Kunal Mitra Professor, Mechanical and Aerospace Engineering Department Director- Biomedical...

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Kunal Mitra Professor, Mechanical and Aerospace Engineering Department Director- Biomedical Engineering Program Florida Institute of Technology, Melbourne, Florida 32901 INTRODUCTION MARKET PROBLEM SOLUTION ULTRASHORT PULSED LASER BASED NON-INVASIVE EARLY CANCER DIAGNOSTIC SYSTEM Short Pulse Laser Based Optical Tomography System - world’s first fully software-controlled, desktop-size produced by Raydiance Inc. (a DFJ Company) - ultra-short pulse laser system providing high spatial and temporal resolution - can provide real-time complete 3-D view of the scanned area - displays soft tissue contrast at cellular level based on functional parameters (e.g. blood volume and oxygenation) as well as structural differences Preliminary proof of concept demonstrated in animal model Provisional Patent (April 2006); Full patent filed (March 2007) What if there is a skin cancer (melanoma) and breast cancer diagnostic technique that is painless, more accurate, less expensive, and quick? - Early cancer detection critical - Current testing can be time-consuming, expensive, invasive, and uncomfortable - Currently dermatologists do multiple biopsies to detect a single case of melanoma - Mammography screening can detect abnormal tissue growths in breast but it cannot distinguish between benign and malignant tumors and is less effective for younger women with dense fibrous breasts Non-invasive Real-time Cancer Diagnostics - Less expensive - Eliminate unnecessary costly biopsies - Comfortable - Transportable compared to other imaging techniques - High sensitivity, specificity, and resolution - Fast image turnaround for patients - Reduce the probability of missing lesions especially in the margins compared to biopsies Volume Production Concept Platform Developer Platform Production Version Medical imaging market worth about $15B in 2006; app. 50% of the revenues garnered by the core modalities MRI, CT, x-ray, ultrasound US markets for breast cancer devices to grow from $1.2B in 2006 to $2.7B by 2012 Breast biopsy devices market valued at over $300M in 2006; double digit growth over the next five years More than 10 million skin biopsies are performed annually in US - by far the most common biopsy Optical Tomograph y Biopsy MRI CT PET time 15 mins 4-14 days 45-60 mins 45-60 mins 75-90 mins cost $ $$ $$$ $$ $$$ safety Excellent Poor Good Poor Fair resolutio n Very Good Good Very Good Very Good Good size Excellent Good Poor Fair Fair COMPETITION “A World Without Skin Biopsies” High sensitivity and specificity system expected to yield physiological and morphological information about breast tumor with a safer, simpler, and cheaper manner compared to existing imaging modalities Conducting animal studies for safety and efficacy Product development partnership in place Completion of clinical trials through partnership Patent application filed (2007) SUMMARY 0. 5 0 1 Lase r Detector 0 100 200 300 400 500 600 10 20 30 40 50 0 200 400 600 800 R e fl ec t e d I n t en s i t y ( a. u . ) ANIMAL STUDIES DATA Pixel representation and 3-D distribution of optical signal for live anaesthetized mouse with two mammary tumors

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Page 1: Kunal Mitra Professor, Mechanical and Aerospace Engineering Department Director- Biomedical Engineering Program Florida Institute of Technology, Melbourne,

Kunal MitraProfessor, Mechanical and Aerospace Engineering Department

Director- Biomedical Engineering ProgramFlorida Institute of Technology, Melbourne, Florida 32901

INTRODUCTION

MARKETPROBLEM

SOLUTION

ULTRASHORT PULSED LASER BASED NON-INVASIVE EARLY CANCER DIAGNOSTIC SYSTEM

Short Pulse Laser Based Optical Tomography System - world’s first fully software-controlled, desktop-size produced by Raydiance Inc. (a DFJ Company) - ultra-short pulse laser system providing high spatial and temporal resolution - can provide real-time complete 3-D view of the scanned area - displays soft tissue contrast at cellular level based on functional parameters (e.g. blood volume and oxygenation) as well as structural differences

· Preliminary proof of concept demonstrated in animal model

· Provisional Patent (April 2006); Full patent filed (March 2007)

What if there is a skin cancer (melanoma) and breast cancer diagnostic technique that is painless, more accurate, less expensive, and quick?

- Early cancer detection critical - Current testing can be time-consuming, expensive, invasive, and uncomfortable - Currently dermatologists do multiple biopsies to detect a single case of melanoma - Mammography screening can detect abnormal tissue growths in breast but it cannot distinguish between benign and malignant tumors and is less effective for younger women with dense fibrous breasts

Non-invasive Real-time Cancer Diagnostics - Less expensive - Eliminate unnecessary costly biopsies - Comfortable - Transportable compared to other imaging techniques - High sensitivity, specificity, and resolution - Fast image turnaround for patients - Reduce the probability of missing lesions especially in the margins compared to biopsies

VolumeProduction

Concept Platform Developer Platform Production Version

Medical imaging market worth about $15B in 2006; app. 50% of the revenues garnered by the core

modalities MRI, CT, x-ray, ultrasound

US markets for breast cancer devices to grow from $1.2B in 2006 to $2.7B by 2012

Breast biopsy devices market valued at over $300M in 2006; double digit growth over the next five years

More than 10 million skin biopsies are performed annually in US - by far the most common biopsy

Optical Tomography

Biopsy MRI CT PET

time 15 mins 4-14 days 45-60 mins

45-60 mins

75-90 mins

cost $ $$ $$$ $$ $$$

safety Excellent Poor Good Poor Fair

resolution Very Good Good Very Good Very Good Good

size Excellent Good Poor Fair Fair

COMPETITION

“A World Without Skin Biopsies”

High sensitivity and specificity system expected to yield

physiological and morphological information about breast tumor

with a safer, simpler, and cheaper manner compared to existing

imaging modalities

Conducting animal studies for safety and efficacy

Product development partnership in place

Completion of clinical trials through partnership

Patent application filed (2007)

SUMMARY

0.5

0

1

LaserDetector

0

100

200

300

400

500

600

1020

3040

50 0

200

400

600

800

Ref

lect

ed I

nten

sity

(a.

u.)

ANIMAL STUDIES DATA

Pixel representation and 3-D distribution of optical signal for live anaesthetized

mouse with two mammary tumors