1. 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 PlatformDeveloper PlatformProduction 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 BiopsyMRICTPET time15 mins4-14 days45-60 mins 75-90 mins cost$$$$$$$$$$$ safetyExcellentPoorGoodPoorFair resolutionVery GoodGoodVery Good Good sizeExcellentGoodPoorFair 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 Laser Detector ANIMAL STUDIES DATA Pixel representation and 3-D distribution of optical signal for live anaesthetized mouse with two mammary tumors