May 2014 Check-Cap Creating a new standard of colon 3D imagery
May 2014 Check-Cap Creating a new standard of colon 3D imagery
Non Confidential
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Company Overview
Ow Founded - 2005
Corporate Headquarters - Carmel, Israel
Employees - 35
Investors — Overall $25m Raised
through March 3152 2014:
GE Ventures, Pontifax Ventures,
Jacobs Investment (Qualcomm),
Counterpoint, Docor, BXR Partners,
Emigrant Saving Bank,
Biomedix (BMDX:TASE) & more. Cash $3.2m as of May 2014
Current Burn Rate - - $400k
Target Bridge - $6-8m
Insider Participation - $3-4m
Most Recent Valuation (2012) - $64m
2 iliircap
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A patient friendly screening method
First imaging capsule for
Colorectal Cancer screening (CRC)
I No bowel cleansing required
Designed for increased compliance
Cap
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Check-Cap Our vision
To become the leading supplier
of colon cancer screening technology
and significantly reduce
global mortality from CRC. ti
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"The most preventable, yet least prevented cancer"
—Journal of the National Cancer Institute
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The importance of CRC screening
Structural Tests - enable both Polyp Detection and Cancer Prevention
Stool / Blood Tests - enable Cancer Detection
Highly Survivable in Early stages Spell to other er-porM1
Mama
trMa, Mood
fig/ vessel
Illustration courtesy of the
Notional Cancer Institute Stage I 93%
Stage II 72-85%
Stage III 44-83%
Stage IV 8%
Testing Compliance Key
Less than 50% of the recommended
population in the U.S is screened for CRC,
while less than 30% is screened in Europe.
6 qiiirCap
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Compelling Market Size
Target population of 365 million people aged 50 to 75 in U.S, Europe and Japan.
> 36 million require screening annually.(1)
Population between
50.75 2015 2016 2017 2018 2019 2020
USA 89,545 90,996 92,179 93,182 94,297 95,618
Europe 233,971 236,374 239,113 242.268 245,372 248,526
Japan 41,397 41,071 40,889 40,843 40,814 41,002
TOTAL 364,913 368,441 372,181 376,293 380,483 385,147 op •
irr
> $18 billion total market opportunity per annumm
(1) Assumes one screening for members of the target population every 1O years.
(2) Based on an average selling price of $5OO.
7
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Attractive Market Opportunity
Poorly
Addressed by
Current
Methods
Check-Cap
Offers a
Differentiated
Solution • Current technologies may compromise accuracy or patient safety and comfort
• Colonoscopies involve significant risks and require aggressive bowel cleansing
• Patient compliance levels far below those recommended by physician societies
• Does not require uncomfortable bowel cleansing_necessary for other methods
• Innovative and proprietary technology platform avoids traditional issues
• Designed to be attractive to physicians and patients, increasing patient compliance
8
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Reasons for Avoiding Existing CRC Screening Procedures
Computed
Tomographic
Colonography
Camera pill a
%.a Embarrassment
11%
Concern
over pain
13%
Fasting
requirements
15% Other
reasons 8% Laxative
Preparation
32%
Insertion of
tube 21%
Check-Cap imaging capsule addresses all these concerns
9 Source: Mayo Clinic Proc. 2007;82(6):666-671. Figure 1, Most troubling part of colon testing. Responses to the question,
"What do you feel is the most troublesome part of colon testing?'
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Current Primary Modalities Detection of polyps > 50%
(Cancer Prevention vs Detection)
O
O
00
oZS
t.)
CU Li-Colonoscopy Safety Comfort
Xv bowel cleansing
n Cross Infection n Embarrassment Pre-Cancerous Efficacy*
1 Sensitivity - 95%
Specificity - 95%
Computed Tomographic v Insufflation
Radiation y bowel cleansing Sensitivity - 85%
Colonography (CTC) X Pain Specificity - 95%
ssfa.- O) Optic Capsules Ni&
Fecal Occult Blood Test
\I Stool DNA
In clinical trials
Blood Tests
In clinical trials VtX_ bowel cleansing Sensitivity - 70%
Specificity - 85%
1 V
1 V X Sensitivity - 23%
Specificity - 97%
Sensitivity - 42%
Specificity - 87%
x Sensitivity - 50%
Specificity - 90% Key Competitors
OLYMPUS PENTAX
PHILIPS
SIEMENS
OLYMPUS
GleING
I
exact stierces
epigenomics
dip Imaging Capsule
io In clinical trials 1 V /Target Sensitivity > 80%
Target Specificity > 90%
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/ The Check-Cap Solution
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Check-Cap -maging Technology
tittering X-ray Fluorescence
Less contrast = Less Absorption - Increase in Comptons
Compton backscattered flux of photons detected
by the capsule are attenuated by the colon
contents in direct proportion to their distance
traveled in the colon contents, as some of the
photons are absorbed by the contrast agent Capsule in
Capsule In Standby Mode The x-ray Florescence flux detected by
the capsule's detectors depends monotonically on the
distance traveled in the colon contents mixed
with the contrast agent
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3D Capsule Technology vs. Optics
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3P Image Reconstruction
I Cap CapScanViewer 1 OA
STUDY - Nov. 2014 Erasmus MC University Hospital, Rotterdam ID-AB20 166585 Dr. Amer
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The data viewer
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Trial Clinical Data
Reconstruction (3D)
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Clinical Proof of Concept
"The Check-Cap novel imaging technology has been proven to be safe and feasible in our preliminary
clinical experience. It has successfully demonstrated imaging of prep-less human colon at ultra-low
dose compared to existing X-Ray based modalities. These results underpin the great potential of
Check-Cap imaging technology to become a very appealing tool for screening of pre-cancerous
polyps and colorectal cancer. Once efficacy is demonstrated, this clearly could make a fantastic
impact on screening and consequently on survival rates from this disease"
> Professor Nadir Arber,
Head of Integrated Cancer Prevention Center,
Tel Aviv Sourasky Medical Center, Israel
16
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Clinical proof of concept — Demonstrated Capabilities
- 3D imaging and representation (with no preparation)
- Reliable correlation between Compton Backscattering & X-Ray Florescence data, leading to clinical diameters values
- Automatic scan in motion triggered by predefined Activation Algorithm settings
- Colon segment position data with high accuracy
- All subjects reported smooth passage of capsule along the GI tract
- Acceptable surface imaging using ultra low dose accumulated during procedure
- Contrast material (oral) well tolerated by subjects
Quantitative colon surface detection and reconstruction along movement track
Results of studies suggest procedure is safe and uneventful
Results of first studies indicate that the current lower limit for visible feature size is 5-6 mm,
and —10mm polyps should be well within the imaging capability of the Check-Cap capsule.
We believe that improvements in hardware and algorithm should enable us to decrease the lower
limit of visible feature size to 2 mm, to provide high detection rate for 5 mm polyps & very high
detection rate for 10 mm polyps.
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Clinical Trial Data
Reconstruction Stages (fused CMT and XRF) - PP100204_P42-Scan01
Reconstruction Stages (fused CMT and XRF)
1. Preprocessed
3. Tubed 3D Reconstruction ellitill e 4. Path 3D reform 2. Fillet 3D Reconstruction
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Commercializable Tracking System
ELS III — Preliminary concept II
ego
Check-Cap 3D VIEWER Check-App - Patient Interface Receiver Unit including Position Tracking System
Disposable Patch on Patient's Back
Data
Download Capsule
in Colon
S
Receiver
I2F
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X-ray radiation control
mSv 16
14
12
10
8
6
4
2
0 Low Energy Low Radiation Exposure
Typical Organ Radiation Doses from Various Radiologic Studies
As reference. below is Data from the National Council on Radiation Protection
and Measurements. 'Ionizing Radiation Exposure of the Population of the
United States' March 3. 2009:
CT procedure Range for effective dose (msv)
Chest 4-18
Abdomen and pelvis 3-25
Virtual colonoscopy 5-15
Whole-body screening 5-15
Angrography. heart 5-32
Check-Cap Dental Lateral Chest Screening Adult Barium Enema
Imaging Radiography Radiography Mammography Abdominal CT
giiircap
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Clinical Data Generation
Motility Clinical Trial
Completed
Sample size - 60 subjects.
Site — Hamburg, Germany.
End points:
GI Motility information
for Activation Algorithm.
CE Pivotal trial
Sample size — 40-60 subjects.
Sites — 2 in Israel,
1 in the Netherlands, possibly 1 more.
End points:
Safety — Continued.
Feasibility — Continued.
Image resolution, Polyp Imaging First clinical cases of
the Imaging Capsule
Completed
•
FDA Pivotal trial Clinical
Proof of Concept
Completed
Sample size - 10 subjects.
Site — Tel Aviv Medical Center.
End points:
Safety — Demonstrated.
Feasibility — Demonstrated.
Sample size — 800 subjects. Sites — 10 in the US, 5 in Europe.
End points:
Safety — Continued. Feasibility — Continued. Image resolution, Polyp Imaging.
Sensitivity & Specificity in detection of polyps 10 mm & above, 6-9 mm:
A i. • I I
Compared to upuLai culuilustupy.
B. Possibly on specific segments:
Clinical surveillance.
Patients negative FOBT when additional info is needed.
Patients with incomplete colonoscopy.
Patients who cannot tolerate prep.
Patients with tortuous anatomy etc.
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Anticipated Development, Clinical & Financial Roadmap
Product
Development
C.E Trials &
European
Market
US Trials &
Regulations 2nd Gen Capsule Development
Inc. cost reduction and optimization Q3-Q4 2013 2014
Clinical Activation & Clinical Reconstruction algorithm op
(Design freeze @ O4/14)
TLV Hospital TLV & Erasmus (NL)
Clinical Proof of
Concept (5 par.)
Clinical AA
(10 par.) CE Pivotal
(50-60 par.)
US Protocol, site selection
and study design Request
for
FDA trial
initiation Post marketing
in Europe
(200 participants)
US Pivotal Trial
800 participants
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Reimbursement Aspects
Current Status
Covered for CRC screening*:
FOBT
Barium Enema
Flexible Sigmoidoscopy
Optical Colonoscopy
Not Covered for CRC Screening Yet:
CTC (Covered by some private insurers)
Stool DNA
Colon - Capsule Endoscopy:
Given's capsule received FDA clearance
Cost effectiveness models have been
designed for Europe
SB & ESO capsules are covered Our Strategy
• Collect information about expected
increase in screening adherence rate
(expected increase > 25%)
• Collect information about direct and
indirect Costs (expected decrease > 15%)
• Emphasized findings are limited to
intra-colon only (as opposed to CTC)
• Utilize capsule endoscopy value story
to demonstrate cost effectiveness
• Penetrate private insurers first as
differentiating service
• Work with ACG, AGA, ACS to achieve
reimbursement as quickly as possible
* All Medicare beneficiaries age 50 and older are covered;
However, when an individual is at high risk, there is no minimum age required to receive a screening colonoscopy or a barium
enema rendered in place of that screening colonoscopy.
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Reimbursement Aspects
ea Original Bride
Cost-effectiveness of capsule endoscopy in screening
for colorectal cancer
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... until colonoscopy adherence was decreased
to 83%, corresponding to a 17% difference in
adherence between the two strategies." Cost of treating CRC is
$14 billion annually in
the US and $99 billion
globally *
17% increase in adherence = capsule endoscopv more cost
effective than screening colonoscopy
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New Health Care Law
One benefit of the new health care law: Free colon
cancer tests
1 in 3 U.S. adults have never been screened but will now have
coverage for this and other preventive services
Published: November 07. 2013 10:30 AM
If you've put off getting screened for colon cancer because you
didn't have health insurance, there's good news. Under the new
health care law. colorectal screening tests are availble at no
cost to you.
About a third of U.S. adults ages 50 to 75 have never been
screened for colon cancer or are not up to date with screening
recommendations, according to a new survey from the Centers
for Disease Control and Prevention. And more than half of
those people had no health insurance. But through the new
health law, more Americans will have access to health
coverage and preventive services such as colorectal cancer
screening tests. During a colonoscopy. doctors can detect and
remove polyps (shown here in red).
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Bridge Financing
• Target raise: US$6m. Minimum: US$4m; Maximum: US$8m
• Terms highly attractive:
Discount 25 25%
Interest 5%
Warrant coverage 100% *
* Warrants for four years, at 120% of Offering price
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Intellectual Property
Check-Cap has received patent grants from the U.S. patent office as well as from China,
EPO, Japan, Hong Kong and India for the core technology — "Intra lumen polyp detection".
Our granted patents (2010-11) cover an ingestible capsule with a radiation source
and radiation detectors that, when used in conjunction with a radio opaque contrast
agent, is adapted to detect clinically relevant findings in the colon.
Utilizing X-ray florescence and Compton back scatterings, the capsule is able to
measure the distance between the capsule and the colon wall and to distinguish
between gas and clinically significant findings in the gastrointestinal tract.
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Company Leadership
Management Team
• Guy Neev - CEO since March 2008.
14 years of executive management experience.
Chief Executive Officer at Cappella. Business unit manager at Boston Scientific.
• Alex Ovadia - VP of since January 2013.
11 years of experience in managing complex projects at Philips Medical.
10 years of development management positions at Elbit Systems.
• Yoav Kimchy - Founder and CTO since Feb 2005.
12 years of executive experience Vice President at V-Target Ltd.
Director of cardiovascular research at Impulse Dynamics Ltd.
• Lior Torem - CFO Since Mar 2010.
Strong Chief Financial Officer experience in both private and public companies.
CFO at Tigo Energy Vice President of finance at Actelis Networks Inc
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Scientific Advisors
Dr. Douglas K. Rex - Professor of Medicine, Indiana University School of Medicine
rIllDr. Perry Pickhardt - Professor of Medicine, University of Wisconsin Medical School
Dr. Peter Fitzgerald - Professor of Cardiology, Stanford University Medical School
Dr. Nadir Arber — Professor of Medicine, Tel Aviv Medical Center
Steve Hanley - Former President, Covidien's Imaging Solutions unit
*Partial list
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Summary
• Target Bridge raise: US $6-8m
• Innovative disruptive technology with clear competitive advantage
• Very attractive market opportunity
• Feasibility & safety clinically proven
• Well defined regulatory pathway
• Core patents granted in all major territories
• Seasoned management & advisory teams
• Leading and committed investors Oos
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Thank You
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📷 Images in this document (31 detected; 6 largest described)
AI-generated factual descriptions of embedded images (llava:13b). These are searchable across the corpus.
[Image 1] The image appears to be a slide from a presentation comparing 3D capsule technology with optics. On the left side, there is a photograph of a medical device, which looks like a 3D capsule, possibly used for medical imaging or treatment. On the right side, there is a photograph of a human heart, which is likely being used to illustrate the application of optics in medical imaging. The slide include
[Image 2] The image appears to be a screenshot of a webpage or a digital document. The main content is a text that discusses the benefits of the new health care law, specifically mentioning that one benefit is free colon cancer screening tests for U.S. adults aged 50 to 75. The text also mentions that this benefit is available without a referral from a healthcare provider.
Below the text, there is a small
[Image 3] The image appears to be a slide from a presentation, possibly educational or informational in nature. The slide is titled "The importance of CRC screening" and includes a subtitle "Structural tests enable both Polyp detection and Cancer prevention." Below the title, there are three bullet points:
1. Stool Blood Tests
2. Highly Susceptible Early Stage
3. Testing Compliance Key
On the left side of
[Image 4] The image is a slide from a presentation, titled "Commercializable Tracking System." It features a diagram of a human torso with a stomach area highlighted, indicating the location of the tracking system. Below the diagram, there is a photograph of a person wearing a medical device, which appears to be a belt with a sensor or transmitter attached to it. The device is likely part of the tracking sy
[Image 5] The image appears to be a slide from a presentation, titled "A Patient Friendly Screening Method." The slide contains text and images related to medical imaging technology. On the left side, there is a photograph of a person's torso with a visible medical device, possibly an endoscope or a similar device, inserted into the mouth. The device is being held by a person's hand, which is visible in the
[Image 6] The image appears to be a slide from a presentation, specifically titled "Clinical Trial Data." The slide contains a section titled "Reconstruction Stage," which is followed by four sub-points. The first point mentions "Processed," the second point refers to "3D Reconstruction," the third point is "3D Reconstruction," and the fourth point is "3D Reconstruction."
Below the text, there are two imag