Download - SPOTLIGHT ON MIGS - InnFocus
Mission
First FDA approved minimally invasive stand alone procedure for mild, moderate, and severe stage open angle Glaucoma, that lowers and sustains IOP under 15 mmHg, and completely eliminates eye drop medications in most
patients.
Russ Trenary – President & CEO
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Why InnFocus®? We address the largest patient population – First and Only Surgical Device/Procedure to
provide treatment for Mild, Moderate, and Severe Stage stand alone Primary Open Angle Glaucoma
Excellent Clinical Data Clinical Outcomes Meet AGIS Zone Objective (<15 mm Hg) No Requirement to Remove the Cataract (but you can) U.S. Reimbursement Code In Place and Surgeon Interest & Clinical Implants Ramping
MicroShunt® Undergoing FDA Randomized Clinical Study against Trabeculectomy Only Product Compared Versus the “Gold Standard” in Glaucoma Surgery Only Product that will have Trabeculectomy Comparative Labeling Only Study Designed to meet pan European Reimbursement Requirements
Unique Patented Material only Glaucoma Product with Proven Long Term Material Biocompatibility Over 15 years & >1 Million In-Patient Product Use as a cardiac stent and 8 years in the
eye – SIBS material is proven Strong IP protection - Seven (7) Granted & four (5) Pending
InnFocus – Largest Patient Population – Great Data
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U.S. Glaucoma Surgical Market
InnFocus Focused on Total Market
Competitors mainly focused only on niche Cataract with Glaucoma
7M U.S. Potential Procedure Market
~$8B Current Market (Rx & Devices)
Projected >40% CAGR for Glaucoma Surgical Procedures (2015 to 2020)
Largest Growth Opportunity in Ophthalmology!
Market Scope 2014
InnFocus Provides 5-6X Market Opportunity Vs. Competitors
18.75 M24%
51.7 M66%
8M10%Open
Angle 59% - 4.15M
Closed Angle 22% - 1.5M
Glaucoma w/Cataract 10%700K
Other 9%650K
Glaucoma Surgical Procedure Market
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Glaucoma Severity Classification
MD = -0.1 dB MD = -5.7 dB
Mild(-0.1 to -6.0)
Moderate (-6.0 to -12.0) Severe (<-12.0 to approx. -32 dB)
MD = -9.2 dB MD = -22.6 dB
Data from INN 003,004,007, 009 and Toronto comparing results of “high” pre-op IOP vs “low” pre-op IOP.
The key difference between pre-op IOP > 24 mm Hg and ≤ 24 mm Hg is the percent drop from baseline is greater for pre-op > 24 mm Hg.
NIOP %Rdctn
Meds/Pt%Off Meds
%≤ 5 mmHg
65n/a
2.5±1.412n/a
64690
10014.1
64650986.3
5860
0.1±0.31003.4
58550980
5257
0.1±0.3960
5254
0.1±0.3861.9
4452
0.2±0.4850
4051
0.2±0.7850
3452
0.5±1.0740
1751
0.5±0.9710
30
25
20
15
10
05
00
Intr
aoc
ula
r P
ress
ure
(m
m H
g)
TimeN
IOP %RdctnMeds/Pt
%Off Meds%≤ 5 mmHg
Pre-Op133n/a
2.7±1.25
n/a
Day-1133520
1008.3
Week-1128520
1006.3
Week-3111460
1001.8
Week-4111400970.9
Week-694390
981.1
Month-39335
0.1±0.3960
Month-67732
0.2±0.6910
Month-95828
0.3±0.7830
Year-14035
0.3±0.8850
Year-21741
0.6±1.3765.9
= 19.4 ± 2.8 mm HgPre-Op IOPon Full Meds
02/22/16
= 29.6 ± 4.9 mm HgPre-Op IOPon Full Meds Eyes with Pre-Op IOP > 24 mm Hg
Eyes with Pre-Op IOP ≤ 24 mm Hg
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IOP With and Without Cataract Removal
The MicroShunt provides low IOP with and without cataract surgery
IMS-OUS Implanted alone
IMS-OUS Implanted with cataract surgery
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Change in average Visual Acuity with time relative to baseline
MicroShunt stand-alone results in average visual acuity being restored approximately 1 week after surgery and is better than baseline in 3 months.
For the MicroShunt implanted in combination with cataract removal, average visual acuity is better than baseline in about 1 week.
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Adverse Events
IOP < 5 mmHg after week 1 under 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 to Risk Ratio for a Glaucoma Procedure
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Why Does MicroShunt® Have the Best Data?
An amazingly proven bio-inert material Revolutionary SIBS material is Ultra-Stable; Does Not
Degrade! >1 Million In-Patient Device Implants (TAXUS® Stent) Proven 15+ Years In-Human Use – 8 years in eyes Dr. Paul Palmberg – “The Eye doesn’t know this Material
is in the Eye” Design Proven to Prevent Chronic Hypotony
Outer diameter (350 µm), Lumen diameter (70 µm) & Length (8.5 mm)
Significant Barriers to Entry & Competitive Advantage
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MicroShunt® Proven Drainage Pathway
Procedure utilizes 50-year proven Trabeculectomy aqueous drainage pathway differentiated from canal and suprachoroidal based MIGS pathways.
Post-Op IOP <15 mmHg at 3 years No requirement for Cataract removal to
Achieve IOP Reduction versus Competitors
Procedure Easy to Perform & Fits Surgeon’s Surgical Sweet Spot
Results not temporary - Same IOP at 3 months & at 3 years
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FDA Study Design
Only Prospective, Randomized & Controlled Clinical Study vs. “Gold Standard” (Trabeculectomy)
Only Study Treating Mild, Moderate, Severe stage Glaucoma Prove Safety Profile with dramatically reduced Adverse Events Over-achieve FDA required Clinical End-Points Two Phases
Phase I (safety) – Completed (75 patients) with 3 month follow-up Final Phase (safety & effectiveness) – Begin 2H 2015 – 400 Patients with 1 year follow-
up Study Design Outcome:
U.S. Label Claims compared to “Gold Standard” (Trabeculectomy) Study Design Meets & Supports EU reimbursement Inability for Competitors to follow – Their results will not beat “Gold Standard”
(Trabeculectomy)
InnFocus Study Provides Game Changing Competitive Advantage