THE PILLCAM™ JOURNEY

SIMON TURNERPRODUCT MANAGER - GIHMINIMALLY INVASIVE THERAPIES GROUP

GUIDED BY OUR MISSIONA SHARED SENSE OF PURPOSE

TENET 6To maintain good citizenship as a company.

TENET 1To contribute to human welfare by application of biomedical engineering in the research, design, manufacture, and sale of instruments or appliances that alleviate pain, restore health, and extend life.

TENET 5To recognize the personal worth of employees by providing an employment framework that allows personal satisfaction in work accomplished, security, advancement opportunity, and means to share in the company’s success.

TENET 2To direct our growth in the areas of biomedical engineering where we display maximum strength and ability; to gather people and facilities that tend to augment these areas; to continuously build on these areas through education and knowledge assimilation; to avoid participation in areas where we cannot make unique and worthy contributions.

TENET 3To strive without reserve for the greatest possible reliability and quality in our products; to be the unsurpassed standard of comparison and to be recognized as a company of dedication, honesty, integrity, and service.

TENET 4To make a fair profit on current operations to meet our obligations, sustain our growth, and reach our goals.

INVENTION

3

GABBI IDDAN

“I had been involved in military work based on optics, and after speaking with an Israeli doctor named Eitan Skapa, who described the challenges in using traditional endoscopies, I realized that the optics work I was doing could provide an alternative solution,” said Iddan. He started working on the idea as a side project in Israel Military Industries, where he was employed, but eventually the project got too big for IMI’s labs – and Iddan struck out on his own, with Given Imaging established in 1997.

It was really a matter of “shrinking” the missiles that Iddan was working with to the size of a small, ingestible pill with a camera attached – a technology he began working on in the 1980s, but was not really technically feasible until the late 1990s, when miniaturized cameras and transmitters (to send the image viewed by the camera to a nearby computer) became economically and technically feasible. Iddan was able to perfect the first version of the Pillcam in 2000, and in 2001 the device received FDA approval. The rest, Iddan said, is history.

4

CAPSULE ENDOSCOPY MILESTONES

founded

19

98

PillCam ESO 2

20

08

PillCam SB 2

20

04

M2A capsule

re-branded

PillCam® ESO

20

01

M2A capsule

Patency System

20

06

20

09

20

10

PillCam C2

PillCam Colon

20

11

PillCam SB

paediatric

2yrs and up

PillCam

Patients

PillCam SB3

20

15

PillCam UGI

20

18

20

13 PillCam

Crohn’s

5

PILLCAM SB CAPSULE EVOLUTION

PillCam SB

– 11 mm x 26 mm

– 1 camera

– 2 frames per second

– Std optics / 1 lens

– 256 x 256 frame

resolution

– Std lighting control

– Std angle of view

140°

– Depth of field 0-30

mm

PillCam SB 2

– 11 mm x 26 mm

– 1 camera

– 2 frames per second

– New optics / 3 lens

– 256 x 256 frame

resolution

– Advanced Automatic

Light Control

– Angle of view 156°

– Depth of field 0-30 mm

PillCam SB 3

– 11 mm x 26 mm

– 1 camera

– Adaptive Frame Rate 2

or 6 frames per sec

– Bidirectional

communications

– 3 lens optical design

– 320 x 320 frame

resolution

– Angle of view 156°

– Depth of field 0-30 mm

6

CAPSULE COMPARISON IN VITRO

0mm 2mm 5mm

PILLCAM™SOFTWAREEVOLUTION

9

PILLCAM SOFTWARE EVOLUTION

2001 RAPID 1.3Automatic Viewing Mode

Variable Viewing Speed

2002 RAPID 1.4 Suspected Blood Indicator (SBI)

2003 RAPID 2Patient De-identification

DoubleView

2004 RAPID 3

My GI Dictionary

QuadView

QuickView

2005 RAPID 4RAPID Atlas

Circumference Scale

2007 RAPID 5

New Image Shape - Increased

AOV

Lewis Score

2008 RAPID 5.2

Image Adjustment (IA)

Study Manager

Network Connectivity

10

PILLCAM SOFTWARE EVOLUTION

2009 RAPID 6

Progress Indicator

DR3, SB Sensor Belt Support

FICE

Mosaic view

2010 RAPID 7

Polyp Size Estimate

Spellchecker

Electronic Signature on report

WIN 7/64 bit support

2013 RAPID 8

New UI - homepage, ribbon

Supports SB3 (SB3\DR3\AFR)

Enhanced algorithms (reading

time)

Improved Progress Indicator

Complementary QuickView mode

Suggested Landmarks for SB3

2015 RAPID 8.3Reporting Improvements

Dynamic Player Control

KEY NEW FEATURESNEW LOOK AND FEEL

Home Screen Study Manager

New Ribbon panel

New icons

PillCam

SW

Double click to

launch the SW

PillCam

Video

Double click to

open a

PillCam Video

PillCam Documents

Double click to

open the

PillCam

Documents

11

PILLCAM™ SOFTWARE V9.0KEY NEW FEATURES

Supports the new PillCam™ Crohn’s capsule

Novel workflow for evaluating and monitoring Crohn’s disease in the small

bowel and colon

Top100 feature which displays the 100 most clinically relevant images that may

include abnormalities

New schematic GI Map showing the capsule location and progress

Addition of hundreds of high-quality images from PillCam™ SB 3 and PillCam™

COLON 2 to the Atlas

Enhanced, modern user interface with intuitive design (colors, icons, flat buttons)

Color-bar image preview that may assist with landmarking for PillCam™ SB

and PillCam™ Crohn’s videos

Support for Microsoft Windows® 10 OS

Support for Ultra HD (4K) monitors (no 96 DPI limitation)

Installation available using a CD or a USB Flash drive and website download

capabilities for the PillCam™ Reader SW

12

KEY NEW FEATURESTOP 100

Top 100: Provides a preview of the 100 most clinically relevant images, likely to

include ulcerations, bleeding, angioectasias, or polyps, depending the capsule type

(PillCam™ SB, COLON and Crohn’s), presented as a video or in page view.

Note

For PillCam™ SB 3 videos the Top 100

feature replaces the SBI functionality and

shows suspected bleeding images

For PillCam™ COLON videos, the Top 100

feature includes suspected polyp and

bleeding images

For PillCam™ Crohn’s videos, the Top 100

feature includes suspected inflammatory

pathologies, bleeding and polyp images

Only available for videos compiled using

PillCam™ Software v9.0

13

KEY NEW FEATURESGI MAP PROGRESS INDICATOR

GI MapThe estimated position and the percentage of the small bowel viewed are calculated based

on:

1. Marking the landmarks of the first duodenal image and the first caecal image

2. Advanced algorithms, which estimate capsule speed

3. Passage time

The SB progress percentage is only available for PillCamTM SB videos, however progress

information available for PillCamTM COLON and PillCamTM Crohn’s studies.

SB percentage

viewed

Estimation of

capsule speedProgress

indicator

Passage

time

SB percentage

viewed

New GI Map Old Progress Indicator

14

KEY NEW FEATURES EXTENDED ATLAS LIBRARY

Ulcer Bleeding

PillCam SB3

Normal Polyp

PillCam Colon2

New high-quality PillCam™ images for a larger library of pathologies to improve diagnostic confidence

15

KEY NEW FEATURESTIME BAR PREVIEW IMAGE

Hovering the mouse over the time bar provides an image display of the

thumbnail at that specific location with the time stamp

Preview image

Time bar

Tip

Using Preview image may aid in landmarking

16

PILLCAMTM SOFTWARE V9.0COMPARISON WITH PREVIOUS VERSIONS

PillCam SW v9.0 RAPID v8.0

PillCam Crohn’s + -

PillCam UGI + -

SB Video Length 30% shorter vs. 8.0 -

Colon Video Length ~45% shorter vs. 8.0 -

SBI

(blood detection tool)

SB2 - SBi

SB3 – Top100SB2, SB3

Top 100 SB3, Colon & Crohn’s -

Localization

GI Map, Suggested

Landmarks, improved Body

Exit & SB-to-Colon

passage detection

GI Spaghetti track,

Suggested Landmarks

Extended Atlas

Library+ -

Data Recorder 3

Firmwarev02B4 v27F

Data Recorder model DR3, DR2C DR3, DR2C

17

18

PILLCAM PATIENT STORY

PILLCAM™CROHN’SINTRODUCTION

PILLCAMTM CROHN’S SYSTEM INTRODUCTION

Key Features:

Efficient Monitoring: The PillCamTM Crohn’s system allows physicians to directly and non-invasively visualise the small bowel and colon in a single procedure

Comprehensive Visualization: Advanced optics and innovative imaging features allow for a thorough evaluation of Crohn’s disease activity and mucosal healing

Patient-Friendly Imaging: The PillCamTM Crohn’s procedure is non-invasive and does not subject the patient to sedation or radiation. It has the potential to reduce the number of exams to make disease management more convenient.

The PillCamTM Crohn’s system was designed to improve physician’s

diagnostic confidence and productivity when managing Crohn’s disease

patients

ADAPTIVE FRAME RATE AND PILLCAMTM CROHN’SFUNCTION

Patient check-in1.

Capsule paired

• Capsule opened

• Paired with

PillCamTM recorder 3

2.

Capsule ingested

• Transmits at 4 fps3.

AFR activated

• Small bowel detection

• Transmits at 4 or 35

fps

4a. Patient completes

instructions from

recorder alerts

• Regimen reminders

4b.

End of procedure

• Capsule passed or

battery expires

(minimum of 10

hours)

5.

PILLCAMTM CROHN’S PATIENT REGIMEN

Begin clear liquid diet

(Approximately 2L of clear liquids should be

consumed throughout the day

7 pm – 9 pm

Ingest 2L of PEG

(ingest over 2 hours)

Continue with clear liquids

7 am – 9 am

Ingest 2L of PEG

(ingest over 2

hours)

10 am

Ingest PillCamTM

SBC

1 hour later

10 mg metoclopramide

At small bowel detection

180 mL oral sulfate solution

added to 300 mL of water

Drink additional 1L of water

(resume clear liquids)

3 hours later

90 mL oral sulfate solution

added to 150 mL of water

Drink additional 1L of water

2 hours later – 10 mg bisacodyl

suppository

2 hours later – Light mealNot required for all patients

Day 1 Prior Day of Procedure

PILLCAMTM CROHN’SLESION SEVERITY

Mild - 1 Moderate- 2 Severe - 3 Stricture- S

Lesion Severity Rating1. Mild: superficial, small ulcer or erosion

2. Moderate: Intermediate ulcer in terms of size and depth

3. Severe: Prominent ulcer (size & depth) with either circular, longitudinal, “kissing”,

fissuring or “cobblestone” morphology

S Stricture: Existence of a stricture

23

PILLCAMTM CROHN’SULCER SIZE ESTIMATION

Ulcer Size Estimation (USE)

Ruler consisting of two orthogonal lines measuring a constant 5 mm length to estimate the

size of ulcers

The ruler adjusts visually based on the capsule’s depth of view

Accessible from the View screen or the Edit Thumbnail box

Available for PillCam™ Crohn’s studies only

Not to be used to measure any pathology other than ulcers

Note

The Ulcer Size Estimation is a tool for research purposes only and the values

displayed should not be used in making diagnostic or treatment decisions.

The size of the ruler lines change

visually based on the capsule’s

depth of view, however the ruler

measures a constant 5mm length

USE

24

PILLCAMTM CROHN’SVIEW SCREEN - DISEASE EVALUATIONSEVERITY RULER

Prepar

e

View Report

Play the video to evaluate the disease.

When you see a finding that you want to rate , click on

the video image to see the Severity Ruler:

Rate the Severity as follow:1. Mild: superficial, small ulcer or erosion

2. Moderate: Intermediate ulcer in terms of size and

depth

3. Severe: Prominent ulcer (size & depth) with either

circular, longitudinal, “kissing”, fissuring or

“cobblestone” morphology

S Stricture: Existence of a stricture

Move the mouse over the options to see a description

and click Show examples to open the Severity Grade

Examples atlas:

25

PILLCAMTM CROHN’SDISEASE EVALUATION METHODOLOGY

30-60%

MCL-1MSL-

2

1/3 SBColo

n1/3 SB1/3 SB

Disease Evaluation

Lesion Severity, Most Severe Lesion (Grade 1-3,

Stricture)

Most Common Lesion

Extent

40%

Disease

Extent

Most

Common

Lesion

(MCL)

Most

Severe

Lesion

(MSL)

Repeat evaluation sequentially for all 3 small bowel segments and the

colon

1 View a segment.

2Grade lesions with

escalating severity

3Evaluate most

common lesion

severity and extent

of the disease in the

segment.

The most severe

lesion is

automatically

included

4

26

PILLCAMTM CROHN’SVIEW SCREEN - DISEASE EVALUATIONGI TABLE AND GI MAP

Prepar

e

View Report

Disease assessment results are automatically populated in the GI Table and GI

Map. Assessment can be modified manually from the GI table at any time.

The GI Map is automatically synchronized with the GI Table

MCL

MSL

The SB is divided

to 3 segments.

Assessment is

performed

separately for

each segment.

Manually evaluate

the involvement of

disease in the

Duodenum,

terminal ileum,

right and left colon

sub-segments

Stricture

Duodenum

TI

SB I

Relevant images are

available by a click

Most

Common

Lesion

Disease

Extent

Most

Severe

Lesion

27

PILLCAMTM CROHN’SVIEW SCREEN - DISEASE EVALUATIONCOMPARE PRIOR VIDEO & FINDINGS

Prepar

e

View Report

If a prior Study is available use the Prior Video or Compare Findings tools:

Review a prior video in

a “Read Only” mode

Click View to return

to current study

Compare current findings to prior

findings and evaluate treatment

Complete the Review and continue to generate the Report.

28

PILLCAMTM CROHN’SREPORT SCREEN - COMPARE REPORT

Prepar

e

View Report

Click Compare

Report to view

prior report

summary

29

Hardware

Software

Capsule

EVOLUTION OF PILLCAM CAPSULE ENDSCOPY

THANK YOU