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OIS, April 2015
InnFocus® - In Studies to prove a Safe, Easy, & Effective Surgical Alternative for all
forms of Glaucoma
Russ Trenary – President & CEO
Investment Opportunity
 Final FDA Phase to begin soon – Phase I Enrollment Complete
 Large Market Potential with Reimbursement in Place

InnFocus is not limited to cataract removal
 Clinical Outcomes in the AGIS Zone

Proven Long Term Material Biocompatibility

12+ years of In-Human Use
 Only Product studied in an FDA Randomized Clinical Study against the “Gold
Standard” of Glaucoma Surgery
InnFocus - Lowest Investment Risk Opportunity in Glaucoma
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Company Overview
 Focused on Glaucoma Surgery - Large & Growing Market
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
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Large & Growing 40% Annually - 3.5MM U.S. & 78MM global Patients
U.S. Reimbursement Code In Place
Only Product & Company with potential to meet EU Reimbursement Requirements
 Unique Product - InnFocus MicroShunt®

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Proven Material – Over 12 years In Human Use that resists Encapsulation & Stays Patent
European CE Mark
Strong IP protection with Five (5) Patents Issued & Numerous Pending
 Excellent IOP Lowering
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Achieves post operative IOP <14 mmHg
150+ patients enrolled in 4 clinical trials in US, EU, and Japan with 3 year follow-up
U.S. IDE Study – compared against Surgical “Gold Standard” – Trabeculectomy
Achieves >80% Glaucoma Rx Reduction
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78.5M Worldwide Glaucoma Market


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~$8B Current Market (Rx &
Devices)
2nd Leading Cause of Blindness
>40% CAGR projected for
Glaucoma Surgical Devices
estimated at 41% for the next 5years
8M
10%
18.75 M
24%
51.7 M
66%
Open Angle
Closed Angle
Other
Glaucoma Surgical Devices
Represents Largest Growth
Opportunity in Ophthalmology!
InnFocus Provides 7X Market Potential Verses Competitors
Market Scope 2014
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InnFocus MicroShunt®
 Shape conforms to ocular tissue curvature
 Soft, Flexible, Compliant with No Erosion
 Atraumatic Fins prevent
 Migration
 Peri-annular leakage
 Design Proven to Prevent Chronic Hypotony
 Outer diameter = 350 µm
 Lumen diameter = 70 µm
 Length = 8.5 mm
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MicroShunt® Product Benefits
 Revolutionary SIBS material responsible
for enhanced IOP lowering over time
 Post – Op IOP below 14 mmHg at 3
years
 Procedure utilizes 50 year proven
aqueous drainage pathway.
 No requirement for Cataract removal to
Achieve IOP Reduction verses
competitors
 Procedure Easy to Perform & Fits
Surgeons Surgical Sweet Spot
 Results not temporary - Same IOP at 3
months & 3 years
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Change in IOP Over Time
Intraocular Pressure (mmHg)
30.0
Pre-Op IOP = 23.0 ± 5.6 mmHg on full meds
25.0
n=82
20.0
15.0
11.8 mmHg
11.4 mmHg
10.0
n=47
n=23
AGIS zone of no progression of vision loss*
05.0
0.0
n=34
10.9 mmHg
0
5
Courtesy Juan Batlle, Isabelle Riss, et al.
* AGIS. Am J Ophthalmol 2000;130(4):429-40.
10
15
20
25
n=22
30
35
40
Months Post-Op
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Dominican Republic and France
Mean change in IOP with InnFocus MicroShunt® for
Early Stage Patients only (MD < -6 Db)
Pre-Op, N=38,
Baseline IOP=24.7±5.7mmHg
Meds/Pt=2.3±1.2
Intraocular Pressure (mmHg)
30.0
Yr-2, N=21
IOP=14.5±4.6mmHg
Yr-1, N=32,
IOP=14.7±3.9mmHg Meds/Pt=0.4
Yr-3, N=8
Meds/Pt= 0.3
IOP=11.6±3.8mmHg
Meds/Pt=0.3
25.0
20.0
15.0
10.0
AGIS zone of no progression of vision loss
05.0
70% of patients totally off glaucoma medications
0.0
0
5
10
15
20
25
30
35
40
Months Post-Op
Courtesy Juan Batlle, Isabelle Riss, et al.
*AGIS 7 Study, Am J Ophthalmology 2000;130:429-440
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Clinical Outcomes
Rate Change in IOP
Time
N
Qualified
Success (%)*
IOP
mmHg
Mean Drop in
IOP (%)
% Patients w/IOP ≤
18 mmHg
% patients w/IOP ≤
14 mmHg
Pre-Op
82
N/A
23.0±5.6
N/A
N/A
N/A
Yr-1
34
100%
11.4±3.1
51%
100%
85%
Yr-2
22
95%
11.8±3.6
49%
91%
82%
Yr-3
22
95%
10.9±3.5
54%
100%
82%
*Qualified success = (< 21mm Hg result, > 20% decline in IOP, and reduced meds usage)
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Glaucoma Medication
Change in Use over Time
Time
N
Glaucoma Meds/Patient
Reduction in Med use
from baseline (%)
Patients off Meds
(%)
Pre-Op
82
2.8 ± 1.2
N/A
0%
Yr-1
34
0.4 ± 0.9
86%
82%
Yr-2
22
0.4 ± 1.0
87%
86%
Yr-3
22
0.5± 0.9
84%
73%
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Adverse Events
 IOP < 5 mmHg after day 1 = 10%
 All resolved spontaneously
 Choroidal Effusion = 5%
 All resolved spontaneously
 No Long-term sight–threatening adverse events
 No endophthalmitis or chronic hypotony
 No progression of cataract in Phakic Patients
Excellent benefit risk ratio for a Glaucoma Procedure
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Clinical Study Outcomes Summary
 >50% IOP reduction from baseline (on full meds) to <14 mmHg
 >80% of eyes with IOP ≤ 14 mmHg
 84% reduction in Glaucoma Rx to 0.5 med/patient
 >70% of Patients Off Glaucoma Rx at 3 years
 No Long-Term Sight-Threatening Adverse Events
Only Glaucoma Product That Achieved AGIS Zone Clinical Outcomes
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Thank you
InnFocus® - In Studies to prove a Safe, Easy, & Effective Surgical Alternative for all
forms of Glaucoma
Russ Trenary – President & CEO
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