post-MarketPOAG

65

Ongoing

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Concept Feasibility Development Validation

2005 2015People

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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 medicationsand 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 medicationsand 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

Mea

n IO

P (

mm

Hg)

-29% -27%% reduction -35%

With PhacoCyCle Study

CyPass OnlyDUETTE Study

24.5

17.716.8

0.0

5.0

10.0

15.0

20.0

25.0

30.0

BL (n=65) M6 (n=52) M12 (n=48)

Mea

n IO

P (

mm

Hg)

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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)

Intr

aocu

lar

Pre

ssu

re D

iffe

ren

ce, m

mH

g

Paired Mean ± SD Change in IOP, by group, Baseline to 12M timepoint

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Stent Technology in OphthalmologyThe Next Frontier

Neurovascular

Cadiovascular

Pulmonary

Gastrointestinal

Urological/Gyncological

Peripheral

Ophthalmology

MIGS