PowerPoint Presentation

Ivantis

Dave Van MeterOIS@AAOOctober 13, 2016

Ivantis OverviewFounded 2007 by top coronary stent inventorsDeveloping the only minimally invasive microstent for glaucoma that dilates and reconstructs the primary outflow path of the eye (Schlemms canal)25 FTEs; based in Irvine, CA$107 MM raised to date (Runway into mid 2018)Over 2,700 patients treated globally (21 countries, 80 surgeons)Nearly 50% of procedures in standalone surgeryAll Procedures in Studies or RegistriesFull 2 Year US Pivotal Trial Results AAO 2017

Investigational Device Only in US

How Will Ivantis Differentiate in a Crowded MIGS Space?The only device that reconstructs the eyes primary outflow pathway Superior Clinical Data within the initial served MIGS market (phaco/glaucoma)Broadest potential in the standalone glaucoma marketExpandable platform for more complex patients

Investigational Device Only in US

We are highly confident we will have superior..Confidential - Proprietary to Ivantis4

Hydrus MicrostentTri-Modal Mechanism of Action

Investigational Device Only in US

Confidential - Proprietary to Ivantis5

Toris, Samuelson, Ahmed et al OutflowIOVS 2013:54:1698-1704Gong, Johnstone, et al. Fluorescent Dye Intensity Study (AGS Paper 2013)

Reconstructs and dilates primary outflow pathway90 scaffolding provides access to multiple collector channelsHydrus MicrostentTri-Modal Mechanism of Action

OutflowRegionInvestigational Device Only in US

Confidential - Proprietary to Ivantis6

Hydrus is a Highly VerifiableProcedure

Investigational Device Only in US

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How Will Ivantis Differentiate in a Crowded MIGS Space?The only device that reconstructs the eyes primary outflow pathway Superior Clinical Data within the initial served MIGS market (phaco/glaucoma)Broadest potential in the standalone glaucoma marketExpandable platform for more complex patients

Investigational Device Only in US

Confidential - Proprietary to Ivantis8

Randomized Multicenter MIGS Trials Phaco + MIGS vs. Phaco Only67%NorthAmerica29%EU4%Asia100%US100%US100%US100%EU

Enrolled US Pivotal TrialsInvestigational Device Only in US

Confidential - Proprietary to Ivantis9

HYDRUS II: Level One Clinical EvidenceTrial was designed to closely simulate US pivotal trial Utilizes the state of the art study design standards utilized in current FDA MIGS trialsMedications removed (washout) prior to surgery and 1 and 2 year follow-ups to remove confounding effect of medications on IOP 7 top EU academic centers (Norbert Pfeiffer, PI) 100 eyes with mild to moderate OAG undergoing cataract surgery1:1 randomization day of surgeryAverage patient entered study at IOP of 19 on 2 meds; washout IOP was 26.510

The HYDRUS II Trial was published in Ophthalmologyand Awarded a Top 10 Paper at the American Glaucoma Society Meeting - 2015

Investigational Device Only in US

Confidential - Proprietary to Ivantis10

TREATMENT RESPONSE Intention-to-treat analysisResults from Multicenter RCTPrimary Endpoint =34%p=0.0008Pfeiffer N, et al. Ophthalmology 2015;122:1283-93Investigational Device Only in US

Confidential - Proprietary to Ivantis11

How Will Ivantis Differentiate in a Crowded MIGS Space?The only device that reconstructs the eyes primary outflow pathway Superior Clinical Data within the initial served MIGS market (phaco/glaucoma)Broadest potential in the standalone glaucoma marketExpandable platform for more complex patients

Investigational Device Only in US

We are highly confident we will have superior..Confidential - Proprietary to Ivantis12

Standalone Opportunity

5M US Glaucoma Patients 1 med2 meds3-4 medsTrab,tubeSLTMIGSopportunityonly for the safest procedures

Advanced DiseaseMild Disease,Hypertension

Moderate DiseaseInvestigational Device Only in US

Glaucoma covers a spectrum of severity from the mild stages usually without symptoms- to advanced stages actively restricting visionCurrent therapy is dominated by medication up to the most advanced stages

In between 1 or 2 meds and very invasive filtration surgery, there is a large opportunity for MIGS.as long as the procedures are effective, safe, and without complications or side effects for the patient.

Confidential - Proprietary to Ivantis13

Versatility in Standalone TreatmentNew Articles & Presentations

Disease SeverityMildAdvanced3-fold greater med decrease in Hydrus at 1 year (-1.4 and -0.5 medications vs. baseline)Similar safety between Hydrus and SLT

Similar efficacy to canaloplasty (IOP of -9 and -10 mm Hg vs. baseline) and similar medication use (0.9 vs. 0.7 meds/patient) at 24 monthsAdvatageous safety profile

Both IOP and Meds significantly reduced in patients with limited optionsNo complications associated with filtration surgery such as hypotony Investigational Device Only in US

A large gap between medical therapy/SLT and trabeculectomy surgery can be filled by MIGSEfficacy must be clinically meaningful (without help of cataract surgery)For earlier treatment, safety should be nearly on par with current treatment (meds/SLT)Hydrus is potentially uniquely positioned for this gap through its safe reconstruction of natural canal

Why do we believe this? Well, over the past year, there has been tremendous interest among Hydrus investigators in standalone setting across full Spectrum of glaucoma severity.

Here are some from Europe..

Note we will be pursuing an IDE in this populationConfidential - Proprietary to Ivantis14

How Will Ivantis Differentiate in a Crowded MIGS Space?The only device that reconstructs the eyes primary outflow pathway Superior Clinical Data within the initial served MIGS market (phaco/glaucoma)Broadest potential in the standalone glaucoma marketExpandable platform for more complex patients

Investigational Device Only in US

Confidential - Proprietary to Ivantis15

Leveraging the Hydrus Platform24 Hour IOP MonitorMicro pressure sensor housed within HydrusWireless link to a smart phone

Hydrus drug eluting coatingProven DES technologySustained release to TM, SC, or AC

Timed release bio- resorbable drug delivery platformTarget the TM, SC, or AC

Diagnostics Therapeutics Advanced Disease

Investigational Device Only in US

Confidential - Proprietary to Ivantis16

Thank YouInvestigational Device Only in US

Investigational Device Only in US