Endopix Presentation - Jan 2016

2014-16 Endopix Ltd. - All rights reserved

Proprietary & Confidential

Endopix Presentation

Rami Guissin, Ph.D., CEO

January 2016

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2014-16 Endopix Ltd. – All rights reserved - Proprietary & Confidential

Goals

1. Immediate (ready for use) commercialization of endoflag,

a proven video enhancement product for enhanced

visualization of polyps and early stage lesions in endoscopic

procedures.

2. Future development and commercialization of endocad, a

next generation, generic computer aided detection processor

for improved detection and classification of polyps and

lesions in endoscopic procedures.

Market potential exceeding $1B, with an

upside potential of doubling this amount.

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Market: Large markets for enhanced endoscopy diagnostics: GI first

Colon Esophagus

Annual cost of digestive diseases (US) = >$107bn, affecting 60-70m people

Colorectal cancer – 3rd most common cancer, 130,000 new patients p.a. >20m relevant procedures p.a.: 18m colonoscopies performed in the US in 2005; 3m flexible sigmoidoscopies in 2002 Room for growth – market could double: screening recommended every 5-10 years over age 50. In 2004 41m Americans were estimated to require colorectal cancer screening GI endoscopy systems sales expected to reach $3.5bn by 2013 (~50,000 units p.a.)

US statistics

Source: National Health Institute, Centers for Disease Control survey, published in Gastroenterology, 2004 Dec; 127(6): 1841-4; Medtech Insight September 2006; interviews; innovations-report.de; interviews

Prevalence: 10m Barrett’s Esophagus patients in the US, only 1m under active physician care including regular upper endoscopy exams (recommended every 3 years) 10% of GERD patients develop Barrett’s Esophagus, 10% of Barrett’s patients develop cancer (Esophageal adenocarcinoma) 8m esophagus endoscopies performed in the US in 2005 Increasing awareness within the medical community re:the magnitude of the issue

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The Need: Significant unmet need in diagnostic endoscopy – too many missed anomalies (e.g. flat polyps, early stage lesions)

Guidelines: take 4 biopsies every 5-10cm of the colon

(random)

White light endoscopes require doctor’s eye to differentiate

between close shades of red – not feasible

False negatives

12%-24%

Source: Medtech Insight September 2006; interviews

Many doctors ignore

guidelines

endoflag200 See more, miss less

The Solution:

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endoflag200 – Patented, generic, standalone and embedded solution, real time, post processing for endoscopic visualization enhancement

• Broad IP base (issued and pending

patents).

• Enhance tissue irregularities in the

mucosal and sub-mucosal layers

for enhanced visualization and

early detection

• Compensate for low

light/contrast/resolution imaging

• Connect to any video endoscope

(standard definition SD and high

definition HD)

• Minimum latency (<0.1 sec)

endoflag200

diagnostic aid screen

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Blood Vessels / Vascularization

HD Endoscope

endoflag200 – Comparative image example

endoflag enhanced imaging

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Flat and small lesions, polyps, pit patterns

HD Endoscope

endoflag200 – Comparative image example

endoflag enhanced imaging

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endoflag200 - fiber-optic imaging enhancement example

endoflag overcomes resolution and pixelation effects of fiber-optic imaging devices including advanced microimaging.

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endoflag300 - combined novel illumination/probe and analytics for improved visualization of tissue anomalies

endoflag utilizes advanced illumination/probe and specialized processing for improved visualization of tissue anomalies.

endoflag300

+

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endoflag300 - combined novel illumination/probe and analytics for improved visualization of tissue anomalies (Cont’)

endoflag300

+

White Light Advanced Light Advanced Light + Analytics

2014-16 Endopix Ltd. - All rights reserved

Proprietary & Confidential

Prospective randomized controlled trial - DDW 2010

Aim Prospective randomized trial to test whether colonoscopy in conjunction with endoflag is superior in detecting intraepithelial neoplasias (IN) compared to standard white light colonoscopy.

Methods Patients with indication for diagnostic or screening colonoscopy were randomly assigned in a 1:1 ratio to undergo Endoflag imaging or conventional colonoscopy without additional filtering options. Processed and unprocessed video imagery were displayed on a second monitor using the standard resolution output of the endoscopic processor (Pentax, Japan). Primary endpoint analysis was the number of adenomas or cancers in each group.

R. Kiesslich1, A. Doleschal1, F. Sar1, A. Hoffman1, M. Goetz1, P.R. Galle1, Z. Halpern2 , R. Guissin3

1. I. Med. Department, Johannes Gutenberg University of Mainz, Germany. 2. Gastroenterology Institute, Tel Aviv Sourasky Medical Center, Israel. 3. Endopix Ltd., Tel Aviv, Israel.

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Prof. Ralf Kiesslich et. al.

I. Medical Department

Johannes Gutenberg University Mainz, Germany

Clear clinical indication:

endoflag leads to a significantly higher (+90%) detection rate of colorectal neoplasias

[adenomas and cancers] compared to standard white light endoscopy in a screening population.

Prospective trial results

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endoflag200 go-to-market

Licensing deal of endoflag penetration to GI

endoscopy embedded capsule application in

2009-2010

1

2

Initial penetration to GI video endoscopy via NovoGI standalone product Q1/2014 (endoflag inside)

4 Initial market penetration via GI endocad sales in

2016

WW total available endoscopy market: Standalone (installed base) total available market > $1.8B Embedded (new systems) additional market potential

3

Initial market penetration via Pneumology, Urology

and ENT endoflag200 standalone sales – late

2015

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endoflag200 - extended utilization in other endoscopy applications

Urology

Pulmonology

Gastrointestinal

Laparoscopy

Ear/Nose/Throat

Oral

Arthroscopy

Gynecology

• Current focus

• Preliminary successful demonstration with Pentax system

• Requires clinical validation trial

• Preliminary successful demonstration with Pentax system

• Requires clinical validation trial

• Preliminary discussions and testing



• Preliminary discussions

• Preliminary discussions

Remarks:

• All applications can use the same endoflag solution in terms of computational requirements

• Expanding to other endoscopy applications may require additional focused clinical validation trials

• TAM – Total available market

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endoflag200 - total WW available endoscopy market

Assumptions:

• Endoscopy projections based on F&S market survey (U.S. only) 2006.

• WW market: ~ X 3 U.S. market.

• Lifetime of endoscope: 7 years

• Installed base: ~ 7 X new units sold annually

• GI Endoscope pricing (Pentax):

• SD: scope ~ $16K; processor ~ $20K

• HD: scope ~ $40K; processor ~ $47K

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Next stage need: Avoid unnecessary biopsies

Guidelines: take 4 biopsies every 5-10cm of the colon

(random)

White light endoscopes require doctor’s eye to differentiate

between close shades of red – not feasible

Too many biopsies

False negatives

10x

12%-24%

High cost – biopsies are

expensive, can exceed

procedure reimbursement

Many doctors ignore

guidelines

endocad Biopsy the right spot

endoflag See more, miss less

The Solution:

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Endopix roadmap for enhanced endoscopy - from visualization to detection

endoflag200 white light video processing

for enhanced endoscopic visualization

endocad computer aided detection

for endoscopy endoflag300 combined illumination and processing for enhanced endoscopic visualization

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• Near-infrared (NIR) bio-markers can bind to colonic adenomas in vivo.

• A pre-clinical research study* demonstrates significantly improved signal-to-clutter ratios

(SCRs) of colonic tumors, using advanced endocad vision processing for fusing white light and

NIR fluorescence image pairs taken from removed rat lumen (colon) subjected to bio-markers.

• Tests were made on strong, weak and non labeled tumors, for exposed and non-exposed tumor

instances.

• Fused SCRs are increased even for non labeled and non exposed tumors, thereby increasing the potential

yield of future bio-markers.

endocad pre-clinical detection study: Improved tumor detection by combining white light and fluorescence in rat lumen

*Bio Medical Photonics Israeli Consortium (Chief Scientist Office) - Image processing for advanced and automated computer aided polyp and anomaly detection

RGB

NIR

Strong Labeling

Weak Labeling

Fused by

endocad

No Labeling

Not exposed to lumen

and not labeled

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endocad processed imagery

Gastric signet ring cell

carcinoma

PINPOINT Novadaq

Input imagery

endocad solution – real time, generic computer aided detection processing of polyps and lesions

• Diagnostic and therapeutic endoscopy applications seek improved efficacy of histological and

optical biopsies.

• The envisioned endocad processing will provide real time, automated delineation, designation

and display of tissue anomalies and lesions for improved physician targeting of biopsies.

• endocad will connect to a broad range of multi-spectral processors and video outpus (e.g. white

light, narrow band imaging, autofluorescence).

RGB in AFI in

White Light

Auto Fluorescence

Auto Fluorescence

http://www.z3technology.com/MVPR-01.htm

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endocad solution – comparative image examples

• Color code display:

Red pixels and delineation: Fluorescence.

Blue pixels: Exclusions.

• Note that the healthy gastric tissue demonstrates significantly

less response compared to the carcinoma example.

Gastric

carcinoma

Pneumology cancerous lesion

White Light

Auto Fluorescence

AFI in AFI in

Gastric healthy

tissue

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Image input Classification Detection

endocad solution – concept and signal flow

endoflag

pre processing

endocad

vision processing

Input image

Detection map

Enhanced image

Classification map

Display

processing

Display imagery

Recording and

Tagging

Playback imagery

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endocad – standalone and embedded computer aided detection of polyps and lesions

• Auxiliary diagnostic aid display (or

graphic overlay) for GI physicians.

• Connect or embed into any video

endoscope (standard definition SD

and high definition HD).

• Minimum latency.

• Broad IP base (issued and pending

patents).

endocad

diagnostic aid screen

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Hyperplastic polyp (HD)

endocad – image example

Image input Pre-Detection Candidates

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Neoplastic lesion (HD)



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Flat Adenoma lesion (HD)



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Hyperplastic polyp (HD)



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Flat Adenoma polyp (SD)



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Flat polyp (SD)



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Hyperplastic polyp (SD)



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Polyp (HD)


Image input

Image input Pre-Detection Candidates (Red) Actual (Green)

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Polyp (HD)


Image input Pre-Detection Candidates (Red) Actual (Green)

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Management, board, advisors

• Deputy Director, Tel Aviv Sourasky Medical Center; Head of Gastroenterology

• Professor of Medicine, Sackler Faculty of Medicine Tel Aviv University

• 18 professional awards and associations • 108 original publications • Fellowship at the Cleveland Clinic • M.D. from the Hebrew University,

Hadassah Medical School

• Founder and CEO, DVP • Technology Advisor to the Israeli MOD and

Defense industries on image processing • Head of image processing, El-Op electrooptics

industries • IDF Major – technical officer in electrooptics

and image processing • BE electrical engineering, City College of New

York; M.Sc engineering, Tel Aviv University; Ph.D Applied Mathematics and optics, Weizmann Institute of Science

• Life Science Partner, Star Ventures • Co-Founder and General Manager, Quantomix • Co-Founder, General Manager and COO, XTL

Biopharmaceuticals • COO, Peptor Ltd. • Assistant to President, Pharmos • B.Sc biology, Tel Aviv University • PhD molecular biology, Weizmann Institute;

MBA, Bar Ilan University

• Managing Partner, Millennium Materials Technologies Fund

• Board member of Tambour Ltd., Agan Technologies Ltd.; joint managing director of Plantex and Ikapharm, Koor’s pharmaceutical ventures; Consultant to Teva Pharmaceutical Industries Ltd. And Savient Ltd.

• B.Sc in chemical engineering from Imperial College in London, business diploma from Hebrew University

Rami Guissin, Ph.D

Co-founder

CEO

Zachi Berger, Ph.D MBA

Investor,

CBO

Zwi Vromen, B.Sc

Investor,

Board member

Zamir Halpern, M.D

Clinical advisor

Israel

• Head of Endoscopic Unit, I. Med. Clinic, University of Mainz, Germany

• Research focus: chromoendoscopy, confocal laser endoscopy, molecular imaging, training in endoscopy

• Board certificaiton for internal medicine and gastroenterology

• Ludwig Demling award 2003, ASGE • Martin Gulzow Award 2004, DGVS • Member of the Editorial Board: Gut,

Endoscopy

Ralf Kiesselich M.D

Clinical advisor

Germany

Sidney Braginsky

Board member

• Serves in multiple BODs of medical technology companies and venture capital funds (e.g. Atropos Technology, Digilab LLC, Double D, Invendo Medical).

• Served for 27 years in various leadership positions in Olympus America, Inc. (President 1994–1999), building a billion dollar business focused on electrooptical products including microscopes, endoscopes and chemistry analyzers.

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Thank you

Rami Guissin, CEO

Email: [email protected]

+972 (54) 4888412

Investors and Partners

…

endoflag endocad

Endopix Presentation - Jan 2016

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