spotlight on migs - innfocus

14
1 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

Upload: healthegy

Post on 15-Feb-2017

539 views

Category:

Healthcare


0 download

TRANSCRIPT

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

2

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

3

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

4

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

OUS data from INN 003, 004, 007, 009 and Toronto

6

Percent of patients off glaucoma medication with time

N=8

N=18

N=22N=35N=74

N=198

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

8

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

9

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.

10

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

11

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

12

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

13

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

14

Thank you!