Infranostics Business PlanDetecting Breast Cancer using Thermal and Optical Data
Angela Ben Funke Mark Nancy
TREATING BREAST CANCER◦ EARLY STAGES
Survival Rate: 90% Cost per Patient: $15,000
◦ LATE STAGES Survival Rate: 20% Cost per Patient: $145,000
Design Problem and Brief
NCI Annual Report, Journal of the National Cancer Institute. Dec. 2, 2008
EARLY DETECTION!
SAVE LIVES
CUT COSTS
MEDICAL IMAGING PHYSIOLOGICAL SCANNING
Design Problem and Brief
•Resolution•Inexpensive (relatively)
•Painful•Radiation•Nonspecific
X-Ray Mammography
•Resolution•Sensitive•Specific
•Expensive!MRI
•Inexpensive•Accessible
•NonspecificUltrasound
Angiogenesis
Increased VasculatureThermal Signature
Near-Infrared Absorption
Sensors are small and cheap!
Use it at HomeUse Frequently
Chosen Idea Bra Mounted Detector Mesh
Control Unit/USB Interface
Data Acquisition + Analysis
Flexible Detector Mesh
Outer
Inner
Lycra (Spandex) Thermistors NIR Diodes
Test on phantom…
Control Unit / USB Interface
PIC18F4550 USB Microcontroller
http://www.create.ucsb.edu/~dano/CUI/#Sec3
Data Acquisition and Analysis
Temp. and NIR absorbance readings from Control UnitUser Commands via Software GUI
Data Analysis and Prediction Algorithms
Self-le
arn
ing
Alg
orith
m
Make Recommendations to Patient
Relay Information
to Physician
Prototype PlanFlexible Sensor Array Control Unit/USB Interface Software
http://liquidmind.files.wordpress.com/2008/08/nml-2.gif
Development Plan (short-term)
Jan JuneMayAprilMarFeb
EARLY 2009
Phase I Phase IIPhase III
Test Components
computer interface
Prototype I Prototype II
Test on phantom breast
Computer algorithm for network
Test/upload network
Acquire Data
Executive SummaryCOMPANY GOAL At-home system For High-risk patients Oncologists will prescribeBUSINESS PLAN < 1 year in initial development 1 to 3 years clinical testing FDA approval
◦ Class II device Research and Development ->most financially
demanding
The MarketHospitals, Physicians Clinics
Reached through oncology conferences
To convince future customers of the benefits
High-Risk Patients
(Those with abnormal BRCA1 or BRCA2 genes)
Reached through hospitals
Help them monitor breast health
Our purpose:
Target consumers:
Patients at risk of relapse
Reached through hospitals
Put people in charge of their own healthcare
Methods of contact:
Competing TechnologyEarly Detection Modalities
Thermography
Thermal Cameras
Single-Sensor Thermography
system
Optical
Drexel/University of Penn. NIR
Our business modelPhase I: Initial Testing
Phase II: Home Market
Phase III: Alternate Uses
Revenue • Device = $500/unit• Software• Service Contracts• Website Advertisements• Partnership with Large
Corporation (i.e. GE), Venture Capital Firms
• Broader range of applications for device = more unit sales
• Corporate endorsements (i.e. Victoria’s Secret)
Costs • Research & Development: Clinical Trials, Improving Hardware and Software, Alternate Applications
• Production Costs
•Marketing • Building support and credibility amongst the local medical community
• Website: Online forum/network
• Expand presence (i.e. oncology conferences)
• Marketing team approach local hospitals/clinicsLater: expand geographical
reach• Physicians recommend
device to patients
Additional Marketing:• Magazine advertisements• Advertising from Corporate
Sponsors
Distribution TestingStage I: Columbia U. Medical Community ⇨ IDEStage II: Clinics/Hospitals that use medical thermography
Patients purchase through physicians
• Patients purchase through physicians
• Purchase through website
Company Structure
Core business group + small research team
Core business group + research + marketing/sales + production + technical support teams
Expansion as needed
Phase I: Initial Testing
Phase II: Home Market
Phase III: Alternate Uses
Revenue
Costs
Marketing
Distribution
Company Structure
Phase IIIPhase IIPhase I
Development Plan (Long-Term)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019
Research & Development
Clinical Trials for Phase III
Obtain IDE
Obtain
510(K)
Initial Product Launch
WebsiteLaunch
Updated Software Release
Obtain Initial Funding (Small Companies, VC Firms)
Partner with Large Corporation (i.e. GE)Seek Additional Corporate
Sponsors/Endorsements (i.e. Victoria’s Secret)
Obtain IDE
Obtain
510(K)
New Product Launch
Clinical Trials for Phases I & II
Financials
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019$0.00
$2,000,000.00
$4,000,000.00
$6,000,000.00
$8,000,000.00
$10,000,000.00
$12,000,000.00
$14,000,000.00
Assets vs Liabilities
AssetsLiabilities
Year
Dollars Break Even Point
Summary
Goals
• Cut costs… Save lives• Early Detection!
Solution to Problem
• Inexpensive, Accessible, Sensitive device to supplement mammography• Monitoring Physiology… not Imaging Tumors• Combine Thermal and Optical
Prototype
• Flexible array of sensors• Will test rough prototypes on phantom
Business Plan
• Develop device and software prototypes• Academic Clinical Trials• Clinical Trials -> Giveaways -> Market -> Diversify
Elizabeth Hillman, Ph.D. Keith Yeager Brenda Chen
William Grace, M.D. Stephanie Bernik, M.D. Matthew Bucklin Jennifer Shen
Andreas Hielscher, Ph.D. Molly Flexman
All the fantastic students and professors joining us today!
Thank You!
? Questions