Detecting Breast Cancer using Thermal and Optical Data AngelaBenFunkeMarkNancy

NCI Annual Report, Journal of the National Cancer Institute. Dec. 2, 2008

Resolution Inexpensive (relatively) Painful Radiation Nonspecific X-Ray Mammography Resolution Sensitive Specific Expensive! MRI Inexpensive Accessible Nonspecific Ultrasound Thermal Signature Near-Infrared Absorption Sensors are small and cheap! Use it at Home Use Frequently

Bra Mounted Detector Mesh Control Unit/USB Interface Data Acquisition + Analysis

Outer Inner Lycra (Spandex) Thermistors NIR Diodes Test on phantom…

PIC18F4550 USB Microcontroller

Temp. and NIR absorbance readings from Control Unit User Commands via Software GUI Data Analysis and Prediction Algorithms Self-learning Algorithm Make Recommendations to Patient Relay Information to Physician to Physician Relay Information to Physician to Physician

Flexible Sensor Array Control Unit/USB Interface SoftwareSoftware

EARLY 2009 Phase I Phase II Phase III Test Components computer interface Prototype IPrototype II Test on phantom breast Computer algorithm for network Test/upload network Acquire Data

Hospitals, 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:

Early Detection Modalities Thermography Thermal Cameras Single-Sensor Thermography system Optical Drexel/University of Penn. NIR

Phase 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. Victorias 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/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 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 I: Initial Testing Phase II: Home Market Phase II: Home Market Phase III: Alternate Uses Phase III: Alternate Uses Revenue Costs Marketing Distribution Company Structure Company Structure

Phase III Phase II Phase I Research & Development Clinical Trials for Phase III Obtain IDE Obtain 510(K) Initial Product Launch Website Launch Website Launch Updated Software Release Obtain Initial Funding (Small Companies, VC Firms) Partner with Large Corporation (i.e. GE) Seek Additional Corporate Sponsors/Endorsements (i.e. Victorias Secret) Obtain IDE Obtain 510(K) New Product Launch Clinical Trials for Phases I & II

Break Even Point

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!

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