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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

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non invasive early skin cancer diagnostic system

NON-INVASIVE EARLY SKIN CANCER DIAGNOSTIC SYSTEM

PULSE IMAGING, Inc.

Company Overview

A World Without Skin Biopsies

11/12/08

problem
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
Background

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

Preliminary proof of concept demonstrated in animal model

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

solution
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
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
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 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)
sales and distribution
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 5
    • 200 systems
    • $300,000 per unit
    • 40% per year growth
management team
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
use of proceeds
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
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.

ProfessorMechanical and Aerospace Engineering DepartmentDirector- Biomedical Engineering ProgramFlorida Institute of Technology

Phone: (321) 674 7131

Email: kmitra@fit.edu