PowerPoint Presentation

OIS-ASCRS New Orleans 2016An Ideal Capsulotomy

ZEPTOTM Innovative, disposable capsulotomy deviceNo disruption to cataract procedure or patient flowProprietary action (no cautery, thermal burning) - stronger, more extensible than femto or CCC.Minimal surgeon trainingLow cost

ZEPTOTM UNIQUE FEATURES:Capsule apposition via suction consistency in every caseZonular stabilization to address weak zonulesUse safely with small pupils (4mm)Effectively deal with corneal opacitiesUnobstructed view for centration using patient visual axis All cases general and complex

ZEPTOTM Capsulotomy SystemControl Console

Disposable Handpiece

CapsulotomyTip

Capsulotomy TipSoft, clearsuction cup

Nitinol capsulotomy ring

ZeptoTM Development

2.2 mm Latest ZeptoTM

2.2 mm

Unique Capabilities

Capsulotomy on patients visual axis using just ZeptoTM and Purkinje images

ZeptoTM posterior capsulotomy with reverse optic capture

Chamber safety -temperature2.94 secs; 1.760 C2.69 secs; 0.890C

A

BNo significant temperature change in eyeLow energy capsulotomyAdditional shielding by silicone cup

4.47 secs; 0.530C4.60 secs; 1.320C3.59 secs; 1.910 C3.69 secs; 2.010 Cduration; peak

Chang et al 2016 Ophthalmology

TEdge strength ZeptoTM vs Femto & CCC

Wilcoxon matched-pairs signed-ranks test P = 0.012Paired cadaver eyesWilcoxon matched-pairs signed-ranks test P = 0.012

ZeptoFemtosecond Laser

ZeptoCCC

Thompson et al 2016 Ophthalmology

Bottom edge ofcapsulotomy ringLens capsule at restPrecision-Pulse Capsulotomy

Suction applied, capsule pulled against ring edgeIncreased tensile stressTrapped water moleculesCross-section through device and capsule

Multipulse energy dischargesRapid phase transition ofwater moleculesCapsule membrane cleaved precisely

Apply a very quick multipulse energy discharge

Creates a rapid phase transition of the trapped water molecules

Cleaving the capsule membrane precisely

As a result, the entire 360o round capsulotomy produced instantaneously all at once11

Scanning Electron Microscopy (SEM)

ACut edgeFunctional edgeduring surgery

DCCC

BZEPTOSchematic

CZEPTO20 microns

Clinical EvaluationClinica Quesada, San Salvador, El Salvador Kevin Waltz, M.D., O.D. & Gabriel Quesada M.D.20 patients (49-85 y.o.) cataract surgery with phacoemulsification, one-piece acrylic IOL

All 20 complete free-floating ZeptoTM capsulotomies6 challenging cases : 2 with brown cataracts, 2 with small pupils, 2 with pterygiumsNo capsule related problems reported or noted out to 30 days

Regulatory Activities

CE mark approval November 2015

Single arm trial protocol with 4 weeks of follow-up submitted to FDA for 510K approval.

Market introduction

Expect to enter the European market in September of 2016

US market introduction expected late 3rd quarter to early 4th quarter 2016

OIS-ASCRS New Orleans 2016