Detecting Breast Cancer using Thermal and Optical Data
Angela
Ben
Funke
Mark
Nancy
 Survival Rate: 90%
 Cost per Patient: $15,000
 Survival Rate: 20%
 Cost per Patient: $145,000
NCI Annual Report, Journal of the National Cancer Institute. Dec. 2, 2008
X-Ray Mammography
•Resolution
•Inexpensive
(relatively)
Ultrasound
•Inexpensive
•Accessible
MRI
•Resolution
•Sensitive
•Specific
•Painful
•Radiation
•Nonspecific
Thermal Signature
•Nonspecific
Near-Infrared
Absorption
Sensors are small and cheap!
•Expensive!
Use it at Home
Use Frequently
Bra Mounted Detector Mesh
Control Unit/USB Interface
Data Acquisition + Analysis
Inner
Outer
Lycra (Spandex)
Thermistors
NIR Diodes
Test on phantom…
PIC18F4550 USB
Microcontroller
http://www.create.ucsb.edu/~dano/CUI/#Sec3
User
Commands via
Software GUI
Data Analysis
and Prediction
Algorithms
Make
Recommendations
to Patient
Self-learning
Algorithm
Temp. and NIR
absorbance
readings from
Control Unit
Relay Information
to Physician
Flexible Sensor Array
Control Unit/USB Interface
Software
http://liquidmind.files.wordpress.com/2008/08/nml-
EARLY 2009
Prototype I
Prototype II
Test/upload network
computer interface
Computer algorithm
for network
Test Components
Acquire Data
Phase I
Test on phantom breast
Phase II
Phase III
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At-home system
For High-risk patients
Oncologists will prescribe
< 1 year in initial development
1 to 3 years clinical testing
FDA approval
◦ Class II device
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Research and Development ->most financially
demanding
Target
consumers:
Hospitals,
Physicians Clinics
High-Risk
Patients
Patients at risk of
relapse
(Those with
abnormal BRCA1
or BRCA2 genes)
Methods of
contact:
Reached through
oncology
conferences
Our purpose: To convince
future customers
of the benefits
Reached through
hospitals
Reached through
hospitals
Help them
monitor breast
health
Put people in
charge of their
own healthcare
Early Detection
Modalities
Thermography
Thermal Cameras
Single-Sensor
Thermography
system
Optical
Drexel/University
of Penn. NIR
Phase I:
Initial Testing
Revenue
Phase II:
Home Market
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Device = $500/unit
Software
Service Contracts
Website Advertisements
Partnership with Large
Corporation (i.e. GE), Venture
Capital Firms
Phase III:
Alternate Uses
• Broader range of applications
for device = more unit sales
• Corporate endorsements (i.e.
Victoria’s Secret)
Costs
Costs
• Research & Development: Clinical Trials, Improving Hardware and Software, Alternate Applications
• Production Costs
•Marketing
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/clinics
Later: expand geographical
reach
• Physicians recommend device
to patients
Additional Marketing:
• Magazine advertisements
• Advertising from Corporate
Sponsors
Distribution
Testing
Stage I:
Columbia U. Medical
Community ⇨ IDE
Stage II: Clinics/Hospitals that
use medical thermography
Patients purchase through
physicians
• Patients purchase through
physicians
• Purchase through website
Company
Company
Structure
Structure
Core business group + small
research team
Core business group + research
+ marketing/sales + production
+ technical support teams
Expansion as needed
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
Research & Development
Clinical Trials for Phase III
Clinical Trials for Phases I & II
Obtain
IDE
Obtain
510(K)
Obtain Initial Funding (Small
Companies, VC Firms)
Website
Launch
Phase I
Initial
Product
Launch
Obtain
IDE
Partner with Large Corporation (i.e. GE)
Obtain
510(K)
Seek Additional Corporate
Sponsors/Endorsements (i.e. Victoria’s
Secret)
New
Product
Launch
Updated
Software
Release
Phase II
Phase III
Assets vs Liabilities
$14,000,000.00
$12,000,000.00
$10,000,000.00
Dollars
$8,000,000.00
Break Even Point
Assets
$6,000,000.00
Liabilities
$4,000,000.00
$2,000,000.00
$0.00
2009
2010
2011
2012
2013
2014
Year
2015
2016
2017
2018
2019
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
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Elizabeth Hillman, Ph.D.
Keith Yeager
Brenda Chen
William Grace, M.D.
Stephanie Bernik, M.D.
Matthew Bucklin
Jennifer Shen
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Andreas Hielscher, Ph.D.
Molly Flexman
All the fantastic students and
professors joining us today!