ULTRASHORT PULSED LASER BASED NON-INVASIVE EARLY CANCER DIAGNOSTIC SYSTEM Kunal Mitra Professor, Mechanical and Aerospace Engineering Department Director- Biomedical Engineering Program Florida Institute of Technology, Melbourne, Florida 32901 ANIMAL STUDIES DATA INTRODUCTION 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 Laser Detector 1 (a.u.) 0.5 ity Reflected Intens 600 500 400 0 300 200 100 0 800 600 10 20 De 30 tect or P 40 osi 50 tion (mm ) Preliminary proof of concept demonstrated in animal model Provisional Patent (April 2006); Full patent filed (March 2007) Pixel representation and 3-D distribution of optical signal for live anaesthetized mouse with two mammary tumors 400 200 0 ps) e( m Ti MARKET PROBLEM Medical imaging market worth about $15B in 2006; app. 50% of the revenues garnered by the core 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 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 COMPETITION SOLUTION 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 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 SUMMARY “A World Without Skin Biopsies” High sensitivity and specificity system expected to yield Volume Production Concept Platform Developer Platform physiological and morphological information about breast tumor with a safer, simpler, and cheaper manner compared to existing imaging modalities Production Version Conducting animal studies for safety and efficacy Product development partnership in place Completion of clinical trials through partnership Patent application filed (2007)