1. Russ Trenary President & CEO
Caution: Investigational device in the U.S.  Limited by Federal Law to Investigational Use.

2. InnFocus Update
1) Define the winning formula
2) Clinical results
3) Status of our US IDE

3. Our Goal
Provide a safe, effective, easy to perform, cost effective, alternative for surgical treatment of Glaucoma.
Primary Open Angle Glaucoma is our first area of investigation.

4. Requirements for success
A proven drainage path that provides for IOP ≤ 14 mmHg
A very inert biomaterial to minimize foreign body reaction
A shunt design that will remain patent, prevent chronic hypotony, leakage, or migration
An antiproliferative drug to minimize the initial surgical insult

5. The Winning Key is the SIBS Material
There is one stretchy biomaterial that will not provoke scar tissue in the eye
Poly(styrene-block-isobutylene-block-styrene)
“SIBS”
SIBS is ultra-stable and will not degrade in the body
No degradation means no chronic inflammation and minimal scar
SIBS is used on drug eluting coronary stents (TAXUS)
Twelve-year history of use in the body
Licensed from BSC for use in the eye

6. Excellent material but what about shunt design?
Make the device thin and soft to conform to the curvature of the eye.
Make the lumen sufficiently large to allow cells to pass yet small and long enough to prevent hypotony.
Add a fin to prevent migration and leakage around the outside of the tube.

7. Implanting the InnFocus MicroShunt™
2.8

8. Implanting the InnFocus MicroShunt™
2.8

9. Implanting the InnFocus MicroShunt™
2.8

10. Implanting the InnFocus MicroShunt™
2.7

11. Clinical study Baseline Characteristics: Dominican Republic and France
35 POAG eyes
All failed maximum tolerated medication
Implanted 23 MicroShunts™ only, and 12 combined with cataract surgery
Baseline IOP = 23.8 ± 5.3 mmHg
Baseline meds per patient = 2.8 ± 1.2

12. Change in IOP with time for the InnFocus MicroShunt™ Combined data for Dominican Republic and France
Baseline IOP = 23.8 ± 5.3 mmHg
Average long-term IOP = 11.3 ± 3.2 mmHg
AGIS zone for no progression of vision loss
Courtesy Dr. Juan Batlle and Dr. Isabelle Riss

13. Conclusions from Studies in Dominican Republic and France; Data out to 2 Years
IOP reduction of 55% from baseline to 11.3 ± 3.2 mmHg
82% of eyes with IOP ≤ 14 mmHg
89% reduction in glaucoma meds to 0.3 med/patient
89% of patients entirely off glaucoma meds
Transient hypotony < 5 mmHg after Day 1 = 12%
all resolved spontaneously
No long-term sight-threatening adverse events
No cases of endophthalmitis, chronic hypotony, choroidal hemorrhage
Easy to perform and quick alternative to tube or trabeculectomy procedures

14. Meeting requirements for success in OUS studies?
√ A proven drainage path that provides for IOP ≤ 14 mmHg
√ A very inert biomaterial to minimize foreign body reaction
√ A shunt design that will remain patent, prevent chronic hypotony, leakage, or migration
√ An antiproliferative drug to minimize the initial surgical insult

15. US IDE Study Design
Prospective, randomized, controlled, masked, multicenter study
Phakic and pseudophakic stratified
Two study groups
test group is InnFocus MicroShunt™ with MMC
control group is trabeculectomy with MMC
Two phases with two year follow-up

16. The Business: Intellectual Property, Regulatory, Financing
Issued US Patents
5,741,331 – SIBS for implant applications
7,431,709 – SIBS for use as a drainage tube
7,594,899 – Any tube from AC, w/wo MMC
7,837,644 – SIBS as drainage tube, w/wo MMC
Others pending
Regulatory
CE Mark received January 2012
FDA clearance and initiation of phase I implants Q3, 2013
Financing
$10 million from Boston Scientific Corporation, plus
$22 million from Hoya, Saints Capital Everest and Angels
2.4

17. Board of Directors and Management
Jean-Luc Boulnois, Ph.D.
Scott Halsted
Randy Lindholm
Leonard Pinchuk, Ph.D.
John Sheets, Ph.D.
Russ Trenary
Russ Trenary
President & CEO
Leonard Pinchuk, Ph.D.
Founder, CSO
Bruce A. Weber, MBA
V.P., Reg., Clinical. and QA
Yasushi P. Kato, Ph.D.
V.P. R&D
John B. Martin Jr.
Chief Engineer, Co-founder

18. Thank you