Presentation from OIS@ASCRS 2016 John Hendrick, President & CEO Video Presentation: https://www.youtube.com/watch?v=c2J1g7HYuek&index=24&list=PL1dmdBNnPTZJBhQxPOp0vdNg3s3wtN2yw

1. OIS-ASCRS New Orleans 2016
An Ideal Capsulotomy

2. ZEPTOTM
• Innovative, disposable capsulotomy device
• No disruption to cataract procedure or patient flow
• Proprietary action (no cautery, thermal burning) -
stronger, more extensible than femto or CCC.
• Minimal surgeon training
• Low cost

3. ZEPTOTM
UNIQUE FEATURES:
• Capsule apposition via suction – consistency in every case
• Zonular stabilization – to address weak zonules
• Use safely with small pupils (4mm)
• Effectively deal with corneal opacities
• Unobstructed view for centration using patient visual axis
• All cases – general and complex

4. ZEPTOTM Capsulotomy System
Control Console
Disposable
Handpiece
Capsulotomy
Tip

5. Capsulotomy Tip
Soft, clear
suction cup
Nitinol
capsulotomy ring

6. ZeptoTM Development

7. 2.2 mm
Latest ZeptoTM
2.2 mm

8. Unique Capabilities
Capsulotomy on patient’s visual axis using just ZeptoTM and Purkinje imagesZeptoTM posterior capsulotomy with reverse optic capture

9. Chamber safety -temperature
2.94 secs; 1.760 C
2.69 secs; 0.890C
A
B
No significant temperature change in eye
• Low energy capsulotomy
• Additional shielding by silicone cup
4.47 secs; 0.530C
4.60 secs; 1.320C
3.59 secs; 1.910 C
3.69 secs; 2.010 C
duration; peak
Chang et al 2016 Ophthalmology

10. T
Edge strength
ZeptoTM vs Femto & CCC
0
20
40
60
80
100
120
140
160
180
200
Pair 9 Pair 10 Pair 11 Pair 12 Pair 13 Pair 14 Pair 15 Pair 16
EdgeTearStrength(mN)
Precision Pulse Capsulotomy
CCC
Wilcoxon matched-pairs
signed-ranks test P = 0.012
Paired cadaver eyes
Wilcoxon matched-pairs
signed-ranks test P = 0.012
Zepto
Femtosecond Laser
Zepto
CCC
Thompson et al 2016 Ophthalmology

11. Bottom edge of
capsulotomy ring
Lens capsule at rest
Precision-Pulse Capsulotomy
Suction applied, capsule
pulled against ring edge
Increased tensile stress
Trapped water
molecules
Cross-section through device and capsule
Multipulse energy
discharges
Rapid phase transition of
water molecules
Capsule membrane
cleaved precisely

12. Scanning Electron Microscopy (SEM)
A
Cut edge
Functional edge
during surgery
D CCC
B ZEPTOSchematic
C ZEPTO
20 microns

13. Clinical Evaluation
Clinica 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 capsulotomies
• 6 challenging cases : 2 with brown cataracts, 2 with small pupils,
2 with pterygiums
• No capsule related problems reported or noted out to 30 days

14. Regulatory Activities
• CE mark approval November 2015
• Single arm trial protocol with 4 weeks of
follow-up submitted to FDA for 510K
approval.

15. Market introduction
• Expect to enter the European market in
September of 2016
• US market introduction expected late 3rd
quarter to early 4th quarter 2016

16. OIS-ASCRS New Orleans 2016