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InnFocus
1. OIS, April 2015
InnFocus® - In Studies to prove a Safe, Easy, & Effective Surgical Alternative for all
forms of Glaucoma
Russ Trenary – President & CEO
2. 2
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
Investment Opportunity
3. 3
Company Overview
Focused on Glaucoma Surgery - Large & Growing Market
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®
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
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
4. 4
78.5M Worldwide Glaucoma Market
~$8B Current Market (Rx &
Devices)
2nd Leading Cause of Blindness
>40% CAGR projected for
Glaucoma Surgical Devices
estimated at 41% for the next 5-
years
Glaucoma Surgical Devices
Represents Largest Growth
Opportunity in Ophthalmology!
Market Scope 2014
InnFocus Provides 7X Market Potential Verses Competitors
Open Angle
Closed Angle
Other
18.75 M
24%
51.7 M
66%
8M
10%
5. 5
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
6. 6
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
7. 7
AGIS zone of no progression of vision loss*
Change in IOP Over Time
IntraocularPressure(mmHg)
30.0
25.0
20.0
15.0
10.0
05.0
0.0
0 5 10 15 20 25 30 35 40
Months Post-Op
n=82
n=47 n=34 n=23 n=22
10.9 mmHg
11.8 mmHg11.4 mmHg
Pre-Op IOP = 23.0 ± 5.6 mmHg on full meds
Courtesy Juan Batlle, Isabelle Riss, et al.
* AGIS. Am J Ophthalmol 2000;130(4):429-40.
8. 8
Dominican Republic and France
Mean change in IOP with InnFocus MicroShunt® for
Early Stage Patients only (MD < -6 Db)
IntraocularPressure(mmHg)
30.0
25.0
20.0
15.0
10.0
05.0
0.0
0 5 10 15 20 25 30 35 40
Months Post-Op
AGIS zone of no progression of vision loss
Courtesy Juan Batlle, Isabelle Riss, et al.
Pre-Op, N=38,
Baseline IOP=24.7±5.7mmHg
Meds/Pt=2.3±1.2
Yr-1, N=32,
IOP=14.7±3.9mmHg
Meds/Pt= 0.3
Yr-2, N=21
IOP=14.5±4.6mmHg
Meds/Pt=0.4
Yr-3, N=8
IOP=11.6±3.8mmHg
Meds/Pt=0.3
70% of patients totally off glaucoma medications
*AGIS 7 Study, Am J Ophthalmology 2000;130:429-440
9. 9
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)
10. 10
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%
11. 11
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
12. 12
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
13. 13
Thank you
InnFocus® - In Studies to prove a Safe, Easy, & Effective Surgical Alternative for all
forms of Glaucoma
Russ Trenary – President & CEO