NON-INVASIVE EARLY SKIN CANCER DIAGNOSTIC SYSTEM PULSE IMAGING, Inc. Company Overview A World Without Skin Biopsies 11/12/08 Problem What if there is a skin cancer diagnostic technique that is painless, more accurate, less expensive, and quick? – Early cancer detection critical – Current testing can be time-consuming, expensive, and uncomfortable – Currently dermatologists do multiple biopsies to detect a single case of melanoma – Lack of accurate instruments Background Short Pulse Laser Based Optical Tomography System – world’s first fully software-controlled, desktopsize – ultra-short pulse laser system providing high spatial and temporal resolution – displays soft tissue contrast at cellular level Preliminary proof of concept demonstrated in animal model Provisional Patent (April 2006); Full patent filed (March 2007) 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 Resources and Capabilities Leverages existing Florida Tech’s human capital and infrastructure Development partnership with Raydiance Inc. Intellectual Property and Business Transactional capabilities through FIT Tech Transfer Office Design and prototyping capabilities Volume Production Concept Platform Developer Platform Production Version Paradigm Shifts Discovery at university Preliminary technology development completed Design factors leading to several generation systems Clinical trials for next generation system Regulatory approval from FDA Manufacture and ship systems to customers Market and Competition Market size and Growth rate – More than 10 million skin biopsies are performed annually in US - by far the most common biopsy – Medical imaging market worth about $15B in 2006; app. 50% of the revenues garnered by the core modalities MRI, CT, x-ray, ultrasound – App. double digit market growth over the next five years – Medical expenditure for melanoma is $2.5B Competitive Technologies – Biopsy vs Imaging Diagnostics such as MRI – Optical Coherence Tomography (OCT) Competition time cost Optical Biopsy MRI CT PET Tomography 15 mins 4-14 45-60 45-60 75-90 days mins mins mins $ $$ $$$ $$ $$$ safety Excellent Poor Good Poor Fair resolu tion size Very Good Good Excellent Good Very Very Good Good Good Poor Fair Fair Sales and Distribution • Research Institutes • Research Hospital • Radiologists Target Distribution Partners or Customers Shands Healthcare Orlando Regional Healthcare Kaiser Permanente • PULSE IMAGING sales in year 5 Mayo Clinic • 200 systems • $300,000 per unit Sloan Kettering • 40% per year growth Management Team CEO - TBA Dr. Kunal Mitra - CTO; Responsible for overall product design and development Robert Merrill - Florida Tech Tech Transfer Office Ari Schuler - Raydiance Inc. (A DFJ Company); Commercialization partner Dr. Carolyn Fausnaugh - Florida Tech School of Business; Responsible for market research Dr. Grace – Florida Tech Biology Department; Responsible for animal studies Regulatory Consultant - TBA Financial Forecast 2009 2010 Revenue $ 1.75 million $ 8.5 million Margin Profit Head count 2011 2012 2013 $16.5 million -$500k $ 2.875 $6.5 million million -$50k $287k $975k $32 million $ 13 million $2.6 million 18 $60 million 3 6 9 $24 million $6 million 30 Use of Proceeds Funding – Initial investment - $1 million – First year (2009) Uses: – Prototype development for animal studies – Regulatory data development cost – Completion of clinical trials through partnership – Working investment capital Summary “A World Without Skin Biopsies” Conducting animal studies for safety and efficacy Product development partnership in place Patent application filed (2007) Need for initial investment of $1 million Kunal Mitra, Ph.D. Professor Mechanical and Aerospace Engineering Department Director- Biomedical Engineering Program Florida Institute of Technology Phone: (321) 674 7131 Email: kmitra@fit.edu