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Resolution Bioimaging���
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“Improving Clinical Trials, ���One Image at a Time”
Mark Punyanitya, Co-Founder & CEO Bio & Health Tech eLab Demo Day
2013-05-16 1
BACKGROUND
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• Imaging allows for earlier detection of change/effect • Enhanced ability to make critical “go/no-go” decisions • Regulatory agencies are increasingly accepting imaging�
1Cutting Edge Information (Clinical Operations: Benchmarking Per-Patient Costs, Staffing and Adaptive Design)
Recruit Subjects
Administer Tests
Collect Results
File Study Report
THERAPEUTIC AREA COST PER PATIENT1
Cardiovascular $34k
Central Nervous System $42k
Obesity/Diabetes $50k
Oncology $73k
Clinical Development is Expensive and Difficult:
PROBLEM
3
Recruit Subjects
Administer Tests
Imaging Process
Collect Results
File Study Report
Technologist Training
Image AcquisiDon Data Transfer Quality
Control
“Consistent Image Quality is Difficult to Standardize”
31% ERROR RATE among local imaging services1 1Chesbrough, RSNA, 2009
PROBLEM
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Recruit Subjects
Administer Tests
Imaging Process
Collect Results
File Study Report
Technologist Training
Image AcquisiDon Data Transfer Quality
Control
“Consistent Image Quality is Difficult to Standardize”
31% ERROR RATE among local imaging services1 1Chesbrough, RSNA, 2009
REJECTED SCANS!
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Tissue Cut-‐off Wrapping
MoDon ArDfact Vessel ArDfact
OUR SOLUTION
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• “VIRTUAL IMAGING LAB”: – Training & Testing – Compliance & Metrics – Quality Control
OUR SOLUTION
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• “VIRTUAL IMAGING LAB”: – Training & Testing – Compliance & Metrics – Quality Control
Imagery AnimaDon, Video, & Virtual Reality
Automated Algorithms
Technologist Training
Image AcquisiDon Data Transfer Quality
Control
OUR SOLUTION
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EXAMPLE: 10% ReducDon, 1000 Subject Study 100 Subjects * $50k (avg per Subject) = $5M
• “VIRTUAL IMAGING LAB”: – Training & Testing – Compliance & Metrics – Quality Control
IMAGE READING CENTER, INC.
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CLINICAL TRIAL EXPERIENCE: TherapeuDc
Area Trials Phase Countries Sites Subjects Images
MyostaDn 3 I 3 5 300 900
Growth Hormone
3 II 25 50 350 1750
Osteoporosis 5 II US Only 15 800 6400
HIV/AIDS 1 III 7 7 350 1050
Diabetes 4 III 10 35 750 3000
Lipodystrophy 3 III 25 25 850 2550
Obesity 4 III US Only 50 800 2400
HIV/AIDS 2 NIH US Only 18 5000 15000
Experience with over 10,000 paDents
THE MARKET
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Imaging with VIL (Share of Market)
Medical Imaging (Total Addressable Market)
$1.7 B 2012
$2.4 B 2017
2marketsandmarkets.com
INCREASED USE OF IMAGING1: CT: 3x over 15 years (7.8% annual) MRI: 4x over 15 years (10% annual)
1JAMA, June 12, 2012
$130 M
Clinical Trial Imaging (Serviceable Addressable Market)
$1.3 B 2016
$600 M 2010
THE COMPETITION
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RESOLUTION BIOIMAGING
AG Mednet mediri Synarc Bioclinica ICON Parexel
Company Size 11-‐50 11-‐50 201-‐500 501-‐1000 10,000+ 10,000+
Imaging CRO ✔ ✔ ✔ ✔ ✔ ✔
Soeware/Plagorm Development ✔ ✔ ✔
Automated QC ✔ ✔ ✔
Online Training ✔ ✔ ✔ ✔ ✔
Virtual Environment ✔
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YEAR 1 YEAR 2 YEAR 3
Clients* 6 22 38
Revenue $600k $2.2M $3.8M
COGS $60k $220k $380k
Gross Margin 90% 90% 90%
Expenses $881k $843k $928k
Net Income ($341k) $1.14M $2.49M
FINANCIALS
-‐$0.5
$0.0
$0.5
$1.0
$1.5
$2.0
$2.5
$3.0
$3.5
Millions
COGS Op Expenses Revenues Cash Flow
*1 addiDonal client per quarter projected
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• Regulatory Consultants (Imaging Focus) ���
• Connections to NIH, FDA & EMA – Subcontractor – Preferred Provider/Vendor – Industry Standard���
• Connections to CRO & Pharma Sponsors – Customers – Partners – Investors (Venture Arms)
STRATEGIC NEEDS
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Looking to Raise: $1 M Runway: 9 months Milestones: 1. Prototype: 2. Beta TesDng: 3. Market Launch:
$250k $250k $500k
Prototype Q3 2013
Beta Test Q4 2013
Market Release Q1 2014
INVESTMENT
OUR TEAM
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Mark Punyanitya, Founder & CEO Image Reading Center, Inc. (Est. 2006) Columbia University-Imaging Core Laboratory
Rodney Agayan, PhD, CTO Columbia University-Biomedical Engineer (Imaging & Optics) University of Michigan-Applied Physics & Electrical Engineering
Pieter Achterberg, Scientific Advisor
ClinTrimag Consultancy, Clinical Trial Imaging Project Manager BioClinica Inc, Senior Project Manager (Previous 10 years)
Sherry Reuter, Business Development Consultant
Sherry Reuter & Associates, LLC, President George Washington University, Adjunct Prof of Clinical Research 10 Years of Experience as Clinical Scientist/Senior CRA
Resolution Bioimaging���
���
������
“Improving Clinical Trials, ���One Image at a Time”
Mark Punyanitya, Co-Founder & CEO [email protected]
646-736-2487
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