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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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2014-16 Endopix Ltd. – All rights reserved - Proprietary & Confidential
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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2014-16 Endopix Ltd. – All rights reserved - Proprietary & Confidential
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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2014-16 Endopix Ltd. – All rights reserved - Proprietary & Confidential
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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2014-16 Endopix Ltd. – All rights reserved - Proprietary & Confidential
Blood Vessels / Vascularization
HD Endoscope
endoflag200 – Comparative image example
endoflag enhanced imaging
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2014-16 Endopix Ltd. – All rights reserved - Proprietary & Confidential
Flat and small lesions, polyps, pit patterns
HD Endoscope
endoflag200 – Comparative image example
endoflag enhanced imaging
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2014-16 Endopix Ltd. – All rights reserved - Proprietary & Confidential
endoflag200 - fiber-optic imaging enhancement example
endoflag overcomes resolution and pixelation effects of fiber-optic imaging devices including advanced microimaging.
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2014-16 Endopix Ltd. – All rights reserved - Proprietary & Confidential
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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2014-16 Endopix Ltd. – All rights reserved - Proprietary & Confidential
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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2014-16 Endopix Ltd. – All rights reserved - Proprietary & Confidential
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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2014-16 Endopix Ltd. – All rights reserved - Proprietary & Confidential
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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2014-16 Endopix Ltd. – All rights reserved - Proprietary & Confidential
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 and testing
• 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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2014-16 Endopix Ltd. – All rights reserved - Proprietary & Confidential
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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2014-16 Endopix Ltd. – All rights reserved - Proprietary & Confidential
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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2014-16 Endopix Ltd. – All rights reserved - Proprietary & Confidential
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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2014-16 Endopix Ltd. – All rights reserved - Proprietary & Confidential
• 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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2014-16 Endopix Ltd. – All rights reserved - Proprietary & Confidential
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
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2014-16 Endopix Ltd. – All rights reserved - Proprietary & Confidential
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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2014-16 Endopix Ltd. – All rights reserved - Proprietary & Confidential
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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2014-16 Endopix Ltd. – All rights reserved - Proprietary & Confidential
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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2014-16 Endopix Ltd. – All rights reserved - Proprietary & Confidential
Hyperplastic polyp (HD)
endocad – image example
Image input Pre-Detection Candidates
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2014-16 Endopix Ltd. – All rights reserved - Proprietary & Confidential
Neoplastic lesion (HD)
endocad – image example
Image input Pre-Detection Candidates
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2014-16 Endopix Ltd. – All rights reserved - Proprietary & Confidential
Flat Adenoma lesion (HD)
endocad – image example
Image input Pre-Detection Candidates
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2014-16 Endopix Ltd. – All rights reserved - Proprietary & Confidential
Hyperplastic polyp (HD)
endocad – image example
Image input Pre-Detection Candidates
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2014-16 Endopix Ltd. – All rights reserved - Proprietary & Confidential
Flat Adenoma polyp (SD)
endocad – image example
Image input Pre-Detection Candidates
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2014-16 Endopix Ltd. – All rights reserved - Proprietary & Confidential
Flat polyp (SD)
endocad – image example
Image input Pre-Detection Candidates
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2014-16 Endopix Ltd. – All rights reserved - Proprietary & Confidential
Hyperplastic polyp (SD)
endocad – image example
Image input Pre-Detection Candidates
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2014-16 Endopix Ltd. – All rights reserved - Proprietary & Confidential
Polyp (HD)
endocad – image example
Image input
Image input Pre-Detection Candidates (Red) Actual (Green)
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2014-16 Endopix Ltd. – All rights reserved - Proprietary & Confidential
Polyp (HD)
endocad – image example
Image input Pre-Detection Candidates (Red) Actual (Green)
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2014-16 Endopix Ltd. – All rights reserved - Proprietary & Confidential
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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2014-16 Endopix Ltd. – All rights reserved - Proprietary & Confidential
Thank you
Rami Guissin, CEO
Email: [email protected]
+972 (54) 4888412
Investors and Partners
…
endoflag endocad