This document discusses the ZeptoTM Capsulotomy System, a new device for performing capsulotomies during cataract surgery. The system uses femtosecond laser technology to perform automated, precise capsulotomies. Clinical experience with the device in 34 patients showed it created tag-free, complete capsulotomies with no complications. Upcoming clinical studies in the US and EU are planned to obtain regulatory approval, with market introduction expected in select countries starting in January 2017. The ZeptoTM system is presented as satisfying unmet needs by maintaining surgical efficiency while allowing capsulotomies for difficult cases like small pupils or weak zonules.

1. OIS
ESCRS 2016
An Ideal Capsulotomy

2. Main Frames tape drives 12MB

3. 100 GB USB Drive

4. Femto

5. ZEPTOTM Capsulotomy System
Control Console
Disposable
Handpiece
Capsulotomy
Tip

6. ZeptoTM Surgical Experience
34 patients (49 -86 y.o.)
Routine cases as well as
with co-morbidities
All tag-free, complete
No capsule related AEs,
some patients – 6 mos.

7. Small Pupil

8. Small Pupil & White Cataract
Kevin Waltz MD

9. Zonular Dehiscence
Kevin Waltz MD

10. ZeptoTM Summary
Satisfies unmet needs in capsulotomy
No interruption of surgical workflow
Maintain (enhance) efficiency
No change in routine steps of phacosurgery
Affordable2.2 mm incision
Fast, automated capsulotomy
Round, Ideal sizing
Strong Edge, added safety
Small pupils
Dense cataracts
Weak zonules
Corneal opacities
Pediatrics
Choice of centration
Intraoperative visual axis centration
Primary posterior capsulotomy

11. Upcoming Clinical Studies
US
FDA study protocol finalized
Enrollment to begin
Expect completion by Nov/Dec
EU
2 sites planned end of 2016

12. Market Introduction
• January 2017 – Select countries EU, Asia,
Latin America
• US market introduction expected Q2 2017

13. OIS
2016

14. OIS
2016