PULSE IMAGING, Inc. Company Overview 11/12/08 A World Without Skin Biopsies NON-INVASIVE EARLY SKIN CANCER DIAGNOSTIC SYSTEM
Problem n 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 n Short Pulse Laser Based Optical Tomography System –world’s first fully software-controlled, desktop- size –ultra-short pulse laser system providing high spatial and temporal resolution –displays soft tissue contrast at cellular level n Preliminary proof of concept demonstrated in animal model n Provisional Patent (April 2006); Full patent filed (March 2007)
Solution n 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 n Leverages existing Florida Tech’s human capital and infrastructure n Development partnership with Raydiance Inc. n Intellectual Property and Business Transactional capabilities through FIT Tech Transfer Office n Design and prototyping capabilities Developer PlatformProduction VersionConcept Platform Volume Production
Paradigm Shifts n Discovery at university n Preliminary technology development completed n Design factors leading to several generation systems n Clinical trials for next generation system n Regulatory approval from FDA n Manufacture and ship systems to customers
Market and Competition n Market size and Growth rate –More than 10 million skin biopsies are performed annually in US- by far the most common biopsy –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 n Competitive Technologies –Biopsy vs Imaging Diagnostics –Biopsy vs Imaging Diagnostics such as MRI –Optical Coherence Tomography (OCT)
Optical Tomography BiopsyMRICTPET time15 mins4-14 days mins mins cost$$$$$$$$$$$ safetyExcellentPoorGoodPoorFair resolu tion Very GoodGoodVery Good Good sizeExcellentGoodPoorFair Competition
Sales and Distribution Target Distribution Partners or Customers Shands Healthcare Orlando Regional Healthcare Kaiser Permanente Mayo Clinic Sloan Kettering Research Institutes Research Hospital Radiologists PULSE IMAGING sales in year systems $300,000 per unit 40% per year growth
Management Team n CEO - TBA n Dr. Kunal Mitra - CTO; Responsible for overall product design and development n Robert Merrill - Florida Tech Tech Transfer Office n n Ari Schuler - Raydiance Inc. (A DFJ Company); Commercialization partner n n Dr. Carolyn Fausnaugh - Florida Tech School of Business; Responsible for market research n n Dr. Grace – Florida Tech Biology Department; Responsible for animal studies n n Regulatory Consultant - TBA
Financial Forecast Revenue $ 1.75 million $ 8.5 million $16.5million$32million $60 million Margin-$500k $ million $6.5 million $ 13 million $24 million Profit-$50k$287k$975k $2.6 million $6 million Headcount
Use of Proceeds n Funding –Initial investment - $1 million –First year (2009) n Uses: –Prototype development for animal studies –Regulatory data development cost –Completion of clinical trials through partnership –Working investment capital
Summary n “A World Without Skin Biopsies” n Conducting animal studies for safety and efficacy n Product development partnership in place n Patent application filed (2007) n 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)