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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
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
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
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
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
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
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
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
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
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
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
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
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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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