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